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

NCT06697561 | Active Not Recruiting DMC

• 1 other identifier: (1106)113A-36
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Scleroderma, Systemic

Keywords

Scleroderma; Hand dysfunction; Evidence-based knowledge translation; Patient education

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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

  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.

  At baseline, 4 weeks, and 8 weeks post-intervention.

Secondary Outcomes (2)

• Overall disease severity visual analog scale

  At baseline, 4 weeks, and 8 weeks post-intervention

• Adherence to Hand Exercise Training

  At baseline, 4 weeks, and 8 weeks post-intervention.

Study Arms (2)

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).

Behavioral: patient education program

control group

NO INTERVENTION

Receives usual care

Interventions

patient education program BEHAVIORAL

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.

Patient education group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. Participants who have participated in any other hand rehabilitation program within the past three months.
• , 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.

Sponsors & Collaborators

• Wen-Shao Lin: lead
• Cheng Hsin Rehabilitation Medical Center: collaborator
• National Taipei University of Nursing and Health Sciences: collaborator

Study Sites (1)

Cheng Hsin General Hospital

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Scleroderma, Systemic; Scleroderma, Diffuse

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Cheng Hsin General Hospital

  Institutional Review Board

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Nurse Practitioner

Study Record Dates

• First Submitted: November 16, 2024
• First Posted: November 20, 2024
• Study Start: July 30, 2024
• Primary Completion: June 30, 2025
• Study Completion: July 31, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-11

Locations

TW (1)