Reducing Disability Via a Bundled Bio-Behavioral-Environmental Approach

NCT ID: NCT01576133

Last Updated: 2018-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2017-05-31

Brief Summary

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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

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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.

Conditions

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Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
Outcomes assessor did not know which study group the person they visited was in and told participant not to reveal it.

Study Groups

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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.

Group Type EXPERIMENTAL

CAPABLE

Intervention Type BEHAVIORAL

Occupational therapy visits plus nursing visits plus handyman repair

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.

Group Type ACTIVE_COMPARATOR

Attention visits

Intervention Type BEHAVIORAL

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

Interventions

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CAPABLE

Occupational therapy visits plus nursing visits plus handyman repair

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarah Szanton, PhD, ANP

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University School of Nursing

Locations

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Johns Hopkins University School of Nursing

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 30615024 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28007445 (View on PubMed)

Other Identifiers

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R01AG040100

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NA_00031539

Identifier Type: -

Identifier Source: org_study_id

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