Caregiver Burden, Quality of Life, Family Function and Family Resilience Among Caregivers of Children With Medical Complexity.

NCT06503419 | Not Yet Recruiting

• 1 other identifier: 202406005RINE
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to employ a mixed methods research approach combining quantitative and qualitative methods to thoroughly understand the relationships among caregiver burden, quality of life, family functioning, and family resilience of children with medical complexity (CMC). The study aims to explore the individual and social factors influencing these variables and investigate the factors impacting caregiver burden, quality of life, family functioning, and family resilience of CMC caregivers. Finally, an integrative analytical framework will be proposed. The study seeks to provide guidance and recommendations for social support for caregivers of children with medical complexity in caregiving practices, aiming to promote the development of relevant policies and services.

Conditions

Caregiver Burden; Quality of Life; Family Function; Family Resilience

Keywords

Children with medical complexity; caregiver burden; quality of life; family functioning; family resilience

Outcome Measures

Primary Outcomes (5)

• Caregiver Burden Inventory (CBI)

  Scale: 0 to 96, with higher scores indicating greater caregiver burden. Description: This measure will assess the time dependence, developmental, physical, social, and emotional burdens experienced by caregivers of children with medical complexity.

  Less than 1 hour.

• Quality of Life [Short Form Health Survey (SF-12)]

  Scale: 0 to 100 for each domain, with higher scores indicating better quality of life. Description: This measure will evaluate the physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health of caregivers.

  Less than 1 hour.

• Family Function (Family APGAR)

  Scale: 0 to 10, with higher scores indicating better family function. Description: This measure will assess family adaptability, partnership, growth, affection, and resolve.

  Less than 1 hour.

• Family Resilience Scale

  Scale: 31 to 155, with higher scores indicating greater family resilience. Description: This measure will evaluate the belief systems, organizational patterns, and communication processes of families dealing with children with medical complexity.

  Less than 1 hour.

• Qualitative Understanding of Caregiver Experiences by Semi-structured Interviews

  This measure will complement the quantitative data by providing in-depth insights into the personal experiences, challenges, coping strategies, and perspectives of caregivers of children with medical complexity. Thematic analysis will be conducted on the qualitative data to identify key themes and factors influencing caregiver burden, quality of life, family function, and family resilience.Description: This measure will complement the quantitative data by providing in-depth insights into the personal experiences, challenges, coping strategies, and perspectives of caregivers of children with medical complexity.

  About 1 hour.

Interventions

non-intervention OTHER

non-intervention

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population comprises primary caregivers of children with medical complexity (CMC)

You may qualify if:

• Must be the primary caregiver of a child with medical complexity, providing care for at least 12 months.
• Aged 20 years or older.
• Must be a cohabiting family member of the child and have a biological relationship with the child.
• Willing to participate in the study.
• The child with medical complexity being cared for by the participant is between the ages of 1 and 20, diagnosed by a physician with a chronic illness or disability. The child requires the use of medical equipment or devices at home, including respiratory support equipment such as tracheostomy care supplies, artificial ventilation masks, mechanical ventilators (respirators), oxygen concentrators and tanks, suction machines, and percussion vests; nutritional and medication devices such as gastric tubes (nasogastric or percutaneous gastrostomy tubes), enteral feeding pumps, and intravenous catheters; mobility aids including wheelchairs, walkers, and rehabilitation assistive devices; monitoring equipment such as electrocardiogram (ECG) monitors, blood pressure monitors, thermometers, and pulse oximeters; and other medical equipment such as urinary bags and catheters, and pain management pumps (e.g., PCA). Additionally, due to their condition, the child receives regular medical examinations or treatments.

You may not qualify if:

• Diagnosed with a mental illness by a physician.
• Assessed by the researcher as lacking the reading and comprehension abilities necessary to complete the study.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• ChingWen Cheng, MD

  National Taiwan University Hospital

  STUDY CHAIR

Central Study Contacts

ChingWen Cheng, MD

CONTACT

+886 966621883; 110036@ntuh.gov.tw

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 16, 2024
• Study Start: August 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share