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

January 8, 2026 updated by: Chi-Wen Chen

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan, 112304
        • College of Nursing, National Yang Ming Chiao Tung University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Experimental group: a 12-week Family WISH program
Behavioral: Family Walking Instruction with Support by Heart (Family WISH) program
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.
Sham Comparator: Comparison group
Comparison group: a family walking health education sheet received
Behavioral: Comparison group
a family walking health education sheet received

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
frailty state
Time Frame: at baseline, and at 6, 12, and 24 weeks
self-reported questionnaire completed
at baseline, and at 6, 12, and 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life and family functioning
Time Frame: at baseline, and at 6, 12, and 24 weeks
self-reported questionnaires completed
at baseline, and at 6, 12, and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chi-Wen Chen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

November 27, 2024

First Submitted That Met QC Criteria

December 3, 2024

First Posted (Actual)

December 5, 2024

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202401204RINC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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