RecoverLINK Technology Pilot for HF Patients

August 28, 2018 updated by: RecoverLINK

Pilot to Assess Feasibility of Using RecoverLINK Technology to Supplement Outpatient Care for Heart Failure Patients

The primary objective is to examine feasibility of incorporating RecoverLINK into the standard of care as a function of (i) user engagement, (ii) user satisfaction, and (iii) workflow efficiency. As secondary objectives, the investigators will collect preliminary data to examine the association between patient engagement with the RecoverLINK app and (i) changes in patient knowledge and behavior, and (ii) hospital readmission(s) at 30, 60, and 90-day time periods post-enrollment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • The Mount Sinai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Heart failure (HF) patients with a rapid follow up appointment scheduled at the Mount Sinai HF clinic
  • English-speaking
  • With either access to (i) an iOS smart device or (ii) wifi at-home

Exclusion Criteria:

Patients meeting any of the following criteria:

  • A heart transplant
  • A mechanical circulatory support (MCS) device
  • An altered mental status
  • Serious co-morbidities (as identified by Mount Sinai team)
  • Cognitive impairments (as identified by Mount Sinai team)
  • Inability to use technology (as identified by Mount Sinai team)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RecoverLINK technology
RecoverLINK is a two-part mHealth technology designed to supplement traditional care transitional programs for heart failure (HF) patients.
Other: RecoverLINK technology
HF patients will receive the RecoverLINK app upon study enrollment for 30-days. The Mount Sinai HF care team will interact with patients via the RecoverLINK cloud-based system during this period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
User engagement: # symptom surveys completed/30 days
Time Frame: 30 days
30 days
User satisfaction: Percent patients report "satisfied" via post-program survey
Time Frame: 30 days
30 days
Workflow efficiency: mean/median time to resolution of patient alerts
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean difference in pre/post SCHIFI score
Time Frame: 30 days
30 days
Hospital admission
Time Frame: 30, 60, 90 days
30, 60, 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RecoverLINK

Collaborators

Mount Sinai Hospital, New York
Digital Health Marketplace (previously Pilot Health Tech NYC)

Investigators

  • Principal Investigator: Sean Pinney, MD, The Mount Sinai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

June 22, 2016

First Submitted That Met QC Criteria

June 23, 2016

First Posted (Estimate)

June 28, 2016

Study Record Updates

Last Update Posted (Actual)

August 31, 2018

Last Update Submitted That Met QC Criteria

August 28, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IF1793800

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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