NCT04966442

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable heart-failure

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

June 7, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 19, 2021

Completed
Last Updated

July 19, 2021

Status Verified

July 1, 2021

Enrollment Period

3 years

First QC Date

June 7, 2021

Last Update Submit

July 14, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • ER visits

    number of ER visits

    3 years

Study Arms (2)

GrandAides

EXPERIMENTAL

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.

Behavioral: GrandAides

Standard of Care

NO INTERVENTION

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

Interventions

GrandAidesBEHAVIORAL

Enhanced post acute care for patients recently admitted for congestive heart failure

GrandAides

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2021

First Posted

July 19, 2021

Study Start

April 1, 2014

Primary Completion

March 31, 2017

Study Completion

March 31, 2017

Last Updated

July 19, 2021

Record last verified: 2021-07