Reducing Disability Via a Bundled Bio-Behavioral-Environmental Approach (CAPABLE)
|ClinicalTrials.gov Identifier: NCT01576133|
Recruitment Status : Completed
First Posted : April 12, 2012
Last Update Posted : August 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Quality of Life||Behavioral: CAPABLE Behavioral: Attention visits||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|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.|
|Official Title:||Reducing Disability Via a Bundled Bio-Behavioral-Environmental Approach|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||April 2017|
|Actual Study Completion Date :||May 2017|
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.
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
- Activities of Daily Living (ADLs) [ Time Frame: 5 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01576133
|United States, Maryland|
|Johns Hopkins University School of Nursing|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Sarah Szanton, PhD, ANP||Johns Hopkins University School of Nursing|