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Improving Aging in Place in Subsidized Housing

Primary Purpose

Physical Disability, Cognitive Impairment, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Independent Living Program for Affordable Housing.
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Physical Disability focused on measuring aging in place, physical activity, cognitive impairment, dementia, affordable housing, subsidized housing, functional impairment, home health aides, activities of daily living

Eligibility Criteria

62 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Northgate 2
  • Haven House
  • Victorian Towers
  • Stonegate 1
  • Stonegate 2
  • Mantua Presbyterian Apartments
  • Old City Presbyterian Apartments
  • Casa Carmen Aponte
  • Neumann Senior Housing
  • St. Francis VIlla
  • Paschall Senior Housing
  • Greenway Presbyterian Apartments
  • Jackson Place

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Immediate Intervention

Wait-list Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Precipitating Events Project (PEP) Functional Status Scale from baseline to 2 months for immediate intervention sites; change from 2 months to 4 months for waitlist control sites
Self-reported ability to perform 8 ADLs and 7 IADLs (Range, 0-30; higher scores indicate more functional impairment)
Change in Short Physical Performance Battery score from baseline to 2 months for immediate intervention sites; change from 2 months to 4 months for waitlist control sites
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 sites; change from 2 to 4 months for waitlist control sites
Measured using Fitbit
Change in time spent in differing levels of activity from baseline to 2 months for immediate intervention sites; change from 2 months to 4 months for waitlist control sites
Measured using Fitbit (minutes spent in each of 4 levels of activity: sedentary; lightly active; fairly active; very active)
Change in Physical Activity Scale for the Elderly (PASE) score from baseline to 2 months for immediate intervention sites; change from 2 months to 4 months for waitlist control sites
Self-reported physical activity (Range, 0-793; higher scores indicate greater physical activity)
Feasibility of study recruitment, measured as percentage of eligible participants recruited
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
Assessed as percentage of participants who remain enrolled in the study
Acceptability assessed using a survey question
Self-reported acceptability of the intervention (5-point Likert scale ranging from very unacceptable (1) to very acceptable (5); higher numbers indicate higher acceptability)
Acceptability assessed using qualitative interviews
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)
Percentage fidelity to treatment protocol, measured using fidelity checklist
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)
Fidelity to motivational interviewing, measured using the Motivational Interviewing Treatment Integrity Scale (MITI 4)
Assessed by psychologist (4 global scores, scored on a 5-point Likert scale from 1 (low) to 5 (high))

Secondary Outcome Measures

EuroQol 5 dimensions (EQ-5D-5L) scale from baseline to 2 months for immediate intervention sites; change from 2 months to 4 months for waitlist control sites
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)
Change in Geriatric Depression Scale Short Form (GDS Short Form) score from baseline to 2 months for immediate intervention sites; change from 2 months to 4 months for waitlist control sites
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)
Percentage of participants with a hospitalization during the study period (baseline to 2 months for immediate intervention sites; 2 months to 4 months for waitlist control sites)
Self-reported hospitalization
Number of hospitalizations during the study period (baseline to 2 months for immediate intervention sites; 2 months to 4 months for waitlist control sites)
Self-reported number of hospitalizations
Percentage of participants with an emergency department visit during the study period (baseline to 2 months for immediate intervention sites; 2 months to 4 months for waitlist control sites)
Self-reported emergency department visit
Number of emergency department visits during the study period (baseline to 2 months for immediate intervention sites; 2 months to 4 months for waitlist control sites)
Self-reported number of emergency department visits
Percentage of participants with a move to a higher level of care (baseline to 2 months for immediate intervention sites; 2 months to 4 months for waitlist control sites)
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

Full Information

First Posted
December 16, 2019
Last Updated
July 21, 2023
Sponsor
University of Pennsylvania
Collaborators
University of California, Berkeley, HumanGood, University of Maryland, Baltimore, Diocesan Housing Services Corporation of the Diocese of Camden, Inc, Fair Share Housing Development
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1. Study Identification

