CAPABLE Family Pilot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Change in Pain as assessed by the Brief Pain Inventory (Short Form)
研究概览
简要总结
The purpose of this study is to test the adapted protocol, CAPABLE Family which builds upon the evidenced based CAPABLE program to address older adults with co-occurring physical disability and mild cognitive impairment or early stage dementia and the older adults' caregivers. It will consist of two phases - an open label pilot and waitlist control trial.
详细描述
CAPABLE (NA_00031539) is an evidence-based program that reduces physical disability, but was designed for people who are cognitively intact.
The investigators seek to adapt CAPABLE to meet the needs of older adults with physical disability and mild cognitive impairment and early stage dementia. The investigators also seek to meet the needs of family members who serve as informal caregivers in relation to the physical function of those with cognitive impairment. The purpose of this pilot study is to test a new protocol for a new program, CAPABLE Family, to address older adults with co-occurring physical disability and dementia and the older adults' caregivers.
CAPABLE is a multicomponent goal-directed program that reduces physical disability by working with the person and environment, but was designed for people who are cognitively intact. Based on the Centers for Medicare and Medicaid (CMS) request, the investigators' team briefly included people with mild dementia in the regular CAPABLE protocol. Looking back on that preliminary data, the investigators identified a subset of 12 older adults with mild dementia with Mini-Mental State Examination (MMSE) scores of 23 or below. The investigators found that more than half improved in Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) which is promising but much lower than CAPABLE the rest of the cohorts which suggests the need to adapt CAPABLE for people with dementia. Therefore, the investigators have adapted CAPABLE for people with mild cognitive impairment or early stage dementia calling it CAPABLE Family.
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).
This research study is a continuation of IRB00243117 during which the investigators conducted preliminary activities to design the CAPABLE Family intervention. This study will include two phases, an open label pilot and a randomized control trial. The investigators will collect feedback during the open label pilot from the study team clinicians, older adult participants and care partners to further refine the intervention that will be tested as part of the randomized control trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The assessment collector will be blinded as to whether a participant is in the intervention or waitlist group
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have at least 1 ADL disability
- •Have mild cognitive impairment or mild dementia (as indicated by clinician diagnosis, subjective cognitive complaints, or Blind/Telephone Montreal Cognitive Assessment (MoCA)(score of 16-23)
- •Care partners will be included if they provide >10 hours of care/week
- •Live in Baltimore City/County
排除标准
- •Live in long term care setting
结局指标
主要结局
Change in Pain as assessed by the Brief Pain Inventory (Short Form)
时间窗: Baseline, 16 weeks, 32 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. The patient is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10 point scale. For the 10 point scale, 0 indicated no pain and 10 indicates the worst imaginable pain.
Change in Depression as assessed by the Patient Health Questionnaire Depression Scale (PHQ-8)
时间窗: Baseline, 16 weeks, 32 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.
Change in Perceived Change in Function Scale Score
时间窗: 16 weeks, 32 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.
Satisfaction at midpoint of intervention assessed by qualitative questions
时间窗: 8 weeks
Older Adult and Care Partner Satisfaction at midpoint of intervention assessed by qualitative questions. Qualitative questions will help us understand how best to tailor the intervention for the randomized control pilot.
Change in Function as assessed by Lawton & Brody's assessment of Instrumental Activities of Daily Living Scale
时间窗: Baseline, 16 weeks, 32 weeks
The assessment contains 8 questions with answers that are either a score of 0 or 1. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women and 0 through 5 for men to avoid potential gender bias.
Change in Function as assessed by the Katz Index of Independence in Activities of Daily Living
时间窗: Baseline, 16 weeks, 32 weeks
6 questions, each 1 point for a total score of 6. A score closer to 6 indicates high patient independence.
Change in caregiving burden as assessed by the Perceived Change Index Scale
时间窗: 16 weeks, 32 weeks
The Perceived Change Index Scale contains13 questions related to change in caregiver self-improvement wellbeing. Each rated on a scale of 1-5, 1 indicating much worse, 5 indicating improved a lot. The higher the overall score, the greater the improvement.
Satisfaction at endpoint of intervention as assessed by qualitative questions
时间窗: 16 weeks
Older Adult and Care Partner Satisfaction at endpoint of intervention assessed by qualitative questions. Qualitative questions will help us understand how best to tailor the intervention for the randomized control pilot.
Level of Cognitive Impairment for eligibility as assessed by the Montreal Cognitive Assessment (MoCA) Blind/Telephone
时间窗: Baseline
Scoring for the Blind/Telephone assessment is out of 22. Score of 12-17 indicates Mild Cognitive Impairment/Early Stage Dementia and is the eligibility requirement for participation in the study.
次要结局
未报告次要终点