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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Johns Hopkins University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sarah Szanton, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01576133
First received: April 4, 2012
Last updated: October 24, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Quality of Life
Behavioral: CAPABLE
Behavioral: Attention visits
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Reducing Disability Via a Bundled Bio-Behavioral-Environmental Approach

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Activities of Daily Living (ADLs) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: April 2012
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CAPABLE
Experimental group participants will receive 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 will happen 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 will receive 10 visits of one hour length spaced across 16 weeks. These visits will include sedentary activities of their choice
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

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01576133

Contacts
Contact: Sarah L Szanton, PhD 410-502-2605 sszanto1@jhu.edu

Locations
United States, Maryland
Johns Hopkins University School of Nursing Recruiting
Baltimore, Maryland, United States, 21205
Contact: Alice Delaney    443-287-1584      
Principal Investigator: Sarah L Szanton, PhD, CRNP         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Sarah Sszanton, PhD, CRNP Johns Hopkins University School of Nursing
  More Information

No publications provided

Responsible Party: Sarah Szanton, Assistant Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01576133     History of Changes
Other Study ID Numbers: NA_00031539, R01AG040100
Study First Received: April 4, 2012
Last Updated: October 24, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Johns Hopkins University:
Quality of Life

ClinicalTrials.gov processed this record on October 20, 2014