Scleroderma, SystemicNCT06697561
Development and Evaluation of an Evidence-based Education Program for People With Hand Dysfunction in Scleroderma
A study testing patient education program in people with Scleroderma, Systemic, run by Wen-Shao Lin at 1 site in Taiwan.
Trial summary
The purpose of this study is to develop an evidence-based educational program for scleroderma patients with hand dysfunction. The program includes a self-care handbook and multimedia video resources. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scleroderma, Systemic
- What is being tested?
- patient education program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Jul 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Participants with systemic sclerosis who meet the 2013 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) diagnostic criteria and have hand dysfunction.
- Adults aged 18 years or older.
- Participants who are conscious and able to communicate in Mandarin Chinese or Taiwanese Hokkien.
- Participants who provide informed consent to participate in the study after being briefed on its purpose.
Who cannot join
- 1. Participants who have participated in any other hand rehabilitation program within the past three months.
- 2, Participants with organic brain dysfunction. 3. Participants with severe visual or hearing impairments. 4. Participants with serious illnesses that hinder communication or interfere with the normal learning process.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Evaluation of an Evidence-based Education Program for People With Hand Dysfunction in Scleroderma: A Randomized Control Trail
The purpose of this study is to develop an evidence-based educational program for scleroderma patients with hand dysfunction. The program includes a self-care handbook and multimedia video resources. The study aims to answer:
Does the intervention improve hand function in the experimental group compared to the control group? Does the intervention improve self-care knowledge of hand dysfunction? Does the intervention improve overall health?
Participants will receive an 8-week program, while the control group receives usual care. Outcome measures include hand function, overall health, and self-care knowledge.
Read the detailed description
The study will adopt a repeated measures randomized controlled trial design (parallel randomized controlled trial) using convenience sampling. Participants in the experimental group will receive an "evidence-based scleroderma hand dysfunction education program" provided by the researchers for eight weeks. The control group will receive standard medical care during the study period and will receive the same scleroderma hand dysfunction education program as the experimental group after the study concludes. Both groups will undergo pre-intervention assessments, as well as post-intervention assessments at the fourth and eighth weeks. The primary outcome measures include evaluating the effectiveness of the education program in improving hand dysfunction severity, overall health, adherence to rehabilitation exercises, and self-care knowledge related to hand dysfunction.
- Conditions
- Scleroderma, Systemic
- Being tested
- patient education program
- Keywords
- Scleroderma, Hand dysfunction, Evidence-based knowledge translation, Patient education
- Medical subject headings
- Scleroderma, Systemic, Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient education programBehavioural
The intervention for the experimental group was an "evidence-based educational program for hand dysfunction in patients with systemic sclerosis," which included a health education manual and multimedia videos developed through evidence translation. Additionally, individual education and consultation were provided.
| Study group | Role | What they receive |
|---|---|---|
| Patient education group | Experimental | receives the "Evidence-Based Education Program for people with hand dysfunction in scleroderma" (which includes: educational handbook on self-care for hand dysfunction in scleroderma, multimedia teaching materials, and individualized consultations). Receives: Behavioral: patient education program |
| control group | No intervention | Receives usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-developed questionnaire on self-care knowledge for scleroderma hand dysfunction
The "Scleroderma Hand Function-Related Self-Care Knowledge Scale," validated by experts for reliability and validity, consists of 15 items. The scale uses a dichotomous scoring method with three response options: "True," "False," and "Don't know." It includes both positively and negatively worded items. Correct answers are scored as one point, while incorrect answers and "Don't know" responses are scored as zero. The total score ranges from 0 to 15, with higher scores indicating a greater level of self-care knowledge regarding scleroderma-related hand function impairments.
Measured: At baseline, 4 weeks, and 8 weeks post-intervention
Grip strength
Grip strength of the dominant hand (in kg) will be measured using a dynamometer, and the average of three trials will be used as the final muscle strength assessment indicator.
