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CAPABLE for Frail Dually Eligible Older Adults (CAPABLE500)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01743495
First Posted: December 6, 2012
Last Update Posted: March 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Centers for Medicare and Medicaid Services
Baltimore City Health Department
Information provided by (Responsible Party):
Johns Hopkins University
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: CAPABLE for Frail Dually Eligible Older Adults

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Cost Effective [ Time Frame: one year after intervention ]
    Chart review to see change between cost of intervention to medicaid before and after CAPABALE

  • Cost Effective [ Time Frame: two years after intervention ]
    Chart review to see change between cost of intervention to medicaid before and after CAPABALE

  • Cost Effective [ Time Frame: one year after intervention ]
    Chart review to see change between cost of intervention to medicare before and after CAPABALE

  • Cost Effective [ Time Frame: two years after intervention ]
    Chart review to see change between cost of intervention to medicare before and after CAPABALE


Secondary Outcome Measures:
  • Quality of Life as assessed by the Activities of Daily Living (ADL) Questionnaire [ Time Frame: four months post intervention ]
    The ADL Questionnaire will be used to assess quality of life in participants. The score ranges from 0 to 32, with 0 being no help required with activities of daily life and 32 representing that the participant is incapable of completing activities of daily life regardless of difficulty without assistance.

  • Quality of Life as assessed by the ADL Questionnaire [ Time Frame: eight months post intervention ]
    The ADL Questionnaire will be used to assess quality of life in participants. The score ranges from 0 to 32, with 0 being no help required with activities of daily life and 32 representing that the participant is incapable of completing activities of daily life regardless of difficulty without assistance.

  • Quality of Life as assessed by the ADL Questionnaire [ Time Frame: twelve months post intervention ]
    The ADL Questionnaire will be used to assess quality of life in participants. The score ranges from 0 to 32, with 0 being no help required with activities of daily life and 32 representing that the participant is incapable of completing activities of daily life regardless of difficulty without assistance.

  • Quality of Life as assessed by the Instrumental Activities of Daily Living (IADL) Questionnaire [ Time Frame: four months post intervention ]
    The IADL Questionnaire will be used to assess quality of life in participants. The score ranges from 0 to 32, with 0 being no help required with activities of daily life and 32 representing that the participant is incapable of completing instrumental activities of daily life regardless of difficulty without assistance.

  • Quality of Life as assessed by the IADL Questionnaire [ Time Frame: eight months post intervention ]
    The IADL Questionnaire will be used to assess quality of life in participants. The score ranges from 0 to 32, with 0 being no help required with activities of daily life and 32 representing that the participant is incapable of completing instrumental activities of daily life regardless of difficulty without assistance.

  • Quality of Life as assessed by the IADL Questionnaire [ Time Frame: twelve months post intervention ]
    The IADL Questionnaire will be used to assess quality of life in participants. The score ranges from 0 to 32, with 0 being no help required with activities of daily life and 32 representing that the participant is incapable of completing instrumental activities of daily life regardless of difficulty without assistance.


Estimated Enrollment: 500
Study Start Date: September 2012
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01743495


Locations
United States, Maryland
Johns Hopkins University School of Nursing
Baltimore, Maryland, United States, 21205
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

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01743495     History of Changes
Other Study ID Numbers: NA_00076471
First Submitted: October 15, 2012
First Posted: December 6, 2012
Last Update Posted: March 3, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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