RecoverLINK Technology Pilot for HF Patients

• Sponsor: RecoverLINK (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02815085
• Collaborator: Mount Sinai Hospital, New York (Other), Digital Health Marketplace (previously Pilot Health Tech NYC) (Other)
• Enrollment: 46
• Location: 1
• Arm: 1
• Duration (Months): 28
• Patients Per Site Per Month: 1.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Other: RecoverLINK technology	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Pilot to Assess Feasibility of Using RecoverLINK Technology to Supplement Outpatient Care for Heart Failure Patients
• Study Start Date: Feb 1, 2016
• Actual Primary Completion Date: Apr 1, 2018
• Actual Study Completion Date: Jun 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. User engagement: # symptom surveys completed/30 days [30 days]

2. User satisfaction: Percent patients report "satisfied" via post-program survey [30 days]

3. Workflow efficiency: mean/median time to resolution of patient alerts [30 days]

Secondary Outcome Measures

1. Mean difference in pre/post SCHIFI score [30 days]

2. Hospital admission [30, 60, 90 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Mount Sinai Hospital	New York	New York	United States	10029

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: RecoverLINK
• ClinicalTrials.gov Identifier: NCT02815085
• Other Study ID Numbers: IF1793800
• First Posted: Jun 28, 2016
• Last Update Posted: Aug 31, 2018
• Last Verified: Aug 1, 2018

• Keywords provided by RecoverLINK: heart failure; mHealth
• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of Aug 31, 2018