Measured: At baseline, 4 weeks, and 8 weeks post-intervention.
delta finger-to-palm, Delta-FTP
Delta-FTP refers to the difference in distance between the tip of the third finger and the midpoint of the distal palmar crease when the finger is fully extended and fully flexed. It is an effective measurement method to assess the range of motion and flexibility of fingers in patients with scleroderma.
Measured: At baseline, 4 weeks, and 8 weeks post-intervention.
Raynaud's phenomenon visual analog scale
This scale evaluates the severity and impact of Raynaud's phenomenon on daily activities in patients with scleroderma over the past week. Scores range from 0 mm (no impact) to 100 mm (very severe impact), with higher scores indicating greater impairment of hand function
Measured: At baseline, 4 weeks, and 8 weeks post-intervention.
Digital ulcers visual analog scale
This scale evaluates the severity and impact of Digital ulcers on daily activities in patients with scleroderma over the past week. Scores range from 0 mm (no impact) to 100 mm (very severe impact), with higher scores indicating greater impairment of hand function.
Measured: At baseline, 4 weeks, and 8 weeks post-intervention.
Secondary outcomes (2)
Overall disease severity visual analog scale
This scale measures the patient's self-assessed overall disease severity, ranging from 0 to 100, where 0 indicates the best health and 100 indicates the worst health, with higher scores indicating poorer overall health status.
Measured: At baseline, 4 weeks, and 8 weeks post-intervention
Adherence to Hand Exercise Training
Using an exercise diary as an evaluation tool to assess the effectiveness of adherence to rehabilitation exercise training
Measured: At baseline, 4 weeks, and 8 weeks post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start30 Jul 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scleroderma, SystemicStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wen-Shao Lin
- Sponsor type
- University, hospital or other
- Collaborators
- Cheng Hsin Rehabilitation Medical Center, National Taipei University of Nursing and Health Sciences
- Responsible party
- Sponsor-investigator, Wen-Shao Lin, Cheng-Hsin General Hospital
- Investigators
- Cheng Hsin General Hospital, Principal investigator, Institutional Review Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697561
- Sponsor's protocol ID
- (1106)113A-36
- Status last verified
- Nov 2024
- First submitted
- 16 Nov 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of an Evidence-based Education Program for People With Hand Dysfunction in Scleroderma: A Randomized Control Trail
- ClinicalTrials.gov ID
- NCT06697561
- Acronym / sponsor ID
- (1106)113A-36
- Conditions
- Scleroderma, Systemic
- Keywords
- Scleroderma, Hand dysfunction, Evidence-based knowledge translation, Patient education
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Wen-Shao LinUniversity, hospital or other
- Collaborators
- Cheng Hsin Rehabilitation Medical Center, National Taipei University of Nursing and Health Sciences
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 20 Nov 2024 (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.
The purpose of this study is to develop an evidence-based educational program for scleroderma patients with hand dysfunction. The program includes a self-care handbook and multimedia video resources. The study aims to answer:
Does the intervention improve hand function in the experimental group compared to the control group? Does the intervention improve self-care knowledge of hand dysfunction? Does the intervention improve overall health?
Participants will receive an 8-week program, while the control group receives usual care. Outcome measures include hand function, overall health, and self-care knowledge.
Detailed description
The study will adopt a repeated measures randomized controlled trial design (parallel randomized controlled trial) using convenience sampling. Participants in the experimental group will receive an "evidence-based scleroderma hand dysfunction education program" provided by the researchers for eight weeks. The control group will receive standard medical care during the study period and will receive the same scleroderma hand dysfunction education program as the experimental group after the study concludes. Both groups will undergo pre-intervention assessments, as well as post-intervention assessments at the fourth and eighth weeks. The primary outcome measures include evaluating the effectiveness of the education program in improving hand dysfunction severity, overall health, adherence to rehabilitation exercises, and self-care knowledge related to hand dysfunction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient education group | Experimental | Behavioral: patient education programreceives the "Evidence-Based Education Program for people with hand dysfunction in scleroderma" (which includes: educational handbook on self-care for hand dysfunction in scleroderma, multimedia teaching materials, and individualized consultations). |
| control group | No intervention | –Receives usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants with systemic sclerosis who meet the 2013 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) diagnostic criteria and have hand dysfunction.
