Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06095921
Other study ID # ERG-EMIRHAN-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 15, 2020
Est. completion date January 15, 2021

Study information

Verified date October 2023
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date January 15, 2021
Est. primary completion date October 15, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Intervention

Behavioral:
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.

Locations

Country Name City State
Turkey Hacettepe University Çankaya Ankara

Sponsors (1)

Lead Sponsor Collaborator
Emirhan Karakus

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
See also
  Status Clinical Trial Phase
Completed NCT03274076 - Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc) Phase 1/Phase 2
Completed NCT04300426 - Safety and Efficacy of Anaerobic Cultivated Human Intestinal Microbiome Transplantation in Systemic Sclerosis (ReSScue) Phase 2
Recruiting NCT06058091 - RY_SW01 Cell Injection Therapy in Systemic Sclerosis Phase 1/Phase 2
Recruiting NCT04356755 - Subcutaneous Injections of ASC to Heal Digital Ulcers in Patients With Scleroderma. Phase 2
Suspended NCT06210945 - Study to Evaluate the Safety, Tolerability, and Activity of CM-101 in Patients With Systemic Sclerosis Phase 2
Not yet recruiting NCT05947682 - Manufacturing of Allogeneic Adipose Tissue-derived Mesenchymal Stromal Cells for Treatment of Severe Systemic Sclerosis N/A
Not yet recruiting NCT05177380 - Efficacy of a Personalized Rehabilitation Program of Facial Involvement in Systemic Sclerosis N/A
Not yet recruiting NCT04303208 - Sirtuin 3 and Sirtuin 7 in Systemic Sclerosis N/A
Recruiting NCT02551042 - CSL Behring Sclero XIII Phase 2
Terminated NCT02243111 - Detecting Pulmonary Arterial Hypertension (PAH) in Patients With Systemic Sclerosis (SSc) by Ultrasound N/A
Terminated NCT02246348 - Evaluating Lung Doppler Signals in Patients With Systemic Sclerosis (SSc) N/A
Completed NCT01933334 - Safety and Tolerability of Pirfenidone in Patients With Systemic Sclerosis−Related Interstitial Lung Disease (SSc-ILD) (LOTUSS) Phase 2
Completed NCT01468792 - Hemodynamic Changes in Connective Tissue Disease N/A
Terminated NCT00848107 - Open-Label Study of Oral Treprostinil in Digital Ulcers Phase 2
Completed NCT00984932 - Effect of Rosuvastatin on Systemic Sclerosis-related Pulmonary Hypertension Phase 3
Completed NCT00074568 - Scleroderma Registry
Not yet recruiting NCT06412614 - Evaluation of Patients With Systemic Sclerosis Without Specific or Associated Autoantibodies
Terminated NCT00622687 - Effect of Different Iloprost Doses on Symptoms in Systemic Sclerosis Phase 2
Recruiting NCT04464434 - Upfront Autologous HSCT Versus Immunosuppression in Early Diffuse Cutaneous Systemic Sclerosis Phase 4
Recruiting NCT04246528 - SPIN Self-Management Feasibility Trial With Progression to Full-scale Trial (SPIN-SELF) N/A