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Reducing Disability Via a Bundled Bio-Behavioral-Environmental Approach (CAPABLE)

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ClinicalTrials.gov Identifier: NCT01576133
Recruitment Status : Completed
First Posted : April 12, 2012
Last Update Posted : August 21, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of the study is to determine whether a combination of occupational therapy visits, nursing visits, and handyman repair are effective in helping low income older adults avoid costly health care services

Condition or disease Intervention/treatment Phase
Quality of Life Behavioral: CAPABLE Behavioral: Attention visits Phase 2

Detailed Description:

We will recruit low-income age 65 or older

-principally African-American, adults from the Baltimore Department of Housing Energy Assistance Program.

-We will interview them at home and randomize participants to either the treatment (CAPABLE intervention) or control (attention-control) group. Participants in the treatment group will receive up to 10 in-home sessions -- 6 visits with an occupational therapist and 4 visits from a nurse - and $1200 in safety and modification services from a licensed handyman. Each treatment participant will receive each intervention component but interventionists will systematically tailor content to the participants' risk profile and goals based on protocols.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Time limited home based intervention of a Nurse, Occupational Therapist, and a "handyman" to work with low income older adults to assess, prioritize and meet their functional goals.
Masking: Single (Outcomes Assessor)
Masking Description: Outcomes assessor did not know which study group the person they visited was in and told participant not to reveal it.
Primary Purpose: Prevention
Official Title: Reducing Disability Via a Bundled Bio-Behavioral-Environmental Approach
Study Start Date : April 2012
Primary Completion Date : April 2017
Study Completion Date : May 2017
Arms and Interventions

Arm Intervention/treatment
Experimental: CAPABLE
Experimental group participants received up to 10 sessions; up to 6 with an OT, and up to 4 sessions with an RN, and ≤ $1200 of safety and functional modifications from a licensed handyman. These sessions happened in coordinated fashion over the course of 4 months.
Behavioral: CAPABLE
Occupational therapy visits plus nursing visits plus handyman repair
Active Comparator: Attention visits
Participants in the attention visit arm received 10 visits of one hour length spaced across 16 weeks. These visits included sedentary activities of their choice based on their goals and interests.
Behavioral: Attention visits
Participants in the attention control arm will receive 10 one hour visits over the course of 16 weeks. These visits will consist of sedentary activities


Outcome Measures

Primary Outcome Measures :
  1. Activities of Daily Living (ADLs) [ Time Frame: 5 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • at least 65 years old
  • cognitively intact
  • difficulty with at least one activity of daily living or two instrumental activities of daily living
  • less than 175% of the Federal Poverty level
  • be able to stand with or without assistance
  • agree to study participation

Exclusion Criteria:

  • hospitalized more than three times in the last year
  • receiving in home rehabilitation
  • have a terminal diagnosis with less than one year life expectancy
  • plan to move in less than one year
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01576133


Locations
United States, Maryland
Johns Hopkins University School of Nursing
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
National Institute on Aging (NIA)
Investigators
Principal Investigator: Sarah Szanton, PhD, ANP Johns Hopkins University School of Nursing
More Information

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01576133     History of Changes
Other Study ID Numbers: NA_00031539
R01AG040100 ( U.S. NIH Grant/Contract )
First Posted: April 12, 2012    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017

Keywords provided by Johns Hopkins University:
Quality of Life