CAPABLE Care + Connect

Официальное название

CAPABLE Care + Connect: Pilot Feasibility of Implementing CAPABLE Into Homebased Primary Care

Обзор

In this evaluation scale-up research project, the investigators seek to test an implementation of CAPABLE on the infrastructure of home-based primary care for individuals who may experience social isolation and/or loneliness. These two home-based care programs may improve each other and provide opportunity to further improve quality of life for people living with disabilities and the caregivers. The purpose of this mixed methods study is to adapt and test CAPABLE, an existing evidence-based program, to a new target population with the scalable infrastructure of home-based primary care.

Подробное описание

CAPABLE is a home-based, interdisciplinary, goal-directed program that reduces physical disability by working with the person and environment. This program has shown improved performance of activities of daily living (ADL), instrumental activities of daily living (IADL), and depression. Coordinating CAPABLE and Johns Hopkins Home-Based Medicine (JHOME) can help address barriers to health, function, and social connection. Amid limited to no evidence-based strategies to address social isolation and loneliness, this study offers a unique opportunity to address this problem. Because CAPABLE addresses environmental and personal needs to improve the ADL and IADL function of people with disabilities, combining the two programs may better enable people who are homebound to more easily navigate and access the home or beyond. Additionally, this effort will enable the investigators to explore the impact of this combined intervention on social isolation and loneliness.

As in CAPABLE (NA\_00031539), the delivery characteristics of CAPABLE Family consist of an assessment-driven, individually tailored package of interventions delivered over the course of 4 months by an occupational therapist (OT) (\~6 home visits for ≤ 1hour), a registered nurse (RN) (\~4 home visits for ≤ 1hour) and a handy worker (HW).

The purpose of this mixed methods study is to adapt and test CAPABLE, an existing evidence-based program, to a new target population with the scalable infrastructure of home-based primary care. The investigators seek to explore if the CAPABLE program increases social connection in homebound older adults, and if the benefits of CAPABLE services improve social connections among socially isolated/lonely homebound older adults.

Вмешательства

• Поведенческое CAPABLE Care + Connect - Open Label Pilot
  As in CAPABLE, the delivery characteristics of CAPABLE Care + Connect consist of an assessment-driven, individually tailored package of interventions delivered over the course of 4 months by an occupational therapist (OT) (\~6 home visits for ≤ 1hour), a registered nurse (RN) (\~4 home visits for ≤ 1hour) and a handy worker (HW). Adaptations targeting those in JHOME will be made on a per-client basis as part of the open-label pilot. The investigators will further refine and develop the intervent
• Поведенческое CAPABLE Care + Connect - Pilot
  As in CAPABLE, the delivery characteristics of CAPABLE Care + Connect consist of an assessment-driven, individually tailored package of interventions delivered over the course of 4 months by an occupational therapist (OT) (\~6 home visits for ≤ 1hour), a registered nurse (RN) (\~4 home visits for ≤ 1hour) and a handy worker (HW). Refinements based on the open label pilot results will be included.

Первичные конечные точки

• Change in Function as assessed by the Katz Index of Independence in Activities of Daily Living Scale [Срок оценки: Baseline, 16 weeks]
• Change in Function as assessed by Lawton & Brody's assessment of Instrumental Activities of Daily Living Scale (IADL) [Срок оценки: Baseline, 16 weeks]
• Change in Pain as assessed by the Brief Pain Inventory Scale (Short Form) [Срок оценки: Baseline, 16 weeks]
• Change in Function as assessed by the American Community Survey Disability Measure [Срок оценки: Baseline, 16 weeks]
• Change in Depression as assessed by the Patient Health Questionnaire Depression Scale (PHQ-8) [Срок оценки: Baseline, 16 weeks]
• Change in Social Connection as assessed by the Lubben Social Network Scale [Срок оценки: Baseline, 16 weeks]
• Change in Social Connection as assessed by the University of California Los Angeles (UCLA) Loneliness Scale [Срок оценки: Baseline, 16 weeks]
• Change in Social Connection as assessed by qualitative questions [Срок оценки: Baseline, 16 weeks]
• Change in Caregiver Burden as assessed by Zarit Burden Inventory [Срок оценки: Baseline, 16 weeks]
• Change in Perceived Change in Function Scale [Срок оценки: 16 weeks]

Вторичные конечные точки (4)

• JHOME Health System Effects- Number Urgent Visits [Срок оценки: 6 months prior to program, 16 weeks]
• JHOME Health System Effects- Number Emergency Room Visits [Срок оценки: 6 months prior to program, 16 weeks]
• JHOME Health System Effects - Nursing Home Placement [Срок оценки: 16 weeks]
• JHOME Health System Effects- Number of Medications [Срок оценки: 6 months prior to program, 16 weeks]

Критерии участия

Критерии включения

• Any patient currently in JHOME
• At risk for or experiencing social isolation as defined by the Lubben Social Network Scale 6 item score less than or equal 12 points or loneliness as defined by the UCLA Loneliness Scale 3 item score of 6 to 9 points
• Cognitive inclusion criteria Montreal Cognitive Assessment (MOCA) >23 as determined by referring JHOME study team member provider
• English speaking (measures are standardized in English)
• Ability to participate in an approximately 45-60 min virtual or in person meeting
• Eligible for CAPABLE
• 50 years or older
• Not hospitalized over night more than 4 times in the last 12 months
• Have some difficulty with any ADL
• Cognitively intact
• Live in Baltimore County or Baltimore City
• Not receiving active cancer treatment
• Interested in participating in CAPABLE Care partners will be included if the care partners provide > 10 hours of care/week

Критерии исключения

• Terminally ill
• live in long term care setting
• receiving active cancer treatment

Standard of Care/Comparison group Inclusion Criteria:

• Any patient currently in JHOME who did not receive the CAPABLE intervention

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Johns Hopkins School of Nursing — Baltimore

Идентификаторы

NCT: NCT07123298 · IRB00471865

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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