- Adults aged 18 years or older.
- Participants who are conscious and able to communicate in Mandarin Chinese or Taiwanese Hokkien.
- Participants who provide informed consent to participate in the study after being briefed on its purpose.
Key exclusion criteria (2 listed)
- 1. Participants who have participated in any other hand rehabilitation program within the past three months.
- 2, Participants with organic brain dysfunction. 3. Participants with severe visual or hearing impairments. 4. Participants with serious illnesses that hinder communication or interfere with the normal learning process.
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 |
|---|---|---|
| patient education programThe intervention for the experimental group was an "evidence-based educational program for hand dysfunction in patients with systemic sclerosis," which included a health education manual and multimedia videos developed through evidence translation. Additionally, individual education and consultation were provided. | Behavioural | Patient education group |
Primary outcome
Self-developed questionnaire on self-care knowledge for scleroderma hand dysfunction
Time frame: At baseline, 4 weeks, and 8 weeks post-intervention
The "Scleroderma Hand Function-Related Self-Care Knowledge Scale," validated by experts for reliability and validity, consists of 15 items. The scale uses a dichotomous scoring method with three response options: "True," "False," and "Don't know." It includes both positively and negatively worded items. Correct answers are scored as one point, while incorrect answers and "Don't know" responses are scored as zero. The total score ranges from 0 to 15, with higher scores indicating a greater level of self-care knowledge regarding scleroderma-related hand function impairments.
Grip strength
Time frame: At baseline, 4 weeks, and 8 weeks post-intervention.
Grip strength of the dominant hand (in kg) will be measured using a dynamometer, and the average of three trials will be used as the final muscle strength assessment indicator.
delta finger-to-palm, Delta-FTP
Time frame: At baseline, 4 weeks, and 8 weeks post-intervention.
Delta-FTP refers to the difference in distance between the tip of the third finger and the midpoint of the distal palmar crease when the finger is fully extended and fully flexed. It is an effective measurement method to assess the range of motion and flexibility of fingers in patients with scleroderma.
Raynaud's phenomenon visual analog scale
Time frame: At baseline, 4 weeks, and 8 weeks post-intervention.
This scale evaluates the severity and impact of Raynaud's phenomenon on daily activities in patients with scleroderma over the past week. Scores range from 0 mm (no impact) to 100 mm (very severe impact), with higher scores indicating greater impairment of hand function
Digital ulcers visual analog scale
Time frame: At baseline, 4 weeks, and 8 weeks post-intervention.
This scale evaluates the severity and impact of Digital ulcers on daily activities in patients with scleroderma over the past week. Scores range from 0 mm (no impact) to 100 mm (very severe impact), with higher scores indicating greater impairment of hand function.
2 secondary outcomes
Overall disease severity visual analog scale
Time frame: At baseline, 4 weeks, and 8 weeks post-intervention
Adherence to Hand Exercise Training
Time frame: At baseline, 4 weeks, and 8 weeks post-intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
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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.
Cheng Hsin General Hospital principal investigator
Institutional Review Board
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patient education program in people with Scleroderma, Systemic, run by Wen-Shao Lin at 1 site in Taiwan.
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 4 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 20 Nov 2024. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
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?
Self-developed questionnaire on self-care knowledge for scleroderma hand dysfunction (time frame: At baseline, 4 weeks, and 8 weeks post-intervention). The study lists 5 primary outcomes in all. 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 20 Nov 2024; AzTrials last refreshed its copy on 29 Oct 2026.