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临床试验/NCT04212442
NCT04212442已完成不适用

Improving Aging in Place for Older Adults in Subsidized Housing

University of Pennsylvania13 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2020年1月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
13
主要终点
Change in Precipitating Events Project (PEP) Functional Status Scale From Baseline to 2 Months for Immediate Intervention Sites and Waitlist Control Sites

研究概览

简要总结

This pilot study will evaluate the feasibility and preliminary effectiveness of an adapted version of the Function Focused Care intervention, delivered by telephone, for improving aging in place for older adults living in subsidized housing. The study will include participants with and without mild cognitive impairment or mild dementia and will examine whether the study outcomes differ by cognitive status. Findings from this study will provide new information about how to optimize function and physical activity among older adults with and without cognitive impairment living in subsidized housing.

详细描述

Millions of older adults with low incomes live in federally-subsidized housing and are at disproportionate risk for nursing home admission. Effective approaches are needed to improve aging in place for this vulnerable population. The objective of this study is to pilot test the feasibility and preliminary effectiveness of a telephone-based intervention to improve aging in place for older adults living in subsidized housing. In the first phase of this study, the investigators used methods of implementation science to adapt an existing intervention, Function Focused Care for Assisted Living, to the unique setting of affordable housing. Function Focused Care is a philosophy of care in which assisted living staff members engage residents in functional and physical activity during all care interactions. Prior research supports the effectiveness of Function Focused Care for maintaining function and increasing physical activity among older adults in assisted living settings.

In the first phase of this study, the investigators interviewed subsidized housing stakeholders - including residents, staff members, and caregivers - to identify barriers, facilitators, and needed adaptations to Function Focused Care for Assisted Living. The investigators used the findings from these interviews to adapt the intervention. In this 2-month pilot study, the investigators will use a wait-list control design with site randomization to assess the feasibility and preliminary effectiveness of the adapted intervention. The investigators will recruit individuals with and without mild cognitive impairment or mild dementia and will examine whether the study outcomes differ by cognitive status. The findings from this study will provide new information about how to optimize function and physical activity among older adults with and without cognitive impairment living in subsidized housing.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
62 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •, Residents:
  • •Lives in an included subsidized housing setting
  • •62 years of age or older
  • •Speaks English or Spanish well or very well
  • •Able to provide informed consent OR able to provide assent and has a proxy who provides informed consent on his/her behalf
  • •Has difficulty or needs help in at least 1 ADL and/or IADL OR has mild cognitive impairment or mild dementia based on their Montreal Cognitive Assessment (MoCA) score
  • •Not enrolled in hospice
  • •Inclusion Criteria, Study Partners:
  • •Speaks English or Spanish well or very well
  • •Able to provide informed consent
  • •Spends at least an hour per week with the resident
  • •Inclusion Criteria, Staff Members:
  • •Speaks English or Spanish well or very well
  • •Able to provide informed consent

排除标准

  • •, Residents:
  • •Younger than 62 years of age
  • •Does not speak English or Spanish
  • •Lacks decision making capacity and lacks a proxy to consent on his/her behalf
  • •Does not have functional impairment or cognitive impairment
  • •Has moderate to severe dementia based on his/her MoCA score
  • •Is enrolled in hospice
  • •Exclusion Criteria, Study Partners:
  • •Does not speak English or Spanish
  • •Unable to provide informed consent
  • •Does not spend at least an hour per week with the resident
  • •Exclusion Criteria, Staff Members:
  • •Does not speak English or Spanish
  • •Unable to provide informed consent

研究组 & 干预措施

Immediate Intervention

Experimental

Upon enrollment, participants receive the adapted telephone-based intervention, the Independent Living Program for Affordable Housing, for two consecutive months.

干预措施: Independent Living Program for Affordable Housing. (Behavioral)

Wait-list Control

Experimental

Two months after study enrollment, participants receive the adapted telephone-based intervention, the Independent Living Program for Affordable Housing, for two consecutive months.

干预措施: Independent Living Program for Affordable Housing. (Behavioral)

结局指标

主要结局

Change in Precipitating Events Project (PEP) Functional Status Scale From Baseline to 2 Months for Immediate Intervention Sites and Waitlist Control Sites

时间窗: Baseline, 2 months

Self-reported ability to perform 7 ADLs, 5 IADLs, and 3 mobility tasks (Range, 0-30; higher scores indicate more functional impairment)

Change in Short Physical Performance Battery Score From Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites

时间窗: Baseline, 2 months

Objective measure of lower extremity functioning in older adults (Range, 0-12; higher scores indicate worse lower extremity functioning) The measure will be collected only if in-person contact is possible during the COVID-19 outbreak.

Change in Average Step Counts From Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites

时间窗: Measured continuously from 0-2 months

Measured using Fitbit

Change in Time Spent in Differing Levels of Activity From Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites

时间窗: Measured continuously from 0-2 months

Measured using Fitbit (minutes spent in each of 4 levels of activity: sedentary; lightly active; fairly active; very active)

Acceptability Assessed Using a Survey Question

时间窗: 2 months

Self-reported acceptability of the intervention (5-point Likert scale ranging from very unacceptable (1) to very acceptable (5); higher numbers indicate higher acceptability)

Change in Physical Activity Scale for the Elderly (PASE) Score From Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites

时间窗: Baseline, 2 months

Self-reported physical activity (Range, 0-793; higher scores indicate greater physical activity)

Feasibility of Study Recruitment, Measured as Percentage of Eligible Participants Recruited

时间窗: 0-4 months

Assessed using participant responses to invitation to participate in the study (enrolled vs. refused)

Feasibility of Study Retention, Measured as Percentage of Participants Retained Over Study Follow-up

时间窗: 0-4 months

Assessed as percentage of participants who remain enrolled in the study

Number of Participants With High Fidelity to Treatment Protocol, Measured Using Fidelity Checklist

时间窗: 0-4 months

Number of participants with \>80% fidelity to treatment protocol, measured using fidelity checklist including each study protocol task

Fidelity to Motivational Interviewing, Measured Using the Motivational Interviewing Treatment Integrity Scale (MITI 4)

时间窗: 2 months

Assessed by psychologist (4 global scores, scored on a 5-point Likert scale from 1 (low) to 5 (high))

次要结局

  • Change in EuroQol 5 Dimensions (EQ-5D-5L) Scale From Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites(Baseline, 2 months)
  • Change in Geriatric Depression Scale Short Form (GDS Short Form) Score From Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites(Baseline, 2 months)
  • Percentage of Participants With a Hospitalization During the Study Period (Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites)(Baseline, 2 months)
  • Change in Number of Hospitalizations During the Study Period (Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites)(Baseline, 2 months)
  • Percentage of Participants With an Emergency Department Visit During the Study Period (Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites)(Baseline, 2 months)
  • Change in Number of Emergency Department Visits During the Study Period (Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites)(Baseline, 2 months)
  • Percentage of Participants With a Move to a Higher Level of Care (Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites)(Baseline, 2 months)
  • Percentage of Participants With a Skilled Nursing Facility Stay (Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites)(Baseline, 2 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rebecca Brown, M.D. MPH

Faculty - Assistant Professor

University of Pennsylvania

研究点 (13)

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