Self-management Telehealth Program for Scleroderma

Khon Kaen University

Status: Completed

Conditions: Scleroderma

Treatments: Behavioral: self-management program; Behavioral: Telephone notification, video guide and usual education; Behavioral: Video guide and usual education

Study type: Interventional

Funder types: Other

Identifiers

NCT06990386

HE661405

Khon Kaen University

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 3 patient groups

usual education

Other group

Description:

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.

Treatment:

Behavioral: self-management program

Video guide and usual education

Active Comparator group

Description:

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.

Treatment:

Behavioral: Video guide and usual education

Telephone notification, video guide and usual education

Active Comparator group

Description:

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.

Treatment:

Behavioral: Telephone notification, video guide and usual education