Graves DiseaseNCT06309316
The Impact of Person Centred Care (PCC) in Grave's Disease
A study testing Person-centred care (PCC) in people with Graves Disease, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
Mental fatigue (MF) is prevalent after Graves' disease (GD), which is the most common form of hyperthyroidism. We have reported that 38% of patients, compared to 11% of control subjects, suffer from MF more than 1 year after successfully reversing of their hyperthyroidism and that MF is an entity of its own, separated… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Graves Disease
- What is being tested?
- Person-centred care (PCC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteSweden
- Study dates
- 25 Mar 2024to 30 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- First time Graves' diseases with elevated FT4 and/or FT3 and positive TSH receptor antibody (TRAb)
Who cannot join
- Patients that cannot attend to the protocol
- Patients with moderate-severe/ severe Graves' eye disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Agneta Lindo
Gothenburg, 413 45
Agneta Lindo, +4676-6185481, agneta.lindo@vgregion.se
Helena Filipsson Nyström
About this study
Official title: The Impact of Person Centred Care (PCC) on Mental Outcome and Work Ability in Graves' Disease - the GRAves CarE (GRACE) PCC Project
Mental fatigue (MF) is prevalent after Graves' disease (GD), which is the most common form of hyperthyroidism. We have reported that 38% of patients, compared to 11% of control subjects, suffer from MF more than 1 year after successfully reversing of their hyperthyroidism and that MF is an entity of its own, separated from MF combined with anxiety or depression. The brain pathophysiology is unknown and there is no medical treatment, which requires patients to simply adapt to the situation. In the new national guideline for hyperthyroidism (Jan 2023), rehabilitation is recommended, but currently rarely offered to these patients. The problem is significant for patients, as illustrated by frequent media appeals. In this project, we hypothesise that person-centred care (PCC), which promotes positive coping strategies and increases self-efficacy by engaging patients as partners in their own care, improves MF, reduces sick leave, and lowers the recurrence rate of GD. In two work packages (WP), we will:
WP1 Evaluate the effect of PCC eHealth intervention (telephone and digital platform) as an add-on to usual care vs usual care alone in a randomized controlled trial (RCT) of 220 patients on self-efficacy, days of sick-leave (composite score as primary outcome), MF, recurrence rate of disease, coping strategies, perceived stress, quality of life (QoL) and personality.
Read more
WP2 Investigate the cost-effectiveness of the intervention
Patients with GD have impaired long-term QoL. PCC could improve long-term outcomes of this autoimmune disease and may apply to other patient groups. This is in line with the societal aim to reduce mental illness.
- Conditions
- Graves Disease
- Being tested
- Person-centred care (PCC)
- Keywords
- Person Centred Care, Mental fatigue, cost-effectiveness, self-efficacy, eHealth
- Medical subject headings
- Graves Disease, Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Person-centred care (PCC)Behavioural
In addition to usual care, patients will receive PCC through physical visits, telephone and through a web-based platform for 15-months. Primary outcome is after 3 month (we expect the need of support is largest in the beginning) but the intervention will continue for the period of care 12-18 months, increasing transferability to regular care.
| Study group | Role | What they receive |
|---|---|---|
| Person-centred care (PCC) | Experimental | Intervention PCC:
In addition to usual care, patients will receive PCC through physical visits, telephone and through a web-based platform for 15-months. The primary outcome is after 3 month (we expect the need of support is largest in the beginning) but the the intervention will continue for the period of care 12-18 months, increasing transferability to regular care.
Usual care:
Patients with GD have regular meetings with the endocrinologist during the treatment with anti-thyroid drugs and leave blod sampels. Many patients are on sick leave in the beginning of treatment. If questions occur between meetings, patients contact a service centre and get feed-back from the nurse or physician on duty at Sahlgrenska University Hospital in Gothenburg. Receives: Behavioral: Person-centred care (PCC) |
| Usual care | No intervention | Usual care: Patients with GD have regular meetings with the endocrinologist during the treatment with anti-thyroid drugs and leave blod sampels. Many patients are on sick leave in the beginning of treatment. If questions occur between meetings, patients contact a service centre and get feed-back from the nurse or physician on duty at Sahlgrenska University Hospital in Gothenburg. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite score of changes
A patient is classified as improved, deteriorated or unchanged:
A patient is classified as improved if:
at 3 months increased general self-efficacy by ≥ 5 units and reduced sick leave percentage (or unchanged if no sick-leave at baseline) at 3 months follow-up
A patient is classified as deteriorated if:
at 3 months reduced general self-efficacy by ≥ 5 units or increased sick-leave percentage (or unchanged if on full-time sick leave at inclusion) Those who have neither improved or deteriorated are classified as unchanged
Measured: Change from baseline examined at 3 months follow-up.
