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NCT Number: NCT06719323

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

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.

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Key information

Conditions

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

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Comparison group

Behavioral

a family walking health education sheet received

Primary outcomes

  1. frailty state

    Time frame: at baseline, and at 6, 12, and 24 weeks

    self-reported questionnaire completed

Secondary outcomes

  1. quality of life and family functioning

    Time frame: at baseline, and at 6, 12, and 24 weeks

    self-reported questionnaires completed

Study contacts

Contact information is provided by the study sponsor or research team.

Chi-Wen Chen, PhD

CONTACT

[email protected]

011-886-228267348

Sponsors and collaborators

Lead sponsor

Chi-Wen Chen

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 5, 2024
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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