Inflammatory ArthritisNCT05759585
Examining the Efficacy of Personalized Lifestyle Intervention in Individuals With Rheumatoid Arthritis
A study testing person-centered lifestyle intervention in people with Inflammatory Arthritis, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
It is aimed to examine the effects of person-centered lifestyle intervention on occupational performance, general health status, and quality of life in individuals with rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Arthritis
- What is being tested?
- person-centered lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 30 Mar 2024
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being diagnosed with RA between the ages of 18-65 and meeting the ACR/EULAR diagnostic criteria
- Patients with low to moderate disease activity (DAS28 ≤5.1)
- No pharmacological treatment changes for RA in the last 3 months
- Have not had any surgery in the last 6 months
- Understand and cooperate with testing guidelines
- to be literate
Who cannot join
- Having any musculoskeletal disease, neurological disease, and/or visual and auditory impairment other than RA
- Pregnancy
Trial locations and contacts
1 site in 1 country.
GAMZE EKICI CAGLAR, PROF contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Manisa Celal Bayar University Hafsa Sultan Hospital
Manisa
TİMUR PIRILDAR, PROF, 0(236) 236 0330, bashekimlik@cbu.edu.tr
About this study
Official title: Examining the Effects of Person-centered Lifestyle Intervention in Individuals With Rheumatoid Arthritis: a Randomized Controlled Trial
It is aimed to examine the effects of person-centered lifestyle intervention on occupational performance, general health status, and quality of life in individuals with rheumatoid arthritis.
Read the detailed description
Rheumatoid arthritis (RA) is defined as a chronic, inflammatory autoimmune disease that can damage both joints and non-articular organs, including the heart, kidneys, lungs, digestive system, eyes, skin, and nervous system.
Management of RA requires a multidisciplinary approach, as common risk factors for RA include both modifiable lifestyle-related variables and non-modifiable traits such as genetics and gender. Although there is no definitive cure, it is necessary to optimize physical, emotional, and social health in order to minimize the impact of the disease. At this point, self-management interventions come to the fore.
Since many areas of life are affected in individuals with RA, it is seen that there is a need for combined treatments that address the individual holistically, as suggested by EULAR. Lifestyle intervention is a combined approach that encourages individuals to change their lifestyles by increasing participation in meaningful readings. There is strong evidence in the literature that Lifestyle intervention is an effective approach to managing the symptoms of many chronic diseases.
The number of studies involving lifestyle interventions in individuals with RA, whose importance is emphasized in the literature, is limited. Therefore, our study was planned to examine the effects of person-centered lifestyle intervention on occupational performance, general health status, and quality of life in individuals with RA. Hypotheses:
- Conditions
- Inflammatory Arthritis
- Being tested
- person-centered lifestyle intervention
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
person-centered lifestyle interventionBehavioural
Lifestyle intervention is a combined approach that encourages individuals to change their lifestyles by increasing participation in meaningful readings. This program aims to facilitate the individual's self-development of healthy routines and habits; It includes techniques such as patient education, occupational self-analysis, problem-solving, motivation generation, and implementation of behaviors to prevent and manage disease-related symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Person-centered lifestyle intervention group | Experimental | Intervention group: Volunteers who were diagnosed with RA by a rheumatologist according to the 2010 criteria of the American College of Rheumatology (ACR)/European Rheumatology Association (ACR/EULAR) will be included in the study.
Person-centered lifestyle intervention in individuals with rheumatoid arthritis is planned as 2 sessions per week, for a total of 4 weeks. Receives: Behavioral: person-centered lifestyle intervention |
| Control group | Experimental | Control group: Volunteers who were diagnosed with RA by a rheumatologist according to the 2010 criteria of the American College of Rheumatology (ACR)/European Rheumatology Association (ACR/EULAR) will be included in the study.
For the control group, they will be called twice a week for 4 weeks and inquired about their general condition. Receives: Behavioral: person-centered lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canadian Occupational Performance Measurement
COPM is a standardized measurement tool that reflects the change in an individual's personal perception of activity performance and satisfaction over a period of time. It is designed to identify the activity performance problems of the individual, to give priority to these areas and to develop person-centered practice. In this assessment scale, activity performance problems faced by the person in the areas of self-care, productivity, play-free time are recorded with a semi-structured interview method. Among these areas, the person is asked to select 5 problems that he prioritizes and to rate each problem area between 1 and 10 points. A higher score on this rating indicates greater performance and satisfaction. The calculation is made by dividing the total performance and satisfaction score by the number of selected activities.
