Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
72 participants
INTERVENTIONAL
2023-10-11
2025-04-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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usual education
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.
self-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.
Video guide and usual education
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.
Video 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.
Telephone 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.
Telephone 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.
Interventions
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self-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.
Video 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.
Telephone 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Khon Kaen University
OTHER
Responsible Party
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Orathai Wantha
Registered Nurse
Locations
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Khon Kaen University
Khon Kaen, Changwat Khon Kaen, Thailand
Countries
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Other Identifiers
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Khon Kaen University
Identifier Type: OTHER
Identifier Source: secondary_id
HE661405
Identifier Type: -
Identifier Source: org_study_id
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