CAPABLE Care + Connect: Pilot Feasibility of Implementing CAPABLE Into Homebased Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Change in Function as assessed by the Katz Index of Independence in Activities of Daily Living Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Open-Label Pilot
The Open Label Pilot will include testing the CAPABLE Care + Connect intervention on a total of 8. The investigators will recruit and provide CAPABLE to four caregiver-patient dyads (eight participants) and four older adults without caregivers.
干预措施: CAPABLE Care + Connect - Open Label Pilot (Behavioral)
Pilot- Intervention
The investigators will recruit fifteen new partner-patient dyads and fifteen participants without caregivers to receive CAPABLE. That is a total of 45 participants that will receive the CAPABLE intervention
干预措施: CAPABLE Care + Connect - Pilot (Behavioral)
Standard of Care Group
The standard of care/comparison group will apply for JHOME patients. There are currently around 400-450 patients in JHOME, therefore, our total sample size including both intervention and standard of care group will be up to 450 people.
It is important to note that the standard of care group is for individuals who did not complete the intervention and is used to evaluate the effectiveness of the intervention itself. Those eligible for the intervention will be included in the study, whereas those ineligible based on intervention screen will be asked about record review. If those ineligible decline record review, those ineligible will be excluded from entire study.
结局指标
主要结局
Change in Function as assessed by the Katz Index of Independence in Activities of Daily Living Scale
时间窗: Baseline, 16 weeks
6 questions, each 1 point for a total score range of 1- 6. A score closer to 6 indicates high patient independence, better outcome.
Change in Function as assessed by Lawton & Brody's assessment of Instrumental Activities of Daily Living Scale (IADL)
时间窗: Baseline, 16 weeks
Participants rate their ability to perform daily tasks on a 5-point scale (1 = no difficulty, 2 = a little difficulty, 3 = moderate difficulty, 4 = a lot of difficulty, 5 = unable to do). Score range 8 to 40, higher scores represent greater difficulty performing ADLs, worse outcome.
Change in Pain as assessed by the Brief Pain Inventory Scale (Short Form)
时间窗: Baseline, 16 weeks
The Brief Pain Inventory - Short Form is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. For the 10 point scale, 0 indicated no pain and 10 indicates the worst imaginable pain. Score range 0-90, higher score worse outcome.
Change in Function as assessed by the American Community Survey Disability Measure
时间窗: Baseline, 16 weeks
This measure is used to identify whether a person is considered to have a disability based on responses to six standardized questions. A person is considered to have a disability if the person answers "Yes" to at least one of the six questions. There is no composite score.
Change in Depression as assessed by the Patient Health Questionnaire Depression Scale (PHQ-8)
时间窗: Baseline, 16 weeks
The PHQ-8 contains 8 questions, with a 0-3 scale. A score of 10 or greater is considered major depression, 20 or more is severe major depression. Score range 0-24, higher score worse outcome.
Change in Social Connection as assessed by the Lubben Social Network Scale
时间窗: Baseline, 16 weeks
The Lubben Social Network Scale - 12 item version (LSNS-12) includes 12 questions, each scored from 0 to 5 based on the number of social contacts, with total scores ranging from 0 to 60, where lower scores indicate greater social isolation, worse outcome.
Change in Social Connection as assessed by the University of California Los Angeles (UCLA) Loneliness Scale
时间窗: Baseline, 16 weeks
The UCLA Loneliness Scale (20-item version) includes 20 questions, each rated on a 1 to 4 scale, with total scores ranging from 20 to 80, where higher scores indicate greater perceived loneliness, worse outcome.
Change in Social Connection as assessed by qualitative questions
时间窗: Baseline, 16 weeks
2 open ended questions about social network. Qualitatively look at answers from descriptive perspective
Change in Caregiver Burden as assessed by Zarit Burden Inventory
时间窗: Baseline, 16 weeks
The Zarit Burden Interview - 12 item version includes 12 questions, each scored from 0 (never) to 4 (nearly always), for a total score range of 0 to 48, with higher scores indicating greater caregiver burden, worse outcome.
Change in Perceived Change in Function Scale
时间窗: 16 weeks
14 questions related to perceived improvement in function. Scale of -2 (gotten much worse) to 2 (improved a lot). The higher the overall score, the greater the improvement, better outcome.
Change in Caregiver Burden as assessed by the Oberest Caregiver Burden Scale
时间窗: Baseline, 16 weeks
The Oberst Caregiver Burden Scale includes 15 items rated on a 5-point scale assessing the time and difficulty of caregiving tasks, with total scores ranging from 15 to 75 per subscale and higher scores indicating greater burden.
Change in Caregiver Outcomes as assessed by the Bakas Caregiving Outcomes Scale
时间窗: Baseline, 16 weeks
The Bakas Caregiving Outcomes Scale includes 15 items, each rated on a 7-point scale from -3 (changed for the worst) to +3 (changed for the best), with total scores reflecting the caregiver's perceived changes in life due to caregiving. Higher score better.
Change in Pain as assessed by the Brief Pain Inventory (Short Form)
时间窗: Baseline, 16 weeks
The Brief Pain Inventory - Short Form is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning on a 10 point scale. 0 = no pain and 10 indicates the worst imaginable pain. Higher score worse outcome.
Change in Pain as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form
时间窗: Baseline, 16 weeks
The PROMIS Pain Interference Short Form includes 6 questions, each rated on a 5-point scale, with raw scores summed and converted to a T-score, where higher scores indicate greater interference from pain in daily activities.
次要结局
- JHOME Health System Effects- Number Urgent Visits(6 months prior to program, 16 weeks)
- JHOME Health System Effects- Number Emergency Room Visits(6 months prior to program, 16 weeks)
- JHOME Health System Effects - Nursing Home Placement(16 weeks)
- JHOME Health System Effects- Number of Medications(6 months prior to program, 16 weeks)