Measured: change from baseline score at the end of 4 weeks and 6 months
Secondary outcomes (6)
The DAS 28 Disease Activity scale
Disease Activity Score (DAS-28), which includes 28 joints, is used to monitor objective and subjective measures of disease activity in individuals with RA [33, 34]. The DAS-28 has been shown to have good validity and internal consistency reliability for monitoring this patient population [35] and is able to distinguish between patients with high and low disease activity [33]. Objective measures for rheumatoid arthritis are the number of swollen joints and the level of inflammation (erythrocyte sedimentation rate or C-reactive protein); subjective measures are the number of tender joints and the patient's overall health assessment. Disease activity scores range from 0 (not completely active) to 9.4 (very active). It is classified as ≤ 3.2 = mild, >3.2 to ≤5.1 = moderate, and >5.1 = severe [36].
Measured: change from baseline score at the end of 4 weeks and 6 months
Health Assessment Questionnaire (HAQ)
Evaluate how an individual's health status affects their physical function. It consists of eight subsections containing 20 activities (dressing and preparation, sitting-standing, eating, walking, hygiene, reaching, grip strength, and other activities) and each subsection contains two or three questions. All questions are rated on a four-point likert (0=I can do it easily), and (3=I can't do it at all). Eight subdivision scores are added up and divided by eight. A high score indicates poor health [37]. The Turkish validity and reliability of the test was established [38].
Measured: change from baseline score at the end of 4 weeks and 6 months
Hospital Anxiety and Depression Scale (HADS)
The hospital anxiety and depression scale was developed by Zigmond and Snaith in 1983 [39]. In our country, the validity and reliability study was carried out by Aydemir[15] in 1997 [40]. The scale is used to determine the risk of anxiety and depression in the patient, to measure its level and change in severity.
Measured: change from baseline score at the end of 4 weeks and 6 months
General Self-Efficacy Scale
The General Self-Efficacy Scale - Turkish form is a valid and reliable tool for measuring the general self-efficacy of people aged 18 years and older who are at least primary school graduates. The scale consists of 17 items and a 5-point likert structure. Bandura argues that the perception of self-efficacy is one of the main determinants of human behavior and behavioral changes [43]. The use of the concept of self-efficacy in the formation and change of patients' health-related behaviors seems to be beneficial in the field of health. The Turkish validity and reliability study of the scale was carried out by Yıldırım and İlhan in 2010 [44].
Measured: change from baseline score at the end of 4 weeks and 6 months
Rheumatoid Arthritis Quality of Life Scale
It is a disease-specific scale developed for patients with Rheumatoid arthritis and evaluates the quality of life multi-dimensionally. It consists of 30 questions prepared to be answered as yes/no. Scores range from 0 to 30, and high scores indicate poor quality of life [45]. The Turkish version of the RAQoL was used in this study [46].
Measured: change from baseline score at the end of 4 weeks and 6 months
The Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire (BRAF-MDQ)
It was developed to evaluate the effect of fatigue in different dimensions in RA patients. In the questionnaire, 4 questions (questions 1-4) evaluate physical fatigue, 7 questions evaluate fatigue in activities of daily living (ADL), 5 questions evaluate cognitive fatigue (questions 12-16), and 4 evaluate emotional fatigue. There are 20 questions in total (questions 17-20). All questions except the first 3 questions are asked to be answered according to the 4-point Likert system (none, a little, a lot, and a lot). The questionnaire completed by the patient evaluates the last seven days. The patient can leave a total of 3 questions blank. But it should answer questions 1 and 2. The patient scores between 0-70. A high score indicates high fatigue [41]. A Turkish validity and reliability study was conducted [42].
Measured: change from baseline score at the end of 4 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start1 Mar 2023
- Primary completion23 Oct 2023
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory ArthritisStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SULTAN BASTURK, Hacettepe University
- Investigators
- TIMUR PIRILDAR, PROF, Study director, Manisa Celal Bayar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759585
- Sponsor's protocol ID
- HU-SBASTURK-001
- Status last verified
- Mar 2024
- First submitted
- 26 Feb 2023
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effects of Person-centered Lifestyle Intervention in Individuals With Rheumatoid Arthritis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05759585
- Acronym / sponsor ID
- HU-SBASTURK-001
- Conditions
- Inflammatory Arthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 23 Oct 2023 (actual)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 8 Mar 2023 (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.
It is aimed to examine the effects of person-centered lifestyle intervention on occupational performance, general health status, and quality of life in individuals with rheumatoid arthritis.
Detailed description
Rheumatoid arthritis (RA) is defined as a chronic, inflammatory autoimmune disease that can damage both joints and non-articular organs, including the heart, kidneys, lungs, digestive system, eyes, skin, and nervous system.