Secondary outcomes (69)
General Self-Efficacy Scale (GSE)
Evaluated by the validated questionnaire General Self-Efficacy. Scores are compared between the intervention and the control group. The total score ranges between 10 and 40, with a higher score indicating more self-efficacy.
Measured: Change from baseline examined at 6 weeks follow-up.
General Self-Efficacy Scale (GSE)
Evaluated by the validated questionnaire General Self-Efficacy. Scores are compared between the intervention and the control group. The total score ranges between 10 and 40, with a higher score indicating more self-efficacy.
Measured: Change from baseline examined at 3 months follow-up.
General Self-Efficacy Scale (GSE)
Evaluated by the validated questionnaire General Self-Efficacy. Scores are compared between the intervention and the control group. The total score ranges between 10 and 40, with a higher score indicating more self-efficacy.
Measured: Change from baseline examined at 6 months follow-up.
General Self-Efficacy Scale (GSE)
Evaluated by the validated questionnaire General Self-Efficacy. Scores are compared between the intervention and the control group. The total score ranges between 10 and 40, with a higher score indicating more self-efficacy.
Measured: Change from baseline examined at 15 months follow-up.
Days of sick-leave
Evaluated sick leave days between the intervention and the control group.
Measured: Change from baseline examined at 6 weeks follow-up.
Days of sick-leave
Evaluated sick leave days between the intervention and the control group.
Measured: Change from baseline examined at 3 months follow-up.
Days of sick-leave
Evaluated sick leave days between the intervention and the control group.
Measured: Change from baseline examined at 6 months follow-up.
Days of sick-leave
Evaluated sick leave days between the intervention and the control group.
Measured: Change from baseline examined at 15 months follow-up.
Mental fatigue score
Scores at the Mental Fatigue Scale are compared between the intervention and the control group. Scores is between 0-42 and higher scores mean more brain fatigue.
Measured: Change from baseline examined at 6 weeks follow-up.
Mental fatigue score
Scores at the Mental Fatigue Scale are compared between the intervention and the control group. Scores is between 0-42 and higher scores mean more brain fatigue.
Measured: Change from baseline examined at 3 months follow-up.
Mental fatigue score
Scores at the Mental Fatigue Scale are compared between the intervention and the control group. Scores is between 0-42 and higher scores mean more brain fatigue.
Measured: Change from baseline examined at 6 months follow-up.
Mental fatigue score
Scores at the Mental Fatigue Scale are compared between the intervention and the control group. Scores is between 0-42 and higher scores mean more brain fatigue.
Measured: Change from baseline examined at 15 months follow-up.
Coping Orientations to Problems Experienced (Brief cope)
Evaluated by the validated questionnaire Brief cope. The Brief COPE is a shorter version of the COPE Inventory composed of 28-items rated on a 4-point ordinal scale that measure 14 subscales of coping style (2-items each). The overall mean is calculated with more than three being worse outcome. Coping strategies are compared between the intervention and the control group.
Measured: Change from baseline examined at 6 weeks follow-up.
Coping Orientations to Problems Experienced (Brief cope)
Evaluated by the validated questionnaire Brief cope. The Brief COPE is a shorter version of the COPE Inventory composed of 28-items rated on a 4-point ordinal scale that measure 14 subscales of coping style (2-items each). The overall mean is calculated with more than three being worse outcome. Coping strategies are compared between the intervention and the control group.
Measured: Change from baseline examined at 3 months follow-up.
Coping Orientations to Problems Experienced (Brief cope)
Evaluated by the validated questionnaire Brief cope. The Brief COPE is a shorter version of the COPE Inventory composed of 28-items rated on a 4-point ordinal scale that measure 14 subscales of coping style (2-items each). The overall mean is calculated with more than three being worse outcome. Coping strategies are compared between the intervention and the control group.
Measured: Change from baseline examined at 6 months follow-up.
Coping Orientations to Problems Experienced (Brief cope)
Evaluated by the validated questionnaire Brief cope. The Brief COPE is a shorter version of the COPE Inventory composed of 28-items rated on a 4-point ordinal scale that measure 14 subscales of coping style (2-items each). The overall mean is calculated with more than three being worse outcome. Coping strategies are compared between the intervention and the control group.
