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

29. Januar 2020 aktualisiert von: Chao A. Hsiung, National Health Research Institutes, Taiwan

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

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.

Studienübersicht

Status

Unbekannt

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Voraussichtlich)

1200

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Taiwan
    • Miaoli County
      • Zhunan, Miaoli County, Taiwan, 35053
        • Chao A. Hsiung

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

20 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

patients with home health care and their caregivers

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
patient
patients who receive home health care
caregiver
caregivers who take care of patients with home health care

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from ability to perform activities of daily living (ADL) at two years
Zeitfenster: 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.
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
Zeitfenster: 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.
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
Zeitfenster: 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.
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
Zeitfenster: 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.
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
Zeitfenster: 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.
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
Zeitfenster: 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.
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
Zeitfenster: 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.
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
Zeitfenster: 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.
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)
Zeitfenster: 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.
Two years
Advance Care Planning (ACP)
Zeitfenster: 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).
Two years
Change from Nutrition status at two years
Zeitfenster: 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.
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
Zeitfenster: 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.
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
Zeitfenster: 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.
Two years
Change from medical resource utilization at two years
Zeitfenster: 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.
Baseline, 3-month follow-up, 12-month follow-up, 24-month follow-up
Change from caregiving burden at two years
Zeitfenster: 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.
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
Zeitfenster: 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.
Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

National Health Research Institutes, Taiwan

Mitarbeiter

Taiwan Society of Home Health Care

Ermittler

  • Studienleiter: Chao A. Hsiung, PhD, National Health Research Institutes, Taiwan
  • Hauptermittler: Sang-Ju Yu, MD, Taiwan Society of Home Health Care and Home Clinic Dulan
  • Hauptermittler: Ping-Jen Chen, MD, Kaohsiung Medical University

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

20. November 2019

Primärer Abschluss (Tatsächlich)

20. November 2019

Studienabschluss (Voraussichtlich)

31. Dezember 2022

Studienanmeldedaten

Zuerst eingereicht

15. Januar 2020

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. Januar 2020

Zuerst gepostet (Tatsächlich)

31. Januar 2020

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

31. Januar 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. Januar 2020

Zuletzt verifiziert

1. Januar 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • EC1080203

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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