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CAPABLE for Frail Dually Eligible Older Adults (CAPABLE500)

Primary Purpose

Muscle Weakness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
10 home-based functional services sessions over 4 months.
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Muscle Weakness focused on measuring Medical Costs, improved IADLs, and/or ADL's, decreased nursing home admissions

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins University School of Nursing

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Functional Services

Arm Description

The program consists of up to 10 home-based functional services sessions over 4 months.

Outcomes

Primary Outcome Measures

Cost Effective
Chart review to see change between cost of intervention to medicaid before and after CAPABALE
Cost Effective
Chart review to see change between cost of intervention to medicaid before and after CAPABALE
Cost Effective
Chart review to see change between cost of intervention to medicare before and after CAPABALE
Cost Effective
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
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
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
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
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
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
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.

Full Information

First Posted
October 15, 2012
Last Updated
February 10, 2020
Sponsor
Johns Hopkins University
Collaborators
Centers for Medicare and Medicaid Services, Baltimore City Health Department
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1. Study Identification

Unique Protocol Identification Number
NCT01743495
Brief Title
CAPABLE for Frail Dually Eligible Older Adults
Acronym
CAPABLE500
Official Title
CAPABLE for Frail Dually Eligible Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
August 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Centers for Medicare and Medicaid Services, Baltimore City Health Department

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness
Keywords
Medical Costs, improved IADLs, and/or ADL's, decreased nursing home admissions

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
281 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Functional Services
Arm Type
Other
Arm Description
The program consists of up to 10 home-based functional services sessions over 4 months.
Intervention Type
Behavioral
Intervention Name(s)
10 home-based functional services sessions over 4 months.
Intervention Description
The program consists of up to 10 home-based functional services sessions over 4 months.
Primary Outcome Measure Information:
Title
Cost Effective
Description
Chart review to see change between cost of intervention to medicaid before and after CAPABALE
Time Frame
one year after intervention
Title
Cost Effective
Description
Chart review to see change between cost of intervention to medicaid before and after CAPABALE
Time Frame
two years after intervention
Title
Cost Effective
Description
Chart review to see change between cost of intervention to medicare before and after CAPABALE
Time Frame
one year after intervention
Title
Cost Effective
Description
Chart review to see change between cost of intervention to medicare before and after CAPABALE
Time Frame
two years after intervention
Secondary Outcome Measure Information:
Title
Quality of Life as assessed by the Activities of Daily Living (ADL) Questionnaire
Description
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.
Time Frame
four months post intervention
Title
Quality of Life as assessed by the ADL Questionnaire
Description
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.
Time Frame
eight months post intervention
Title
Quality of Life as assessed by the ADL Questionnaire
Description
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.
Time Frame
twelve months post intervention
Title
Quality of Life as assessed by the Instrumental Activities of Daily Living (IADL) Questionnaire
Description
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.
Time Frame
four months post intervention
Title
Quality of Life as assessed by the IADL Questionnaire
Description
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.
Time Frame
eight months post intervention
Title
Quality of Life as assessed by the IADL Questionnaire
Description
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.
Time Frame
twelve months post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Szanton
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University School of Nursing
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29165789
Citation
Szanton SL, Alfonso YN, Leff B, Guralnik J, Wolff JL, Stockwell I, Gitlin LN, Bishai D. Medicaid Cost Savings of a Preventive Home Visit Program for Disabled Older Adults. J Am Geriatr Soc. 2018 Mar;66(3):614-620. doi: 10.1111/jgs.15143. Epub 2017 Nov 22.
Results Reference
derived
PubMed Identifier
28007445
Citation
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.
Results Reference
derived

Learn more about this trial

CAPABLE for Frail Dually Eligible Older Adults

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