Measured: Change from baseline examined at 15 months follow-up.
Perceived Stress Scale (PSS-14)
Evaluated by the validated questionnaire Perceived Stress Scale (PSS-14). Scores are compared between the intervention and the control group. The total score ranges between 0 and 56, with a higher score indicate more symptoms of stress.
Measured: Change from baseline examined at 6 weeks follow-up.
Perceived Stress Scale (PSS-14)
Evaluated by the validated questionnaire Perceived Stress Scale (PSS-14). Scores are compared between the intervention and the control group. The total score ranges between 0 and 56, with a higher score indicate more symptoms of stress.
Measured: Change from baseline examined at 3 months follow-up.
Perceived Stress Scale (PSS-14)
Evaluated by the validated questionnaire Perceived Stress Scale (PSS-14). Scores are compared between the intervention and the control group. The total score ranges between 0 and 56, with a higher score indicate more symptoms of stress.
Measured: Change from baseline examined at 6 months follow-up.
Perceived Stress Scale (PSS-14)
Evaluated by the validated questionnaire Perceived Stress Scale (PSS-14). Scores are compared between the intervention and the control group. The total score ranges between 0 and 56, with a higher score indicate more symptoms of stress.
Measured: Change from baseline examined at 15 months follow-up.
Personality Assessment Guardian NEO-FFI-3
The NEO Five Factor Inventory-3 (NEO-FFI-3) is a measure of the five domains of personality: neuroticism, extraversion, openness to experience, agreeableness, and conscientiousness.
Measured: Change from baseline examined at 6 weeks follow-up.
Personality Assessment Guardian NEO-FFI-3
The NEO Five Factor Inventory-3 (NEO-FFI-3) is a measure of the five domains of personality: neuroticism, extraversion, openness to experience, agreeableness, and conscientiousness.
Measured: Change from baseline examined at 3 months follow-up.
Personality Assessment Guardian NEO-FFI-3
The NEO Five Factor Inventory-3 (NEO-FFI-3) is a measure of the five domains of personality: neuroticism, extraversion, openness to experience, agreeableness, and conscientiousness.
Measured: Change from baseline examined at 6 months follow-up.
Personality Assessment Guardian NEO-FFI-3
The NEO Five Factor Inventory-3 (NEO-FFI-3) is a measure of the five domains of personality: neuroticism, extraversion, openness to experience, agreeableness, and conscientiousness.
Measured: Change from baseline examined at 15 months follow-up.
Comprehensive psychopathological rating questionnaire (CPRS)
Evaluated by the validated questionnaire the Comprehensive Psychopathological Rating Scale (CPRS). Scores are compared between the intervention and the control group. Higher scores at the Comprehensive Psychopathological Rating Scale mean more symptoms of anxiety and depression. The Scores for anxiety is between 0-27 and for depression is between 0-27.
Measured: Change from baseline examined at 6 weeks follow-up.
Comprehensive psychopathological rating questionnaire (CPRS)
Evaluated by the validated questionnaire the Comprehensive Psychopathological Rating Scale (CPRS). Scores are compared between the intervention and the control group. Higher scores at the Comprehensive Psychopathological Rating Scale mean more symptoms of anxiety and depression. The Scores for anxiety is between 0-27 and for depression is between 0-27.
Measured: Change from baseline examined at 3 months follow-up.
Comprehensive psychopathological rating questionnaire (CPRS)
Evaluated by the validated questionnaire the Comprehensive Psychopathological Rating Scale (CPRS). Scores are compared between the intervention and the control group. Higher scores at the Comprehensive Psychopathological Rating Scale mean more symptoms of anxiety and depression. The Scores for anxiety is between 0-27 and for depression is between 0-27.
Measured: Change from baseline examined at 6 months follow-up.
Comprehensive psychopathological rating questionnaire (CPRS)
Evaluated by the validated questionnaire the Comprehensive Psychopathological Rating Scale (CPRS). Scores are compared between the intervention and the control group. Higher scores at the Comprehensive Psychopathological Rating Scale mean more symptoms of anxiety and depression. The Scores for anxiety is between 0-27 and for depression is between 0-27.
Measured: Change from baseline examined at 15 months follow-up.
Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39)
Evaluated by the validated questionnaire Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39). Scores are compared between the intervention and the control group. ThyPRO scales is scored as a summary score and linearly transformed to range 0- 100. Higher scores at the Thyroid-specific Patient-Reported Outcome short-form means worse quality of life.
