NCT02815085

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

2.2 years

First QC Date

June 22, 2016

Last Update Submit

August 28, 2018

Conditions

Keywords

heart failuremHealth

Outcome Measures

Primary Outcomes (3)

  • User engagement: # symptom surveys completed/30 days

    30 days

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

    30 days

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

    30 days

Secondary Outcomes (2)

  • Mean difference in pre/post SCHIFI score

    30 days

  • Hospital admission

    30, 60, 90 days

Study Arms (1)

RecoverLINK technology

EXPERIMENTAL

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

Other: RecoverLINK technology

Interventions

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

RecoverLINK technology

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Mount Sinai Hospital

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Sean Pinney, MD

    The Mount Sinai Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2016

First Posted

June 28, 2016

Study Start

February 1, 2016

Primary Completion

April 1, 2018

Study Completion

June 1, 2018

Last Updated

August 31, 2018

Record last verified: 2018-08

Locations