NCT04076319

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 3, 2019

Completed
1.3 years until next milestone

Study Start

First participant enrolled

December 17, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2022

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

June 15, 2025

Completed
Last Updated

June 15, 2025

Status Verified

May 1, 2025

Enrollment Period

1.6 years

First QC Date

August 27, 2019

Results QC Date

March 1, 2024

Last Update Submit

May 28, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • Activities of Daily Living Limitations Score

    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

    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

    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

    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

    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

    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 Outcomes (2)

  • Self-rated Health

    Change in self-rated health from baseline to 6-month follow up (post-intervention).

  • Overall Quality of Life

    Change in quality of life from baseline to 6-month follow up (post-intervention).

Other Outcomes (4)

  • Proportion of Participants With Emergency Room Visits in Past 6 Months

    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

    Number of ER visits in past 6 months reported at follow up.

  • Proportion of Participants With Hospitalizations in Past 6 Months

    Proportion of participants with hospitalizations in past 6 months reported at 6-month follow-up

  • +1 more other outcomes

Study Arms (1)

CAPABLE

OTHER

CAPABLE Intervention

Behavioral: CAPABLE: Community Aging in Place-Advancing Better Living for Elders

Interventions

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.

CAPABLE

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • see above

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skid Row Housing Trust

Los Angeles, California, 90021, United States

Location

MeSH Terms

Conditions

FrailtyDepression

Interventions

elderberry extract

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Limitations and Caveats

Pilot study resulting in a small number of individuals assigned to each study arm and potentially limiting the ability to detect significant differences. Further, because assessments were based solely on self-report, objective measurements on outcomes such as hospitalization and health care utilization require additional investigation. This would allow for the development of a comprehensive picture of the intervention's potential to positively affect health and behavior outcomes.

Results Point of Contact

Title
Dr. Benjamin Henwood
Organization
USC Suzanne Dworak-Peck School of Social Work

Study Officials

  • Benjamin F Henwood, PhD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Waitlist control design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 27, 2019

First Posted

September 3, 2019

Study Start

December 17, 2020

Primary Completion

July 25, 2022

Study Completion

July 30, 2022

Last Updated

June 15, 2025

Results First Posted

June 15, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations