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

NCT06719323 | Not Yet Recruiting DMC

• 1 other identifier: 202401204RINC
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Defects, Congenital

Outcome Measures

Primary Outcomes (1)

• frailty state

  self-reported questionnaire completed

  at baseline, and at 6, 12, and 24 weeks

Secondary Outcomes (1)

• quality of life and family functioning

  at baseline, and at 6, 12, and 24 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

Experimental group: a 12-week Family WISH program

Comparison group

SHAM COMPARATOR

Comparison group: a family walking health education sheet received

Behavioral: Comparison group

Interventions

Comparison group BEHAVIORAL

a family walking health education sheet received

Comparison group

Family Walking Instruction with Support by Heart (Family WISH) program BEHAVIORAL

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.

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chi-Wen Chen: lead

Study Sites (1)

College of Nursing, National Yang Ming Chiao Tung University

Taipei, 112304, Taiwan

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Chi-Wen Chen, PhD

CONTACT

011-886-228267348; chiwenchen@nycu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: To ensure assessor blinding, different personnel conducted the interventions and outcome assessments.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 5, 2024
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)