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Not yet recruiting NCT06719323

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

No phase Interventional Heart Defects, Congenital

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Family Walking Instruction with Support by Heart (Family WISH) program, Comparison group.
Who it may be relevant to
Registry conditions: Heart Defects, Congenital. Basic parameters: 12 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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.
  • Behavioral Comparison group
    a family walking health education sheet received

Primary outcome measures

  • frailty state [Time frame: at baseline, and at 6, 12, and 24 weeks]
Secondary outcome measures (1)
  • quality of life and family functioning [Time frame: at baseline, and at 6, 12, and 24 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Taiwan · 1 center
  • College of Nursing, National Yang Ming Chiao Tung University — Taipei

Identifiers

NCT: NCT06719323 · 202401204RINC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