SclerodermaNCT06095921
The Effect of a Self-Management Program on Individuals With Scleroderma
A study testing Self Management Intervention Program in people with Scleroderma and Systemic Sclerosis, run by Emirhan Karakuş at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Scleroderma, Systemic Sclerosis
- What is being tested?
- Self Management Intervention Program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2020to 15 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Neurological disease, continuing a different study or rehabilitation programme, having COVID-19 infection, exacerbation the disease in the last 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Self-Management Programme Performed Via Telerehabilitation on Occupational Performance and Satisfaction of Individuals With Systemic Sclerosis
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.
Read the 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
- Being tested
- Self Management Intervention Program
- Medical subject headings
- Scleroderma, Diffuse, Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self Management Intervention ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Self Management Intervention Program |
| Statistical Analysis | No intervention | One week after the program, the biostatistician evaluated the results. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: One week after the rehabilitation program ended.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start15 Jul 2020
- Primary completion15 Oct 2020
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SclerodermaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emirhan Karakuş
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emirhan Karakuş, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095921
- Sponsor's protocol ID
- ERG-EMIRHAN-001
- Status last verified
- Oct 2023
- First submitted
- 15 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karakus E, Sari F, Avanoglu Guler A, Oskay D, Oksuz C. The Effect of Telerehabilitation-Based Self-Management Programme on Individuals With Scleroderma. Musculoskeletal Care. 2024 Dec;22(4):e1947. doi: 10.1002/msc.1947.
PubMed 39327669
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Self-Management Programme Performed Via Telerehabilitation on Occupational Performance and Satisfaction of Individuals With Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT06095921
- Acronym / sponsor ID
- ERG-EMIRHAN-001
- Conditions
- Scleroderma, Systemic Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Emirhan KarakuşUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self Management Intervention Program | Experimental | Behavioral: Self Management Intervention ProgramThat 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. |
| Statistical Analysis | No intervention | –One week after the program, the biostatistician evaluated the results. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Neurological disease, continuing a different study or rehabilitation programme, having COVID-19 infection, exacerbation the disease in the last 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self Management Intervention ProgramSSc, 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. | Behavioural | Self Management Intervention Program |
Primary outcome
Canadian Occupational Performance Measurement (COPM)
Time frame: One week before the rehabilitation program is implemented.
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.
Canadian Occupational Performance Measurement (COPM)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Derived from this study: PubMed 39327669Karakus E, Sari F, Avanoglu Guler A, Oskay D, Oksuz C. The Effect of Telerehabilitation-Based Self-Management Programme on Individuals With Scleroderma. Musculoskeletal Care. 2024 Dec;22(4):e1947. doi: 10.1002/msc.1947.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self Management Intervention Program in people with Scleroderma and Systemic Sclerosis, run by Emirhan Karakuş at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canadian Occupational Performance Measurement (COPM) (time frame: One week before the rehabilitation program is implemented.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06095921, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.