Health-Related BehaviorNCT06464900
Effects of a Health Intervention on Fear of Hypoglycemia
A study testing Routine Care and Based on BCW Theory of Health Education in people with Health-Related Behavior and Health Education, run by Yangzhou University at 1 site in China.
Trial summary
To examine the effects of a health Education Intervention based on the Behaviour Change Wheel (BCW) theory on fear of hypoglycemia and relevant outcomes of type 2 diabetic patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health-Related Behavior, Health Education, Fear of Hypoglycemia
- What is being tested?
- Routine Care and Based on BCW Theory of Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Jul 2024to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Comply with the 2020 Chinese guidelines for the prevention and treatment of type 2 diabetes mellitus;
- Age ≥18 years;
- Duration of diabetes mellitus ≥1 year;
- FoH according to the elevated item endorsement criterion (E I criterion): ≥3 points on any item of the Hypoglycemic Fear-Worry Scale (HFS-WS);
- Patients who have the ability to listen, read, write, walk, and cooperate to complete the study;
- Patients who have a smart phone, and can skillfully use WeChat or telephone to communicate;
- Voluntarily participate in this study and sign the informed consent form.
Who cannot join
- Patients with comorbid acute complications or other serious diseases or disorders of consciousness, such as diabetic hypertonic state, tumors, coma, etc;
- Patients with comorbid psychiatric diseases or taking psychotropic drugs;
- Patients who have recently or are participating in other studies on similar topics.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Health Education Intervention Based on the Behaviour Change Wheel on Fear of Hypoglycemia in Patients With Type 2 Diabetes Mellitus: a Randomized Controlled Study
To examine the effects of a health Education Intervention based on the Behaviour Change Wheel (BCW) theory on fear of hypoglycemia and relevant outcomes of type 2 diabetic patients.
Read the detailed description
In this study, eligible participants were randomized in a 1:1 ratio into an intervention group (health education based on BCW theory given on top of regular diabetes health education) and a control group (regular diabetes health education), with a 4-week intervention period and a 8-week follow-up period, for a total of 12 weeks.
- Conditions
- Health-Related Behavior, Health Education, Fear of Hypoglycemia, Impaired Awareness of Hypoglycemia, Self-Management, Type2 Diabetes Mellitus
- Being tested
- Routine Care, Based on BCW Theory of Health Education
- Keywords
- Behaviour Change Wheel, Health educational intervention, Fear of hypoglycaemic, Impaired awareness of hypoglycaemia, Medical support, Self-management attitude, Type 2 diabetes mellitus
- Medical subject headings
- Health Behavior, Health Education, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine CareBehavioural
Provide patients with regular medication guidance, dietary guidance, exercise guidance and knowledge about diabetes mellitus and hypoglycaemia; test and record blood glucose regularly every day; answer patients' clinical questions and provide psychological support in a timely manner.
Based on BCW Theory of Health EducationBehavioural
BCW theory was applied to analyse behaviour and develop interventions in terms of capability, motivation and opportunity. Capability: Intensive daily management of diabetes through intervention functions (education, training, persuasion, modelling) to change attitudes and habits, understand the negative consequences of fear of hypoglycaemia, improve hypoglycaemia awareness and self-regulation skills. Opportunity: Through the intervention function (education, training, realization) to improve the awareness of hypoglycemia awareness, timely detection of hypoglycemia. In the event of a hypoglycaemic event patients know how to deal with it. Motivation: Through intervention functions (environmental reconstruction, realisation) that take full account of external factors and their own opportunities. Glucose management through microsoft platforms, on-site teaching and coaching by specialist nurses to create opportunities for patients who can change excessive/avoidant behaviours.
