Reducing Disability Via a Bundled Bio-Behavioral-Environmental Approach

NCT01576133 | Completed DMC

• 2 other identifiers: NA_00031539R01AG040100
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

Quality of Life

Keywords

Quality of Life

Outcome Measures

Primary Outcomes (1)

• Activities of Daily Living (ADLs)

  5 months

Study Arms (2)

CAPABLE

EXPERIMENTAL

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

Attention visits

ACTIVE COMPARATOR

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

Interventions

CAPABLE BEHAVIORAL

Occupational therapy visits plus nursing visits plus handyman repair

CAPABLE

Attention visits 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

Attention visits

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Johns Hopkins University School of Nursing

Baltimore, Maryland, 21205, United States

Location

Related Publications (2)

• 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.

  PMID: 30615024 DERIVED

• 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.

  PMID: 28007445 DERIVED

MeSH Terms

Interventions

CAPABLE protocol

Study Officials

• Sarah Szanton, PhD, ANP

  Johns Hopkins University School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor did not know which study group the person they visited was in and told participant not to reveal it.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 4, 2012
• First Posted: April 12, 2012
• Study Start: April 1, 2012
• Primary Completion: April 1, 2017
• Study Completion: May 1, 2017
• Last Updated: July 2, 2018

Record last verified: 2018-06

Locations

US (1)