Unique Protocol Identification Number
NCT04212442
Brief Title
Improving Aging in Place in Subsidized Housing
Official Title
Improving Aging in Place for Older Adults in Subsidized Housing
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 13, 2020 (Actual)
Primary Completion Date
January 24, 2023 (Actual)
Study Completion Date
March 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
Collaborators
University of California, Berkeley, HumanGood, University of Maryland, Baltimore, Diocesan Housing Services Corporation of the Diocese of Camden, Inc, Fair Share Housing Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate Intervention
Arm Type
Experimental
Arm Description
Upon enrollment, participants receive the adapted telephone-based intervention, the Independent Living Program for Affordable Housing, for two consecutive months.
Arm Title
Wait-list Control
Arm Type
Experimental
Arm Description
Two months after study enrollment, participants receive the adapted telephone-based intervention, the Independent Living Program for Affordable Housing, for two consecutive months.
Intervention Type
Behavioral
Intervention Name(s)
Independent Living Program for Affordable Housing.
Intervention Description
Two-month program intended to increase physical activity and function, including the following 4 steps: 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. Education: Nurse educates residents and study partners in the principles of the Independent Living Program, using established materials and adult learning techniques. Establishing Resident Goals: The nurse completes Capability Assessment Forms and helps resident set goals to increase function and physical activity. The nurse helps to motivate and mentor residents and study partners to achieve and maintain their goals, using evidence-based approaches.
Primary Outcome Measure Information:
Title
Change in Precipitating Events Project (PEP) Functional Status Scale from baseline to 2 months for immediate intervention sites; change from 2 months to 4 months for waitlist control sites
Description
Self-reported ability to perform 8 ADLs and 7 IADLs (Range, 0-30; higher scores indicate more functional impairment)
Time Frame
Baseline, 2 months, 4 months for wait-list control
Title
Change in Short Physical Performance Battery score from baseline to 2 months for immediate intervention sites; change from 2 months to 4 months for waitlist control sites
Description
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.
Time Frame
Baseline, 2 months, 4 months for wait-list control
Title
Change in average step counts from baseline to 2 months for immediate intervention sites; change from 2 to 4 months for waitlist control sites
Description
Measured using Fitbit
Time Frame
Measured continuously from 0-4 months
Title
Change in time spent in differing levels of activity from baseline to 2 months for immediate intervention sites; change from 2 months to 4 months for waitlist control sites
Description
Measured using Fitbit (minutes spent in each of 4 levels of activity: sedentary; lightly active; fairly active; very active)
Time Frame
0-4 months
Title
Change in Physical Activity Scale for the Elderly (PASE) score from baseline to 2 months for immediate intervention sites; change from 2 months to 4 months for waitlist control sites
Description
Self-reported physical activity (Range, 0-793; higher scores indicate greater physical activity)
Time Frame
Baseline, 2 months, 4 months for wait-list control
Title
Feasibility of study recruitment, measured as percentage of eligible participants recruited
Description
Assessed using participant responses to invitation to participate in the study (enrolled vs. refused)
Time Frame
0-4 months
Title
Feasibility of study retention, measured as percentage of participants retained over study follow-up
Description
Assessed as percentage of participants who remain enrolled in the study
Time Frame
0-4 months
Title
Acceptability assessed using a survey question
Description
Self-reported acceptability of the intervention (5-point Likert scale ranging from very unacceptable (1) to very acceptable (5); higher numbers indicate higher acceptability)
Time Frame
0-4 months
Title
Acceptability assessed using qualitative interviews
Description
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)
Time Frame
0-4 months
Title
Percentage fidelity to treatment protocol, measured using fidelity checklist
Description
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)
Time Frame
0-4 months
Title
Fidelity to motivational interviewing, measured using the Motivational Interviewing Treatment Integrity Scale (MITI 4)
Description
Assessed by psychologist (4 global scores, scored on a 5-point Likert scale from 1 (low) to 5 (high))
Time Frame
0-4 months
Secondary Outcome Measure Information:
Title
EuroQol 5 dimensions (EQ-5D-5L) scale from baseline to 2 months for immediate intervention sites; change from 2 months to 4 months for waitlist control sites
Description
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)
Time Frame
Baseline, 2 months, 4 months for wait-list control
Title
Change in Geriatric Depression Scale Short Form (GDS Short Form) score from baseline to 2 months for immediate intervention sites; change from 2 months to 4 months for waitlist control sites
Description
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)
Time Frame
Baseline, 2 months, 4 months for wait-list control
Title
Percentage of participants with a hospitalization during the study period (baseline to 2 months for immediate intervention sites; 2 months to 4 months for waitlist control sites)
Description
Self-reported hospitalization
Time Frame
Baseline, 2 months, 4 months for wait-list control
Title
Number of hospitalizations during the study period (baseline to 2 months for immediate intervention sites; 2 months to 4 months for waitlist control sites)
Description
Self-reported number of hospitalizations
Time Frame
Baseline, 2 months, 4 months for wait-list control
Title
Percentage of participants with an emergency department visit during the study period (baseline to 2 months for immediate intervention sites; 2 months to 4 months for waitlist control sites)
Description
Self-reported emergency department visit
Time Frame
Baseline, 2 months, 4 months for wait-list control
Title
Number of emergency department visits during the study period (baseline to 2 months for immediate intervention sites; 2 months to 4 months for waitlist control sites)
Description
Self-reported number of emergency department visits
Time Frame
Baseline, 2 months, 4 months for wait-list control
Title
Percentage of participants with a move to a higher level of care (baseline to 2 months for immediate intervention sites; 2 months to 4 months for waitlist control sites)
Description
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
Time Frame
Baseline, 2 months, 4 months for wait-list control

10. Eligibility

Sex
All
Minimum Age & Unit of Time
62 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Brown, MD, MPH
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northgate 2
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08102
Country
United States
Facility Name
Haven House
City
Cape May
State/Province
New Jersey
ZIP/Postal Code
08204
Country
United States
Facility Name
Victorian Towers
City
Cape May
State/Province
New Jersey
ZIP/Postal Code
08204
Country
United States
Facility Name
Stonegate 1
City
Pennsauken
State/Province
New Jersey
ZIP/Postal Code
08109
Country
United States
Facility Name
Stonegate 2
City
Pennsauken
State/Province
New Jersey
ZIP/Postal Code
08109
Country
United States
Facility Name
Mantua Presbyterian Apartments
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Old City Presbyterian Apartments
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
Casa Carmen Aponte
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19122
Country
United States
Facility Name
Neumann Senior Housing
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19125
Country
United States
Facility Name
St. Francis VIlla
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19125
Country
United States
Facility Name
Paschall Senior Housing
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19142
Country
United States
Facility Name
Greenway Presbyterian Apartments
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19143
Country
United States
Facility Name
Jackson Place
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19148
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Improving Aging in Place in Subsidized Housing

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