Measured: Change from baseline examined at 6 weeks follow-up.
Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39)
Evaluated by the validated questionnaire Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39). Scores are compared between the intervention and the control group. ThyPRO scales is scored as a summary score and linearly transformed to range 0- 100. Higher scores at the Thyroid-specific Patient-Reported Outcome short-form means worse quality of life.
Measured: Change from baseline examined at 3 months follow-up.
Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39)
Evaluated by the validated questionnaire Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39). Scores are compared between the intervention and the control group. ThyPRO scales is scored as a summary score and linearly transformed to range 0- 100. Higher scores at the Thyroid-specific Patient-Reported Outcome short-form means worse quality of life.
Measured: Change from baseline examined at 6 months follow-up.
Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39)
Evaluated by the validated questionnaire Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39). Scores are compared between the intervention and the control group. ThyPRO scales is scored as a summary score and linearly transformed to range 0- 100. Higher scores at the Thyroid-specific Patient-Reported Outcome short-form means worse quality of life.
Measured: Change from baseline examined at 15 months follow-up.
Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL).
Evaluated by the validated questionnaire the Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL). Scores are compared between the intervention and the control group. The range of each score is from 0 to 100, higher scores indicating better health.
Measured: Change from baseline examined at 6 weeks follow-up
Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL).
Evaluated by the validated questionnaire the Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL). Scores are compared between the intervention and the control group. The range of each score is from 0 to 100, higher scores indicating better health.
Measured: Change from baseline examined at 3 months follow-up
Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL).
Evaluated by the validated questionnaire the Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL). Scores are compared between the intervention and the control group. The range of each score is from 0 to 100, higher scores indicating better health.
Measured: Change from baseline examined at 6 months follow-up
Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL).
Evaluated by the validated questionnaire the Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL). Scores are compared between the intervention and the control group. The range of each score is from 0 to 100, higher scores indicating better health.
Measured: Change from baseline examined at 15 months follow-up
EuroQol- health questionnaire (EQ-5D)
Evaluated by the validated questionnaire EuroQol- health (EQ-5D). Scores are compared between the intervention and the control group. Each question may have 1 of 3-level answers, and a visual analog scale (VAS) on which patients can mark their current health state. The EQ-5D-3L index is calculated by subtracting the values of the descriptive EQ-5D system from the numerical value 1. This corresponds to the best possible health status, while an index value of <0 represents the worst possible health status.
Measured: Change from baseline examined at 6 weeks follow-up
EuroQol- health questionnaire (EQ-5D)
Evaluated by the validated questionnaire EuroQol- health (EQ-5D). Scores are compared between the intervention and the control group. Each question may have 1 of 3-level answers, and a visual analog scale (VAS) on which patients can mark their current health state. The EQ-5D-3L index is calculated by subtracting the values of the descriptive EQ-5D system from the numerical value 1. This corresponds to the best possible health status, while an index value of <0 represents the worst possible health status.
Measured: Change from baseline examined at 3 months follow-up
EuroQol- health questionnaire (EQ-5D)
Evaluated by the validated questionnaire EuroQol- health (EQ-5D). Scores are compared between the intervention and the control group. Each question may have 1 of 3-level answers, and a visual analog scale (VAS) on which patients can mark their current health state. The EQ-5D-3L index is calculated by subtracting the values of the descriptive EQ-5D system from the numerical value 1. This corresponds to the best possible health status, while an index value of <0 represents the worst possible health status.
Measured: Change from baseline examined at 6 months follow-up
EuroQol- health questionnaire (EQ-5D)
Evaluated by the validated questionnaire EuroQol- health (EQ-5D). Scores are compared between the intervention and the control group. Each question may have 1 of 3-level answers, and a visual analog scale (VAS) on which patients can mark their current health state. The EQ-5D-3L index is calculated by subtracting the values of the descriptive EQ-5D system from the numerical value 1. This corresponds to the best possible health status, while an index value of <0 represents the worst possible health status.
Measured: Change from baseline examined at 15 months follow-up
Frenchay Activities Index (FAI)
Evaluated by the validated Frenchay Activities Index (FAI). Compare function and work ability between the intervention and the control group. Questionnaire consisting of 15 items on frequency of social everyday activities and the score is based on the frequency with which an activity has been performed during the previous 3 or 6 months. The total score ranges from 0 (inactive) to 45 (very active).
