- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04076319
Implementing CAPABLE in PSH
Implementing CAPABLE in Permanent Supportive Housing
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90021
- Skid Row Housing Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: CAPABLE
CAPABLE Intervention
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Activities of Daily Living Limitations Score
Time Frame: Change of ability to perform activities of daily living from baseline to 6-month follow up (post-intervention).
|
The modified Katz Activities of Daily Living (ADL) Index is an 8-item questionnaire that was completed by participants to rate their ability to perform daily activities, such as bathing, toileting, eating, and dressing, across a 5-point Likert scale (1 = no difficulty, 2 = a little difficulty, 3 = moderate difficulty, 4 = a lot of difficulty, 5 = unable to do).
Items are summed to obtain a score with minimum and maximum values of 8 to 40, respectively, whereby higher scores represent greater difficulty performing ADLs.
|
Change of ability to perform activities of daily living from baseline to 6-month follow up (post-intervention).
|
|
Instrumental Activities of Daily Living Score
Time Frame: Change of ability to perform IADLs from baseline to 6-month follow up (post-intervention).
|
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).
Items are summed to obtain a score with minimum and maximum values of 8 to 40, respectively, whereby higher scores represent greater difficulty performing ADLs.
|
Change of ability to perform IADLs from baseline to 6-month follow up (post-intervention).
|
|
Depression
Time Frame: Change in depression symptoms from baseline to 6-month follow up (post-intervention).
|
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).
Items are summed to obtain a score with minimum and maximum values of 0 to 24, respectively, whereby higher scores represent greater depressive symptoms.
|
Change in depression symptoms from baseline to 6-month follow up (post-intervention).
|
|
Falls Efficacy
Time Frame: Change of falls efficacy from baseline to 6-month follow up (post-intervention).
|
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.
Thus, higher scores indicate greater efficacy related to falls.
|
Change of falls efficacy from baseline to 6-month follow up (post-intervention).
|
|
Pain Interference With Usual Activities
Time Frame: Change in the degree that pain interferes with usual activities from baseline to 6-month follow up (post-intervention).
|
Pain interference with usual activities was assessed using an item from the 3-item PEG to assess average pain intensity (P), interference with enjoyment of life (E), and interference with general activity (G) on a 10-point Likert scale from 0 (does not interfere) to 10 (completely interferes).
|
Change in the degree that pain interferes with usual activities from baseline to 6-month follow up (post-intervention).
|
|
Number of Falls in the Past Year or 6 Months
Time Frame: Number of falls in the past year reported at 6-month follow up.
|
Mean number of falls to the ground during the past year.
|
Number of falls in the past year reported at 6-month follow up.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-rated Health
Time Frame: Change in self-rated health from baseline to 6-month follow up (post-intervention).
|
Self-rated health was measured on a 5-point scale (1 = excellent, 2 = very good, 3 = good, 4 = fair, 5 = poor).
A higher score indicates poorer self-rated quality of health.
|
Change in self-rated health from baseline to 6-month follow up (post-intervention).
|
|
Overall Quality of Life
Time Frame: Change in quality of life from baseline to 6-month follow up (post-intervention).
|
Quality of life was assessed using a single item: "Overall, how would you rate your quality of life?" Response options ranged from 1 = worst possible quality of life to 11 = best possible quality of life.
Thus, a higher value indicated greater self-rated quality of life.
|
Change in quality of life from baseline to 6-month follow up (post-intervention).
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of Participants With Emergency Room Visits in Past 6 Months
Time Frame: Proportion of participants with ER visits in past 6 months reported at 6-month follow up.
|
History of emergency room visits during the past year assessed by asking: "How many times did you visit the emergency room in the past year (since the last survey)?
|
Proportion of participants with ER visits in past 6 months reported at 6-month follow up.
|
|
Number of Emergency Room Visits in Past 6 Months
Time Frame: Number of ER visits in past 6 months reported at follow up.
|
History of emergency room visits during the past year assessed by asking: "How many times did you visit the emergency room in the past year (since the last survey)?
Outcome is the mean number of ER visits in past 6 months.
|
Number of ER visits in past 6 months reported at follow up.
|
|
Proportion of Participants With Hospitalizations in Past 6 Months
Time Frame: Proportion of participants with hospitalizations in past 6 months reported at 6-month follow-up
|
History of hospitalization during the past year assessed by asking: How many times did you stay overnight in a hospital in the past year (since the last survey)?"
|
Proportion of participants with hospitalizations in past 6 months reported at 6-month follow-up
|
|
Number of Overnight Hospitalizations in Past 6 Months
Time Frame: Number of overnight hospitalizations in past 6 months reported at 6-month follow up.
|
History of hospitalization during the past year assessed by asking: How many times did you stay overnight in a hospital in the past year (since the last survey)?"
Outcome measure is the mean number of overnight hospitalizations in past 6 months.
|
Number of overnight hospitalizations in past 6 months reported at 6-month follow up.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Benjamin F Henwood, PhD, University of Southern California
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UP-19-00361
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
-
Massachusetts General HospitalRecruitingDepression | Depression - Major Depressive Disorder | Depression Chronic | Depression in Adults | Depression Disorders | Depression DisorderUnited States
-
University of California, San FranciscoNational Center for Complementary and Integrative Health (NCCIH)Active, not recruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
ProgenaBiomeWithdrawnDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Sorlandet Hospital HFUniversity of Oslo; Karolinska Institutet; Australian Catholic University; Helse...RecruitingAnxiety | Anxiety Depression | Depression Anxiety Disorder | Depression - Major Depressive DisorderNorway
-
Lipocine Inc.CompletedDepression, Postpartum | Postnatal Depression | Peripartum Depression | Depression, Post-Partum | Postpartum Depression (PPD) | Post-Natal DepressionUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryActive, not recruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Kolby Walker, DO; Brittany KimbleRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of CincinnatiNational Center for Complementary and Integrative Health (NCCIH)RecruitingMild DepressionUnited States
-
University of MinnesotaCompletedDepression SymptomsUnited States