Improving Aging in Place in Subsidized Housing

NCT04212442 | Completed Results

• 2 other identifiers: 831642K76AG057016
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 13

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.

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

Outcome Measures

Primary Outcomes (10)

• Change in Precipitating Events Project (PEP) Functional Status Scale From Baseline to 2 Months for Immediate Intervention Sites and Waitlist Control Sites

  Self-reported ability to perform 7 ADLs, 5 IADLs, and 3 mobility tasks (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

  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

  Measured using Fitbit

  Measured continuously from 0-2 months

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

  Measured using Fitbit (minutes spent in each of 4 levels of activity: sedentary; lightly active; fairly active; very active)

  Measured continuously from 0-2 months

• Change in Physical Activity Scale for the Elderly (PASE) Score From Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites

  Self-reported physical activity (Range, 0-793; higher scores indicate greater physical activity)

  Baseline, 2 months

• 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)

  0-4 months

• 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

  0-4 months

• 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)

  2 months

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

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

  0-4 months

• 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))

  2 months

Secondary Outcomes (8)

• Change in EuroQol 5 Dimensions (EQ-5D-5L) Scale From Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites

  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

  Baseline, 2 months

• Percentage of Participants With a Hospitalization During the Study Period (Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites)

  Baseline, 2 months

• Change in Number of Hospitalizations During the Study Period (Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites)

  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)

  Baseline, 2 months

Study Arms (2)

Immediate Intervention

EXPERIMENTAL

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

Behavioral: Independent Living Program for Affordable Housing.

Wait-list Control

EXPERIMENTAL

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

Behavioral: Independent Living Program for Affordable Housing.

Interventions

Independent Living Program for Affordable Housing. BEHAVIORAL

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.

Immediate Intervention; Wait-list Control

Eligibility Criteria

• Age: 62 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Lives in an included subsidized housing setting
• 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
• Speaks English or Spanish well or very well
• Able to provide informed consent
• Spends at least an hour per week with the resident
• Speaks English or Spanish well or very well
• Able to provide informed consent

You may not qualify if:

• 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
• Does not speak English or Spanish
• Unable to provide informed consent
• Does not spend at least an hour per week with the resident
• Does not speak English or Spanish
• Unable to provide informed consent

Sponsors & Collaborators

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

Study Sites (13)

Northgate 2

Camden, New Jersey, 08102, United States

Location

Haven House

Cape May, New Jersey, 08204, United States

Location

Victorian Towers

Cape May, New Jersey, 08204, United States

Location

Stonegate 1

Pennsauken, New Jersey, 08109, United States

Location

Stonegate 2

Pennsauken, New Jersey, 08109, United States

Location

Mantua Presbyterian Apartments

Philadelphia, Pennsylvania, 19104, United States

Location

Old City Presbyterian Apartments

Philadelphia, Pennsylvania, 19106, United States

Location

Casa Carmen Aponte

Philadelphia, Pennsylvania, 19122, United States

Location

Neumann Senior Housing

Philadelphia, Pennsylvania, 19125, United States

Location

St. Francis VIlla

Philadelphia, Pennsylvania, 19125, United States

Location

Paschall Senior Housing

Philadelphia, Pennsylvania, 19142, United States

Location

Greenway Presbyterian Apartments

Philadelphia, Pennsylvania, 19143, United States

Location

Jackson Place

Philadelphia, Pennsylvania, 19148, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Motor Activity; Dementia

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Limitations and Caveats

The study was conducted during the COVID pandemic. Due to challenges with participant follow-up in the setting of the pandemic, outcome data is missing for multiple participants.

Results Point of Contact

• Title: Dr. Rebecca Brown
• Organization: University of Pennsylvania

rebecca.brown@pennmedicine.upenn.edu

215-573-2021

Study Officials

• Rebecca Brown, MD, MPH

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty - Assistant Professor

Model Details: This is a pilot study testing the adapted Function Focused Care intervention. The study employs a wait-list control design and site randomization.

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: December 27, 2019
• Study Start: January 13, 2020
• Primary Completion: January 24, 2023
• Study Completion: March 2, 2023
• Last Updated: November 15, 2024
• Results First Posted: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: At the end of the 3 year study period for the full parent study
• Access Criteria: Identification of the purpose for wanting the data

Locations

US (13)