- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04212442
Improving Aging in Place in Subsidized Housing
Improving Aging in Place for Older Adults in Subsidized Housing
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New Jersey
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Camden, New Jersey, United States, 08102
- Northgate 2
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Cape May, New Jersey, United States, 08204
- Haven House
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Cape May, New Jersey, United States, 08204
- Victorian Towers
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Pennsauken, New Jersey, United States, 08109
- Stonegate 1
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Pennsauken, New Jersey, United States, 08109
- Stonegate 2
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Mantua Presbyterian Apartments
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Philadelphia, Pennsylvania, United States, 19106
- Old City Presbyterian Apartments
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Philadelphia, Pennsylvania, United States, 19122
- Casa Carmen Aponte
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Philadelphia, Pennsylvania, United States, 19125
- Neumann Senior Housing
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Philadelphia, Pennsylvania, United States, 19125
- St. Francis VIlla
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Philadelphia, Pennsylvania, United States, 19142
- Paschall Senior Housing
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Philadelphia, Pennsylvania, United States, 19143
- Greenway Presbyterian Apartments
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Philadelphia, Pennsylvania, United States, 19148
- Jackson Place
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Immediate Intervention
Upon enrollment, participants receive the adapted telephone-based intervention, the Independent Living Program for Affordable Housing, for two consecutive months.
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Two-month program intended to increase physical activity and function, including the following 4 steps:
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Experimental: Wait-list Control
Two months after study enrollment, participants receive the adapted telephone-based intervention, the Independent Living Program for Affordable Housing, for two consecutive months.
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Two-month program intended to increase physical activity and function, including the following 4 steps:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of study recruitment, measured as percentage of eligible participants recruited
Time Frame: 0-4 months
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Assessed using participant responses to invitation to participate in the study (enrolled vs. refused)
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0-4 months
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Feasibility of study retention, measured as percentage of participants retained over study follow-up
Time Frame: 0-4 months
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Assessed as percentage of participants who remain enrolled in the study
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0-4 months
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Percentage fidelity to treatment protocol, measured using fidelity checklist
Time Frame: 0-4 months
|
Fidelity checklist including each component, with fidelity measured as the percentage of total study protocol tasks completed (Range, 0-100%; higher percentage indicates higher fidelity)
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0-4 months
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Fidelity to motivational interviewing, measured using the Motivational Interviewing Treatment Integrity Scale (MITI 4)
Time Frame: 0-4 months
|
Assessed by psychologist (4 global scores, scored on a 5-point Likert scale from 1 (low) to 5 (high))
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0-4 months
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Acceptability assessed using a survey question
Time Frame: 0-4 months
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Self-reported acceptability of the intervention (5-point Likert scale ranging from very unacceptable (1) to very acceptable (5); higher numbers indicate higher acceptability)
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0-4 months
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Acceptability assessed using qualitative interviews
Time Frame: 0-4 months
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Self-reported acceptability of the intervention assessed using open-ended questions (e.g., "How did the program fit into your life?"; no pre-specified range as responses are qualitative; more positive responses indicate higher acceptability)
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0-4 months
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Change in Precipitating Events Project (PEP) Functional Status Scale from baseline to 2 months for immediate intervention sites and waitlist control sites
Time Frame: Baseline, 2 months
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Self-reported ability to perform 7 ADLs, 3 higher-level mobility tasks, and 5 IADLs (Range, 0-30; higher scores indicate more functional impairment)
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Baseline, 2 months
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Change in Short Physical Performance Battery score from baseline to 2 months for immediate intervention and waitlist control sites
Time Frame: Baseline, 2 months
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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. |
Baseline, 2 months
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Change in average step counts from baseline to 2 months for immediate intervention and waitlist control sites
Time Frame: Measured continuously from 0-4 months
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Measured using Fitbit
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Measured continuously from 0-4 months
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Change in time spent in differing levels of activity from baseline to 2 months for immediate intervention and waitlist control sites
Time Frame: 0-4 months
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Measured using Fitbit (minutes spent in each of 4 levels of activity: sedentary; lightly active; fairly active; very active)
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0-4 months
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Change in Physical Activity Scale for the Elderly (PASE) score from baseline to 2 months for immediate intervention and waitlist control sites
Time Frame: Baseline, 2 months
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Self-reported physical activity (Range, 0-793; higher scores indicate greater physical activity)
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Baseline, 2 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EuroQol 5 dimensions (EQ-5D-5L) scale from baseline to 2 months for immediate intervention and waitlist control sites
Time Frame: Baseline, 2 months
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Self-reported measure (Range, 11111-55555, converted to a single index utility score ranging from of 0-1; higher scores indicate better quality of life)
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Baseline, 2 months
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Change in Geriatric Depression Scale Short Form (GDS Short Form) score from baseline to 2 months for immediate intervention and waitlist control sites
Time Frame: Baseline, 2 months
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Self-reported measure of depressive symptoms (Range, 0-15; score of 5-8 suggests mild depression, 9-11 moderate depression, and 12-15 severe depression)
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Baseline, 2 months
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Percentage of participants with a hospitalization during the study period (baseline to 2 months for immediate intervention and waitlist control sites)
Time Frame: Baseline, 2 months
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Self-reported hospitalization
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Baseline, 2 months
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Number of hospitalizations during the study period (baseline to 2 months for immediate intervention and waitlist control sites)
Time Frame: Baseline, 2 months
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Self-reported number of hospitalizations
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Baseline, 2 months
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Percentage of participants with an emergency department visit during the study period (baseline to 2 months for immediate intervention and waitlist control sites)
Time Frame: Baseline, 2 months
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Self-reported emergency department visit
|
Baseline, 2 months
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Number of emergency department visits during the study period (baseline to 2 months for immediate intervention and waitlist control sites)
Time Frame: Baseline, 2 months
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Self-reported number of emergency department visits
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Baseline, 2 months
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Percentage of participants with a move to a higher level of care (baseline to 2 months for immediate intervention and waitlist control sites)
Time Frame: Baseline, 2 months
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Self-reported or emergency contact-reported move to a higher level of care, defined as a move to assisted living, board and care, or nursing home
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Baseline, 2 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Rebecca Brown, MD, MPH, University of Pennsylvania
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 831642
- K76AG057016 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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