- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT04798196
Умная система ElderTree для пожилых людей
Использование интеллектуальных устройств для внедрения научно обоснованной системы электронного здравоохранения для пожилых людей
Multiple chronic conditions (MCCs) are costly and pervasive among older adults. MCCs account for 90% of Medicare spending, and 65% of Medicare beneficiaries have 3 or more chronic conditions; 23% have 5 or more. MCCs are often addressed in primary care, where time pressures force a focus on medication and lab results rather than self-management skills.
The primary purpose of this study is to investigate whether voice-activated "smart" technology increases adoption and sustains use of an evidence-based electronic health intervention (Elder Tree, or ET) for older adults with multiple chronic conditions, and thereby improves its potential to widely enhance quality of life and health outcomes. ET is an existing intervention providing tools, motivation, and support on a computer platform to help older adults manage their health.
An Agency for Health Care Research and Quality (AHRQ)-funded randomized controlled trial (RCT) found that ET improved quality of life and other factors among high users of primary care with multiple chronic conditions such as diabetes and hypertension. However, many people did not use it extensively, which is a common problem with all web apps.
Обзор исследования
Статус
Условия
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Wisconsin
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Madison, Wisconsin, Соединенные Штаты, 53704
- University of Wisconsin School of Medicine and Public Health
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Be ≥60 years old;
- Have been treated in University of Wisconsin (UW) Health clinics, with no plans to leave during the study period (only relevant for UW Health patients, not patients recruited from the community);
- Have a chronic pain diagnosis AND a medical diagnoses of three or more of the following common chronic conditions: Chronic obstructive pulmonary disease (COPD), asthma, diabetes, hyperlipidemia, hypertension, ischemic heart disease, atrial fibrillation, heart failure, stroke, BMI 30+, cancer, chronic kidney disease, depression, osteoporosis, arthritis, or dizziness/falls/loss of vestibular function;
- Be willing to share healthcare use (e.g. 30-day readmissions) in electronic health records (only relevant for UW Health patients, not patients recruited from the community); and
- Allow researchers to share information about a patient's health status with their primary care physician (PCP).
Exclusion Criteria:
-
Require an interpreter
-
Have a medical diagnosis of any of the following:
- Alzheimer's
- Schizophrenia/other psychotic disorders
- Dementia
- Autism spectrum disorder
- Known terminal illness with less than 6 months to live
- Acute medical problem requiring immediate hospitalization
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Плацебо Компаратор: Control group
Participants will receive treatment as usual (TAU). |
Treatment as usual (TAU) |
|
Экспериментальный: ElderTree on laptop (ET- LT)
Participants will receive ElderTree on a laptop. |
ElderTree (ET) is an existing intervention providing tools, motivation, and support on a computer platform to help older adults manage their health. ET is based on the extensively tested Comprehensive Health Enhancement Support System (CHESS). ET is a "walled garden" free of ads, with design features based on older users' feedback as well as best-practice principles such as uncluttered screens and large type. ET uses computers to deliver key elements of successful interventions: long duration, ongoing outreach, prompts, monitoring, cognitive reframing, action planning, problem solving, self-tailoring, and peer support. ET-LT arm will access ET on Laptop (ET- LT) |
|
Экспериментальный: ElderTree on smart system (ET- SS)
Participants will receive ElderTree on a smart system. |
ElderTree (ET) is an existing intervention providing tools, motivation, and support on a computer platform to help older adults manage their health. ET is based on the extensively tested Comprehensive Health Enhancement Support System (CHESS). ET is a "walled garden" free of ads, with design features based on older users' feedback as well as best-practice principles such as uncluttered screens and large type. ET uses computers to deliver key elements of successful interventions: long duration, ongoing outreach, prompts, monitoring, cognitive reframing, action planning, problem solving, self-tailoring, and peer support. ElderTree on smart system (ET- SS) will use voice-activated "smart" speakers connected to the Internet. Because they are used by talking and listening rather than typing and reading, many barriers associated with laptop use can be avoided. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v2.1 - Pain Interference Score
Временное ограничение: Baseline, 4 months, 8 months
|
Pain interference was measured using the 4-item subscale from the PROMIS 29. The items asked participants to answer regarding the past 7 days. Scoring of individual items varies and is calculated by the scale's developers; with higher values indicating more pain interference. The possible range is 41.1 to 76.3 (PROMIS scores reported here have weighted ranges). |
