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GrandAides; a Workforce Innovation to Address Post Acute Care

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
GrandAides
Sponsored by
Temple University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Failure

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Clinical diagnosis of heart failure Lives in 6 zipcode catchment area of Temple University Hospital Is followed by Temple Cardiology

Exclusion Criteria:

End Stage Renal Disease Housed in a Skilled Nursing Facility Substance Use Disorder Unable to give consent Doesn't speak English Under age 18

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    GrandAides

    Standard of Care

    Arm Description

    Patients randomized to this arm of the trial received access to a specially trained GrandAide to work as a credible messenger community health worker. This GrandAide received 6 weeks of education around congestive heart failure to support the patient in the outpatient setting.

    This arm served as the control and included standard of care outpatient support for patients with heart failure.This support was done telephonically.

    Outcomes

    Primary Outcome Measures

    ER visits
    number of ER visits

    Secondary Outcome Measures

    Full Information

    First Posted
    June 7, 2021
    Last Updated
    July 14, 2021
    Sponsor
    Temple University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04966442
    Brief Title
    GrandAides; a Workforce Innovation to Address Post Acute Care
    Official Title
    GrandAides; a Workforce Innovation to Address Post Acute Care
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1, 2014 (Actual)
    Primary Completion Date
    March 31, 2017 (Actual)
    Study Completion Date
    March 31, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Temple University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Randomized controlled trial with two groups looking at post hospital care for patients who were admitted with congestive heart failure. The control group includes standard of care provided to the patients after discharge including a hospital employed community health worker. The intervention group receives a specially trained GrandAide following the GrandAide model for post acute care. Difference in ER visits and readmissions was measured.
    Detailed Description
    GrandAides program is a credible messenger community health worker based program that assumes a community health worker from the community who has specialized education around a certain chronic condition will be able to support patients in the outpatient setting more effectively than current standard of care. In this study a GrandAide visited a patient discharged from the hospital in their home for 4 weeks providing education, checking vital signs, and assisting with communication with the cardiologist. The study measured the difference in hospital admissions and ER visits between the group that was assigned a GrandAid and the group that took part in standard care. The groups were assigned randomly. The difference was calculated using one and two tailed t-test results.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    98 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    GrandAides
    Arm Type
    Experimental
    Arm Description
    Patients randomized to this arm of the trial received access to a specially trained GrandAide to work as a credible messenger community health worker. This GrandAide received 6 weeks of education around congestive heart failure to support the patient in the outpatient setting.
    Arm Title
    Standard of Care
    Arm Type
    No Intervention
    Arm Description
    This arm served as the control and included standard of care outpatient support for patients with heart failure.This support was done telephonically.
    Intervention Type
    Behavioral
    Intervention Name(s)
    GrandAides
    Intervention Description
    Enhanced post acute care for patients recently admitted for congestive heart failure
    Primary Outcome Measure Information:
    Title
    ER visits
    Description
    number of ER visits
    Time Frame
    3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis of heart failure Lives in 6 zipcode catchment area of Temple University Hospital Is followed by Temple Cardiology Exclusion Criteria: End Stage Renal Disease Housed in a Skilled Nursing Facility Substance Use Disorder Unable to give consent Doesn't speak English Under age 18

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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