Clinical trial NCT06697561: Development and Evaluation of an Evidence-based Education Program for People With Hand Dysfunction in Scleroderma
Official title: Development and Evaluation of an Evidence-based Education Program for People With Hand Dysfunction in Scleroderma: A Randomized Control Trail
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Scleroderma, Systemic
Keywords: Scleroderma
Hand dysfunction
Evidence-based knowledge translation
Patient education
Lead sponsor: Cheng-Hsin General Hospital
Sponsor class: OTHER
Collaborators: name: Cheng Hsin Rehabilitation Medical Center
name: National Taipei University of Nursing and Health Sciences
First posted: 2024-11-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Participants with systemic sclerosis who meet the 2013 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) diagnostic criteria and have hand dysfunction.
2. Adults aged 18 years or older.
3. Participants who are conscious and able to communicate in Mandarin Chinese or Taiwanese Hokkien.
4. Participants who provide informed consent to participate in the study after being briefed on its purpose.

Exclusion Criteria:

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.

Primary outcomes:
measure: Self-developed questionnaire on self-care knowledge for scleroderma hand dysfunction
timeFrame: At baseline, 4 weeks, and 8 weeks post-intervention
measure: Grip strength
timeFrame: At baseline, 4 weeks, and 8 weeks post-intervention.
measure: delta finger-to-palm, Delta-FTP
timeFrame: At baseline, 4 weeks, and 8 weeks post-intervention.
measure: Raynaud's phenomenon visual analog scale
timeFrame: At baseline, 4 weeks, and 8 weeks post-intervention.
measure: Digital ulcers visual analog scale
timeFrame: At baseline, 4 weeks, and 8 weeks post-intervention.
Secondary outcomes:
measure: Overall disease severity visual analog scale
timeFrame: At baseline, 4 weeks, and 8 weeks post-intervention
measure: Adherence to Hand Exercise Training
timeFrame: At baseline, 4 weeks, and 8 weeks post-intervention.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Cheng Hsin General Hospital
Study officials:
affiliation: Institutional Review Board
name: Cheng Hsin General Hospital
role: PRINCIPAL_INVESTIGATOR
References: