Improving Aging in Place in Subsidized Housing

Physical Activity Clinical Trial

Official title:

Improving Aging in Place for Older Adults in Subsidized Housing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04212442
• Other study ID #: 831642
• Secondary ID: K76AG057016
• Status: Completed
• Phase: N/A
• Start date: January 13, 2020
• Est. completion date: March 2, 2023

Study information

• Verified date: April 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: March 2, 2023
• Est. primary completion date: January 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 62 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Physical Activity
• Physical Disability

Intervention

Behavioral:
• Independent Living Program for Affordable Housing.
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.

Locations

Country	Name	City	State
United States	Northgate 2	Camden	New Jersey
United States	Haven House	Cape May	New Jersey
United States	Victorian Towers	Cape May	New Jersey
United States	Stonegate 1	Pennsauken	New Jersey
United States	Stonegate 2	Pennsauken	New Jersey
United States	Casa Carmen Aponte	Philadelphia	Pennsylvania
United States	Greenway Presbyterian Apartments	Philadelphia	Pennsylvania
United States	Jackson Place	Philadelphia	Pennsylvania
United States	Mantua Presbyterian Apartments	Philadelphia	Pennsylvania
United States	Neumann Senior Housing	Philadelphia	Pennsylvania
United States	Old City Presbyterian Apartments	Philadelphia	Pennsylvania
United States	Paschall Senior Housing	Philadelphia	Pennsylvania
United States	St. Francis VIlla	Philadelphia	Pennsylvania

Sponsors (7)

Lead Sponsor	Collaborator
University of Pennsylvania	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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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, 3 higher-level mobility tasks, and 5 IADLs (Range, 0-30; higher scores indicate more functional impairment)	Baseline, 2 months
Primary	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
Primary	Change in average step counts from baseline to 2 months for immediate intervention and waitlist control sites	Measured using Fitbit	Measured continuously from 0-4 months
Primary	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)	0-4 months
Primary	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
Primary	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
Primary	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
Primary	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)	0-4 months
Primary	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)	0-4 months
Primary	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)	0-4 months
Primary	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))	0-4 months
Secondary	EuroQol 5 dimensions (EQ-5D-5L) scale from baseline to 2 months for immediate intervention and 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)	Baseline, 2 months
Secondary	Change in Geriatric Depression Scale Short Form (GDS Short Form) score from baseline to 2 months for immediate intervention and 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)	Baseline, 2 months
Secondary	Percentage of participants with a hospitalization during the study period (baseline to 2 months for immediate intervention and waitlist control sites)	Self-reported hospitalization	Baseline, 2 months
Secondary	Number of hospitalizations during the study period (baseline to 2 months for immediate intervention and waitlist control sites)	Self-reported number of hospitalizations	Baseline, 2 months
Secondary	Percentage of participants with an emergency department visit during the study period (baseline to 2 months for immediate intervention and waitlist control sites)	Self-reported emergency department visit	Baseline, 2 months
Secondary	Number of emergency department visits during the study period (baseline to 2 months for immediate intervention and waitlist control sites)	Self-reported number of emergency department visits	Baseline, 2 months
Secondary	Percentage of participants with a move to a higher level of care (baseline to 2 months for immediate intervention and 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	Baseline, 2 months