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Completed

NCT Number: NCT04212442

Improving Aging in Place 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.

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Key information

Conditions

Physical Disability Behavior Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Cognitive Impairment Dementia Mental Disorders Motor Activity Nervous System Diseases Neurocognitive Disorders Physical Activity

Age range

62 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northgate 2, Camden, New Jersey, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Independent Living Program for Affordable Housing.

Behavioral

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 outcomes

  1. 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, 5 IADLs, and 3 mobility tasks (Range, 0-30; higher scores indicate more functional impairment)

  2. 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.

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

    Time frame: Measured continuously from 0-2 months

    Measured using Fitbit

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

    Time frame: 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)

  5. 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)

  6. 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)

  7. 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

  8. Acceptability Assessed Using a Survey Question

    Time frame: 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)

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

    Time frame: 0-4 months

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

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

    Time frame: 2 months

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

Secondary outcomes

  1. Change in 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)

  2. 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)

  3. 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

  4. Change in 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

  5. 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

  6. Change in 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

  7. 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

  8. Percentage of Participants With a Skilled Nursing Facility Stay (Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites)

    Time frame: Baseline, 2 months

    Self-reported skilled nursing facility stay

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Diocesan Housing Services Corporation of the Diocese of Camden, Inc
  • Fair Share Housing Development
  • HumanGood
  • National Institute on Aging (NIA)
  • University of California, Berkeley
  • University of Maryland, Baltimore

Registry information

Official study title

Improving Aging in Place for Older Adults in Subsidized Housing

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 27, 2019
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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