Measured: Change from baseline examined at 6 weeks follow-up
Frenchay Activities Index (FAI)
Evaluated by the validated Frenchay Activities Index (FAI). Compare function and work ability between the intervention and the control group. Questionnaire consisting of 15 items on frequency of social everyday activities and the score is based on the frequency with which an activity has been performed during the previous 3 or 6 months. The total score ranges from 0 (inactive) to 45 (very active).
Measured: Change from baseline examined at 3 months follow-up
Frenchay Activities Index (FAI)
Evaluated by the validated Frenchay Activities Index (FAI). Compare function and work ability between the intervention and the control group. Questionnaire consisting of 15 items on frequency of social everyday activities and the score is based on the frequency with which an activity has been performed during the previous 3 or 6 months. The total score ranges from 0 (inactive) to 45 (very active).
Measured: Change from baseline examined at 6 months follow-up
Frenchay Activities Index (FAI)
Evaluated by the validated Frenchay Activities Index (FAI). Compare function and work ability between the intervention and the control group. Questionnaire consisting of 15 items on frequency of social everyday activities and the score is based on the frequency with which an activity has been performed during the previous 3 or 6 months. The total score ranges from 0 (inactive) to 45 (very active).
Measured: Change from baseline examined at 15 months follow-up
Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI)
Evaluated by the validated Work Productivity and Activity Impairment questionnaire (WPAI). Compare Work Productivity and Activity between the intervention and the control group.
Four main outcomes can be generated from the WPAI-GH and expressed in percentages by multiplying the following scores by 100: 1) percent work time missed due to health = Q2/(Q2 + Q4) for those who were currently employed; 2) percent impairment while working due to health = Q5/10 for those who were currently employed and actually worked in the past seven days; 3) percent overall work impairment due to health Q2/(Q2 + Q4) + ((1 - Q2/(Q2 + Q4)) × (Q5/10)) for those who were currently employed; 4) percent activity impairment due to health Q6/10 for all respondents.
Measured: Change from baseline examined at 6 weeks follow-up
Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI)
Evaluated by the validated Work Productivity and Activity Impairment questionnaire (WPAI). Compare Work Productivity and Activity between the intervention and the control group.
Four main outcomes can be generated from the WPAI-GH and expressed in percentages by multiplying the following scores by 100: 1) percent work time missed due to health = Q2/(Q2 + Q4) for those who were currently employed; 2) percent impairment while working due to health = Q5/10 for those who were currently employed and actually worked in the past seven days; 3) percent overall work impairment due to health Q2/(Q2 + Q4) + ((1 - Q2/(Q2 + Q4)) × (Q5/10)) for those who were currently employed; 4) percent activity impairment due to health Q6/10 for all respondents.
Measured: Change from baseline examined at 3 months follow-up
Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI)
Evaluated by the validated Work Productivity and Activity Impairment questionnaire (WPAI). Compare Work Productivity and Activity between the intervention and the control group.
Four main outcomes can be generated from the WPAI-GH and expressed in percentages by multiplying the following scores by 100: 1) percent work time missed due to health = Q2/(Q2 + Q4) for those who were currently employed; 2) percent impairment while working due to health = Q5/10 for those who were currently employed and actually worked in the past seven days; 3) percent overall work impairment due to health Q2/(Q2 + Q4) + ((1 - Q2/(Q2 + Q4)) × (Q5/10)) for those who were currently employed; 4) percent activity impairment due to health Q6/10 for all respondents.
Measured: Change from baseline examined at 6 months follow-up
Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI)
Evaluated by the validated Work Productivity and Activity Impairment questionnaire (WPAI). Compare Work Productivity and Activity between the intervention and the control group.
Four main outcomes can be generated from the WPAI-GH and expressed in percentages by multiplying the following scores by 100: 1) percent work time missed due to health = Q2/(Q2 + Q4) for those who were currently employed; 2) percent impairment while working due to health = Q5/10 for those who were currently employed and actually worked in the past seven days; 3) percent overall work impairment due to health Q2/(Q2 + Q4) + ((1 - Q2/(Q2 + Q4)) × (Q5/10)) for those who were currently employed; 4) percent activity impairment due to health Q6/10 for all respondents.
Measured: Change from baseline examined at 15 months follow-up
Levels of thyroid autoantibodies
Levels of thyroid autoantibodies, analysed with the standard method of the laboratory at Sahlgrenska University Hospital, compared between the intervention and the control group.
Measured: Change from baseline examined at 6 weeks follow-up
Levels of thyroid autoantibodies
Levels of thyroid autoantibodies, analysed with the standard method of the laboratory at Sahlgrenska University Hospital, compared between the intervention and the control group.
