Home-based Longitudinal Investigation of the Multidisciplinary Team Integrated Care (HOLISTIC)
2020年1月29日 更新者：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.
調査の概要
状態
わからない
詳細な説明
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.
研究の種類
観察的
入学 (予想される)
1200
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Miaoli County
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Zhunan、Miaoli County、台湾、35053
- Chao A. Hsiung
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
20年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
patients with home health care and their caregivers
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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patient
patients who receive home health care
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caregiver
caregivers who take care of patients with home health care
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Change from ability to perform activities of daily living (ADL) at two years
時間枠：Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
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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.
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Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
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Change from frailty at two years
時間枠：Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
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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.
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Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
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Change from cognitive function/memory at two years
時間枠：Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
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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.
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Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
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Change from percentage of participants with Dementia at two years
時間枠：Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
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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.
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Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
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Change from mean score of depression at two years
時間枠：Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
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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.
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Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
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Change from neuropsychiatric status at two years
時間枠：Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
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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.
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Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
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Change from quality of life (QOL) at two years
時間枠：Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
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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.
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Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
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Change from mental wellbeing at two years
時間枠：Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
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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.
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Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
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Shared decision making (SDM)
時間枠：Two years
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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.
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Two years
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Advance Care Planning (ACP)
時間枠：Two years
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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).
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Two years
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Change from Nutrition status at two years
時間枠：Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
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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.
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Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
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Change from risk for pressure injury at two years
時間枠：Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
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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.
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Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
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Needs assessment for supportive & palliative care
時間枠：Two years
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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.
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Two years
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Change from medical resource utilization at two years
時間枠：Baseline, 3-month follow-up, 12-month follow-up, 24-month follow-up
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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.
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Baseline, 3-month follow-up, 12-month follow-up, 24-month follow-up
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Change from caregiving burden at two years
時間枠：Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
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It will be measured by the revised version of Zarit Burden interview containing 22 items, with higher scores indicating greater burden.
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Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
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Change from number of used chronic disease drug at two years
時間枠：Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
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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.
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Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディディレクター：Chao A. Hsiung, PhD、National Health Research Institutes, Taiwan
- 主任研究者：Sang-Ju Yu, MD、Taiwan Society of Home Health Care and Home Clinic Dulan
- 主任研究者：Ping-Jen Chen, MD、Kaohsiung Medical University
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2019年11月20日
一次修了 (実際)
2019年11月20日
研究の完了 (予想される)
2022年12月31日
試験登録日
最初に提出
2020年1月15日
QC基準を満たした最初の提出物
2020年1月29日
最初の投稿 (実際)
2020年1月31日
学習記録の更新
投稿された最後の更新 (実際)
2020年1月31日
QC基準を満たした最後の更新が送信されました
2020年1月29日
最終確認日
2020年1月1日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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