Caregiver BurdenNCT06503419
Caregiver Burden, Quality of Life, Family Function and Family Resilience Among Caregivers of Children With Medical Complexity.
An observational study of Caregiver Burden and Quality of Life, run by National Taiwan University Hospital.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver Burden, Quality of Life, Family Function
- What is being tested?
- non-intervention
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population comprises primary caregivers of children with medical complexity (CMC)
Who may be able to join
- 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.
- Note: Inclusion criteria are the same for both quantitative and qualitative studies.
Who cannot join
- Diagnosed with a mental illness by a physician.
- Assessed by the researcher as lacking the reading and comprehension abilities necessary to complete the study.
- Note: Exclusion criteria are the same for both quantitative and qualitative studies.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Caregiver Burden, Quality of Life, Family Function and Family Resilience Among Caregivers of Children With Medical Complexity: A Mixed Methods Convergent Parallel Design
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.
Read the detailed description
This study employs a convergent parallel mixed methods design. The quantitative part involves a questionnaire survey using purposive and snowball sampling methods, inviting 400 caregivers of children with medical complexity (CMC) to participate. Stratified sampling is then applied, with 62 samples selected per age group (1-5 years, 6-10 years, 11-15 years, 16-20 years), resulting in a total of 248 valid samples. The aim is to measure the correlations among caregiver burden, quality of life, family functioning, and family resilience. For the qualitative research, purposive and snowball sampling methods are also used to recruit 10 caregivers of CMC from different age groups who meet the inclusion criteria and agree to participate. These caregivers undergo semi-structured in-depth interviews, with interview content recorded to gain deeper insights into their experiences and feelings regarding caregiver burden, quality of life, family functioning, and family resilience. The study instruments include validated tools such as the Caregiver Burden Inventory (CBI), SF-12 Health Survey for quality of life, the APGAR Family Functioning Scale, and a Chinese version of the Family Resilience Scale. Qualitative data are collected through semi-structured interviews. Data analysis involves descriptive statistics, analysis of variance (ANOVA), and multiple linear regression models using IBM SPSS Statistics 27 for quantitative data. Qualitative data are analyzed using textual and thematic analysis methods, supported by NVivo qualitative analysis software. Finally, data triangulation is employed to integrate and compare quantitative and qualitative findings, leading to conclusions and recommendations.
- Conditions
- Caregiver Burden, Quality of Life, Family Function, Family Resilience
- Being tested
- non-intervention
- Keywords
- Children with medical complexity, caregiver burden, quality of life, family functioning, family resilience
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-interventionOther
non-intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: About 1 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver BurdenStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ChingWen Cheng, MD, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06503419
- Sponsor's protocol ID
- 202406005RINE
- Status last verified
- Jul 2024
- First submitted
- 1 Jul 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregiver Burden, Quality of Life, Family Function and Family Resilience Among Caregivers of Children With Medical Complexity: A Mixed Methods Convergent Parallel Design
- ClinicalTrials.gov ID
- NCT06503419
- Acronym / sponsor ID
- 202406005RINE
- Conditions
- Caregiver Burden, Quality of Life, Family Function, Family Resilience
- Keywords
- Children with medical complexity, caregiver burden, quality of life, family functioning, family resilience
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study employs a convergent parallel mixed methods design. The quantitative part involves a questionnaire survey using purposive and snowball sampling methods, inviting 400 caregivers of children with medical complexity (CMC) to participate. Stratified sampling is then applied, with 62 samples selected per age group (1-5 years, 6-10 years, 11-15 years, 16-20 years), resulting in a total of 248 valid samples. The aim is to measure the correlations among caregiver burden, quality of life, family functioning, and family resilience. For the qualitative research, purposive and snowball sampling methods are also used to recruit 10 caregivers of CMC from different age groups who meet the inclusion criteria and agree to participate. These caregivers undergo semi-structured in-depth interviews, with interview content recorded to gain deeper insights into their experiences and feelings regarding caregiver burden, quality of life, family functioning, and family resilience. The study instruments include validated tools such as the Caregiver Burden Inventory (CBI), SF-12 Health Survey for quality of life, the APGAR Family Functioning Scale, and a Chinese version of the Family Resilience Scale. Qualitative data are collected through semi-structured interviews. Data analysis involves descriptive statistics, analysis of variance (ANOVA), and multiple linear regression models using IBM SPSS Statistics 27 for quantitative data. Qualitative data are analyzed using textual and thematic analysis methods, supported by NVivo qualitative analysis software. Finally, data triangulation is employed to integrate and compare quantitative and qualitative findings, leading to conclusions and recommendations.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprises primary caregivers of children with medical complexity (CMC)
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- Diagnosed with a mental illness by a physician.
- Assessed by the researcher as lacking the reading and comprehension abilities necessary to complete the study.
- Note: Exclusion criteria are the same for both quantitative and qualitative studies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-interventionnon-intervention | Other | – |
Primary outcome
Caregiver Burden Inventory (CBI)
Time frame: Less than 1 hour.
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.
Quality of Life [Short Form Health Survey (SF-12)]
Time frame: Less than 1 hour.
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.
Family Function (Family APGAR)
Time frame: Less than 1 hour.
Scale: 0 to 10, with higher scores indicating better family function. Description: This measure will assess family adaptability, partnership, growth, affection, and resolve.
Family Resilience Scale
Time frame: Less than 1 hour.
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.
Qualitative Understanding of Caregiver Experiences by Semi-structured Interviews
Time frame: About 1 hour.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ChingWen Cheng, MD study chair
National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Caregiver Burden and Quality of Life, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ChingWen Cheng, MD (+886 966621883, 110036@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver Burden Inventory (CBI) (time frame: Less than 1 hour.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.