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

Condition(s) studied

Investigational drug(s) / intervention(s)

patient education program: 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 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (1)