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

NCT06095921 | Completed

• 1 other identifier: ERG-EMIRHAN-001
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Scleroderma; Systemic Sclerosis

Outcome Measures

Primary Outcomes (2)

• Canadian Occupational Performance Measurement (COPM)

  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.

  One week before the rehabilitation program is implemented.

• Canadian Occupational Performance Measurement (COPM)

  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.

  One week after the rehabilitation program ended.

Study Arms (2)

Self Management Intervention Program

EXPERIMENTAL

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.

Behavioral: Self Management Intervention Program

Statistical Analysis

NO INTERVENTION

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

Interventions

Self Management Intervention Program 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.

Self Management Intervention Program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Emirhan Karakuş: lead

Study Sites (1)

Hacettepe University

Çankaya, Ankara, 06060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Scleroderma, Diffuse; Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Our employee's statistical analysis was conducted by a biostatistician unrelated to her work.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 15, 2023
• First Posted: October 23, 2023
• Study Start: July 15, 2020
• Primary Completion: October 15, 2020
• Study Completion: January 15, 2021
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)