Examining the Efficacy of Personalized Lifestyle Intervention in Individuals With Rheumatoid Arthritis
Examining the Effects of Person-centered Lifestyle Intervention in Individuals With Rheumatoid Arthritis: a Randomized Controlled Trial
1 other identifier
interventional
40
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2023
CompletedStudy Start
First participant enrolled
March 1, 2023
CompletedFirst Posted
Study publicly available on registry
March 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 23, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2024
CompletedMarch 4, 2024
March 1, 2024
8 months
February 26, 2023
March 1, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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.
change from baseline score at the end of 4 weeks and 6 months
Secondary Outcomes (6)
The DAS 28 Disease Activity scale
change from baseline score at the end of 4 weeks and 6 months
Health Assessment Questionnaire (HAQ)
change from baseline score at the end of 4 weeks and 6 months
Hospital Anxiety and Depression Scale (HADS)
change from baseline score at the end of 4 weeks and 6 months
General Self-Efficacy Scale
change from baseline score at the end of 4 weeks and 6 months
Rheumatoid Arthritis Quality of Life Scale
change from baseline score at the end of 4 weeks and 6 months
- +1 more secondary outcomes
Study Arms (2)
Person-centered lifestyle intervention group
EXPERIMENTALIntervention 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
EXPERIMENTALControl 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Having any musculoskeletal disease, neurological disease, and/or visual and auditory impairment other than RA
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Manisa Celal Bayar University Hafsa Sultan Hospital
Manisa, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
TIMUR PIRILDAR, PROF
Manisa Celal Bayar University
Central Study Contacts
GAMZE EKICI CAGLAR, PROF
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professional
Study Record Dates
First Submitted
February 26, 2023
First Posted
March 8, 2023
Study Start
March 1, 2023
Primary Completion
October 23, 2023
Study Completion
March 30, 2024
Last Updated
March 4, 2024
Record last verified: 2024-03