Clinical trial NCT05533346: Long-term Effects of WISE Program Improving Frailty Status and Quality of Life for Adolescents With CHD
Official title: Long-term Effects of WISE Program Improving Frailty Status and Quality of Life for Adolescents With Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Frailty
Keywords: CHD, adolescents, quality of life, walking
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2022-09-09
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Most children with congenital heart disease (CHD) are expected to survive until adulthood. In addition to physical limitations, the growing adolescents with CHD are also challenged at the psychosocial domains. Previous studies have investigated the frailty of elderly, but the research on the intervention to the frailty of adolescents with CHD has been limited. The aims of this study will apply the Walking Instruction based on Self-Efficacy (WISE) program to examine the long-term effects of improving frailty state and quality of life for adolescents with CHD.

Detailed description: This proposal will conduct a three-year series of studies. In the first year, a cross-sectional survey will be used to evaluate the applicability of the Fried frailty index to adolescents with CHD, and to examine the correlation between frailty index and quality of life in adolescent patients. In the second year, investigators will conduct individual in-depth interviews with selected pre-frailty/frailty adolescent participants and their main caregivers to gain insights into their views, connotations and support needs for frailty, which will serve as the basis for the design of the next interventional study. In the third year, the WISE program will be developed to provide 12-week walking self-efficacy improvement education strategies and exercise bracelets with heart rate monitoring. The recruited pre-frailty/frailty adolescent participants will be randomly assigned to experimental and control groups respectively in the pretest-posttest control group design. The changes in frailty state and quality of life for the two groups will be evaluated at 6, 12 and 24 weeks. The results of this study can provide frailty evaluation indicators for adolescents with CHD, timely detect the pre-frailty stage, and provide an important reference for the prevention of frailty intervention for adolescents with CHD as early as possible.

Eligibility criteria: Inclusion Criteria:

1. Aged between 12-18 years old.
2. Congenital heart disease diagnosed by a doctor before the age of 2.
3. The American New York Heart Association (NYHA) classifies the cardiac function as I-III grades.
4. Adolescents and their parents or guardians can communicate in Mandarin and Taiwanese and have normal cognitive abilities.
5. Those who are willing to cooperate with the research and complete the consent form.

Exclusion Criteria:

1. Received a heart transplant within one year.
2. Have undergone open-heart surgery within six months.
3. The New York Heart Association (NYHA) classifies the cardiac function as class IV.
4. Combined with other congenital diseases.

Primary outcomes:
measure: Frailty Status
timeFrame: change from baseline to post-intervention at 6-week follow-up
measure: Frailty Status
timeFrame: change from baseline to post-intervention at 12-week follow-up
measure: Frailty Status
timeFrame: change from baseline to post-intervention at 24-week follow-up
Secondary outcomes:
measure: Quality of life for adolescents with congenital heart disease
timeFrame: change from baseline to post-intervention at 6-week follow-up
measure: Quality of life for adolescents with congenital heart disease
timeFrame: change from baseline to post-intervention at 12-week follow-up
measure: Quality of life for adolescents with congenital heart disease
timeFrame: change from baseline to post-intervention at 24 week follow-up
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Yang Ming Chiao Tung University
Study officials:
References: