Heart Failure Clinical Trial
Official title:
Pilot to Assess Feasibility of Using RecoverLINK Technology to Supplement Outpatient Care for Heart Failure Patients
| NCT number | NCT02815085 |
| Other study ID # | IF1793800 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | February 2016 |
| Est. completion date | June 2018 |
| Verified date | August 2018 |
| Source | RecoverLINK |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 46 |
| Est. completion date | June 2018 |
| Est. primary completion date | April 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| United States | The Mount Sinai Hospital | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| RecoverLINK | Digital Health Marketplace (previously Pilot Health Tech NYC), Mount Sinai Hospital, New York |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | User engagement: # symptom surveys completed/30 days | 30 days | ||
| Primary | User satisfaction: Percent patients report "satisfied" via post-program survey | 30 days | ||
| Primary | Workflow efficiency: mean/median time to resolution of patient alerts | 30 days | ||
| Secondary | Mean difference in pre/post SCHIFI score | 30 days | ||
| Secondary | Hospital admission | 30, 60, 90 days |
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