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

NCT ID: NCT06095921

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-15
• Study Completion Date: 2021-01-15

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.

Conditions

Scleroderma; Systemic Sclerosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Self Management Intervention Program

Intervention Type: BEHAVIORAL

SSc, the course of the disease, symptoms and coping strategies, medications and treatment methods? The importance of exercise for individuals with SSc, and how to create an action plan for an exercise? were discussed. What are fatigue and its symptoms? How can we protect our articular-energy and how should a quality rest be? What is pain and what are coping approaches? What is the pain-related area of influence? What are body image problems, how to use problem solving approach and what is its importance? What is Stress? What is mindfulness? What are mindfulness exercises? What are the ways to cope with stress? What are the daily life occupations and how can we facilitate them? How can we solve problems in difficult occupations? How to create an occupation plan to facilitate daily occupations? What are oral stretching exercises and how to do them? What are the factors affecting sleep? What is advocacy and why is it important? Answers to these questions were sought.

Statistical Analysis

One week after the program, the biostatistician evaluated the results.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Self Management Intervention Program

SSc, the course of the disease, symptoms and coping strategies, medications and treatment methods? The importance of exercise for individuals with SSc, and how to create an action plan for an exercise? were discussed. What are fatigue and its symptoms? How can we protect our articular-energy and how should a quality rest be? What is pain and what are coping approaches? What is the pain-related area of influence? What are body image problems, how to use problem solving approach and what is its importance? What is Stress? What is mindfulness? What are mindfulness exercises? What are the ways to cope with stress? What are the daily life occupations and how can we facilitate them? How can we solve problems in difficult occupations? How to create an occupation plan to facilitate daily occupations? What are oral stretching exercises and how to do them? What are the factors affecting sleep? What is advocacy and why is it important? Answers to these questions were sought.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emirhan Karakuş

OTHER

Sponsor Role: lead

Responsible Party

Emirhan Karakuş

Director

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hacettepe University

Çankaya, Ankara, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

ERG-EMIRHAN-001

Identifier Type: -

Identifier Source: org_study_id