Back to resultsMobile Technology-Based System for Patient Engagement and Physician-Directed Remote Management of Heart Failure
Primary Purpose
Heart Failure
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
A combination of a provider-facing desktop and mobile application with a patient-facing mobile application
Sponsored by
About this trial
This is an interventional other trial for Heart Failure focused on measuring Heart Failure, Digital Health, Remote monitoring, Mobile Application
Eligibility Criteria
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
Sites / Locations
- Stanford Hospital & Clinics
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Digital technology-based system for heart failure management
Arm Description
This is a single-arm study to assess the feasibility and preliminary effectiveness of a digital technology-based system for heart failure management
Outcomes
Primary Outcome Measures
Patient Acceptability of the intervention
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.
Patients' Engagement score
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%.
Clinicians' Response to Notification
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.
Secondary Outcome Measures
Proportion of days with weight assessed
The proportion of days weight is recorded by the participant using the ENGAGE-HF app. The minimum is 0% and maximum is 100%.
Proportion of days with daily health status completed
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%.
Proportion of Kansas City Cardiomyopathy Questionnaire-12 assessments completed
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%.
Proportion of days with blood pressure (systolic) assessed
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%.
Proportion of days with medication adherence assessed
The proportion of days medication adherence is recorded by the participant using the ENGAGE-HF app. The minimum is 0% and maximum is 100%.
Sustainability of DOT-HF technology for Patients
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.
Feasibility of DOT-HF technology for Patients
Feasibility will be assessed via semi-structured interview questions to assess barriers to use the DOT-HF intervention.
Utility of DOT-HF technology for Clinicians
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:
Notification of eligible therapy adjustment
Worsening patient-reported health status
Weight gain
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.
Acceptability of DOT-HF technology for Clinicians
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.
Generalizability of the DOT-HF Intervention
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.
Guideline-Directed Medical Therapy Score
A score based on the heart failure medications prescribed. The minimum score is 0% and maximum score is 100%.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05647317
Brief Title
Mobile Technology-Based System for Patient Engagement and Physician-Directed Remote Management of Heart Failure
Official Title
Design of a Mobile Technology-Based System for Patient Engagement and Physician-Directed Remote Management of Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 28, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
April 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This pilot study is to assess the feasibility, preliminary utility and acceptance of a digital technology-based system for heart failure management.
Detailed Description
Heart failure continues to be a major public health problem. High-value, guideline-directed medical therapies (GDMT) for heart failure can reduce mortality and improve quality of life. However, large gaps in treatment with GDMT persist. While prior quality improvement efforts have focused on heart failure hospitalizations, there is a critical need to improve the quality-of-care post-discharge when the initiation and up-titration of GDMT is critical to optimizing outcomes. The main purpose of this pilot study is to assess the feasibility, preliminary utility and acceptance of a digital technology-based system for heart failure management.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, Digital Health, Remote monitoring, Mobile Application
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single arm study
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Digital technology-based system for heart failure management
Arm Type
Other
Arm Description
This is a single-arm study to assess the feasibility and preliminary effectiveness of a digital technology-based system for heart failure management
Intervention Type
Other
Intervention Name(s)
A combination of a provider-facing desktop and mobile application with a patient-facing mobile application
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient Acceptability of the intervention
Description
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.
Time Frame
At Study completion (12-week follow-up visit)
Title
Patients' Engagement score
Description
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%.
Time Frame
At Study completion (12-week follow-up visit)
Title
Clinicians' Response to Notification
Description
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.
Time Frame
At Study completion (12-week follow-up visit)
Secondary Outcome Measure Information:
Title
Proportion of days with weight assessed
Description
The proportion of days weight is recorded by the participant using the ENGAGE-HF app. The minimum is 0% and maximum is 100%.
Time Frame
At Study Completion (12-week follow-up visit)
Title
Proportion of days with daily health status completed
Description
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%.
Time Frame
At Study Completion (12-week follow-up visit)
Title
Proportion of Kansas City Cardiomyopathy Questionnaire-12 assessments completed
Description
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%.
Time Frame
At Study Completion (12-week follow-up visit)
Title
Proportion of days with blood pressure (systolic) assessed
Description
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%.
Time Frame
At Study Completion (12-week follow-up visit)
Title
Proportion of days with medication adherence assessed
Description
The proportion of days medication adherence is recorded by the participant using the ENGAGE-HF app. The minimum is 0% and maximum is 100%.
Time Frame
At Study Completion (12-week follow-up visit)
Title
Sustainability of DOT-HF technology for Patients
Description
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.
Time Frame
At 6 week, At Study Completion (12-week follow-up visit)
Title
Feasibility of DOT-HF technology for Patients
Description
Feasibility will be assessed via semi-structured interview questions to assess barriers to use the DOT-HF intervention.
Time Frame
At Study Completion (12 week follow up visit)
Title
Utility of DOT-HF technology for Clinicians
Description
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:
Notification of eligible therapy adjustment
Worsening patient-reported health status
Weight gain
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.
Time Frame
At study completion (12 week follow up visit)
Title
Acceptability of DOT-HF technology for Clinicians
Description
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.
Time Frame
At study completion (12 week follow up visit)
Title
Generalizability of the DOT-HF Intervention
Description
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.
Time Frame
At study completion (12 week follow up visit)
Title
Guideline-Directed Medical Therapy Score
Description
A score based on the heart failure medications prescribed. The minimum score is 0% and maximum score is 100%.
Time Frame
Baseline, At study completion (12 week follow-up visit)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Sandhu, MD
Phone
650 7234000
Email
ats114@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Karma Lhamo, MS
Phone
9713362450
Email
karmalh@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex Sandhu, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Hospital & Clinics
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Sandhu, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mobile Technology-Based System for Patient Engagement and Physician-Directed Remote Management of Heart Failure
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