Heart FailureNCT02815085
RecoverLINK Technology Pilot for HF Patients
A study testing RecoverLINK technology in people with Heart Failure, run by RecoverLINK at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- What is being tested?
- RecoverLINK technology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Heart Failure
- Being tested
- RecoverLINK technology
- Keywords
- heart failure, mHealth
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RecoverLINK technologyOther
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
| Study group | Role | What they receive |
|---|---|---|
| RecoverLINK technology | Experimental | RecoverLINK is a two-part mHealth technology designed to supplement traditional care transitional programs for heart failure (HF) patients. Receives: Other: RecoverLINK technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
User engagement: # symptom surveys completed/30 days
Measured: 30 days
User satisfaction: Percent patients report "satisfied" via post-program survey
Measured: 30 days
Workflow efficiency: mean/median time to resolution of patient alerts
Measured: 30 days
Secondary outcomes (2)
Mean difference in pre/post SCHIFI score
Measured: 30 days
Hospital admission
Measured: 30, 60, 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startFeb 2016
- Primary completionApr 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- RecoverLINK
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mount Sinai Hospital, New York, Digital Health Marketplace (previously Pilot Health Tech NYC)
- Responsible party
- Sponsor
- Investigators
- Sean Pinney, MD, Principal investigator, The Mount Sinai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02815085
- Sponsor's protocol ID
- IF1793800
- Status last verified
- Aug 2018
- First submitted
- 22 Jun 2016
- Last updated
- 31 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot to Assess Feasibility of Using RecoverLINK Technology to Supplement Outpatient Care for Heart Failure Patients
- ClinicalTrials.gov ID
- NCT02815085
- Acronym / sponsor ID
- IF1793800
- Conditions
- Heart Failure
- Keywords
- heart failure, mHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- RecoverLINKIndustry (pharma, biotech, devices)
- Collaborators
- Mount Sinai Hospital, New York, Digital Health Marketplace (previously Pilot Health Tech NYC)
- Study start
- Feb 2016
- Primary completion
- Apr 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 28 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RecoverLINK technology | Experimental | Other: RecoverLINK technologyRecoverLINK is a two-part mHealth technology designed to supplement traditional care transitional programs for heart failure (HF) patients. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RecoverLINK technologyHF 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 | Other | RecoverLINK technology |
Primary outcome
User engagement: # symptom surveys completed/30 days
Time frame: 30 days
User satisfaction: Percent patients report "satisfied" via post-program survey
Time frame: 30 days
Workflow efficiency: mean/median time to resolution of patient alerts
Time frame: 30 days
2 secondary outcomes
Mean difference in pre/post SCHIFI score
Time frame: 30 days
Hospital admission
Time frame: 30, 60, 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
Related trials for Heart Failure
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Recruiting
Leg Heat Therapy in Heart Failure With Preserved Ejection Fraction
Heart Failure With Preserved Ejection Fraction
Recruiting
Vsling™ III: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients With Heart Failure
HFrEF - Heart Failure With Reduced Ejection Fraction
RecruitingPhase 3
A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure
Heart Failure
Active, not recruiting
Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction
Heart Failure With Preserved Ejection Fraction, Concentric Hypertrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean Pinney, MD principal investigator
The Mount Sinai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RecoverLINK technology in people with Heart Failure, run by RecoverLINK at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
User engagement: # symptom surveys completed/30 days (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2018.