Heart FailureNCT05647317
Mobile Technology-Based System for Patient Engagement and Physician-Directed Remote Management of Heart Failure
A study testing A combination of a provider-facing desktop and mobile application with a patient-facing mobile application in people with Heart Failure, run by Stanford University at 1 site in United States.
Trial summary
This pilot study is to assess the feasibility, preliminary utility and acceptance of a digital technology-based system for heart failure management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- A combination of a provider-facing desktop and mobile application with a patient-facing mobile application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2023to 15 Apr 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Hospital & Clinics
Stanford, California, 94305
Alexander Sandhu, MD
About this study
Official title: Design of a Mobile Technology-Based System for Patient Engagement and Physician-Directed Remote Management of Heart Failure
This pilot study is to assess the feasibility, preliminary utility and acceptance of a digital technology-based system for heart failure management.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- A combination of a provider-facing desktop and mobile application with a patient-facing mobile application
- Keywords
- Heart Failure, Digital Health, Remote monitoring, Mobile Application
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A combination of a provider-facing desktop and mobile application with a patient-facing mobile applicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Digital technology-based system for heart failure management | Other | This is a single-arm study to assess the feasibility and preliminary effectiveness of a digital technology-based system for heart failure management Receives: Other: A combination of a provider-facing desktop and mobile application with a patient-facing mobile application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Study completion (12-week follow-up visit)
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%.
Measured: At Study completion (12-week follow-up visit)
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.
Measured: At Study completion (12-week follow-up visit)
Secondary outcomes (11)
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%.
Measured: At Study Completion (12-week follow-up visit)
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%.
Measured: At Study Completion (12-week follow-up visit)
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%.
Measured: At Study Completion (12-week follow-up visit)
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%.
Measured: At Study Completion (12-week follow-up visit)
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%.
Measured: At Study Completion (12-week follow-up visit)
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.
Measured: At 6 week, At Study Completion (12-week follow-up visit)
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.
Measured: At Study Completion (12 week follow up visit)
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.
Measured: At study completion (12 week follow up visit)
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.
Measured: At study completion (12 week follow up visit)
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.
Measured: At study completion (12 week follow up visit)
Guideline-Directed Medical Therapy Score
A score based on the heart failure medications prescribed. The minimum score is 0% and maximum score is 100%.
Measured: Baseline, At study completion (12 week follow-up visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start28 Jul 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion15 Apr 2024 (estimated)
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.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Sandhu, Stanford University
- Investigators
- Alex Sandhu, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647317
- Sponsor's protocol ID
- 67924
- Status last verified
- Jul 2023
- First submitted
- 1 Nov 2022
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design of a Mobile Technology-Based System for Patient Engagement and Physician-Directed Remote Management of Heart Failure
- ClinicalTrials.gov ID
- NCT05647317
- Acronym / sponsor ID
- 67924
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Digital Health, Remote monitoring, Mobile Application
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 28 Jul 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 15 Apr 2024 (estimated)
- First posted
- 12 Dec 2022 (actual)
- 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm study
| Arm | Type | Receives |
|---|---|---|
| Digital technology-based system for heart failure management | Other | Other: A combination of a provider-facing desktop and mobile application with a patient-facing mobile applicationThis is a single-arm study to assess the feasibility and preliminary effectiveness of a digital technology-based system for heart failure management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| A combination of a provider-facing desktop and mobile application with a patient-facing mobile applicationA 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. | Other | Digital technology-based system for heart failure management |
Primary outcome
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.
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%.
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.
11 secondary outcomes
Proportion of days with weight assessed
Time frame: 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)
Proportion of Kansas City Cardiomyopathy Questionnaire-12 assessments completed
Time frame: 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)
Proportion of days with medication adherence assessed
Time frame: At Study Completion (12-week follow-up visit)
Sustainability of DOT-HF technology for Patients
Time frame: 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)
Utility of DOT-HF technology for Clinicians
Time frame: 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)
Generalizability of the DOT-HF Intervention
Time frame: At study completion (12 week follow up visit)
Guideline-Directed Medical Therapy Score
Time frame: Baseline, At study completion (12 week follow-up visit)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Alex Sandhu, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A combination of a provider-facing desktop and mobile application with a patient-facing mobile application in people with Heart Failure, run by Stanford University 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 6 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 1 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander Sandhu, MD (650 7234000, ats114@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Acceptability of the intervention (time frame: At Study completion (12-week follow-up visit)). 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 1 Aug 2023.