Management of RA requires a multidisciplinary approach, as common risk factors for RA include both modifiable lifestyle-related variables and non-modifiable traits such as genetics and gender. Although there is no definitive cure, it is necessary to optimize physical, emotional, and social health in order to minimize the impact of the disease. At this point, self-management interventions come to the fore.
Since many areas of life are affected in individuals with RA, it is seen that there is a need for combined treatments that address the individual holistically, as suggested by EULAR. Lifestyle intervention is a combined approach that encourages individuals to change their lifestyles by increasing participation in meaningful readings. There is strong evidence in the literature that Lifestyle intervention is an effective approach to managing the symptoms of many chronic diseases.
The number of studies involving lifestyle interventions in individuals with RA, whose importance is emphasized in the literature, is limited. Therefore, our study was planned to examine the effects of person-centered lifestyle intervention on occupational performance, general health status, and quality of life in individuals with RA. Hypotheses:
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Person-centered lifestyle intervention group | Experimental | Behavioral: person-centered lifestyle interventionIntervention group: Volunteers who were diagnosed with RA by a rheumatologist according to the 2010 criteria of the American College of Rheumatology (ACR)/European Rheumatology Association (ACR/EULAR) will be included in the study. Person-centered lifestyle intervention in individuals with rheumatoid arthritis is planned as 2 sessions per week, for a total of 4 weeks. |
| Control group | Experimental | Behavioral: person-centered lifestyle interventionControl group: Volunteers who were diagnosed with RA by a rheumatologist according to the 2010 criteria of the American College of Rheumatology (ACR)/European Rheumatology Association (ACR/EULAR) will be included in the study. For the control group, they will be called twice a week for 4 weeks and inquired about their general condition. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Being diagnosed with RA between the ages of 18-65 and meeting the ACR/EULAR diagnostic criteria
- Patients with low to moderate disease activity (DAS28 ≤5.1)
- No pharmacological treatment changes for RA in the last 3 months
- Have not had any surgery in the last 6 months
- Understand and cooperate with testing guidelines
Key exclusion criteria (2 listed)
- Having any musculoskeletal disease, neurological disease, and/or visual and auditory impairment other than RA
- Pregnancy
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-centered lifestyle interventionLifestyle intervention is a combined approach that encourages individuals to change their lifestyles by increasing participation in meaningful readings. This program aims to facilitate the individual's self-development of healthy routines and habits; It includes techniques such as patient education, occupational self-analysis, problem-solving, motivation generation, and implementation of behaviors to prevent and manage disease-related symptoms. | Behavioural | Control group, Person-centered lifestyle intervention group |
Primary outcome
Canadian Occupational Performance Measurement
Time frame: change from baseline score at the end of 4 weeks and 6 months
COPM is a standardized measurement tool that reflects the change in an individual's personal perception of activity performance and satisfaction over a period of time. It is designed to identify the activity performance problems of the individual, to give priority to these areas and to develop person-centered practice. In this assessment scale, activity performance problems faced by the person in the areas of self-care, productivity, play-free time are recorded with a semi-structured interview method. Among these areas, the person is asked to select 5 problems that he prioritizes and to rate each problem area between 1 and 10 points. A higher score on this rating indicates greater performance and satisfaction. The calculation is made by dividing the total performance and satisfaction score by the number of selected activities.
6 secondary outcomes
The DAS 28 Disease Activity scale
Time frame: change from baseline score at the end of 4 weeks and 6 months
Health Assessment Questionnaire (HAQ)
Time frame: change from baseline score at the end of 4 weeks and 6 months
Hospital Anxiety and Depression Scale (HADS)
Time frame: change from baseline score at the end of 4 weeks and 6 months
General Self-Efficacy Scale
Time frame: change from baseline score at the end of 4 weeks and 6 months
Rheumatoid Arthritis Quality of Life Scale
Time frame: change from baseline score at the end of 4 weeks and 6 months
The Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire (BRAF-MDQ)
Time frame: change from baseline score at the end of 4 weeks and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
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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.
GAMZE EKICI CAGLAR, PROF contact
TIMUR PIRILDAR, PROF study director
Manisa Celal Bayar 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 person-centered lifestyle intervention in people with Inflammatory Arthritis, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 6 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: status not confirmed, as of the sponsor's last update on 4 Mar 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SULTAN BASTURK (05073689316, fzt.sbasturk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canadian Occupational Performance Measurement (time frame: change from baseline score at the end of 4 weeks and 6 months). 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 4 Mar 2024; AzTrials last refreshed its copy on 8 Nov 2026.