| Study group | Role | What they receive |
|---|---|---|
| Routine Care | Placebo comparator | Implementation of routine diabetes health education. Receives: Behavioral: Routine Care |
| Based on BCW Theory of Health Education | Experimental | A FoH intervention program based on BCW theory was implemented on top of the routine care. Receives: Behavioral: Based on BCW Theory of Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoglycemia fear survey
Fear of hypoglycemia (FoH) was assessed using the Hypoglycemic Fear Survey Scale (HFS), which consists of two subscales, the Hypoglycemic Fear Survey- Behavioral Scale (HFS-BS) and the Hypoglycemic Fear Survey-Worry Scale (HFS-WS). (1) The HFS-BS scale has 19 entries, using a 5-point Likert scale, with scores ranging from 1 ~ 5 in descending order, and a total score of 15 ~ 95, with higher scores indicating more obvious hypoglycemic fearful behaviors in patients. (2) HFS-WS has 13 entries, which were scored using a 5-point Likert scale, with scores ranging from 0 to 4 from low to high, and a total score of 0 ~ 52. The higher the score, the higher the degree of fear of hypoglycemia in patients. The two subscale scores were added together, and the higher the total score, the more severe the fear of hypoglycemia.
Measured: Baseline, 4 and 12 weeks post-intervention
Secondary outcomes (3)
Gold Rating
The Gold Score, first proposed by Professor Gold of the United Kingdom in 1994, is currently the most commonly used method of assessing Impaired Awareness of Hypoglycemia (IAH), which reflects the patient's awareness of hypoglycemia side by side. The method consists of a single question, "Do you know when your hypoglycemia began?" Answers are given on a 7-point Likert scale ranging from "1" (always aware) to "7" (never aware), with a score of 1-3 being considered normal self-awareness of hypoglycemia, and a score of ≥4 indicating the presence of IAH.
Measured: Baseline, 4 and 12 weeks post-intervention
The Patients Assessment Chronic Illness Care( PACIC)
Used to assess the quality of care provided by healthcare organizations in the U.S. chronic disease management model. The scale is completed by patients to report the extent to which they have received care in the past 6 months consistent with the chronic disease management model and can be used to reflect the level of medical support provided to patients by chronic disease management organizations such as hospitals.The PACIC scale is divided into 5 dimensions and 20 questions, each of which is based on the use of a 5-dimensional model of care. 7~11), problem solving/coherence (entries 12~15), and follow-up/collaboration (entries 16~20), and each entry is rated on a 5-point Likert scale, with scores ranging from 1~5 from the lowest to the highest, and with scores closer to 5, the higher the evaluation of chronic disease management, and the more support the patient receives from healthcare professionals.
Measured: Baseline, 4 and 12 weeks post-intervention
The self-management attitude scale for diabetes patients
The subscale has 5 entries to evaluate patients' attitudes toward diabetes health education, diet control, exercise, medication compliance, and blood glucose monitoring. A Likert 5-point scale was used, assigning values of 1.0, 0.8, 0.6, 0.4, 0.2 in descending order, and the total mean scores of the 5 entries (range 0.2-1.0) represented the self-management attitude scores. A total mean score of <3.0 indicates a poor self-management attitude, 3.0 to 4.25 indicates a moderate self-management attitude, and >4.25 indicates a good self-management attitude.
Measured: Baseline, 4 and 12 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study startJul 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health-Related BehaviorStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yangzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Yueqi, Yangzhou University
- Investigators
- Zhao Yueqi, Master, Principal investigator, Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464900
- Sponsor's protocol ID
- YZUHL20230040
- Status last verified
- Jul 2024
- First submitted
- 13 Jun 2024
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Health Education Intervention Based on the Behaviour Change Wheel on Fear of Hypoglycemia in Patients With Type 2 Diabetes Mellitus: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06464900
- Acronym / sponsor ID
- YZUHL20230040
- Conditions
- Health-Related Behavior, Health Education, Fear of Hypoglycemia, Impaired Awareness of Hypoglycemia, Self-Management, Type2 Diabetes Mellitus
- Keywords
- Behaviour Change Wheel, Health educational intervention, Fear of hypoglycaemic, Impaired awareness of hypoglycaemia, Medical support, Self-management attitude, Type 2 diabetes mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Yangzhou UniversityUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 18 Jun 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.
To examine the effects of a health Education Intervention based on the Behaviour Change Wheel (BCW) theory on fear of hypoglycemia and relevant outcomes of type 2 diabetic patients.
