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RecoverLINK Technology Pilot for HF Patients

Primary Purpose

Heart Failure

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

RecoverLINK technology

About this trial

This is an interventional supportive care trial for Heart Failure focused on measuring heart failure, mHealth

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

The Mount Sinai Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RecoverLINK technology

Arm Description

RecoverLINK is a two-part mHealth technology designed to supplement traditional care transitional programs for heart failure (HF) patients.

Outcomes

Primary Outcome Measures

User engagement: # symptom surveys completed/30 days

User satisfaction: Percent patients report "satisfied" via post-program survey

Workflow efficiency: mean/median time to resolution of patient alerts

Secondary Outcome Measures

Mean difference in pre/post SCHIFI score

Hospital admission

Full Information

NCT ID

NCT02815085

First Posted

June 22, 2016

Last Updated

August 28, 2018

Sponsor

RecoverLINK

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02815085

Brief Title

RecoverLINK Technology Pilot for HF Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

February 2016 (undefined)

Primary Completion Date

April 2018 (Actual)

Study Completion Date

June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

RecoverLINK

Collaborators

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

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

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

Heart Failure

Keywords

heart failure, mHealth

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RecoverLINK technology

Arm Type

Experimental

Arm Description

RecoverLINK is a two-part mHealth technology designed to supplement traditional care transitional programs for heart failure (HF) patients.

Intervention Type

Other

Intervention Name(s)

RecoverLINK technology

Intervention Description

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

Primary Outcome Measure Information:

Title

User engagement: # symptom surveys completed/30 days

Time Frame

30 days

Title

User satisfaction: Percent patients report "satisfied" via post-program survey

Time Frame

30 days

Title

Workflow efficiency: mean/median time to resolution of patient alerts

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Mean difference in pre/post SCHIFI score

Time Frame

30 days

Title

Hospital admission

Time Frame

30, 60, 90 days

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sean Pinney, MD

Organizational Affiliation

The Mount Sinai Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Mount Sinai Hospital

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

12. IPD Sharing Statement

Learn more about this trial

RecoverLINK Technology Pilot for HF Patients

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