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Implementing CAPABLE in PSH

Primary Purpose

Accidental Fall, Frailty, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CAPABLE: Community Aging in Place-Advancing Better Living for Elders
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Accidental Fall

Eligibility Criteria

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

Inclusion Criteria:

  • Older than 50 years in age
  • cognitively intact or have only mild cognitive impairment
  • have some or a lot of difficulty performing ADLs
  • tenant of Skid Row Housing Trust

Exclusion Criteria:

  • see above

Sites / Locations

  • Skid Row Housing Trust

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

CAPABLE

Arm Description

CAPABLE Intervention

Outcomes

Primary Outcome Measures

Activities of Daily Living
The modified Katz Activities of Daily Living (ADL) Scale will be used to rate ability to bathe, dress, transfer, toilet, and eat using five categories; participants rated their ability to perform daily tasks on a 5-point scale (1 = no difficulty, 2 = a little difficulty, 3 = moderate difficulty, 4 = a lot of difficulty, 5 = unable to do). Higher scores represent greater difficulty performing ADLs
Brief Instrumental Functioning
The Brief Instrumental Functioning Scale will be used to assess ability to perform in six functions: bathing, dressing, going to toilet, transferring, continence, and feeding. Each area is assessed on a five point scale; participants rated their ability to perform daily tasks on a 5-point scale (1 = no difficulty, 2 = a little difficulty, 3 = moderate difficulty, 4 = a lot of difficulty, 5 = unable to do). Higher scores represent more issues with functioning.
Depression
Eight of the nine items in the Patient Health Questionnaire-9 were used to measure depression, rated on a 4-point scale of how frequently participants were bothered by the eight problems during a 2-week period (0 = not at all, 1 = several days, 2 = more than half the days, and 3 = nearly every day).
Falls Efficacy
participants rated their confidence they could do each of 10 activities without falling on a 10-point scale, with total scores ranging from 10 (not very confident) to 100 (very confident) using the Tinetti Falls Efficacy Scale.
Pain interference with normal, everyday activities
Pain interference with normal, everyday activities was measured using a 3-item brief pain inventory relative to the past week on a 10-point scale for describing pain (0 = no pain; 10 = pain as bad as you can imagine); pain that interfered with enjoyment of life (0 = does not interfere; 10 = completely interferes); and pain that interfered with general activity (0 = does not interfere; 10 = completely interferes).
Falls
History of falls during the past year and since last assessment period by asking: "Did you fall to the ground in the past year (since the last survey)?"

Secondary Outcome Measures

Self-rated health
Self-rated health was measured on a 5-point scale (1 = excellent, 2 = very good, 3 = good, 4 = fair, 5 = poor).
Quality of life
Quality of life from the 12-item Short Form instrument was scored on a 10-point scale (1 = worst possible quality of life; 10 = best possible quality of life).

Full Information

First Posted
August 27, 2019
Last Updated
December 28, 2022
Sponsor
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT04076319
Brief Title
Implementing CAPABLE in PSH
Official Title
Implementing CAPABLE in Permanent Supportive Housing
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
December 17, 2020 (Actual)
Primary Completion Date
July 25, 2022 (Actual)
Study Completion Date
July 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California

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 project seeks to implement an intervention known as CAPABLE (Community Aging in Place-Advancing Better Living for Elders) for formerly homeless adults living in permanent supportive housing. This home-based intervention that consists of time-limited services (no more than 6-months) from an occupational therapist, a nurse, and a handyman is intended to improve functioning and decrease falls among this population that prematurely ages and is at increased fall risk.
Detailed Description
Permanent supportive housing (PSH) using a housing first approach is an evidence-based intervention to end chronic homelessness by providing low-barrier affordable housing paired with flexible health and social services. In Los Angeles County (LAC), where the number of PSH units is expected to increase dramatically over the next 10 years, clinical guidelines and/or standards for support services are lacking. This is especially problematic given the that the target population is older and prematurely aging. The chronically homeless population in the United States has an average age approaching 60 years old and experiences accelerated aging, including an elevated prevalence of geriatric syndromes such as functional impairment, falls, and urinary incontinence that can jeopardize PSH tenants' ability to live independently and age in place. Current support services are not equipped to address these needs, which ultimately jeopardizes the success of PSH to maintain high rates of housing stability while tenants "age in place." The investigators propose conducting a pilot project to implement the CAPABLE model in PSH. CAPABLE, which stands for "Community Aging in Place-Advancing Better Living for Elders" is a client-directed home-based intervention that consists of time-limited services (no more than 6-months) from an occupational therapist, a nurse, and a handyman working collaboratively with the older adult client. CAPABLE was developed to target older adults who are returning to independent living after hospitalization and has been shown to improve functioning (activities of daily living - ADLs and instrumental activities of daily living - IADLs), decrease falls and nursing home admissions, and reduce healthcare costs based on multiple studies including several randomized control trials. CAPABLE has the potential to be used in PSH as a model of support services that can address needs of prematurely aging tenants, which could help transform PSH from an intervention that ends homeless to an intervention that addresses homelessness and supports successful aging in place. The specific aims of this study are to: Examine the impact of CAPABLE on PSH client outcomes (e.g. ADLs, IADLs, falls). This aim will be accomplished using a pre-/post-design with a wait-list control group. Determine what adaptations, if any, need to be made to implement CAPABLE in PSH. The investigators will accomplish this aim using the Dynamic Adaptation Process (DAP) implementation approach, which was designed to allow for an evidenced-based practice to be adapted in a planned and considered, rather than ad hoc, manner. Important to note is that this project was conducted during the COVID-19 pandemic so that adaptations to CAPABLE may be due to the context of the pandemic as opposed to being implemented in PSH.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Accidental Fall, Frailty, Depression, Activities of Daily Living, Housing Problems

