Heart Failure Self-care Mobile Application to Reduce Readmissions Trial

NCT ID: NCT03982017

Last Updated: 2021-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-12

Study Completion Date

2020-07-30

Brief Summary

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This is a patient-centered comparative effectiveness feasibility pilot designed to examine an intervention to increase heart failure self-care and symptom recognition. The investigators will randomize 100 participants to receive either usual care at the time of discharge after heart failure admission or a smartphone application that enhances self-care.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Usual care

Consists of routine care at the time of hospital discharge, to be provided at the discretion of the clinicians caring for the participant.

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type OTHER

Routine care at the time of hospital discharge, to be provided at the discretion of the clinicians caring for the participant.

Application

Participants will be provided a special link to navigate to the online content and resources.

Group Type EXPERIMENTAL

Mobile Health Technology Platform

Intervention Type OTHER

When the participant navigates to the program, s/he will follow the directions on how to use the program, sign the terms of agreement, put in a password and begin the welcome page. The participant will receive daily prompts to complete brief questionnaires and review specialized content.

Interventions

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Mobile Health Technology Platform

When the participant navigates to the program, s/he will follow the directions on how to use the program, sign the terms of agreement, put in a password and begin the welcome page. The participant will receive daily prompts to complete brief questionnaires and review specialized content.

Intervention Type OTHER

Usual care

Routine care at the time of hospital discharge, to be provided at the discretion of the clinicians caring for the participant.

Intervention Type OTHER

Other Intervention Names

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Smartphone Program

Eligibility Criteria

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Inclusion Criteria

* Inpatient admission for acute decompensated heart failure
* Left ventricular systolic or diastolic heart failure
* Owns a smartphone with a data plan

Exclusion Criteria

* Hospice or life expectancy less than 6 months
* Palliative inotrope use
* Heart transplant listed, or status post transplant
* Ventricular assist devise present, or awaiting placement
* Not being discharged to home
* Unable to provide consent or comply with the intervention
* Current enrollment in a remote monitoring/ telehealth program
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Amber Johnson

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amber E Johnson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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Johnson AE, Routh S, Taylor CN, Leopold M, Beatty K, McNamara DM, Davis EM. Developing and Implementing an mHealth Heart Failure Self-care Program to Reduce Readmissions: Randomized Controlled Trial. JMIR Cardio. 2022 Mar 21;6(1):e33286. doi: 10.2196/33286.

Reference Type DERIVED
PMID: 35311679 (View on PubMed)

Other Identifiers

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K12HS019461

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

STUDY18110012

Identifier Type: -

Identifier Source: org_study_id

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