Clinical trial NCT04212442: Improving Aging in Place in Subsidized Housing
Official title: Improving Aging in Place for Older Adults in Subsidized Housing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Disability
Cognitive Impairment
Physical Activity
Keywords: aging in place
physical activity
cognitive impairment
dementia
affordable housing
subsidized housing
functional impairment
home health aides
activities of daily living
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: University of California, Berkeley
name: HumanGood
name: University of Maryland, Baltimore
name: Diocesan Housing Services Corporation of the Diocese of Camden, Inc
name: Fair Share Housing Development
name: National Institute on Aging (NIA)
First posted: 2019-12-27
Enrollment: 75
Sex: ALL
Minimum age (years): 62
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a pilot study testing the adapted Function Focused Care intervention. The study employs a wait-list control design and site randomization.
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria, 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

Exclusion Criteria, 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

Primary outcomes:
measure: Change in Precipitating Events Project (PEP) Functional Status Scale From Baseline to 2 Months for Immediate Intervention Sites and Waitlist Control Sites
timeFrame: Baseline, 2 months
measure: Change in Short Physical Performance Battery Score From Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites
timeFrame: Baseline, 2 months
measure: Change in Average Step Counts From Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites
timeFrame: Measured continuously from 0-2 months
measure: Change in Time Spent in Differing Levels of Activity From Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites
timeFrame: Measured continuously from 0-2 months
measure: Change in Physical Activity Scale for the Elderly (PASE) Score From Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites
timeFrame: Baseline, 2 months
measure: Feasibility of Study Recruitment, Measured as Percentage of Eligible Participants Recruited
timeFrame: 0-4 months
measure: Feasibility of Study Retention, Measured as Percentage of Participants Retained Over Study Follow-up
timeFrame: 0-4 months
measure: Acceptability Assessed Using a Survey Question
timeFrame: 2 months
measure: Number of Participants With High Fidelity to Treatment Protocol, Measured Using Fidelity Checklist
timeFrame: 0-4 months
measure: Fidelity to Motivational Interviewing, Measured Using the Motivational Interviewing Treatment Integrity Scale (MITI 4)
timeFrame: 2 months
Secondary outcomes:
measure: Change in EuroQol 5 Dimensions (EQ-5D-5L) Scale From Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites
timeFrame: Baseline, 2 months
measure: Change in Geriatric Depression Scale Short Form (GDS Short Form) Score From Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites
timeFrame: Baseline, 2 months
measure: Percentage of Participants With a Hospitalization During the Study Period (Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites)
timeFrame: Baseline, 2 months
measure: Change in Number of Hospitalizations During the Study Period (Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites)
timeFrame: Baseline, 2 months
measure: Percentage of Participants With an Emergency Department Visit During the Study Period (Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites)
timeFrame: Baseline, 2 months
measure: Change in Number of Emergency Department Visits During the Study Period (Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites)
timeFrame: Baseline, 2 months
measure: Percentage of Participants With a Move to a Higher Level of Care (Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites)
timeFrame: Baseline, 2 months
measure: Percentage of Participants With a Skilled Nursing Facility Stay (Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites)
timeFrame: Baseline, 2 months
Other outcomes:
Locations:
city: Camden
country: United States
facility: Northgate 2
state: New Jersey
city: Cape May
country: United States
facility: Haven House
state: New Jersey
city: Cape May
country: United States
facility: Victorian Towers
state: New Jersey
city: Pennsauken
country: United States
facility: Stonegate 1
state: New Jersey
city: Pennsauken
country: United States
facility: Stonegate 2
state: New Jersey
city: Philadelphia
country: United States
facility: Mantua Presbyterian Apartments
state: Pennsylvania
city: Philadelphia
country: United States
facility: Old City Presbyterian Apartments
state: Pennsylvania
city: Philadelphia
country: United States
facility: Casa Carmen Aponte
state: Pennsylvania
city: Philadelphia
country: United States
facility: Neumann Senior Housing
state: Pennsylvania
city: Philadelphia
country: United States
facility: St. Francis VIlla
state: Pennsylvania
city: Philadelphia
country: United States
facility: Paschall Senior Housing
state: Pennsylvania
city: Philadelphia
country: United States
facility: Greenway Presbyterian Apartments
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jackson Place
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Rebecca Brown, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: