Congestive Heart FailureNCT04394754
Evaluating Efficacy of Digital Health Technology in the Treatment of Congestive Heart Failure
A study testing BodyPort, Noom and Conversa in people with Congestive Heart Failure, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to determine the efficacy of three novel digital health technologies versus usual care in the management of congestive heart failure, as assessed by a primary outcome of improvement in quality of life, and a variety of secondary outcomes that include metrics measuring patient and provider… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- BodyPort, Noom and Conversa
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2020to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults greater than or equal to 18 and less than 80 years of age
- Enrolled in one of Yale New Haven Hospital's Disease Management or Heart Failure-focused cardiology clinics
- Diagnosed with congestive heart failure (preserved or reduced ejection fraction with or without diabetes)
Who cannot join
- Class IV heart failure
- Stage 4 or end stage renal disease (eGFR < 30)
- Recipient of a heart transplant of ventricular assist device
- Under hospice care
- Dementia
- Incarceration
Show all 14Show fewer
- Pregnancy
- Currently homeless or residing in an unstable living situation (i.e., transitional housing, rehab facility, etc.)
- Inability to consent
- Currently enrolled in a study investigating a digital health product or technology
- Life expectancy of less than 6 months as determined by clinical judgement of primary treating physician
- weight greater than 400 pounds
- unable to stand straight up for 30 seconds without assistance, such as from a cane, walker, or wall.
- non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06520
About this study
Official title: Assessing the Efficacy of Digital Health Technology in the Management of Congestive Heart Failure: An Evaluation of Three Novel Digital Health Products
The purpose of this study is to determine the efficacy of three novel digital health technologies versus usual care in the management of congestive heart failure, as assessed by a primary outcome of improvement in quality of life, and a variety of secondary outcomes that include metrics measuring patient and provider satisfaction, clinical efficiency, and patient outcomes.
Read the detailed description
Heart failure is the most common cause of mortality and morbidity in the United States and in Western Europe. However, patient etiology and prognosis varies considerably, and guidance about how to best treat patients has relied on large clinical trials that only include snapshots of the syndrome (at the time the patient interaction with the healthcare system). It remains to be seen whether behavioral interventions can improve patient engagement, increase self-management of the conditions, and thus improve overall clinical outcomes.
Digital health technologies have a great potential to streamline and optimize the clinical management of heart failure. Such technologies can take the form of mobile applications or wearable devices that may provide both patients and providers with valuable real-time information about patient status and cardiovascular health, provide automated patient-tailored coaching and motivational tools, or a mix of both. Integration of these technologies into healthcare systems may allow for genuine engagement of the patient in their own care and management of their disease and/or enhance clinical decision making. To date, no prior study has comprehensively examined the ability of digital heath technologies to improve self-management of heart failure or subsequent clinical outcomes.
This study is an unblinded, 4-arm, parallel group randomized controlled trial to measure the efficacy of four digital health technologies in improving the management of care and quality of life of patients with congestive heart failure (CHF). Patients actively managed by one of Yale New Haven Hospital's heart failure-based clinics will be eligible for this study and approached for consent. Enrolled subjects will be randomized to one of four groups: a control (usual care) arm, or to one of three intervention arms, each of which assesses one of three digital health technologies. These technologies are:
- BodyPort: A data-driven smart scale that provides enhanced cardiac monitoring and risk assessment data.
- Noom: A live, data-driven coaching application providing personalized diet and weight management.
- Conversa: An automated conversational platform providing patient motivation and educational tools for CHF management.
Patients will be enrolled in the study for 6 months. The first three months will typically involve active clinic management and will be the point of our primary outcome assessment, while the final three months will assess stability of effect on patient care and outcomes.
The primary outcome is the rate of improvement in quality of life after 90 days post-enrollment, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). A variety of prespecified secondary outcomes will be measured to determine effects on patient outcomes, quality of care, clinical efficiency, and provider and patient satisfaction with the product.
- Conditions
- Congestive Heart Failure
- Being tested
- BodyPort, Noom, Conversa
- Keywords
- Digital Health
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BodyPortDevice
Patients will receive BodyPort, a smart scale that provides advanced cardiac monitoring.
NoomOther
Patients will receive a subscription to use Noom, a personalized diet and weight management application.
ConversaOther
patients will receive a subscription to use Conversa, a personalized automated coaching and motivational application.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients will receive usual care and no digital health device. |
| BodyPort | Experimental | Patients will receive the BodyPort device. Receives: Device: BodyPort |
| Noom | Experimental | Patients will receive a subscription to the Noom platform. Receives: Other: Noom |
| Conversa | Experimental | Patients will receive a subscription to the Conversa platform. Receives: Other: Conversa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life at 90 Days Post Enrollment
Assessed by the change in score of the Kansas City Cardiomyopathy Questionnaire (KCCQ) survey between baseline scoring (at enrollment) and at 90 days post-enrollment. This survey is a 23 item self-administered instrument used to quantify a patient's perception of health status. For each domain reported, an overall summary scored is derived and transformed to a score range of 0-100. The Total Symptom score is the mean of the Symptom Frequency and Symptom Burden scores. The Overall Summary Score is the mean of the Physical Limitation, Total Symptom, Quality of Life and Social Limitation Scores. The Clinical Summary score is the mean of the Physical Limitation and Total Symptom scores. All KCCQ scores are summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
Measured: Day 90 after enrollment
Secondary outcomes (28)
Change in Quality of Life at 180 Days Post Enrollment
Assessed by the change in score of the Kansas City Cardiomyopathy Questionnaire (KCCQ) survey between day 90 post enrollment and at day 180 post enrollment. This survey is a 23 item self-administered instrument used to quantify a patient's perception of health status. For each domain reported, an overall summary scored is derived and transformed to a score range of 0-100. The Total Symptom score is the mean of the Symptom Frequency and Symptom Burden scores. The Overall Summary Score is the mean of the Physical Limitation, Total Symptom, Quality of Life and Social Limitation Scores. The Clinical Summary score is the mean of the Physical Limitation and Total Symptom scores. All KCCQ scores are summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
Measured: 180 days post enrollment
Number of Participants With Hospital Admission at 90 Days Post Enrollment
Via medical record review. Number of patients with a hospital admission between enrollment to day 90 post enrollment.
Measured: 90 days post enrollment
Number of Participants With Hospital Admission at 180 Days Post Enrollment
Via medical record review. This measure is calculated as the number of participants with a hospital admission from day 90 to day 180 post enrollment.
Measured: 180 days post enrollment
Prescribing of Guideline-directed Medical Therapy
Documented prescription or change in dosing of any one of the following medication classes: beta blockers, ACEi/ARBs, and/or spironolactone; assessed via Surescripts data collection.
Measured: 90 days post enrollment
Prescribing of Guideline-directed Medical Therapy
Documented prescription or change in dosing of any one of the following medication classes: beta blockers, ACEi/ARBs, and/or spironolactone; assessed via Surescripts data collection.
Measured: 180 days post enrollment
Number of Subjects Using Guideline-directed Medical Therapy at 90 Days Post Enrollment
Number of patients having documented prescription of all of the following medication classes between enrollment and day 90 post enrollment: beta blockers, angiotensin-converting enzyme inhibitors (ACEi)/angiotensin receptor blockers (ARBs)/angiotensin receptor-neprilysin inhibitors (ARNI), sodium/glucose cotransporter-2 inhibitors (SGLT2i) and aldosterone receptor antagonists (MRAs); assessed via Surescripts data collection.
Measured: 90 days post enrollment
Number of Subjects Using Guideline-directed Medical Therapy at 180 Days Post Enrollment
Number of patients having documented prescription of all of the following medication classes between day 90 post enrollment and day 180 post enrollment: beta blockers, angiotensin-converting enzyme inhibitors (ACEi)/angiotensin receptor blockers (ARBs)/angiotensin receptor-neprilysin inhibitors (ARNI), sodium/glucose cotransporter-2 inhibitors (SGLT2i) and aldosterone receptor antagonists (MRAs); assessed via Surescripts data collection.
Measured: 180 days post enrollment
Number of Participants With Emergency Department (ED) Visits at 90 Days Post Enrollment
Via medical record review. Number of participants with an emergency department visit between enrollment and day 90 post enrollment.
Measured: 90 days post enrollment
Number of Participants With Emergency Department Visits at 180 Days Post Enrollment
Via medical record review. Number of participants with an emergency department visit between day 90 and day 180 post enrollment.
Measured: 180 days post enrollment
Number of Participants With Acute Kidney Injury (AKI) Development at 90 Days Post Enrollment
Via medical record review, defined as an increase in serum creatinine by 50% over baseline (pre-enrollment creatinine) at any point between enrollment day 90 post enrollment.
Measured: 90 days post enrollment
Number of Participants With Acute Kidney Injury (AKI) Development at 180 Days Post Enrollment
Via medical record review, defined as an increase in serum creatinine by 50% over baseline (pre-enrollment creatinine) at any point between day 90 and day 180 post enrollment.
Measured: 180 days post enrollment
Mortality Rate at 90 Days Post Enrollment
Via medical record review. Number of deaths between enrollment and 90 days post enrollment.
Measured: 90 days post enrollment
Mortality Rates at 180 Days Post Enrollment
Via medical record review. Number of deaths between day 90 and day 180 post enrollment.
Measured: 180 days post enrollment
Number of Participants With at Least One Clinic No-show at 90 Days Post Enrollment
Via medical record review; number of participants with at least one clinic no show between enrollment and day 90 post enrollment.
Measured: 90 days post enrollment
Number of In-person and Remote Clinic Visits at 90 Days Post Enrollment
Via medical record review. Number of visits between enrollment and 90 days post enrollment.
Measured: 90 days post enrollment
Number of In-person and Remote Clinic Visits at 180 Days Post Enrollment
Via medical record review. Number of visits between day 90 and day 180 post enrollment.
Measured: 180 days post enrollment
Number of Remote Device Checks by Providers at 90 Days Post Enrollment
Via medical record review
Measured: 90 days post enrollment
Number of Remote Device Checks by Providers at 180 Days Post Enrollment
Via medical record review
Measured: 180 days post enrollment
Number of Phone Calls Between Provider and Participant at 90 Days Post Enrollment
Via medical record review of telephone logs between enrollment and day 90 post enrollment.
Measured: 90 days post enrollment
Number of Phone Calls Between Provider and Participant at 180 Days Post Enrollment
Via medical record review of telephone logs
Measured: 180 days post enrollment
Average Time Devoted by Provider to Patient Care
Via medical record review of chart openings per patient
Measured: 90 days post enrollment
Average Time Devoted by Provider to Patient Care
Via medical record review of chart openings per patient
Measured: 180 days post enrollment
Number of Subjects Who Complete on Boarding and Baseline Assessments
Collected from patient enrollment platform
Measured: Within one week of consent
Number of Subjects Who Complete Digital Health Product Set up
Assessed as number of subjects who used device at least once during their duration in the study, up to 90 days post enrollment.
Measured: 90 days post enrollment
Number of Weekly Interactions With the Device
Information collected from device metrics to assess frequency of use
Measured: 90 days post enrollment
Number of Weekly Interactions With the Device
Information collected from device metrics to assess frequency of use
Measured: 180 days post enrollment
Average Number of Daily Interactions With the Device
Information collected from device metric to assess frequency of use
Measured: 90 days post enrollment
Average Number of Daily Interactions With the Device
Information collected from device metric to assess frequency of use
Measured: 180 days post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start21 Sep 2020
- Primary completion20 Sep 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by Yale 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim, ZS
- Responsible party
- Sponsor
- Investigators
- Francis P Wilson, MD MSCE, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04394754
- Sponsor's protocol ID
- 2000027325
- Status last verified
- Apr 2023
- First submitted
- 14 May 2020
- Last updated
- 18 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Deidentified data underlying results will be made available upon publication in an appropriate database.
Publications
Victoria-Castro AM, Martin ML, Yamamoto Y, Melchinger H, Weinstein J, Nguyen A, Lee KA, Gerber B, Calderon F, Subair L, Lee V, Williams A, Shaw M, Arora T, Garcez A, Desai NR, Ahmad T, Wilson FP. Impact of Digital Health Technology on Quality of Life in Patients With Heart Failure. JACC Heart Fail. 2024 Feb;12(2):336-348. doi: 10.1016/j.jchf.2023.09.022. Epub 2023 Nov 8.
PubMed 37943227
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy of Digital Health Technology in the Management of Congestive Heart Failure: An Evaluation of Three Novel Digital Health Products
- ClinicalTrials.gov ID
- NCT04394754
- Acronym / sponsor ID
- 2000027325
- Conditions
- Congestive Heart Failure
- Keywords
- Digital Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim, ZS
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 19 May 2020 (actual)
- Results
- Posted 23 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the efficacy of three novel digital health technologies versus usual care in the management of congestive heart failure, as assessed by a primary outcome of improvement in quality of life, and a variety of secondary outcomes that include metrics measuring patient and provider satisfaction, clinical efficiency, and patient outcomes.
Detailed description
Heart failure is the most common cause of mortality and morbidity in the United States and in Western Europe. However, patient etiology and prognosis varies considerably, and guidance about how to best treat patients has relied on large clinical trials that only include snapshots of the syndrome (at the time the patient interaction with the healthcare system). It remains to be seen whether behavioral interventions can improve patient engagement, increase self-management of the conditions, and thus improve overall clinical outcomes.
Digital health technologies have a great potential to streamline and optimize the clinical management of heart failure. Such technologies can take the form of mobile applications or wearable devices that may provide both patients and providers with valuable real-time information about patient status and cardiovascular health, provide automated patient-tailored coaching and motivational tools, or a mix of both. Integration of these technologies into healthcare systems may allow for genuine engagement of the patient in their own care and management of their disease and/or enhance clinical decision making. To date, no prior study has comprehensively examined the ability of digital heath technologies to improve self-management of heart failure or subsequent clinical outcomes.
This study is an unblinded, 4-arm, parallel group randomized controlled trial to measure the efficacy of four digital health technologies in improving the management of care and quality of life of patients with congestive heart failure (CHF). Patients actively managed by one of Yale New Haven Hospital's heart failure-based clinics will be eligible for this study and approached for consent. Enrolled subjects will be randomized to one of four groups: a control (usual care) arm, or to one of three intervention arms, each of which assesses one of three digital health technologies. These technologies are:
- BodyPort: A data-driven smart scale that provides enhanced cardiac monitoring and risk assessment data.
- Noom: A live, data-driven coaching application providing personalized diet and weight management.
- Conversa: An automated conversational platform providing patient motivation and educational tools for CHF management.
Patients will be enrolled in the study for 6 months. The first three months will typically involve active clinic management and will be the point of our primary outcome assessment, while the final three months will assess stability of effect on patient care and outcomes.
The primary outcome is the rate of improvement in quality of life after 90 days post-enrollment, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). A variety of prespecified secondary outcomes will be measured to determine effects on patient outcomes, quality of care, clinical efficiency, and provider and patient satisfaction with the product.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients will receive usual care and no digital health device. |
| BodyPort | Experimental | Device: BodyPortPatients will receive the BodyPort device. |
| Noom | Experimental | Other: NoomPatients will receive a subscription to the Noom platform. |
| Conversa | Experimental | Other: ConversaPatients will receive a subscription to the Conversa platform. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults greater than or equal to 18 and less than 80 years of age
- Enrolled in one of Yale New Haven Hospital's Disease Management or Heart Failure-focused cardiology clinics
- Diagnosed with congestive heart failure (preserved or reduced ejection fraction with or without diabetes)
Key exclusion criteria (14 listed)
- Class IV heart failure
- Stage 4 or end stage renal disease (eGFR < 30)
- Recipient of a heart transplant of ventricular assist device
- Under hospice care
- Dementia
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 |
|---|---|---|
| BodyPortPatients will receive BodyPort, a smart scale that provides advanced cardiac monitoring. | Device | BodyPort |
| NoomPatients will receive a subscription to use Noom, a personalized diet and weight management application. | Other | Noom |
| Conversapatients will receive a subscription to use Conversa, a personalized automated coaching and motivational application. | Other | Conversa |
Primary outcome
Change in Quality of Life at 90 Days Post Enrollment
Time frame: Day 90 after enrollment
Assessed by the change in score of the Kansas City Cardiomyopathy Questionnaire (KCCQ) survey between baseline scoring (at enrollment) and at 90 days post-enrollment. This survey is a 23 item self-administered instrument used to quantify a patient's perception of health status. For each domain reported, an overall summary scored is derived and transformed to a score range of 0-100. The Total Symptom score is the mean of the Symptom Frequency and Symptom Burden scores. The Overall Summary Score is the mean of the Physical Limitation, Total Symptom, Quality of Life and Social Limitation Scores. The Clinical Summary score is the mean of the Physical Limitation and Total Symptom scores. All KCCQ scores are summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
28 secondary outcomes
Change in Quality of Life at 180 Days Post Enrollment
Time frame: 180 days post enrollment
Number of Participants With Hospital Admission at 90 Days Post Enrollment
Time frame: 90 days post enrollment
Number of Participants With Hospital Admission at 180 Days Post Enrollment
Time frame: 180 days post enrollment
Prescribing of Guideline-directed Medical Therapy
Time frame: 90 days post enrollment
Prescribing of Guideline-directed Medical Therapy
Time frame: 180 days post enrollment
Number of Subjects Using Guideline-directed Medical Therapy at 90 Days Post Enrollment
Time frame: 90 days post enrollment
Number of Subjects Using Guideline-directed Medical Therapy at 180 Days Post Enrollment
Time frame: 180 days post enrollment
Number of Participants With Emergency Department (ED) Visits at 90 Days Post Enrollment
Time frame: 90 days post enrollment
Number of Participants With Emergency Department Visits at 180 Days Post Enrollment
Time frame: 180 days post enrollment
Number of Participants With Acute Kidney Injury (AKI) Development at 90 Days Post Enrollment
Time frame: 90 days post enrollment
Number of Participants With Acute Kidney Injury (AKI) Development at 180 Days Post Enrollment
Time frame: 180 days post enrollment
Mortality Rate at 90 Days Post Enrollment
Time frame: 90 days post enrollment
Mortality Rates at 180 Days Post Enrollment
Time frame: 180 days post enrollment
Number of Participants With at Least One Clinic No-show at 90 Days Post Enrollment
Time frame: 90 days post enrollment
Number of In-person and Remote Clinic Visits at 90 Days Post Enrollment
Time frame: 90 days post enrollment
Number of In-person and Remote Clinic Visits at 180 Days Post Enrollment
Time frame: 180 days post enrollment
Number of Remote Device Checks by Providers at 90 Days Post Enrollment
Time frame: 90 days post enrollment
Number of Remote Device Checks by Providers at 180 Days Post Enrollment
Time frame: 180 days post enrollment
Number of Phone Calls Between Provider and Participant at 90 Days Post Enrollment
Time frame: 90 days post enrollment
Number of Phone Calls Between Provider and Participant at 180 Days Post Enrollment
Time frame: 180 days post enrollment
Average Time Devoted by Provider to Patient Care
Time frame: 90 days post enrollment
Average Time Devoted by Provider to Patient Care
Time frame: 180 days post enrollment
Number of Subjects Who Complete on Boarding and Baseline Assessments
Time frame: Within one week of consent
Number of Subjects Who Complete Digital Health Product Set up
Time frame: 90 days post enrollment
Number of Weekly Interactions With the Device
Time frame: 90 days post enrollment
Number of Weekly Interactions With the Device
Time frame: 180 days post enrollment
Average Number of Daily Interactions With the Device
Time frame: 90 days post enrollment
Average Number of Daily Interactions With the Device
Time frame: 180 days post enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37943227Victoria-Castro AM, Martin ML, Yamamoto Y, Melchinger H, Weinstein J, Nguyen A, Lee KA, Gerber B, Calderon F, Subair L, Lee V, Williams A, Shaw M, Arora T, Garcez A, Desai NR, Ahmad T, Wilson FP. Impact of Digital Health Technology on Quality of Life in Patients With Heart Failure. JACC Heart Fail. 2024 Feb;12(2):336-348. doi: 10.1016/j.jchf.2023.09.022. Epub 2023 Nov 8.
- Individual participant dataSharing planned: Yes. Deidentified data underlying results will be made available upon publication in an appropriate database.
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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.
Francis P Wilson, MD MSCE principal investigator
Yale 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 BodyPort, Noom and Conversa in people with Congestive Heart Failure, run by Yale 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 3 inclusion and 14 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 18 May 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?
Yes. Results are posted in the registry (first posted 23 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Quality of Life at 90 Days Post Enrollment (time frame: Day 90 after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04394754, which also lists 1 linked publication.
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 18 May 2023.