NCT06990386Completed
Self-management Telehealth Program for Scleroderma
Effect of a Self-management Telehealth Program on Improving Strength and Hand Function in Systemic Sclerosis Patients: a Randomized Control Trial
Source: ClinicalTrials.gov · Last updated 30 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Scleroderma causes the skin on the hands to harden, causing the hands to contract, and the fingers to bend abnormally, which affect the patient's work and quality of life. This project aims to test the effect of a self-management telehealth program. The goal of this clinical trial is to improving hand strength and function in SSc patients. Participants will: randomly into 3 groups; a) usual education, b) watching 3.27-minute video guide as needed adding on usual education, c) watching video guide and weekly telephone notifications adding to usual education. A physical therapist coached home program for self-hand and joint exercise, a nursing coach home routine hand care. Visit the clinic with a diary at 6 weeks after program for checkups and tests Researchers will compare hand strength and function, self-management behavior, HAMIS scores, hand grip strength (HGS), and quality of life (QoL) between groups, as well as the changes in these parameters at week 6 compared to baseline.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 72 (actual)
- First submitted
- 18 May 2025
- Start date
- 11 Oct 2023
- Primary completion date
- 29 Aug 2024
- Lead sponsor
- Khon Kaen University
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT06990386
What you commit to
- Study type: Interventional
- Participants enrolled: 72
- From 11 Oct 2023 to the primary completion date, 29 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Scheduled surgery involving the hand, eyes, or ears; or required hospitalization within the past 6 weeks
Other illness
- Impaired hand sensation; cognitive, hearing, or visual impairment; or physical limitations (e.g., paralysis, muscle weakness)
- Presence of infected wounds or active inflammation on the hand, wrist, or fingers that prevents performance of hand exercises
Other
- Severe contracture deformity of the hands (defined as a hand mobility in scleroderma score of 27)
Who the study is looking for
- Adult SSc patients who met the 2013 classification criteria of the American College of Rheumatology/European Alliance of Associations for Rheumatology and fulfilled all of the following criteria were included:
- Ability to communicate in the Thai language
- Stable disease
- Hand involvement defined as a hand mobility in scleroderma score ≥1 or a limited range of motion in at least one hand joint
- Ownership of a smartphone capable of recording video clips
- Ability to access videos on their smartphone independently
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Khon Kaen University Coordinator of this site? Confirm its status | Khon Kaen | Thailand | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.