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CAPABLE for Frail Dually Eligible Older Adults (CAPABLE500)

This study is currently recruiting participants.
Verified December 2012 by Johns Hopkins University
Sponsor:
Collaborators:
Centers for Medicare and Medicaid Services
Baltimore City Health Department
Information provided by (Responsible Party):
Sarah Szanton, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01743495
First received: October 15, 2012
Last updated: December 4, 2012
Last verified: December 2012
History of Changes
  Purpose

The Johns Hopkins School of Nursing offers this research study which aims to learn more about whether services that help with medications, muscle strengthening, pain management and changes to houses can help improve older adults' ability to, walk, and take care of themselves while saving costs by reducing hospitalizations and nursing home admissions.


Condition Intervention
Muscle Weakness
 Behavioral: 10 home-based functional services sessions over 4 months.

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: CAPABLE for Frail Dually Eligible Older Adults

Resource links provided by NLM:

MedlinePlus related topics: Nursing Homes
U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Cost Effective [ Time Frame: Time Points are assessed one year after the intervention for two years ] [ Designated as safety issue: No ]
    Primary aim is to test whether the CAPABLE intervention saves costs to Medicaid and Medicare relative to the cost of the intervention.


Secondary Outcome Measures:
  • IMPROVED QUALITY OF LIFE [ Time Frame: Outcomes Measures are assessed every four months up to one year ] [ Designated as safety issue: Yes ]
    Secondary aim is to test whether the CAPABLE intervention decreases ADL and IADL limitations and increases Health Related Quality of Life in older adults with disabilities who have Medicaid and Medicare eligibility.


Estimated Enrollment: 500
Study Start Date: September 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Functional Services
The program consists of up to 10 home-based functional services sessions over 4 months.
 Behavioral: 10 home-based functional services sessions over 4 months.
The program consists of up to 10 home-based functional services sessions over 4 months.

Detailed Description:
  • 65yrs or older
  • Be able to stand (with or without assistance)
  • Have some difficulty with getting dressed, or preparing food, bathing
  • Receive a low monthly income
  • Have no plans to move in the next year
  • NOT be receiving home nursing or other therapy right now
  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 65 or older
  • Cognitively intact (≥ 10 on Brief Interview of Mental Status)
  • Difficulty with ≥ 2 IADLS or ≥ 1 ADL
  • ≤ 199% of Federal Poverty level

Exclusion Criteria:

  • Terminally ill

    --Active cancer treatment

  • Hospitalized > 3 times in last 3 years
  • Receiving home nursing, Occupational Therapy or Physical Therapy
  • Don't have phone or do plan to move in less than a year
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01743495

Locations
United States, Maryland
Johns Hopkins University School of Nursing Recruiting
Baltimore, Maryland, United States, 21205
Contact: Sarah Szanton, PHD, CRNP     410-502-2605     sszanto1@jhu.edu    
Contact: Alice Delaney, BS, MA, M.Ed     443-287-1584     adelane7@jhmi.edu    
Principal Investigator: Sarah Szanton, PhD,CRNP            
Sponsors and Collaborators
Johns Hopkins University
Centers for Medicare and Medicaid Services
Baltimore City Health Department
Investigators
Principal Investigator: Sarah Szanton Johns Hopkins University
  More Information

No publications provided

Responsible Party: Sarah Szanton, PhD, CRNP, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01743495     History of Changes
Other Study ID Numbers: NA_00076471
Study First Received: October 15, 2012
Last Updated: December 4, 2012
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Medical Costs
improved IADLs
and/or ADL's
decreased nursing home admissions

Additional relevant MeSH terms:
Asthenia
Muscle Weakness
Paresis
Signs and Symptoms
Muscular Diseases
 Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013