Detailed description
In this study, eligible participants were randomized in a 1:1 ratio into an intervention group (health education based on BCW theory given on top of regular diabetes health education) and a control group (regular diabetes health education), with a 4-week intervention period and a 8-week follow-up period, for a total of 12 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Care | Placebo comparator | Behavioral: Routine CareImplementation of routine diabetes health education. |
| Based on BCW Theory of Health Education | Experimental | Behavioral: Based on BCW Theory of Health EducationA FoH intervention program based on BCW theory was implemented on top of the routine care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Comply with the 2020 Chinese guidelines for the prevention and treatment of type 2 diabetes mellitus;
- Age ≥18 years;
- Duration of diabetes mellitus ≥1 year;
- FoH according to the elevated item endorsement criterion (E I criterion): ≥3 points on any item of the Hypoglycemic Fear-Worry Scale (HFS-WS);
- Patients who have the ability to listen, read, write, walk, and cooperate to complete the study;
Key exclusion criteria (3 listed)
- Patients with comorbid acute complications or other serious diseases or disorders of consciousness, such as diabetic hypertonic state, tumors, coma, etc;
- Patients with comorbid psychiatric diseases or taking psychotropic drugs;
- Patients who have recently or are participating in other studies on similar topics.
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 |
|---|---|---|
| Routine CareProvide patients with regular medication guidance, dietary guidance, exercise guidance and knowledge about diabetes mellitus and hypoglycaemia; test and record blood glucose regularly every day; answer patients' clinical questions and provide psychological support in a timely manner. | Behavioural | Routine Care |
| Based on BCW Theory of Health EducationBCW theory was applied to analyse behaviour and develop interventions in terms of capability, motivation and opportunity. Capability: Intensive daily management of diabetes through intervention functions (education, training, persuasion, modelling) to change attitudes and habits, understand the negative consequences of fear of hypoglycaemia, improve hypoglycaemia awareness and self-regulation skills. Opportunity: Through the intervention function (education, training, realization) to improve the awareness of hypoglycemia awareness, timely detection of hypoglycemia. In the event of a hypoglycaemic event patients know how to deal with it. Motivation: Through intervention functions (environmental reconstruction, realisation) that take full account of external factors and their own opportunities. Glucose management through microsoft platforms, on-site teaching and coaching by specialist nurses to create opportunities for patients who can change excessive/avoidant behaviours. | Behavioural | Based on BCW Theory of Health Education |
Primary outcome
Hypoglycemia fear survey
Time frame: Baseline, 4 and 12 weeks post-intervention
Fear of hypoglycemia (FoH) was assessed using the Hypoglycemic Fear Survey Scale (HFS), which consists of two subscales, the Hypoglycemic Fear Survey- Behavioral Scale (HFS-BS) and the Hypoglycemic Fear Survey-Worry Scale (HFS-WS). (1) The HFS-BS scale has 19 entries, using a 5-point Likert scale, with scores ranging from 1 ~ 5 in descending order, and a total score of 15 ~ 95, with higher scores indicating more obvious hypoglycemic fearful behaviors in patients. (2) HFS-WS has 13 entries, which were scored using a 5-point Likert scale, with scores ranging from 0 to 4 from low to high, and a total score of 0 ~ 52. The higher the score, the higher the degree of fear of hypoglycemia in patients. The two subscale scores were added together, and the higher the total score, the more severe the fear of hypoglycemia.
3 secondary outcomes
Gold Rating
Time frame: Baseline, 4 and 12 weeks post-intervention
The Patients Assessment Chronic Illness Care( PACIC)
Time frame: Baseline, 4 and 12 weeks post-intervention
The self-management attitude scale for diabetes patients
Time frame: Baseline, 4 and 12 weeks post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Zhao Yueqi, Master principal investigator
Yangzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine Care and Based on BCW Theory of Health Education in people with Health-Related Behavior and Health Education, run by Yangzhou University at 1 site in China.
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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 9 Jul 2024. 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 China. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ma Hongxin, Master (+86 87974902, 007032@yzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoglycemia fear survey (time frame: Baseline, 4 and 12 weeks post-intervention). 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 9 Jul 2024.