Home-based Longitudinal Investigation of the Multidisciplinary Team Integrated Care

Health Care Utilization Clinical Trial

— HOLISTIC  

Official title:

Developing Innovative Models for Health & Long-term Care Facilities and Technology Services: Prospective Cohort Study for Home Health Care

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04250103
• Other study ID #: EC1080203
• Status: Enrolling by invitation
• Start date: November 20, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2020
• Source: National Health Research Institutes, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1200
• Est. completion date: December 31, 2022
• Est. primary completion date: November 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burnout, Psychological
• Caregiver Burnout
• Health Care Utilization

Locations

Country	Name	City	State
Taiwan	Chao A. Hsiung	Zhunan	Miaoli County

Sponsors (2)

Lead Sponsor	Collaborator
National Health Research Institutes, Taiwan	Taiwan Society of Home Health Care

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from ability to perform activities of daily living (ADL) at two years	The Barthel Index will be adapted to assess ADL. The total score ranges from 0 to 100, with 100 indicating full independence in doing daily activities.	Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
Primary	Change from frailty at two years	It will be measured by the 9-point Clinical Frailty Scale (CFS). The total score ranges from 1 to 9, with 7 or higher indicating severe frailty, even being terminally ill.	Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
Primary	Change from cognitive function/memory at two years	It will be measured by the Brain Health Test (Chinese version) via testing the orientation to time, immediate and delayed recall of five items, categorical verbal fluency test. The total score ranges from 0 to 16, with higher scores indicating worse cognitive impairment.	Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
Primary	Change from percentage of participants with Dementia at two years	The Functional Assessment Staging Test (FAST) will be adapted to assess an individual's stage of Alzheimer's disease. It includes seven stages from normal aging to sever Dementia.	Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
Primary	Change from mean score of depression at two years	It will be measured by the 5-item Geriatric Depression Scale (GDS). The total score ranges from 0 to 5, with higher scores indicating more depression.	Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
Primary	Change from neuropsychiatric status at two years	It will be measured by the Neuropsychiatric Inventory. The 10 sub-domains of behavioral functioning are examined, including delusions, hallucinations, agitation/aggression, dysphoria, anxiety, euphoria, apathy, disinhibition, irritability/lability, and aberrant motor activity syndrome.	Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
Primary	Change from quality of life (QOL) at two years	We will adapt the Quality of Life in Alzheimer's Disease (QOL-AD) scale for patients with cognitive impairment, and Quality of Life Survey for Home Care (QOL-HC) scale for those without cognitive impairment. The total score of QOL-AD ranges from 13 to 52, with higher values indicating a higher QoL. The total score of QOL-HC ranges from 0 to 8, with higher values indicating a higher QoL.	Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
Primary	Change from mental wellbeing at two years	It will be measured by the World Health Organization- Five Well-Being Index (WHO-5). The raw score ranges from 0 to 25, 0 representing worst possible and 25 representing best possible quality of life.	Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
Primary	Shared decision making (SDM)	It will be measured by the Decision-making Participation Self-Efficacy Scale (DEPS). The total score ranges from 5 to 25, with higher scores indicating higher self-efficacy.	Two years
Primary	Advance Care Planning (ACP)	It will be measured by the 4-question version of UCSF-ACP with the Process Measures (knowledge, contemplation, self-efficacy, and readiness, 5-point Likert scales) and Action Measures (yes/no whether an ACP behavior is completed).	Two years
Primary	Change from Nutrition status at two years	It will include the Mini Nutritional Assessment (MNA). The total score of MNA ranges from 0-14, with more than 11 indicating normal nutrition status.	Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
Primary	Change from risk for pressure injury at two years	It will be measured by the sale of Braden Scale for Predicting Pressure Sore Risk. The scale is composed of six subscales that reflect sensory perception, skin moisture, activity, mobility, friction and shear, and nutritional status. The total score ranges from 6 to 23, with higher scores indicating lower risk for forming pressure sores.	Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
Primary	Needs assessment for supportive & palliative care	It will be measured by the Supportive & Palliative Care Indicators Tool (SPICT). Following the guideline, the Chinese version will be developed before the cohort study starts.	Two years
Primary	Change from medical resource utilization at two years	Assessments include medical costs and out-of-pocket costs regarding utilization of medical resource and home health care. The used scales are developed by our research team.	Baseline, 3-month follow-up, 12-month follow-up, 24-month follow-up
Primary	Change from caregiving burden at two years	It will be measured by the revised version of Zarit Burden interview containing 22 items, with higher scores indicating greater burden.	Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
Primary	Change from number of used chronic disease drug at two years	It will be measured by two items which are developed by our research team. Based on patients' prescriptions, they will be required to answer the number of chronic disease drug they used and these drugs' information, including the names, administrations and dosages.	Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up