Clinical trial NCT01576133: Reducing Disability Via a Bundled Bio-Behavioral-Environmental Approach
Official title: Reducing Disability Via a Bundled Bio-Behavioral-Environmental Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Keywords: Quality of Life
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2012-04-12
Enrollment: 300
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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

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.

Eligibility 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

Primary outcomes:
measure: Activities of Daily Living (ADLs)
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Nursing
state: Maryland
Study officials:
affiliation: Johns Hopkins University School of Nursing
name: Sarah Szanton, PhD, ANP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Szanton SL, Xue QL, Leff B, Guralnik J, Wolff JL, Tanner EK, Boyd C, Thorpe RJ Jr, Bishai D, Gitlin LN. Effect of a Biobehavioral Environmental Approach on Disability Among Low-Income Older Adults: A Randomized Clinical Trial. JAMA Intern Med. 2019 Feb 1;179(2):204-211. doi: 10.1001/jamainternmed.2018.6026.
citation: Waldersen BW, Wolff JL, Roberts L, Bridges AE, Gitlin LN, Szanton SL. Functional Goals and Predictors of Their Attainment in Low-Income Community-Dwelling Older Adults. Arch Phys Med Rehabil. 2017 May;98(5):896-903. doi: 10.1016/j.apmr.2016.11.017. Epub 2016 Dec 19.