Self-management Telehealth Program for Scleroderma

Not Applicable

Completed

• Conditions: Scleroderma

• Registration Number: NCT06990386
• Lead Sponsor: Khon Kaen University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-11
• Primary Completion: 2024-08-29
• Study Completion: 2025-04-30
• Status Verified: 2025-05
• Study First Submitted: 2025-05-18
• Study First Submitted QC: 2025-05-18
• Last Update Submitted: 2025-05-24
• Study First Posted: 2025-05-25
• Last Update Posted: 2025-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

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

Exclusion Criteria

• Severe contracture deformity of the hands (defined as a hand mobility in scleroderma score of 27)
• Impaired hand sensation; cognitive, hearing, or visual impairment; or physical limitations (e.g., paralysis, muscle weakness)
• Scheduled surgery involving the hand, eyes, or ears; or required hospitalization within the past 6 weeks
• Presence of infected wounds or active inflammation on the hand, wrist, or fingers that prevents performance of hand exercises

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hand grip strength	6 weeks

Secondary Outcome Measures

Name	Time	Method
Visual analog scale of Quality of life	6 weeks	The health status quality of life self-assessment is assessed via a visual analog scale from 0 to 100.
Hand mobility in scleroderma score	6 weeks	The hand mobility in scleroderma score includes 9 items that assess finger flexion and extension, thumb abduction, pincer grip, finger adduction, volar flexion of the wrist, dorsal extension, and pronation and supination of the forearm. Each item is scored from 0 (fully performed) to 3 (unable to perform). The total score ranged from 0 to 27, with higher scores indicating worse hand mobility.
Self-management behavior score	6 weeks	The Self-Management Behavior Questionnaire consisted of an 11-item questionnaire using a 4-point Likert scale (1 = never, 4 = always) to assess patients based on the self-management framework. The total score ranged from 11 to 44. A higher score indicated better self-management behavior.

Trial Locations

Locations (1)

Khon Kaen University; 🇹🇭 Khon Kaen, Thailand