Measured: Change from baseline examined at 3 months follow-up
Levels of thyroid autoantibodies
Levels of thyroid autoantibodies, analysed with the standard method of the laboratory at Sahlgrenska University Hospital, compared between the intervention and the control group.
Measured: Change from baseline examined at 6 months follow-up
Levels of thyroid autoantibodies
Levels of thyroid autoantibodies, analysed with the standard method of the laboratory at Sahlgrenska University Hospital, compared between the intervention and the control group.
Measured: Change from baseline examined at 15 months follow-up
Levels of thyroid hormones
Levels of thyroid hormones, analysed with the standard method of the laboratory at Sahlgrenska University Hospital, compared between the intervention and the control group.
Measured: Change from baseline examined at 6 weeks follow-up
Levels of thyroid hormones
Levels of thyroid hormones, analysed with the standard method of the laboratory at Sahlgrenska University Hospital, compared between the intervention and the control group.
Measured: Change from baseline examined at 3 months follow-up
Levels of thyroid hormones
Levels of thyroid hormones, analysed with the standard method of the laboratory at Sahlgrenska University Hospital, compared between the intervention and the control group.
Measured: Change from baseline examined at 6 months follow-up
Levels of thyroid hormones
Levels of thyroid hormones, analysed with the standard method of the laboratory at Sahlgrenska University Hospital, compared between the intervention and the control group.
Measured: Change from baseline examined at 15 months follow-up
Clinical Activity Score (CAS)
Comparison of Clinical Activity Score (a composite measure of ophthalmological signs and symptoms) between the intervention and the control group. Scores can be between 0-10 and higher scores mean more eye symptoms.
Measured: Change from baseline examined at 6 weeks follow-up
Clinical Activity Score (CAS)
Comparison of Clinical Activity Score (a composite measure of ophthalmological signs and symptoms) between the intervention and the control group. Scores can be between 0-10 and higher scores mean more eye symptoms.
Measured: Change from baseline examined at 3 months follow-up
Clinical Activity Score (CAS)
Comparison of Clinical Activity Score (a composite measure of ophthalmological signs and symptoms) between the intervention and the control group. Scores can be between 0-10 and higher scores mean more eye symptoms.
Measured: Change from baseline examined at 6 months follow-up
Clinical Activity Score (CAS)
Comparison of Clinical Activity Score (a composite measure of ophthalmological signs and symptoms) between the intervention and the control group. Scores can be between 0-10 and higher scores mean more eye symptoms.
Measured: Change from baseline examined at 15 months follow-up
Severity score
Comparison of Severity score (a composite measure of ophthalmological signs and symptoms) between the intervention and the control group. Scores can be between 0-29 and higher scores mean more eye symptoms.
Measured: Change from baseline examined at 6 weeks follow-up
Severity score
Comparison of Severity score (a composite measure of ophthalmological signs and symptoms) between the intervention and the control group. Scores can be between 0-29 and higher scores mean more eye symptoms.
Measured: Change from baseline examined at 3 months follow-up
Severity score
Comparison of Severity score (a composite measure of ophthalmological signs and symptoms) between the intervention and the control group. Scores can be between 0-29 and higher scores mean more eye symptoms.
Measured: Change from baseline examined at 6 months follow-up
Severity score
Comparison of Severity score (a composite measure of ophthalmological signs and symptoms) between the intervention and the control group. Scores can be between 0-29 and higher scores mean more eye symptoms.
Measured: Change from baseline examined at 15 months follow-up
Saltin-Grimby Physical Activity Scale (SGPAS)
Physical activity level, 1-4 (4 highest activity level).
Measured: Change from baseline examined at 6 weeks follow-up
Saltin-Grimby Physical Activity Scale (SGPAS)
Physical activity level, 1-4 (4 highest activity level).
Measured: Change from baseline examined at 3 months follow-up
Saltin-Grimby Physical Activity Scale (SGPAS)
Physical activity level, 1-4 (4 highest activity level).
Measured: Change from baseline examined at 6 months follow-up
Saltin-Grimby Physical Activity Scale (SGPAS)
Physical activity level, 1-4 (4 highest activity level).
