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Home-based Longitudinal Investigation of the Multidisciplinary Team Integrated Care (HOLISTIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04250103
Recruitment Status : Enrolling by invitation
First Posted : January 31, 2020
Last Update Posted : January 31, 2020
Sponsor:
Collaborator:
Taiwan Society of Home Health Care
Information provided by (Responsible Party):
Chao A. Hsiung, National Health Research Institutes, Taiwan

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.

Condition or disease
Health Care Utilization Caregiver Burnout

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.

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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Developing Innovative Models for Health & Long-term Care Facilities and Technology Services: Prospective Cohort Study for Home Health Care
Actual Study Start Date : November 20, 2019
Actual Primary Completion Date : November 20, 2019
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Group/Cohort
patient
patients who receive home health care
caregiver
caregivers who take care of patients with home health care



Primary Outcome Measures :
  1. Change from ability to perform activities of daily living (ADL) at two years [ Time Frame: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up ]
    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.

  2. Change from frailty at two years [ Time Frame: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up ]
    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.

  3. Change from cognitive function/memory at two years [ Time Frame: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up ]
    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.

  4. Change from percentage of participants with Dementia at two years [ Time Frame: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up ]
    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.

  5. Change from mean score of depression at two years [ Time Frame: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up ]
    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.

  6. Change from neuropsychiatric status at two years [ Time Frame: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up ]
    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.

  7. Change from quality of life (QOL) at two years [ Time Frame: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up ]
    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.

  8. Change from mental wellbeing at two years [ Time Frame: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up ]
    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.

  9. Shared decision making (SDM) [ Time Frame: Two years ]
    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.

  10. Advance Care Planning (ACP) [ Time Frame: Two years ]
    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).

  11. Change from Nutrition status at two years [ Time Frame: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up ]
    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.

  12. Change from risk for pressure injury at two years [ Time Frame: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up ]
    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.

  13. Needs assessment for supportive & palliative care [ Time Frame: Two years ]
    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.

  14. Change from medical resource utilization at two years [ Time Frame: Baseline, 3-month follow-up, 12-month follow-up, 24-month follow-up ]
    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.

  15. Change from caregiving burden at two years [ Time Frame: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up ]
    It will be measured by the revised version of Zarit Burden interview containing 22 items, with higher scores indicating greater burden.

  16. Change from number of used chronic disease drug at two years [ Time Frame: Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients with home health care and their caregivers
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04250103


Locations
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Taiwan
Chao A. Hsiung
Zhunan, Miaoli County, Taiwan, 35053
Sponsors and Collaborators
National Health Research Institutes, Taiwan
Taiwan Society of Home Health Care
Investigators
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Study Director: Chao A. Hsiung, PhD National Health Research Institutes, Taiwan
Principal Investigator: Sang-Ju Yu, MD Taiwan Society of Home Health Care and Home Clinic Dulan
Principal Investigator: Ping-Jen Chen, MD Kaohsiung Medical University
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Responsible Party: Chao A. Hsiung, Institute of population health sciences, National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier: NCT04250103    
Other Study ID Numbers: EC1080203
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chao A. Hsiung, National Health Research Institutes, Taiwan:
Home health care
Super-aged society
Additional relevant MeSH terms:
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Burnout, Psychological
Stress, Psychological
Behavioral Symptoms