NCT01743495

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
281

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 15, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 6, 2012

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

6 years

First QC Date

October 15, 2012

Last Update Submit

February 10, 2020

Conditions

Muscle Weakness

Keywords

Medical Costsimproved IADLsand/or ADL'sdecreased nursing home admissions

Outcome Measures

Primary Outcomes (4)

  • Cost Effective

    Chart review to see change between cost of intervention to medicaid before and after CAPABALE

    one year after intervention

  • Cost Effective

    Chart review to see change between cost of intervention to medicaid before and after CAPABALE

    two years after intervention

  • Cost Effective

    Chart review to see change between cost of intervention to medicare before and after CAPABALE

    one year after intervention

  • Cost Effective

    Chart review to see change between cost of intervention to medicare before and after CAPABALE

    two years after intervention

Secondary Outcomes (6)

  • Quality of Life as assessed by the Activities of Daily Living (ADL) Questionnaire

    four months post intervention

  • Quality of Life as assessed by the ADL Questionnaire

    eight months post intervention

  • Quality of Life as assessed by the ADL Questionnaire

    twelve months post intervention

  • Quality of Life as assessed by the Instrumental Activities of Daily Living (IADL) Questionnaire

    four months post intervention

  • Quality of Life as assessed by the IADL Questionnaire

    eight months post intervention

  • +1 more secondary outcomes

Study Arms (1)

Functional Services

OTHER

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.

Interventions

10 home-based functional services sessions over 4 months.BEHAVIORAL

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

Functional Services

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University School of Nursing

Baltimore, Maryland, 21205, United States

Location

Related Publications (2)

  • 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.

    PMID: 29165789DERIVED

  • 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: 28007445DERIVED

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Sarah Szanton

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2012

First Posted

December 6, 2012

Study Start

September 1, 2012

Primary Completion

August 31, 2018

Study Completion

August 31, 2019

Last Updated

February 12, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)