Measured: Change from baseline examined at 15 months follow-up
Composite score of changes
A patient is classified as improved, deteriorated or unchanged:
A patient is classified as improved if:
at 3 months increased general self-efficacy by ≥ 5 units and reduced sick leave percentage (or unchanged if no sick-leave at baseline) at 3 months follow-up
A patient is classified as deteriorated if:
at 3 months reduced general self-efficacy by ≥ 5 units or increased sick-leave percentage (or unchanged if on full-time sick leave at inclusion) Those who have neither improved or deteriorated are classified as unchanged
Measured: Change from 6weeks examined at 3 months follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start25 Mar 2024
- Primary completion25 Feb 2029 (estimated)
- Study completion30 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves DiseaseStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Helena Filipsson Nyström, Principal investigator, Sahlgrenska Universitet sjukhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309316
- Sponsor's protocol ID
- Grace-PCC
- Status last verified
- Oct 2025
- First submitted
- 6 Mar 2024
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Person Centred Care (PCC) on Mental Outcome and Work Ability in Graves' Disease - the GRAves CarE (GRACE) PCC Project
- ClinicalTrials.gov ID
- NCT06309316
- Acronym / sponsor ID
- Grace-PCC
- Conditions
- Graves Disease
- Keywords
- Person Centred Care, Mental fatigue, cost-effectiveness, self-efficacy, eHealth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 25 Feb 2029 (estimated)
- Study completion
- 30 Jan 2030 (estimated)
- First posted
- 13 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mental fatigue (MF) is prevalent after Graves' disease (GD), which is the most common form of hyperthyroidism. We have reported that 38% of patients, compared to 11% of control subjects, suffer from MF more than 1 year after successfully reversing of their hyperthyroidism and that MF is an entity of its own, separated from MF combined with anxiety or depression. The brain pathophysiology is unknown and there is no medical treatment, which requires patients to simply adapt to the situation. In the new national guideline for hyperthyroidism (Jan 2023), rehabilitation is recommended, but currently rarely offered to these patients. The problem is significant for patients, as illustrated by frequent media appeals. In this project, we hypothesise that person-centred care (PCC), which promotes positive coping strategies and increases self-efficacy by engaging patients as partners in their own care, improves MF, reduces sick leave, and lowers the recurrence rate of GD. In two work packages (WP), we will:
WP1 Evaluate the effect of PCC eHealth intervention (telephone and digital platform) as an add-on to usual care vs usual care alone in a randomized controlled trial (RCT) of 220 patients on self-efficacy, days of sick-leave (composite score as primary outcome), MF, recurrence rate of disease, coping strategies, perceived stress, quality of life (QoL) and personality.
WP2 Investigate the cost-effectiveness of the intervention
Patients with GD have impaired long-term QoL. PCC could improve long-term outcomes of this autoimmune disease and may apply to other patient groups. This is in line with the societal aim to reduce mental illness.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Person-centred care (PCC) | Experimental | Behavioral: Person-centred care (PCC)Intervention PCC: In addition to usual care, patients will receive PCC through physical visits, telephone and through a web-based platform for 15-months. The primary outcome is after 3 month (we expect the need of support is largest in the beginning) but the the intervention will continue for the period of care 12-18 months, increasing transferability to regular care. Usual care: Patients with GD have regular meetings with the endocrinologist during the treatment with anti-thyroid drugs and leave blod sampels. Many patients are on sick leave in the beginning of treatment. If questions occur between meetings, patients contact a service centre and get feed-back from the nurse or physician on duty at Sahlgrenska University Hospital in Gothenburg. |
| Usual care | No intervention | –Usual care: Patients with GD have regular meetings with the endocrinologist during the treatment with anti-thyroid drugs and leave blod sampels. Many patients are on sick leave in the beginning of treatment. If questions occur between meetings, patients contact a service centre and get feed-back from the nurse or physician on duty at Sahlgrenska University Hospital in Gothenburg. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-65 years
- First time Graves' diseases with elevated FT4 and/or FT3 and positive TSH receptor antibody (TRAb)
Key exclusion criteria (2 listed)
- Patients that cannot attend to the protocol
- Patients with moderate-severe/ severe Graves' eye disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Person-centred care (PCC)In addition to usual care, patients will receive PCC through physical visits, telephone and through a web-based platform for 15-months. Primary outcome is after 3 month (we expect the need of support is largest in the beginning) but the intervention will continue for the period of care 12-18 months, increasing transferability to regular care. | Behavioural | Person-centred care (PCC) |
Primary outcome
Composite score of changes
Time frame: Change from baseline examined at 3 months follow-up.
