Clinical trial NCT06004622: Effectiveness of Calgary Family Intervention Model in Caregivers
Official title: Effectiveness of Calgary Family Intervention Model Improving on Uncertainty, Family Functioning, and Resilience in Caregivers of Infants and Toddlers Undergoing Open-heart Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing
Keywords: Calgary family intervention model
caregiver
uncertainty
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-08-22
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Effectiveness of Calgary family intervention model improving on uncertainty, family functioning, and resilience in caregivers of infants and toddlers undergoing open-heart surgery.Research hypothesis is The experimental group of caregivers for infants and toddlers undergoing open-heart surgery showed significant differences in uncertainty, family functioning, and family resilience before surgery, prior to transferring out of the intensive care unit, and before discharge.

Detailed description: Background: For caregivers of infants and toddlers with congenital heart disease, the experience of their young children undergoing open-heart surgery brings about uncertainty, including waiting for the child's recovery, providing care in the intensive care unit, and the possibility of death. These uncertainties can significantly impact the caregivers' physical and mental well-being, as well as their ability to provide subsequent care and nurture for the child. Therefore, it is crucial to implement intervention measures that focus on caring for the caregivers, reducing their sense of uncertainty, and implementing effective nursing strategies to enhance family functioning and resilience.

Purpose: This study aims to investigate the effectiveness of implementing the Calgary Family Intervention Model on caregivers of infants and toddlers undergoing open-heart surgery in terms of reducing their uncertainty, improving family functioning, and enhancing resilience.

Methods: This study adopts a quasi-experimental research design and will be conducted at a medical center in northern Taiwan. A total of 96 caregivers of infants and toddlers undergoing open-heart surgery will be recruited, and a pre- and post-test design will be employed with two groups. The control group will receive routine nursing care, while the experimental group will receive routine nursing care supplemented with the Calgary Family Intervention Model, which encompasses cognitive, emotional, and behavioral domains. The experimental group will participate in two therapeutic sessions: 1. The day after surgery and before visiting the child, and 2. Prior to transferring out of the intensive care unit. Both groups will be assessed using the parental uncertainty perception scale, APGAR family function assessment scale, and the family resilience scale as outcome measures. Data will be collected before surgery, prior to transferring out of the intensive care unit, and before discharge. Interviews will be conducted with the experimental group, and data analysis will involve Generalized Estimating Equations (GEE) for quantitative data and content analysis for qualitative data.

Expected contributions: In future clinical practice, this study aims to provide valuable insights into the use of family nursing intervention for caregivers of infants and toddlers undergoing open-heart surgery, specifically in managing the uncertainties associated with the illness context. Through therapeutic conversations, this intervention can help identify family strengths and resources, thereby serving as an important reference strategy for enhancing family resilience.

Eligibility criteria: Inclusion Criteria:

1. Father or mother of infants and toddlers aged from 1 month to 3 years (inclusive) undergoing open-heart surgery.
2. Infants and toddlers diagnosed with congenital heart disease who are undergoing their first open-heart surgery.
3. Caregivers who are proficient in the national or Taiwanese language and have normal cognitive abilities.
4. Caregivers who can read and understand Chinese characters, enabling them to complete the questionnaires.
5. After explanation and reading of the informed consent, caregivers will provide written consent for participation.

Exclusion Criteria:

1. Father or mother of newborns who undergoing open-heart surgery within the first month after birth.
2. Caregivers with mental illness or intellectual disabilities.

Primary outcomes:
measure: parental uncertainty perception scale
timeFrame: one year
measure: APGAR family function assessment scale
timeFrame: one year
measure: family resilience scale
timeFrame: one year
Secondary outcomes:
measure: Interview Outline
timeFrame: approximately one year.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Yang Ming Chiao Tung University
name: Chi-Wen Chen, doctor
role: STUDY_DIRECTOR
References: