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

29 января 2020 г. обновлено: 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.

Обзор исследования

Статус

Неизвестный

Условия

Подробное описание

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.

Тип исследования

Наблюдательный

Регистрация (Ожидаемый)

1200

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

20 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Да

Полы, имеющие право на обучение

Все

Метод выборки

Невероятностная выборка

Исследуемая популяция

patients with home health care and their caregivers

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Когорты и вмешательства

Группа / когорта
patient
patients who receive home health care
caregiver
caregivers who take care of patients with home health care

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change from ability to perform activities of daily living (ADL) at two years
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

National Health Research Institutes, Taiwan

Соавторы

Taiwan Society of Home Health Care

Следователи

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

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

20 ноября 2019 г.

Первичное завершение (Действительный)

20 ноября 2019 г.

Завершение исследования (Ожидаемый)

31 декабря 2022 г.

Даты регистрации исследования

Первый отправленный

15 января 2020 г.

Впервые представлено, что соответствует критериям контроля качества

29 января 2020 г.

Первый опубликованный (Действительный)

31 января 2020 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

31 января 2020 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

29 января 2020 г.

Последняя проверка

1 января 2020 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • EC1080203

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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