The Effect of a Self-Management Program on Individuals With Scleroderma

Not Applicable

Completed

• Conditions: Systemic Sclerosis; Scleroderma
• Interventions: Behavioral: Self Management Intervention Program

• Registration Number: NCT06095921
• Lead Sponsor: Emirhan Karakuş

Brief Summary

Introduction: Individuals with systemic sclerosis (SSc) have problems with perceived occupational performance and satisfaction in daily life activities due to many symptoms caused by the disease.

Purpose: This study will plan to examine the effect of a self-management program for individuals with SSc on perceived occupational performance and satisfaction.

Materials and Methods : Twenty-nine individuals with SSC, 28 females and 1 male will participate in the study. Perceived occupational performance and satisfaction levels before and after the program will evaluate with the Canadian Ocupational Performance Measure (COPM). The training programme will design according to the activities of COPM, the needs of the patients, and the literature. The programme consists of 8 sessions for 8 weeks, 1 day a week for 45 minutes.

Detailed Description

In this study, 36 individuals, diagnosed with scleroderma by a rheumatologist at Gazi University, were included. In the study approved by the Gazi University Clinical Research Ethics Committee (21.09.2020, Decree No: 635) and planned by the Declaration of Helsinki, consent forms were sent to all participants to confirm that they were volunteers. Demographic information of the individuals was obtained. The Canadian Occupational Performance Measure (COPM) was used to identify occupational problems and to implement a person-centered program. This information was obtained by submitting online forms. The videos were prepared by a team of physiotherapists, occupational therapists, and rheumatology doctors. The program manager was an occupational therapist. 29 people completed the 8-week program, which included 40-50 minute videos and assignments (keeping a pain diary, creating an exercise routine, etc.). At the end of the program, individuals were reminded of the difficult occupations again so that the Canadian Occupational Performance Measure could be re-scored. Initially, the open-ended question "In which ways did the program contribute to you?" was asked. Individuals were evaluated in the first and last week of the program and the results were compared. These evaluations and interventions were made during the Covid-19 pandemic.

Study Timeline

• Study Start: 2020-07-15
• Primary Completion: 2020-10-15
• Study Completion: 2021-01-15
• Status Verified: 2023-10
• Study First Submitted: 2023-10-15
• Study First Submitted QC: 2023-10-19
• Last Update Submitted: 2023-10-19
• Study First Posted: 2023-10-23
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

Clinical diagnosis of Scleroderma's Disease, being in remission period for 6 months, being between the ages of 18-65, knowing how to use technological devices.

Exclusion criteria:

Neurological disease, continuing a different study or rehabilitation programme, having COVID-19 infection, exacerbation the disease in the last 6 months.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Self Management Intervention Program	Self Management Intervention Program	That program was created by sending 40-minute videos 1 day a week for 8 weeks. The programme was developed both according to the achievements of previous self-management studies and according to the occupations that individuals with SSc have difficulty with.

Primary Outcome Measures

Name	Time	Method
Canadian Occupational Performance Measurement (COPM)	One week after the rehabilitation program ended.	COPM was developed in 1990. The scale determines the daily life occupations experienced by individuals in the areas of self-care, productivity and leisure time. It grades the occupational performance and satisfaction points of these determined occupations according to the Likert scale between 1-10. A minimum of one and a maximum of 5 occupations could be written, resulted in a total performance and satisfaction point. The average performance and satisfaction points were divided by the number of readings. The highest point that can be obtained from the scale is 10 and the lowest point is 1. The Turkish cultural adaptation, validity and reliability study of the scale was conducted by Torpil in 2017 in individuals with multiple sclerosis and the test-retest reliability of the Turkish version was found to be 0.98.

Trial Locations

Locations (1)

Hacettepe University; 🇹🇷 Çankaya, Ankara, Turkey