Self-management Telehealth Program for Scleroderma

NCT06990386 | Completed

• 2 other identifiers: HE661405Khon Kaen University
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Scleroderma

Keywords

systemic sclerosis; scleroderma and related disorders; exercise; hand function; hand deformity; disability; clinical trials

Outcome Measures

Primary Outcomes (1)

• Hand grip strength

  6 weeks

Secondary Outcomes (3)

• Hand mobility in scleroderma score

  6 weeks

• Visual analog scale of Quality of life

  6 weeks

• Self-management behavior score

  6 weeks

Study Arms (3)

usual education

OTHER

An usual education included self-management booklet that developed based on the self-management framework consisting of 4 categories: a) self-monitoring, which consisted of self-observation and self-recording of DU and RP; b) performing special tasks to manage the disease, including keeping warm, maintaining moisture, and taking traumatic wound precautions; c) information seeking; and d) self-adjustment based on disease activity and treatment.

Behavioral: self-management program

Video guide and usual education

ACTIVE COMPARATOR

Video guide add on usual education was the hand and joint exercise video guide that included a 3.27-minute educational video on 6 basic daily hand exercises including: a) stretching wrist flexion and extension, b) range of motion (ROM) ulnar and radial deviation, c) ROM finger abduction and adduction, d) finger pincer, e) finger flexion and extension, and f) finger grab.

Behavioral: Video guide and usual education

Telephone notification, video guide and usual education

ACTIVE COMPARATOR

Telephone notifications consisted of weekly calls for further continuity and engagement with hand exercises. Each call lasted about 10 minutes, providing problem-solving support, knowledge reinforcement, and motivation to encourage adherence to the program.

Behavioral: Telephone notification, video guide and usual education

Interventions

self-management program BEHAVIORAL

Self-management booklet based on the self-management framework consisting of 4 categories: a) self-monitoring, which consisted of self-observation and self-recording of DU and RP; b) performing special tasks to manage the disease, including keeping warm, maintaining moisture, and taking traumatic wound precautions; c) information seeking; and d) self-adjustment based on disease activity and treatment.

usual education

Video guide and usual education BEHAVIORAL

Video guide was the hand and joint exercise video guide that included a 3.27-minute educational video on 6 basic daily hand exercises including: a) stretching wrist flexion and extension, b) range of motion (ROM) ulnar and radial deviation, c) ROM finger abduction and adduction, d) finger pincer, e) finger flexion and extension, and f) finger grab.

Video guide and usual education

Telephone notification, video guide and usual education BEHAVIORAL

Telephone notifications consisted of weekly calls for further continuity and engagement with hand exercises. Each call lasted about 10 minutes, providing problem-solving support, knowledge reinforcement, and motivation to encourage adherence to the program.

Telephone notification, video guide and usual education

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Khon Kaen University

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

Location

MeSH Terms

Conditions

Scleroderma, Diffuse; Scleroderma, Systemic; Motor Activity; Hand Deformities

Interventions

Self-Management

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Behavior; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registered Nurse

Model Details: An usual education; included booklet that developed based on the self-management framework consisting of 4 categories: a) self-monitoring, which consisted of self-observation and self-recording of DU and RP; b) performing special tasks to manage the disease, including keeping warm, maintaining moisture, and taking traumatic wound precautions; c) information seeking; and d) self-adjustment based on disease activity and treatment Video guide ; was the hand and joint exercise video guide that included a 3.27-minute educational video on 6 basic daily hand exercises including: a) stretching wrist flexion and extension, b) range of motion (ROM) ulnar and radial deviation, c) ROM finger abduction and adduction, d) finger pincer, e) finger flexion and extension, and f) finger grab Telephone notifications ; consisted of weekly calls for further continuity and engagement with hand exercises. Each call lasted about 10 minutes, providing problem-solving support, knowledge reinforcement

Study Record Dates

• First Submitted: May 18, 2025
• First Posted: May 25, 2025
• Study Start: October 11, 2023
• Primary Completion: August 29, 2024
• Study Completion: April 30, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)