Clinical trial NCT05647317: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
Digital Health
Remote monitoring
Mobile Application
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-12-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm study
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Patient Acceptability of the intervention
timeFrame: At Study completion (12-week follow-up visit)
measure: Patients' Engagement score
timeFrame: At Study completion (12-week follow-up visit)
measure: Clinicians' Response to Notification
timeFrame: At Study completion (12-week follow-up visit)
Secondary outcomes:
measure: Proportion of days with weight assessed
timeFrame: At Study Completion (12-week follow-up visit)
measure: Proportion of days with daily health status completed
timeFrame: At Study Completion (12-week follow-up visit)
measure: Proportion of Kansas City Cardiomyopathy Questionnaire-12 assessments completed
timeFrame: At Study Completion (12-week follow-up visit)
measure: Proportion of days with blood pressure (systolic) assessed
timeFrame: At Study Completion (12-week follow-up visit)
measure: Proportion of days with medication adherence assessed
timeFrame: At Study Completion (12-week follow-up visit)
measure: Sustainability of DOT-HF technology for Patients
timeFrame: At 6 week, At Study Completion (12-week follow-up visit)
measure: Feasibility of DOT-HF technology for Patients
timeFrame: At Study Completion (12 week follow up visit)
measure: Utility of DOT-HF technology for Clinicians
timeFrame: At study completion (12 week follow up visit)
measure: Acceptability of DOT-HF technology for Clinicians
timeFrame: At study completion (12 week follow up visit)
measure: Generalizability of the DOT-HF Intervention
timeFrame: At study completion (12 week follow up visit)
measure: Guideline-Directed Medical Therapy Score
timeFrame: Baseline, At study completion (12 week follow-up visit)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Hospital & Clinics
state: California
Study officials:
affiliation: Stanford University
name: Alex Sandhu, MD
role: PRINCIPAL_INVESTIGATOR
References: