- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05647317
Mobile Technology-Based System for Patient Engagement and Physician-Directed Remote Management of Heart Failure
Design of a Mobile Technology-Based System for Patient Engagement and Physician-Directed Remote Management of Heart Failure
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Karma Lhamo, MS
- Phone Number: 9713362450
- Email: karmalh@stanford.edu
Study Contact Backup
- Name: Alexander Sandhu, MD
- Phone Number: 650 7234000
- Email: ats114@stanford.edu
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford Hospital & Clinics
-
Contact:
- Alexander Sandhu, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 18
- Diagnosis of heart failure
- Most recent left ventricular ejection fraction ≤ 40% in the prior year based on echocardiogram, MRI, CT, or nuclear perfusion
- Primary cardiologist enrolled in the study
- Currently admitted with upcoming discharge or discharged from hospital within the prior 2 weeks
- At least two eligible heart failure therapies (guideline-recommended BB, RASI, MRA, or SGLT2i) not yet initiated or on ≤ 50% of target dose
Exclusion Criteria:
- Receives dialysis
- Inotropic therapy during hospitalization
- History of heart transplant or actively listed on heart transplant waiting list
- History of left ventricular assist device implantation
- Cardiac amyloidosis
- Pregnant or currently trying to be pregnant
- Life expectancy estimated less than 6 months related to non-cardiac comorbidities as per investigator's judgement
- Actively enrolled in hospice or comfort care
- Currently participating in an investigational device or drug study or having participated in such a study within 30 days prior to screening
- Subject or their caregiver without a smartphone
- Subject or their caregiver not proficient with written and spoken English
- Subject unavailable to complete all study procedures (e.g., interviews) to the best of the subject and investigator's knowledge
- Any other disorder or condition that, in the opinion of the investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
- Subject has diminished decision-making capacity
- Planned discharge to skilled nursing facility
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Digital technology-based system for heart failure management
This is a single-arm study to assess the feasibility and preliminary effectiveness of a digital technology-based system for heart failure management
|
A combination of a provider-facing desktop and mobile application with a patient-facing mobile application that is integrated with a remote blood pressure cuff, heart rate monitor, and scale.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Acceptability of the intervention
Time Frame: At Study completion (12-week follow-up visit)
|
The proportion of patients who assess the DOT-HF intervention as an acceptable method of post-discharge heart failure management.
This will be assessed during a semi-structured interview between individual participants and a trained interviewer.
|
At Study completion (12-week follow-up visit)
|
Clinicians' Response to Notification
Time Frame: At Study completion (12-week follow-up visit)
|
The proportion of DOT-HF clinician notifications that lead to a clinician response over the 12-week follow-up period.
Each of the clinician DOT-HF notifications are detailed below.
These include notification of eligible therapy adjustment, worsening patient-reported health status, and weight gain.
Eligible clinician actions include medication changes or new telephone, video, or in-person clinic encounters in response to the notification.
|
At Study completion (12-week follow-up visit)
|
Patients' Engagement score
Time Frame: At Study completion (12-week follow-up visit)
|
A weighted proportion of requested actions completed by the patient.
These actions include daily blood pressure measurements, daily weight assessment, daily health status assessment, biweekly KCCQ-12 assessment, and review of educational videos and health summary data.
The minimum score is 0% and maximum score is 100%.
|
At Study completion (12-week follow-up visit)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sustainability of DOT-HF technology for Patients
Time Frame: At 6 week, At Study Completion (12-week follow-up visit)
|
Sustainability will also be assessed via semi-structured interview questions to assess patient's and clinician's interest in continuing to use the DOT-HF intervention.
|
At 6 week, At Study Completion (12-week follow-up visit)
|
Feasibility of DOT-HF technology for Patients
Time Frame: At Study Completion (12 week follow up visit)
|
Feasibility will be assessed via semi-structured interview questions to assess barriers to use the DOT-HF intervention.
|
At Study Completion (12 week follow up visit)
|
Utility of DOT-HF technology for Clinicians
Time Frame: At study completion (12 week follow up visit)
|
Clinician perception of the utility of DOT-HF will be assessed based on clinician actions in response to DOT-HF notifications. We will assess each of the types of notifications aggregated in co-primary endpoint #3:
For each endpoint, we will separately evaluate the proportion of notifications that were followed by a medication adjustment and the proportion that were followed by a previously unplanned encounter between the clinician/clinic nurse and the patient. |
At study completion (12 week follow up visit)
|
Acceptability of DOT-HF technology for Clinicians
Time Frame: At study completion (12 week follow up visit)
|
Clinician perception of the acceptability of DOT-HF will be assessed by clinician responses to a survey administered at the end of the study and semi-structured interview.
|
At study completion (12 week follow up visit)
|
Generalizability of the DOT-HF Intervention
Time Frame: At study completion (12 week follow up visit)
|
The generalizability of our study will be evaluated by comparing sociodemographic data between participants and eligible individuals who decline participation.
Sociodemographics include age, gender, and race.
|
At study completion (12 week follow up visit)
|
Proportion of days with weight assessed
Time Frame: At Study Completion (12-week follow-up visit)
|
The proportion of days weight is recorded by the participant using the ENGAGE-HF app.
The minimum is 0% and maximum is 100%.
|
At Study Completion (12-week follow-up visit)
|
Proportion of days with daily health status completed
Time Frame: At Study Completion (12-week follow-up visit)
|
The proportion of days daily health status is recorded by the participant using the ENGAGE-HF app.
The minimum is 0% and maximum is 100%.
|
At Study Completion (12-week follow-up visit)
|
Proportion of Kansas City Cardiomyopathy Questionnaire-12 assessments completed
Time Frame: At Study Completion (12-week follow-up visit)
|
The proportion of biweekly periods that the Kansas City Cardiomyopathy Questionnaire-12 health status is recorded by the participant using the ENGAGE-HF app.
The minimum is 0% and maximum is 100%.
|
At Study Completion (12-week follow-up visit)
|
Proportion of days with medication adherence assessed
Time Frame: At Study Completion (12-week follow-up visit)
|
The proportion of days medication adherence is recorded by the participant using the ENGAGE-HF app.
The minimum is 0% and maximum is 100%.
|
At Study Completion (12-week follow-up visit)
|
Guideline-Directed Medical Therapy Score
Time Frame: Baseline, At study completion (12 week follow-up visit)
|
A score based on the heart failure medications prescribed.
The minimum score is 0% and maximum score is 100%.
|
Baseline, At study completion (12 week follow-up visit)
|
Proportion of days with blood pressure (systolic) assessed
Time Frame: At Study Completion (12-week follow-up visit)
|
The proportion of days blood pressure (systolic) is recorded by the participant using the ENGAGE-HF app.
The minimum is 0% and maximum is 100%.
|
At Study Completion (12-week follow-up visit)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alex Sandhu, MD, Stanford University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 67924
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heart Failure
-
Tufts Medical CenterMetro West Medical CenterCompletedCongestive Heart Failure | Diastolic Heart Failure | Systolic Heart FailureUnited States
-
Abbott Medical DevicesCompletedHeart Failure | Heart Failure, Diastolic | Heart Failure, Systolic | Heart Failure NYHA Class II | Heart Failure NYHA Class III | Heart Failure With Reduced Ejection Fraction | Heart Failure NYHA Class IV | Heart Failure With Normal Ejection Fraction | Heart Failure; With Decompensation | Heart Failure...United States, Canada
-
Manipal UniversityUnknownHeart Failure | Decompensated Heart Failure | Acute Heart Failure | Diastolic Heart Failure | Systolic Heart FailureIndia
-
VA Eastern Colorado Health Care SystemNational Institute on Aging (NIA)CompletedHeart Failure | Heart Failure, Diastolic | Heart Failure, Systolic | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction | Heart Failure; With Decompensation | Heart Failure,Congestive | Heart Failure AcuteUnited States
-
University Hospital, MontpellierCompletedHeart Failure | Diastolic Heart Failure | Systolic Heart Failure Stage CFrance
-
Wake Forest UniversityCompletedHeart Failure, Congestive | Heart Failure With Preserved Ejection Fraction
-
Lancaster General HospitalLouise von Hess Medical Research InstituteEnrolling by invitationDiastolic Heart FailureUnited States
-
Wake Forest UniversityNational Institute on Aging (NIA)CompletedHeart Failure, Congestive | Diastolic Heart FailureUnited States
-
Giresun UniversityIstanbul University - Cerrahpasa (IUC)RecruitingHeart Failure | Diastolic Heart Failure | Systolic Heart FailureTurkey
-
US Department of Veterans AffairsCompleted
Clinical Trials on A combination of a provider-facing desktop and mobile application with a patient-facing mobile application
-
Bournemouth UniversityCompletedNutritional Status | Nutrition Assessment
-
Aristotle University Of ThessalonikiCompletedAttention Deficit Hyperactivity DisorderGreece
-
Seoul National University Bundang HospitalKT CorporationCompleted
-
National Taiwan University Hospital Hsin-Chu BranchNational Taipei University of Nursing and Health SciencesRecruitingWound | Pressure InjuryTaiwan
-
University of ValenciaCompletedObsessive-Compulsive DisorderSpain
-
The New Model of Care, Hail Health ClusterHealth Holding Company, Hail Health Cluster, Saudi ArabiaNot yet recruiting
-
Boehringer IngelheimCompletedPulmonary FibrosisUnited States, Germany, Netherlands, Belgium
-
1800 Contacts, Inc.RecruitingRefractive ErrorsUnited States
-
Ain Shams UniversityRecruitingMedication ManagementEgypt
-
University of AlicanteCompletedCardiovascular Diseases | Hypertension | Exercise | Body Composition | Overweight and Obesity | Machine Learning | Diet, Mediterranean | Triglyceride-Storage; DiseaseSpain