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Clinical Trials/NCT05759585
NCT05759585
Recruiting
N/A

Examining the Effects of Person-centered Lifestyle Intervention in Individuals With Rheumatoid Arthritis: a Randomized Controlled Trial

Hacettepe University1 site in 1 country40 target enrollmentMarch 1, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Inflammatory Arthritis
Sponsor
Hacettepe University
Enrollment
40
Locations
1
Primary Endpoint
Canadian Occupational Performance Measurement
Status
Recruiting
Last Updated
2 years ago

Overview

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.

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:

Registry
clinicaltrials.gov
Start Date
March 1, 2023
End Date
March 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

SULTAN BASTURK

professional

Hacettepe University

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Having any musculoskeletal disease, neurological disease, and/or visual and auditory impairment other than RA
  • Pregnancy

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Rheumatoid Arthritis Quality of Life Scale(change from baseline score at the end of 4 weeks and 6 months)
  • The Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire (BRAF-MDQ)(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)
  • General Self-Efficacy Scale(change from baseline score at the end of 4 weeks and 6 months)
  • The DAS 28 Disease Activity scale(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)

Study Sites (1)

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