Clinical trial NCT04250103: Home-based Longitudinal Investigation of the Multidisciplinary Team Integrated Care
Official title: Developing Innovative Models for Health & Long-term Care Facilities and Technology Services: Prospective Cohort Study for Home Health Care
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Health Care Utilization
Caregiver Burnout
Keywords: Home health care
Super-aged society
Lead sponsor: National Health Research Institutes, Taiwan
Sponsor class: OTHER
Collaborators: name: Taiwan Society of Home Health Care
First posted: 2020-01-31
Enrollment: 1200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with home health care and their caregivers

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.

Eligibility criteria: Inclusion Criteria:

* Aged 20 years or older
* Receiving home health care services at least two months
* Either the patient or caregiver can express clearly

Exclusion Criteria:

* Reject to sign the informed consent
* Both the patient and caregiver cannot complete the interview
* Both the patient and caregiver cannot communicate with an interviewer in a familiar language

Primary outcomes:
measure: Change from ability to perform activities of daily living (ADL) at two years
timeFrame: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
measure: Change from frailty at two years
timeFrame: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
measure: Change from cognitive function/memory at two years
timeFrame: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
measure: Change from percentage of participants with Dementia at two years
timeFrame: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
measure: Change from mean score of depression at two years
timeFrame: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
measure: Change from neuropsychiatric status at two years
timeFrame: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
measure: Change from quality of life (QOL) at two years
timeFrame: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
measure: Change from mental wellbeing at two years
timeFrame: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
measure: Shared decision making (SDM)
timeFrame: Two years
measure: Advance Care Planning (ACP)
timeFrame: Two years
measure: Change from Nutrition status at two years
timeFrame: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
measure: Change from risk for pressure injury at two years
timeFrame: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
measure: Needs assessment for supportive & palliative care
timeFrame: Two years
measure: Change from medical resource utilization at two years
timeFrame: Baseline, 3-month follow-up, 12-month follow-up, 24-month follow-up
measure: Change from caregiving burden at two years
timeFrame: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
measure: Change from number of used chronic disease drug at two years
timeFrame: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Zhunan
country: Taiwan
facility: Chao A. Hsiung
state: Miaoli County
Study officials:
affiliation: National Health Research Institutes, Taiwan
name: Chao A. Hsiung, PhD
role: STUDY_DIRECTOR
affiliation: Taiwan Society of Home Health Care and Home Clinic Dulan
name: Sang-Ju Yu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaohsiung Medical University
name: Ping-Jen Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liao JY, Chen PJ, Wu YL, Cheng CH, Yu SJ, Huang CH, Li CM, Wang YW, Zhang KP, Liu IT, Umegaki H, Hamano J, Mori M, Petersen I, Sampson EL, Hsiung CA. HOme-based Longitudinal Investigation of the multidiSciplinary Team Integrated Care (HOLISTIC): protocol of a prospective nationwide cohort study. BMC Geriatr. 2020 Nov 27;20(1):511. doi: 10.1186/s12877-020-01920-1.