SclerodermaNCT06990386
Self-management Telehealth Program for Scleroderma
A study testing self-management program, Video guide and usual education and Telephone notification, video guide and usual education in people with Scleroderma, run by Khon Kaen University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scleroderma
- What is being tested?
- self-management program, Video guide and usual education and Telephone notification, video guide and usual education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteThailand
- Study dates
- 11 Oct 2023to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Self-management Telehealth Program on Improving Strength and Hand Function in Systemic Sclerosis Patients: a Randomized Control Trial
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.
Read more
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.
- Conditions
- Scleroderma
- Being tested
- self-management program, Video guide and usual education, Telephone notification, video guide and usual education
- Keywords
- systemic sclerosis, scleroderma and related disorders, exercise, hand function, hand deformity, disability, clinical trials
- Medical subject headings
- Scleroderma, Diffuse, Scleroderma, Systemic, Motor Activity, Hand Deformities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-management programBehavioural
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 educationBehavioural
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 educationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| usual education | Other | 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. Receives: Behavioral: self-management program |
| Video guide and usual education | Active comparator | 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. Receives: Behavioral: Video guide and usual education |
| Telephone notification, video guide and usual education | Active comparator | 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. Receives: Behavioral: Telephone notification, video guide and usual education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand grip strength
Measured: 6 weeks
Secondary outcomes (3)
Hand mobility in scleroderma score
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.
Measured: 6 weeks
Visual analog scale of Quality of life
The health status quality of life self-assessment is assessed via a visual analog scale from 0 to 100.
Measured: 6 weeks
Self-management behavior score
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start11 Oct 2023
- Primary completion29 Aug 2024
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SclerodermaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orathai Wantha, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990386
- Sponsor's protocol ID
- HE661405
- Other IDs
- Khon Kaen University
- Status last verified
- May 2025
- First submitted
- 18 May 2025
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Self-management Telehealth Program on Improving Strength and Hand Function in Systemic Sclerosis Patients: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06990386
- Acronym / sponsor ID
- HE661405
- Conditions
- Scleroderma
- Keywords
- systemic sclerosis, scleroderma and related disorders, exercise, hand function, hand deformity, disability, clinical trials
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 11 Oct 2023 (actual)
- Primary completion
- 29 Aug 2024 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| usual education | Other | Behavioral: self-management programAn 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. |
| Video guide and usual education | Active comparator | Behavioral: Video guide and usual educationVideo 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. |
| Telephone notification, video guide and usual education | Active comparator | Behavioral: Telephone notification, video guide and usual educationTelephone 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-management programSelf-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. | Behavioural | usual education |
| Video guide and usual educationVideo 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. | Behavioural | Video guide and usual education |
| Telephone notification, video guide and usual educationTelephone 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. | Behavioural | Telephone notification, video guide and usual education |
Primary outcome
Hand grip strength
Time frame: 6 weeks
3 secondary outcomes
Hand mobility in scleroderma score
Time frame: 6 weeks
Visual analog scale of Quality of life
Time frame: 6 weeks
Self-management behavior score
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: No
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Scleroderma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-management program, Video guide and usual education and Telephone notification, video guide and usual education in people with Scleroderma, run by Khon Kaen University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand grip strength (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.