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Completed

NCT Number: NCT06990386

Self-management Telehealth Program for Scleroderma

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.

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Key information

Conditions

Scleroderma Behavior Connective Tissue Diseases Hand Deformities Motor Activity Musculoskeletal Diseases Scleroderma, Diffuse Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Khon Kaen University

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Hand grip strength

    Time frame: 6 weeks

Secondary outcomes

  1. Hand mobility in scleroderma score

    Time frame: 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.

  2. Visual analog scale of Quality of life

    Time frame: 6 weeks

    The health status quality of life self-assessment is assessed via a visual analog scale from 0 to 100.

  3. Self-management behavior score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Registry information

Official study title

Effect of a Self-management Telehealth Program on Improving Strength and Hand Function in Systemic Sclerosis Patients: a Randomized Control Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
May 25, 2025
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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