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

C

Chi-Wen Chen

Status

Begins enrollment in 3 months

Conditions

Heart Defects, Congenital

Treatments

Behavioral: Comparison group
Behavioral: Family Walking Instruction with Support by Heart (Family WISH) program

Study type

Interventional

Funder types

Other

Identifiers

NCT06719323
202401204RINC

Details and patient eligibility

About

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.

Enrollment

104 estimated patients

Sex

All

Ages

12 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

104 participants in 2 patient groups

Experimental group
Experimental group
Description:
Experimental group: a 12-week Family WISH program
Comparison group
Sham Comparator group
Description:
Comparison group: a family walking health education sheet received
Treatment:
Behavioral: Comparison group

Trial contacts and locations

1

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Central trial contact

Chi-Wen Chen, PhD

Data sourced from clinicaltrials.gov

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