Baseline, 4 months, 8 months
|
|
Change in PROMIS Short Form v2.1 - Psychosocial Quality of Life Score
Временное ограничение: Baseline, 4 months, 8 months
|
Psychosocial quality of life was measured using the 12-item subscale from the PROMIS 29. The items asked participants to answer regarding the past 7 days. Scoring of individual items varies and is calculated by the scale's developers; with higher values indicating better quality of life. The possible range is 21.2 to 67.6. |
Baseline, 4 months, 8 months
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
ElderTree Days of Use
Временное ограничение: baseline to 4 months, and 4 months to 8 months
|
Days of ElderTree use within a 4 month period before their survey date. The possible range for days of ElderTree use is 0 to 120. |
baseline to 4 months, and 4 months to 8 months
|
|
Physical Quality of Life
Временное ограничение: Baseline, 4 months, 8 months
|
Physical quality of life was measured using the 12-item subscale from the PROMIS 29 (Patient-Reported Outcomes Measurement Information System) Global Health. The items asked participants to answer regarding the past 7 days. Scoring of individual items varies and is calculated by the scale's developers; with higher values indicating more physical quality of life. The possible range is 16.2-67.7. |
Baseline, 4 months, 8 months
|
|
Pain Intensity
Временное ограничение: Baseline, 4 months, 8 months
|
Pain intensity was measured using a single item subscale from the PROMIS 29 (Patient-Reported Outcomes Measurement Information System) Global Health. The item asked participants to answer regarding the past 7 days. The raw score of the item was used (range: 0-10); with higher values indicating more pain intensity. |
Baseline, 4 months, 8 months
|
|
Number of Participants Readmitted Within 30-days
Временное ограничение: Baseline, 4 months, 8 months
|
30-day readmissions were measured using a single item asking participants to answer regarding the past 4 months. The raw score, answering yes/no to having a 30-day readmission, was used. Those participants answering 'yes' to being readmitted in the last 30 days are reported for each time point. |
Baseline, 4 months, 8 months
|
|
Health Distress
Временное ограничение: Baseline, 4 months, 8 months
|
Health distress was measured using the 4-item Lorig Health Distress Scale. The items asked participants to answer regarding the past month. The measure was scored by averaged the items; with higher values indicating more health distress. Possible range is 0 to 5. |
Baseline, 4 months, 8 months
|
|
Well-being
Временное ограничение: Baseline, 4 months, 8 months
|
Well-being was measured using the 5-items World Health Organization (WHO) Well-Being Index. The items asked participants to answer regarding the past 7 days. The measure was scored by summing the items; with higher values indicating better well-being. Possible range is 0 to 25. |
Baseline, 4 months, 8 months
|
|
Loneliness
Временное ограничение: Baseline, 4 months, 8 months
|
Loneliness was measured using the 5-item NIH Toolbox Social Relationship Scale Loneliness. The items asked participants to answer regarding the past month. Scoring of individual items varies and is calculated by the scale's developers; with higher values indicating more Loneliness. Possible range is 20 to 80. |
Baseline, 4 months, 8 months
|
|
Irritability
Временное ограничение: Baseline, 4 months, 8 months
|
Irritability was measured using the 5-item Brief Irritability Test. The items asked participants to answer regarding the past 7 days. The measure was scored by summing the items; with higher values indicating more irritability. Possible range is 5 to 30. |
Baseline, 4 months, 8 months
|
|
Communication With Physicians
Временное ограничение: Baseline, 4 months, 8 months
|
Communication with physicians was measured using the 3-item Lorig Communication with Physicians. The items asked participants to answer regarding the past 4 months. The measure was scored by averaging the items; with higher values indicating better communication with the healthcare provider. Possible range is 0 to 5. |
Baseline, 4 months, 8 months
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: David H. Gustafson, PhD, UW-Madison
Публикации и полезные ссылки
Общие публикации
- Gustafson DH Sr, Mares ML, Johnston DC, Landucci G, Pe-Romashko K, Vjorn OJ, Hu Y, Gustafson DH Jr, Maus A, Mahoney JE, Mutlu B. Using Smart Displays to Implement an eHealth System for Older Adults With Multiple Chronic Conditions: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 May 5;11(5):e37522. doi: 10.2196/37522.
- Landucci G, Gustafson DH Sr, Mares ML, Pe-Romashko K, Curtin JJ, Hu Y, Maus A, Thompson K, Saunders S, Brown K, Woodburn J, Mutlu B. Using Smart Displays to Implement an eHealth System for Older Adults With Multiple Chronic Conditions: Randomized Controlled Trial. JMIR Aging. 2025 Nov 18;8:e75991. doi: 10.2196/75991.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2020-0868
- ENGR/INDUSTRIAL ENGR (Другой идентификатор: UW Madison)
- A195000 (Другой идентификатор: UW Madison)
- Protocol Version 10/20/2021 (Другой идентификатор: UW Madison)
- 1R18HS026853-01A1 (Грант/контракт AHRQ США)
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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