Caregiver Burden of CaregiversNCT07201753
Hospital-integrated Care Services
An observational study of Caregiver Burden of Caregivers and Hospital-Integrated Care Services, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This study aims to explore the relationship between hospital-integrated care services and caregivers' psychological outcomes. The study will be conducted as a cross-sectional observational design at a medical center in northern Taiwan. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver Burden of Caregivers, Hospital-Integrated Care Services
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Sep 2025to 25 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary caregivers of hospitalized adult patients receiving integrated inpatient care services at a medical center in northern Taiwan. Caregivers must be aged 18 years or older and able to complete the study questionnaires.
Who may be able to join
- Participants include inpatients receiving integrated inpatient care services at our hospital and their primary family caregivers. The patient or family member must have signed the consent form for integrated inpatient care services. The specific conditions are as follows:
- Primary Caregiver Criteria:
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- The primary caregiver is a family member aged 18 years or older who can communicate in Mandarin or Taiwanese.
- The family member is willing to sign the participant consent form. 2.Patient Criteria:
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- The patient has been admitted to the pilot ward for at least 24 hours.
Who cannot join
- Patients who are discharged or transferred out of the pilot ward within 24 hours of admission.
- If a patient is re-hospitalized during the study enrollment period and their primary caregiver is the same as in the previous enrollment, the subsequent duplicate case will be excluded.
- Patients without family members will be enrolled in the ward's mandatory integrated inpatient care service program, but follow-up care issues will be handled by social workers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring the Relationship Between Hospital-integrated Care Services and Caregiver Burden at a Medical Center in Northern Taiwan.
This study aims to explore the relationship between hospital-integrated care services and caregivers' psychological outcomes. The study will be conducted as a cross-sectional observational design at a medical center in northern Taiwan. Data will be collected from primary caregivers of hospitalized patients through validated questionnaires. The findings are expected to provide insights into improving caregiver support and enhancing patient and caregiver experiences during hospital stays.
What is being measured
The primary outcome is the main question the study is designed to answer.
Total score of caregiver burden as measured by the Zarit Burden Interview (ZBI-22)
The Traditional Chinese version of the ZBI-22 includes 22 Likert-type items (0-4); total scores range from 0 to 88, with higher scores indicating greater burden.
Measured: Within 48 hours prior to hospital discharge.
Secondary outcomes (3)
Total score of caregiver burden as measured by the Caregiver Burden Inventory (CBI)
The Traditional Chinese version of the CBI includes 24 Likert-type items (0-4); total scores range from 0 to 96, with higher scores indicating greater burden across multiple domains.
Measured: Within 48 hours prior to hospital discharge.
Subscale scores of anxiety and depression as measured by the Hospital Anxiety and Depression Scale (HADS)
The Traditional Chinese version of HADS contains 14 items, 7 for anxiety and 7 for depression. Each item is scored 0-3; subscale scores range from 0 to 21, with higher scores indicating more severe symptoms.
Measured: Within 48 hours prior to hospital discharge.
Domain mean scores of inpatient satisfaction as measured by the standardized hospital inpatient satisfaction survey
The hospital's standardized inpatient satisfaction survey includes 31 items. Each item is rated on a 5-point Likert-type scale, with response anchors varying by question (e.g., from "very sufficient" to "very insufficient," or from "strongly agree" to "strongly disagree"). Scores are calculated as domain means, with higher scores indicating greater inpatient satisfaction.
Measured: Within 48 hours prior to hospital discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start29 Sep 2025
- Primary completion28 Feb 2026
- Study completion25 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver Burden of CaregiversStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201753
- Sponsor's protocol ID
- 202506121RINB
- Status last verified
- Jan 2026
- First submitted
- 14 Aug 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Relationship Between Hospital-integrated Care Services and Caregiver Burden at a Medical Center in Northern Taiwan.
- ClinicalTrials.gov ID
- NCT07201753
- Acronym / sponsor ID
- 202506121RINB
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 25 Aug 2026 (estimated)
- First posted
- 1 Oct 2025 (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.
This study aims to explore the relationship between hospital-integrated care services and caregivers' psychological outcomes. The study will be conducted as a cross-sectional observational design at a medical center in northern Taiwan. Data will be collected from primary caregivers of hospitalized patients through validated questionnaires. The findings are expected to provide insights into improving caregiver support and enhancing patient and caregiver experiences during hospital stays.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary caregivers of hospitalized adult patients receiving integrated inpatient care services at a medical center in northern Taiwan. Caregivers must be aged 18 years or older and able to complete the study questionnaires.
Key inclusion criteria (7 listed)
- Participants include inpatients receiving integrated inpatient care services at our hospital and their primary family caregivers. The patient or family member must have signed the consent form for integrated inpatient care services. The specific conditions are as follows:
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Key exclusion criteria (3 listed)
- Patients who are discharged or transferred out of the pilot ward within 24 hours of admission.
- If a patient is re-hospitalized during the study enrollment period and their primary caregiver is the same as in the previous enrollment, the subsequent duplicate case will be excluded.
- Patients without family members will be enrolled in the ward's mandatory integrated inpatient care service program, but follow-up care issues will be handled by social workers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total score of caregiver burden as measured by the Zarit Burden Interview (ZBI-22)
Time frame: Within 48 hours prior to hospital discharge.
The Traditional Chinese version of the ZBI-22 includes 22 Likert-type items (0-4); total scores range from 0 to 88, with higher scores indicating greater burden.
3 secondary outcomes
Total score of caregiver burden as measured by the Caregiver Burden Inventory (CBI)
Time frame: Within 48 hours prior to hospital discharge.
Subscale scores of anxiety and depression as measured by the Hospital Anxiety and Depression Scale (HADS)
Time frame: Within 48 hours prior to hospital discharge.
Domain mean scores of inpatient satisfaction as measured by the standardized hospital inpatient satisfaction survey
Time frame: Within 48 hours prior to hospital discharge.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Caregiver Burden of Caregivers and Hospital-Integrated Care Services, run by National Taiwan University Hospital at 1 site in Taiwan.
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 7 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: under way, not looking for participants, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total score of caregiver burden as measured by the Zarit Burden Interview (ZBI-22) (time frame: Within 48 hours prior to hospital discharge.). 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 1 Apr 2026.