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Waitlist control design
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CAPABLE
Arm Type
Other
Arm Description
CAPABLE Intervention
Intervention Type
Behavioral
Intervention Name(s)
CAPABLE: Community Aging in Place-Advancing Better Living for Elders
Intervention Description
CAPABLE is a client-directed home-based intervention that consists of time-limited services from an occupational therapist, a nurse, and a handyman working collaboratively with the older adult client. In most cases, the OT makes 6 visits, the RN makes 4 visits, and a handyman makes 1 to 2 visits to make any modifications to a person's home during a 6-month period. The first visits for the OT and RN are usually 90 minutes each and the later ones are usually an hour each. Visits are spaced to enable older adults to practice new strategies learned in the previous visit. There should be a clear "conclusion/graduation," with the older adult understanding how to use their new skills and apply them to future situations.
Primary Outcome Measure Information:
Title
Activities of Daily Living
Description
The modified Katz Activities of Daily Living (ADL) Scale will be used to rate ability to bathe, dress, transfer, toilet, and eat using five categories; participants rated their ability to perform daily tasks on a 5-point scale (1 = no difficulty, 2 = a little difficulty, 3 = moderate difficulty, 4 = a lot of difficulty, 5 = unable to do). Higher scores represent greater difficulty performing ADLs
Time Frame
Change of ability to perform activities of daily living from baseline to 6-month follow up (post-intervention).
Title
Brief Instrumental Functioning
Description
The Brief Instrumental Functioning Scale will be used to assess ability to perform in six functions: bathing, dressing, going to toilet, transferring, continence, and feeding. Each area is assessed on a five point scale; participants rated their ability to perform daily tasks on a 5-point scale (1 = no difficulty, 2 = a little difficulty, 3 = moderate difficulty, 4 = a lot of difficulty, 5 = unable to do). Higher scores represent more issues with functioning.
Time Frame
Change of ability to perform IADLs from baseline to 6-month follow up (post-intervention).
Title
Depression
Description
Eight of the nine items in the Patient Health Questionnaire-9 were used to measure depression, rated on a 4-point scale of how frequently participants were bothered by the eight problems during a 2-week period (0 = not at all, 1 = several days, 2 = more than half the days, and 3 = nearly every day).
Time Frame
Change in depression symptoms from baseline to 6-month follow up (post-intervention).
Title
Falls Efficacy
Description
participants rated their confidence they could do each of 10 activities without falling on a 10-point scale, with total scores ranging from 10 (not very confident) to 100 (very confident) using the Tinetti Falls Efficacy Scale.
Time Frame
Change of falls efficacy from baseline to 6-month follow up (post-intervention).
Title
Pain interference with normal, everyday activities
Description
Pain interference with normal, everyday activities was measured using a 3-item brief pain inventory relative to the past week on a 10-point scale for describing pain (0 = no pain; 10 = pain as bad as you can imagine); pain that interfered with enjoyment of life (0 = does not interfere; 10 = completely interferes); and pain that interfered with general activity (0 = does not interfere; 10 = completely interferes).
Time Frame
Change in pain from baseline to 6-month follow up (post-intervention).
Title
Falls
Description
History of falls during the past year and since last assessment period by asking: "Did you fall to the ground in the past year (since the last survey)?"
Time Frame
Falls reported at baseline and at 6-month follow up (post-intervention).
Secondary Outcome Measure Information:
Title
Self-rated health
Description
Self-rated health was measured on a 5-point scale (1 = excellent, 2 = very good, 3 = good, 4 = fair, 5 = poor).
Time Frame
Change in self-rated health from baseline to 6-month follow up (post-intervention).
Title
Quality of life
Description
Quality of life from the 12-item Short Form instrument was scored on a 10-point scale (1 = worst possible quality of life; 10 = best possible quality of life).
Time Frame
Change in quality of life from baseline to 6-month follow up (post-intervention).
Other Pre-specified Outcome Measures:
Title
Emergency room visits and hospitalization
Description
History of emergency room visits and hospitalization during the past year and since last assessment period by asking: "How many times did you visit the emergency room in the past year (since the last survey)?; How many times did you stay overnight in a hospital in the past year (since the last survey)?"
Time Frame
ER visits and hospitalizations reported at baseline and at 6-month follow up (post-intervention).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Older than 50 years in age cognitively intact or have only mild cognitive impairment have some or a lot of difficulty performing ADLs tenant of Skid Row Housing Trust Exclusion Criteria: see above
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin F Henwood, PhD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Skid Row Housing Trust
City
Los Angeles
State/Province
California
ZIP/Postal Code
90021
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Implementing CAPABLE in PSH

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