Long-term Effects of Family WISH Program for Adolescents with Congenital Heart Disease

Not Applicable

Not yet recruiting

• Conditions: Heart Defects, Congenital

• Registration Number: NCT06719323
• Lead Sponsor: Chi-Wen Chen

Brief Summary

The goal of this clinical trial is to learn the long-term effects of "Family Walking Instruction with Support by Heart" (Family WISH) on frailty state, quality of life and family functioning among adolescents with congenital heart disease (CHD).

Researchers will compare the 12-week Family WISH program, based on self-efficacy theory, to a comparison group receiving a family walking health education sheet to evaluate the long-term effectiveness of the Family WISH program.

Participants will:

* Walk with family members for 20-30 minutes daily, at least 5 times per week, totaling 150 minutes per week.

* Keep a diary to record the frequency of their walks and any symptoms experienced.

* Complete questionnaires at baseline, and at 6, 12, and 24 weeks.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-27
• Study First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-03
• Study First Posted: 2024-12-05
• Last Update Posted: 2024-12-05
• Study Start: 2025-12-01
• Primary Completion: 2027-07-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

• being between 12 and 18 years old;
• having received a diagnosis of CHD by a physician before age 2;
• having received a diagnosis of CHD with New York Heart Association (NYHA) functional class I, II, or III;
• having parents or guardians who were able to communicate in Mandarin, and being able to communicate in Mandarin themselves;
• not having cognitive impairments, and;
• voluntarily signing informed consent forms.

Exclusion Criteria

• undergoing heart transplant surgery within the past year;
• receiving cardiac catheterization intervention or open-heart surgery within the past 6 months;
• having CHD with NYHA functional class IV; and
• having other congenital diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
frailty state	at baseline, and at 6, 12, and 24 weeks	self-reported questionnaire completed

Secondary Outcome Measures

Name	Time	Method
quality of life and family functioning	at baseline, and at 6, 12, and 24 weeks	self-reported questionnaires completed

Trial Locations

Locations (1)

College of Nursing, National Yang Ming Chiao Tung University; 🇨🇳 Taipei, Taiwan