Scleroderma
Conditions
Keywords
systemic sclerosis, scleroderma and related disorders, exercise, hand function, hand deformity, disability, clinical trials
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.
Interventions
BEHAVIORALself-management program
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.
BEHAVIORALVideo guide and usual education
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.
BEHAVIORALTelephone notification, video guide and usual education
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.
Sponsors
Khon Kaen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hand grip strength | 6 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
Thailand
Outcome results
None listed