Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
Study NCT ID:
NCT04250103
Status:
UNKNOWN
Last Update Posted:
2020-01-31
First Post:
2020-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Home-based Longitudinal Investigation of the Multidisciplinary Team Integrated Care
Sponsor:
National Health Research Institutes, Taiwan
Organization:
Study Overview
Official Title:
Developing Innovative Models for Health & Long-term Care Facilities and Technology Services: Prospective Cohort Study for Home Health Care
Status:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HOLISTIC
Brief Summary:
Some research found the effectiveness of implementation of home health care on patients' physical function, quality of life (QoL) and decreased the risk of hospitalization and medical costs. However, little was known about the longitudinal change of comprehensive assessments of physical and mental health, QoL, well-being, and medical resource utilization of patients receiving home health care and their caregivers. Furthermore, the evaluation of advance care planning, palliative care need, and the quality of dying and death were also insufficient among the aforementioned population. Therefore, this cohort study aims to investigate the longitudinal change of health-related outcomes and utilization of resource utilization, and explore their trajectories in two years for patients who receive home health care and their caregivers in Taiwan.
Detailed Description:
This is a prospective longitudinal cohort study in Taiwan. Data will be collected by trained interviewers at the baseline (T0), 3-month follow-up (T1), 6-month follow-up (T2), 12-month follow-up (T3), 18-month follow-up (T4), and 24-month follow-up (T5). Via home visits, interviewer-administered questionnaires (informed consent, contact/follow-up information, background information, health condition, physical functioning, cognitive function, etc.) will be used. It estimates that the home visit will take up to 2 hours.
The investigators will recruit at least 1200 eligible patients and caregivers (600 dyads) from at least 15 institutions (e.g., home clinics and hospitals) which provide home health care. Trained research assistants will touch based with eligible participants recommended by institution staff and invite them to take part in the study. To ensure the study are achieving the target sample the investigators will examine the distribution of living area and number of participants in each type of home health care unit during recruiting. Moreover, the investigators have estimated an attrition rate of 20% over the study. Higher drop-off rates in certain sub-groups may be problematic, so the investigators will monitor participants' attrition.
In addition, the cohort the investigators enrolled will be linked to their data in Taiwan's National Health Insurance Research Database to analyze the medical resource utilization of participants in our study. The results will show the health status and resource utilization as well as quality of home health care in Taiwan for clinical practices, research and future policy making.
The investigators will recruit at least 1200 eligible patients and caregivers (600 dyads) from at least 15 institutions (e.g., home clinics and hospitals) which provide home health care. Trained research assistants will touch based with eligible participants recommended by institution staff and invite them to take part in the study. To ensure the study are achieving the target sample the investigators will examine the distribution of living area and number of participants in each type of home health care unit during recruiting. Moreover, the investigators have estimated an attrition rate of 20% over the study. Higher drop-off rates in certain sub-groups may be problematic, so the investigators will monitor participants' attrition.
In addition, the cohort the investigators enrolled will be linked to their data in Taiwan's National Health Insurance Research Database to analyze the medical resource utilization of participants in our study. The results will show the health status and resource utilization as well as quality of home health care in Taiwan for clinical practices, research and future policy making.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: