Home-based Longitudinal Investigation of the Multidisciplinary Team Integrated Care

NCT04250103 | Unknown

• 1 other identifier: EC1080203
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Care Utilization; Caregiver Burnout

Keywords

Home health care; Super-aged society

Outcome Measures

Primary Outcomes (16)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

patient

patients who receive home health care

caregiver

caregivers who take care of patients with home health care

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with home health care and their caregivers

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead
• Taiwan Society of Home Health Care: collaborator

Study Sites (1)

Chao A. Hsiung

Zhunan, Miaoli County, 35053, Taiwan

Location

Related Publications (3)

• Lin CP, Liao JY, Huang CH, Cheng SY, Tseng WZ, Mori M, Chang HC, Li CM, Sun WJ, Wu CY, Chiou HY, Yu SJ, Hsiung CA, Chen PJ; HOLISTIC Investigators. Association Between Current Medical Decision-Making Participation Self-Efficacy and Advance Care Planning Engagement Among Older Adults: Baseline Findings from a Nationwide Longitudinal Cohort Study. J Palliat Med. 2025 Jan;28(1):50-58. doi: 10.1089/jpm.2024.0106. Epub 2024 Dec 5.

  PMID: 39636682 DERIVED

• Lai YC, Tsai KT, Ho CH, Liao JY, Tseng WZ, Petersen I, Wang YC, Chen YH, Chiou HY, Hsiung CA, Yu SJ, Sampson EL, Chen PJ. Mortality rate and its determinants among people with dementia receiving home healthcare: a nationwide cohort study. Intern Emerg Med. 2023 Oct;18(7):2121-2130. doi: 10.1007/s11739-023-03319-3. Epub 2023 May 30.

  PMID: 37253992 DERIVED

• 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.

  PMID: 33246407 DERIVED

MeSH Terms

Conditions

Patient Acceptance of Health Care; Caregiver Burden

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Stress, Psychological; Behavioral Symptoms

Study Officials

• Chao A. Hsiung, PhD

  National Health Research Institutes, Taiwan

  STUDY DIRECTOR

• Sang-Ju Yu, MD

  Taiwan Society of Home Health Care and Home Clinic Dulan

  PRINCIPAL INVESTIGATOR

• Ping-Jen Chen, MD

  Kaohsiung Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Institute of population health sciences

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 31, 2020
• Study Start: November 20, 2019
• Primary Completion: November 20, 2019
• Study Completion: December 31, 2022
• Last Updated: January 31, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)