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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
40
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.
Cheng Hsin General Hospital
Taipei, Taiwan
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: At baseline, 4 weeks, and 8 weeks post-intervention.
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.
Time frame: 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
Time frame: At baseline, 4 weeks, and 8 weeks post-intervention.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.