A patient is classified as improved, deteriorated or unchanged: A patient is classified as improved if: at 3 months increased general self-efficacy by ≥ 5 units and reduced sick leave percentage (or unchanged if no sick-leave at baseline) at 3 months follow-up A patient is classified as deteriorated if: at 3 months reduced general self-efficacy by ≥ 5 units or increased sick-leave percentage (or unchanged if on full-time sick leave at inclusion) Those who have neither improved or deteriorated are classified as unchanged
69 secondary outcomes
General Self-Efficacy Scale (GSE)
Time frame: Change from baseline examined at 6 weeks follow-up.
General Self-Efficacy Scale (GSE)
Time frame: Change from baseline examined at 3 months follow-up.
General Self-Efficacy Scale (GSE)
Time frame: Change from baseline examined at 6 months follow-up.
General Self-Efficacy Scale (GSE)
Time frame: Change from baseline examined at 15 months follow-up.
Days of sick-leave
Time frame: Change from baseline examined at 6 weeks follow-up.
Days of sick-leave
Time frame: Change from baseline examined at 3 months follow-up.
Days of sick-leave
Time frame: Change from baseline examined at 6 months follow-up.
Days of sick-leave
Time frame: Change from baseline examined at 15 months follow-up.
Mental fatigue score
Time frame: Change from baseline examined at 6 weeks follow-up.
Mental fatigue score
Time frame: Change from baseline examined at 3 months follow-up.
Mental fatigue score
Time frame: Change from baseline examined at 6 months follow-up.
Mental fatigue score
Time frame: Change from baseline examined at 15 months follow-up.
Coping Orientations to Problems Experienced (Brief cope)
Time frame: Change from baseline examined at 6 weeks follow-up.
Coping Orientations to Problems Experienced (Brief cope)
Time frame: Change from baseline examined at 3 months follow-up.
Coping Orientations to Problems Experienced (Brief cope)
Time frame: Change from baseline examined at 6 months follow-up.
Coping Orientations to Problems Experienced (Brief cope)
Time frame: Change from baseline examined at 15 months follow-up.
Perceived Stress Scale (PSS-14)
Time frame: Change from baseline examined at 6 weeks follow-up.
Perceived Stress Scale (PSS-14)
Time frame: Change from baseline examined at 3 months follow-up.
Perceived Stress Scale (PSS-14)
Time frame: Change from baseline examined at 6 months follow-up.
Perceived Stress Scale (PSS-14)
Time frame: Change from baseline examined at 15 months follow-up.
Personality Assessment Guardian NEO-FFI-3
Time frame: Change from baseline examined at 6 weeks follow-up.
Personality Assessment Guardian NEO-FFI-3
Time frame: Change from baseline examined at 3 months follow-up.
Personality Assessment Guardian NEO-FFI-3
Time frame: Change from baseline examined at 6 months follow-up.
Personality Assessment Guardian NEO-FFI-3
Time frame: Change from baseline examined at 15 months follow-up.
Comprehensive psychopathological rating questionnaire (CPRS)
Time frame: Change from baseline examined at 6 weeks follow-up.
Comprehensive psychopathological rating questionnaire (CPRS)
Time frame: Change from baseline examined at 3 months follow-up.
Comprehensive psychopathological rating questionnaire (CPRS)
Time frame: Change from baseline examined at 6 months follow-up.
Comprehensive psychopathological rating questionnaire (CPRS)
Time frame: Change from baseline examined at 15 months follow-up.
Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39)
Time frame: Change from baseline examined at 6 weeks follow-up.
Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39)
Time frame: Change from baseline examined at 3 months follow-up.
Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39)
Time frame: Change from baseline examined at 6 months follow-up.
Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39)
Time frame: Change from baseline examined at 15 months follow-up.
Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL).
Time frame: Change from baseline examined at 6 weeks follow-up
Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL).
Time frame: Change from baseline examined at 3 months follow-up
Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL).
Time frame: Change from baseline examined at 6 months follow-up
Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL).
Time frame: Change from baseline examined at 15 months follow-up
EuroQol- health questionnaire (EQ-5D)
Time frame: Change from baseline examined at 6 weeks follow-up
EuroQol- health questionnaire (EQ-5D)
Time frame: Change from baseline examined at 3 months follow-up
EuroQol- health questionnaire (EQ-5D)
Time frame: Change from baseline examined at 6 months follow-up
EuroQol- health questionnaire (EQ-5D)
Time frame: Change from baseline examined at 15 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Helena Filipsson Nyström principal investigator
Sahlgrenska Universitet sjukhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Person-centred care (PCC) in people with Graves Disease, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Agneta Lindo (+46766185481, agneta.lindo@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite score of changes (time frame: Change from baseline examined at 3 months follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.