Physical DisabilityNCT04212442
Improving Aging in Place in Subsidized Housing
A study testing Independent Living Program for Affordable Housing. in people with Physical Disability and Cognitive Impairment, run by University of Pennsylvania at 13 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 62 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Disability, Cognitive Impairment, Physical Activity
- What is being tested?
- Independent Living Program for Affordable Housing.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 13 sitesUnited States
- Study dates
- 13 Jan 2020to 2 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 62 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Northgate 2
Camden, New Jersey, 08102
Haven House
Cape May, New Jersey, 08204
Victorian Towers
Cape May, New Jersey, 08204
Stonegate 1
Pennsauken, New Jersey, 08109
Stonegate 2
Pennsauken, New Jersey, 08109
Mantua Presbyterian Apartments
Philadelphia, Pennsylvania, 19104
Old City Presbyterian Apartments
Philadelphia, Pennsylvania, 19106
Casa Carmen Aponte
Philadelphia, Pennsylvania, 19122
Neumann Senior Housing
Philadelphia, Pennsylvania, 19125
St. Francis VIlla
Philadelphia, Pennsylvania, 19125
Paschall Senior Housing
Philadelphia, Pennsylvania, 19142
Greenway Presbyterian Apartments
Philadelphia, Pennsylvania, 19143
Jackson Place
Philadelphia, Pennsylvania, 19148
About this study
Official title: 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.
Read the 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.
- Conditions
- Physical Disability, Cognitive Impairment, Physical Activity
- Being tested
- Independent Living Program for Affordable Housing.
- Keywords
- aging in place, physical activity, cognitive impairment, dementia, affordable housing, subsidized housing, functional impairment, home health aides, activities of daily living
- Medical subject headings
- Cognitive Dysfunction, Motor Activity, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Independent Living Program for Affordable Housing.Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Intervention | Experimental | Upon enrollment, participants receive the adapted telephone-based intervention, the Independent Living Program for Affordable Housing, for two consecutive months. Receives: 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. Receives: Behavioral: Independent Living Program for Affordable Housing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: Baseline, 2 months
Change in Average Step Counts From Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites
Measured using Fitbit
Measured: 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: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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))
Measured: 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
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)
Measured: 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
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)
Measured: Baseline, 2 months
Percentage of Participants With a Hospitalization During the Study Period (Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites)
Self-reported hospitalization
Measured: Baseline, 2 months
Change in Number of Hospitalizations During the Study Period (Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites)
Self-reported number of hospitalizations
Measured: 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)
Self-reported emergency department visit
Measured: Baseline, 2 months
Change in 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
Measured: 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)
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
Measured: Baseline, 2 months
Percentage of Participants With a Skilled Nursing Facility Stay (Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites)
Self-reported skilled nursing facility stay
Measured: Baseline, 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2019
- Study start13 Jan 2020
- Primary completion24 Jan 2023
- Study completion2 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Physical DisabilityStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Berkeley, HumanGood, University of Maryland, Baltimore, Diocesan Housing Services Corporation of the Diocese of Camden, Inc, Fair Share Housing Development, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Rebecca Brown, M.D. MPH, University of Pennsylvania
- Investigators
- Rebecca Brown, MD, MPH, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212442
- Sponsor's protocol ID
- 831642
- Other IDs
- K76AG057016
- Status last verified
- Nov 2024
- First submitted
- 16 Dec 2019
- Last updated
- 15 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will share data based on request and following the development of an IPD sharing plan with the IRB.
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Aging in Place for Older Adults in Subsidized Housing
- ClinicalTrials.gov ID
- NCT04212442
- Acronym / sponsor ID
- 831642
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- University of California, Berkeley, HumanGood, University of Maryland, Baltimore, Diocesan Housing Services Corporation of the Diocese of Camden, Inc, Fair Share Housing Development, National Institute on Aging (NIA)
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 24 Jan 2023 (actual)
- Study completion
- 2 Mar 2023 (actual)
- First posted
- 27 Dec 2019 (actual)
- Results
- Posted 15 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention | Experimental | Behavioral: Independent Living Program for Affordable Housing.Upon enrollment, participants receive the adapted telephone-based intervention, the Independent Living Program for Affordable Housing, for two consecutive months. |
| Wait-list Control | Experimental | Behavioral: Independent Living Program for Affordable Housing.Two months after study enrollment, participants receive the adapted telephone-based intervention, the Independent Living Program for Affordable Housing, for two consecutive months. |
Who may qualify
- Ages
- 62 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Independent Living Program for Affordable Housing.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. | Behavioural | Immediate Intervention, Wait-list Control |
Primary outcome
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)
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.
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
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)
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)
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)
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
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)
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
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))
8 secondary outcomes
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
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
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
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
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
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Will share data based on request and following the development of an IPD sharing plan with the IRB.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Brown, MD, MPH principal investigator
University of Pennsylvania
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Independent Living Program for Affordable Housing. in people with Physical Disability and Cognitive Impairment, run by University of Pennsylvania at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.