Development and Evaluation of an Evidence-based Education Program for People With Hand Dysfunction in Scleroderma

Not Applicable

Active, not recruiting

• Conditions: Scleroderma, Systemic

• Registration Number: NCT06697561
• Lead Sponsor: Wen-Shao Lin

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.

Study Timeline

• Study Start: 2024-07-30
• Status Verified: 2024-11
• Study First Submitted: 2024-11-16
• Study First Submitted QC: 2024-11-19
• Last Update Submitted: 2024-11-19
• Study First Posted: 2024-11-20
• Last Update Posted: 2024-11-20
• Primary Completion: 2025-06-30
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Self-developed questionnaire on self-care knowledge for scleroderma hand dysfunction	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	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	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Overall disease severity visual analog scale	At baseline, 4 weeks, and 8 weeks post-intervention	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.
Adherence to Hand Exercise Training	At baseline, 4 weeks, and 8 weeks post-intervention.	Using an exercise diary as an evaluation tool to assess the effectiveness of adherence to rehabilitation exercise training

Trial Locations

Locations (1)

Cheng Hsin General Hospital; 🇨🇳 Taipei, Taiwan