Multicomponent Telerehabilitation to Engage Veterans in Effective Self-Management of Complex Health Conditions
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Motivational Interviewing Techniques, Physical Therapy Interventions, Education, Health Status Updates.
- Кому может быть актуально
- Состояния в реестре: Multimorbidity, Physical Deconditioning. Базовые параметры: от 60 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Multicomponent Telerehabilitation to Engage Veterans in Effective Self-Management of ComplexHealth Conditions
Обзор
Medically complex older Veterans are at greater risk for progressive declines in physical function, lower quality of life, and increasing care needs. Additionally, older Veterans experience social isolation and loneliness, and have low levels of physical activity. While the Veterans Health Administration has established programs to address rehabilitation needs, these programs tend to be diagnosis-focused, lack self-management approaches, include low-intensity rehabilitation, and typically require in-person attendance. A MultiComponent TeleRehabilitation (MCTR) program that includes high-intensity rehabilitation and self-management interventions, social support, and telehealth and technology supports may be more effective in improving and sustaining physical function for older Veterans with complex health conditions. Therefore, this project is designed to determine whether the MCTR program improves strength and physical function more effectively than traditional interventions.
Подробное описание
The proposed MultiComponent TeleRehabilitation (MCTR) program addresses current healthcare deficiencies by using a multicomponent approach that includes both high-intensity rehabilitation interventions and self-management interventions that are not part of traditional physical therapy interventions. Therefore, the investigators propose a two-arm, parallel randomized trial using a crossover study design to determine the effectiveness (AIM 1) of a 12-week multicomponent telerehabilitation program to improve physical function. The investigators will also measure Veterans' clinical outcomes to evaluate the effectiveness of the MCTR program to improve physical activity, health self-management, and self-reported health (AIM 2). Lastly, the investigators will explore the effects of the MCTR program on safety events such as emergency room visits, hospitalizations, falls, and other adverse events (AIM 3). Participants (n=126) will be randomized to MCTR or Control group using computer-generated random blocks, stratified by sex. The MCTR group will participate in the 24-week program consisting of 1) progressive, high-intensity rehabilitation, 2) self-management interventions, 3) social support, and 4) technology supports. The 12-week program is split into three phases: the Active Phase (weeks 1-6), the Transition Phase (weeks 7-12), and the Sustainability Phase (weeks 13-24). The Control group will participate in education and health status update sessions in parallel to the MCTR 12-week program. Outcomes will be collected at baseline, 6 weeks, 12 weeks (primary endpoint), and 24 weeks. Achievement of the proposed aims will provide evidence to expand high quality telerehabilitation services for medically complex older Veterans with multiple factors contributing to poor health (e.g., social isolation, loneliness, physical inactivity, poor self-management). Importantly, results will guide the advancement of rehabilitation practices, moving away from a traditionally narrow, episodic, diagnosis-focused approach to a model emphasizing whole health self-management and sustained healthy living. Study findings will have immediate clinical impact as they will be directly translatable to other medically complex and underserved populations who will benefit from innovative telerehabilitation care approaches.
Вмешательства
- Поведенческое Motivational Interviewing Techniques
Motivational Interviewing Techniques including but not limited to open-ended questions, reflection, affirmations, and summary will be used to build participant rapport, support behavior change (physical activity), and facilitate program engagement. - Другое Physical Therapy Interventions
Strengthening, balance, functional activities, stretching, breathing, aerobic endurance exercise. - Другое Education
Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene, etc. - Другое Health Status Updates
Health Status Updates will be completed by a trained assessor. The assessor will ask about adverse events, general health topics, medication changes, and changes in social circumstances. - Другое Physical Therapy Consult
Participants in the control condition will be offered a physical therapy consult at the end of their 24 week study involvement.
Первичные конечные точки
- 2 Minute Step Test [Срок оценки: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.]
Вторичные конечные точки (12)
- Arm Curl Test [Срок оценки: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.]
- 30 Second Sit To Stand [Срок оценки: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.]
- Physical Activity [Срок оценки: Will be collected at Baseline, 12 weeks, and 24 weeks.]
- Exercise readiness to change [Срок оценки: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.]
- Self-efficacy for Exercise Scale [Срок оценки: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.]
- Self-efficacy of Managing Chronic Conditions [Срок оценки: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.]
- The Patient-Specific Functional Scale [Срок оценки: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.]
- Activity Measure for Post-Acute Care (AM-PAC) basic mobility outpatient routine short form [Срок оценки: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.]
- Patient-Reported Outcomes Measurement Information System (PROMIS) 29+2 Profile v2.1 (PROPr) survey [Срок оценки: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.]
- Patient-Reported Outcomes Measurement Information System (PROMIS) v2 social isolation short form (SF) 8a [Срок оценки: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.]
- Patient-Reported Outcomes Measurement Information System (PROMIS) satisfaction with participation in discretionary social activities short form (SF) 7a [Срок оценки: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.]
- Physical Activity and Social Support Scale [Срок оценки: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.]
Критерии участия
Критерии включения
- 60 years of age and older
- Multiple chronic conditions (Functional Comorbidity Index > or = 3)
- Impaired physical function (< or = 8 repetitions on 30 second sit to stand test)
Критерии исключения
- Life expectancy < 12 months
- Acute or progressive neurological disorder (e.g. amyotrophic lateral sclerosis, recent stroke)
- Moderate to severe dementia (<11 on telephone Montreal Cognitive Assessment(T-MoCA))
- Medical conditions precluding safe participation in high-intensity rehabilitation (e.g. unstable angina)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Rocky Mountain Regional VA Medical Center, Aurora, CO — Aurora
Идентификаторы
NCT: NCT06288438 · E5012-R · 23-2306