Improving Aging in Place in Subsidized Housing

April 10, 2024 updated by: Rebecca Brown, M.D. MPH, University of Pennsylvania

Improving Aging in Place for Older Adults in Subsidized Housing

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.

Study Overview

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

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New Jersey
      • Camden, New Jersey, United States, 08102
        • Northgate 2
      • Cape May, New Jersey, United States, 08204
        • Haven House
      • Cape May, New Jersey, United States, 08204
        • Victorian Towers
      • Pennsauken, New Jersey, United States, 08109
        • Stonegate 1
      • Pennsauken, New Jersey, United States, 08109
        • Stonegate 2
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Mantua Presbyterian Apartments
      • Philadelphia, Pennsylvania, United States, 19106
        • Old City Presbyterian Apartments
      • Philadelphia, Pennsylvania, United States, 19122
        • Casa Carmen Aponte
      • Philadelphia, Pennsylvania, United States, 19125
        • Neumann Senior Housing
      • Philadelphia, Pennsylvania, United States, 19125
        • St. Francis VIlla
      • Philadelphia, Pennsylvania, United States, 19142
        • Paschall Senior Housing
      • Philadelphia, Pennsylvania, United States, 19143
        • Greenway Presbyterian Apartments
      • Philadelphia, Pennsylvania, United States, 19148
        • Jackson Place

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

62 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.

Two-month program intended to increase physical activity and function, including the following 4 steps:

  1. Environmental and Policy Assessments: Nurse facilitator works with the affordable housing staff to identify and recommend feasible interventions to alter the environment, policy, and procedures to optimize resident function and physical activity.
  2. Education: Nurse educates residents and study partners in the principles of the Independent Living Program, using established materials and adult learning techniques.
  3. Establishing Resident Goals: The nurse completes Capability Assessment Forms and helps resident set goals to increase function and physical activity.
  4. The nurse helps to motivate and mentor residents and study partners to achieve and maintain their goals, using evidence-based approaches.
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.

Two-month program intended to increase physical activity and function, including the following 4 steps:

  1. Environmental and Policy Assessments: Nurse facilitator works with the affordable housing staff to identify and recommend feasible interventions to alter the environment, policy, and procedures to optimize resident function and physical activity.
  2. Education: Nurse educates residents and study partners in the principles of the Independent Living Program, using established materials and adult learning techniques.
  3. Establishing Resident Goals: The nurse completes Capability Assessment Forms and helps resident set goals to increase function and physical activity.
  4. The nurse helps to motivate and mentor residents and study partners to achieve and maintain their goals, using evidence-based approaches.

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
Assessed using participant responses to invitation to participate in the study (enrolled vs. refused)
0-4 months
Feasibility of study retention, measured as percentage of participants retained over study follow-up
Time Frame: 0-4 months
Assessed as percentage of participants who remain enrolled in the study
0-4 months
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)
0-4 months
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))
0-4 months
Acceptability assessed using a survey question
Time Frame: 0-4 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)
0-4 months
Acceptability assessed using qualitative interviews
Time Frame: 0-4 months
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)
0-4 months
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
Self-reported ability to perform 7 ADLs, 3 higher-level mobility tasks, and 5 IADLs (Range, 0-30; higher scores indicate more functional impairment)
Baseline, 2 months
Change in Short Physical Performance Battery score from baseline to 2 months for immediate intervention and waitlist control sites
Time Frame: 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.

Baseline, 2 months
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
Measured using Fitbit
Measured continuously from 0-4 months
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
Measured using Fitbit (minutes spent in each of 4 levels of activity: sedentary; lightly active; fairly active; very active)
0-4 months
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
Self-reported physical activity (Range, 0-793; higher scores indicate greater physical activity)
Baseline, 2 months

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
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)
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
Time Frame: Baseline, 2 months
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)
Baseline, 2 months
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
Self-reported hospitalization
Baseline, 2 months
Number of hospitalizations during the study period (baseline to 2 months for immediate intervention and waitlist control sites)
Time Frame: Baseline, 2 months
Self-reported number of hospitalizations
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)
Time Frame: Baseline, 2 months
Self-reported emergency department visit
Baseline, 2 months
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
Self-reported number of emergency department visits
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)
Time Frame: Baseline, 2 months
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
Baseline, 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2020

Primary Completion (Actual)

January 24, 2023

Study Completion (Actual)

March 2, 2023

Study Registration Dates

First Submitted

December 16, 2019

First Submitted That Met QC Criteria

December 23, 2019

First Posted (Actual)

December 27, 2019

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Will share data based on request and following the development of an IPD sharing plan with the IRB.

IPD Sharing Time Frame

At the end of the 3 year study period for the full parent study

IPD Sharing Access Criteria

Identification of the purpose for wanting the data

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Physical Activity

Clinical Trials on Independent Living Program for Affordable Housing.

3
Subscribe