Clinical trial NCT06990386: Self-management Telehealth Program for Scleroderma
Official title: Effect of a Self-management Telehealth Program on Improving Strength and Hand Function in Systemic Sclerosis Patients: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scleroderma
Keywords: systemic sclerosis
scleroderma and related disorders
exercise
hand function
hand deformity
disability
clinical trials
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Hand grip strength
timeFrame: 6 weeks
Secondary outcomes:
measure: Hand mobility in scleroderma score
timeFrame: 6 weeks
measure: Visual analog scale of Quality of life
timeFrame: 6 weeks
measure: Self-management behavior score
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Khon Kaen University
Study officials:
References: