Heart FailurePhase 3NCT04755816
A Mobile Application to Promote Self-management and Improve Outcomes in Heart Failure
A Phase 3 study testing Sodium intervention, Clinical worsening intervention and Educational content in people with Heart Failure, run by University of Michigan at 9 sites in United States.
Trial summary
This study will investigate the effectiveness of two contextual just-in-time adaptive interventions (JITAIs) delivered via a mobile app for heart failure patients. 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?
- Sodium intervention, Clinical worsening intervention and Educational content
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 9 sitesUnited States
- Study dates
- 14 Jun 2021to 17 May 2023
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years and older at screening
- Currently admitted or discharged from the hospital within the last 14 days with a diagnosis of acute or acute on chronic decompensated HF.
- Based on one of the EF criteria (LVEF within 12 months of randomization. BNP or NT-proBNP criteria within 30 days prior to randomization):
- Left ventricular ejection fraction (LVEF) ≤ 40%.
- LVEF >40% and BNP > 175 pg/ml or NT-proBNP > 700 pg/ml. Thresholds for NT-proBNP and BNP for LVEF > 40% will be corrected for body mass index (BMI) using a 4% reduction per BMI unit over 25 kg/m2.
- Have a personal physician for follow-up
Show all 9Show fewer
- A smartphone with a compatible Apple or Android operating system installed and able to download and use ManageHF including accepting all permissions
- A valid email address
- Fluent in spoken and written English
Who cannot join
- Contraindication to recommending a sodium restriction diet
- Scheduled intervention for primary valvular heart disease will occur during the study period.
- Cardiac resynchronization therapy (CRT) within 3 months prior to screening or current plan to implant CRT device during the study period.
- Dialysis
- Previous cardiac transplantation or implantation of a ventricular assistance device or similar device.
- Listed status 1, 2 or 3 for heart transplant
Show all 12Show fewer
- Implantation of a ventricular assistance device is expected within 3 months after randomization
- Non-cardiac illness with expected survival of less than 3 months
- Discharge to a setting other than home
- Requirement for chronic inotropic therapy (e.g. milrinone, dobutamine)
- Inability to use Withings devices due to equipment limitations or contraindications
- Currently pregnant or intend to become pregnant during the study period.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Emory University
Altanta, Georgia, 30322
University of Michigan
Ann Arbor, Michigan, 48109
University of Alabama at Birmingham
Birmingham, Alabama, 35294
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
Atlanta VA Health Care System
Decatur, Georgia, 30033
Henry Ford Hospital System
Detroit, Michigan, 48202
Virginia Commonwealth University
Richmond, Virginia, 23284
Washington University in St. Louis
St Louis, Missouri, 63130
Stanford University
Stanford, California, 94305
About this study
Official title: A Multifaceted Adaptive Mobile Application to Promote Self-management and Improve Outcomes in Heart Failure
This study will investigate the effectiveness of two contextual just-in-time adaptive interventions (JITAIs) delivered via a mobile app for heart failure patients.
Read the detailed description
The Manage HF study is a multicenter 12-week randomized controlled double-blind 2x2 factorial clinical trial. This study will investigate the effectiveness of two contextual just-in-time adaptive interventions (JITAIs) delivered via a mobile app for heart failure patients. The clinical worsening intervention targets self-management of behaviors to prevent worsening of a patient's heart failure symptoms. The dietary sodium intervention promotes lower sodium intake. Eligible participants will be randomized to the dietary sodium intervention, the clinical worsening intervention, both interventions, or no intervention in a 1:1:1:1 manner, stratified by site, gender, and HF type (HFpEF versus HFrEF).
- Conditions
- Heart Failure
- Being tested
- Sodium intervention, Clinical worsening intervention, Educational content
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium interventionBehavioural
The sodium dietary intervention provides the user with a tailored message to assist with making dietary choices based on sodium content when they arrive at a grocery store or restaurant.
Clinical worsening interventionBehavioural
The intervention adapts to the participant's reported symptoms and provides feedback with a global health status indicator (HSI). Users will receive tailored push notification based on their HSI status.
Educational contentBehavioural
Standard heart failure educational information and a daily symptom survey.
| Study group | Role | What they receive |
|---|---|---|
| Control Group 'A' | Sham comparator | Standard heart failure educational information. Receives: Behavioral: Educational content |
| Dietary Sodium Intervention 'B' | Experimental | The dietary sodium intervention facilitates lower sodium choices using tailored push notifications. Receives: Behavioral: Sodium intervention |
| Clinical Worsening Intervention 'C' | Experimental | The clinical worsening intervention promotes self-monitoring and self-management and is linked tailored push notifications. Receives: Behavioral: Clinical worsening intervention |
| Dietary Sodium and Clinical Worsening 'D' | Experimental | Full access to all content in the control, dietary sodium, and clinical worsening interventions. Receives: Behavioral: Sodium intervention; Behavioral: Clinical worsening intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hierarchical Combination ("Win Ratio") of Time to All-cause Mortality, Time to Heart Failure Hospital Readmission, and Decline in Health-related Quality of Life (HRQOL) [ Time Frame: Baseline up to Week 12 ]
Time to all-cause mortality (ACM), time to heart failure hospital readmission (HFHR), and decline in quality of life will be analyzed using the Finkelstein-Schoenfeld method. The method combines these three endpoints in a hierarchical fashion using ACM first, HRHR second, and change in HRQOL third. The method pairs every participant receiving the diet intervention with every participant not receiving the diet intervention within each stratum. Within each pairing, a +1 is assigned to the "better" participant, -1 to the "worse" participant, and 0 if they are "tied". The comparison begins with ACM. Tied pairings are then compared using HFHR. Any remaining tied pairings are compared using change in HRQOL. A 'Win' represents a participant doing better within each pairing (receiving +1) based on the hierarchical comparison. The reported unit is the total "wins" for each intervention group from performing such a hierarchical comparison across all strata.
Measured: 12 weeks
Hierarchical Combination ("Win Ratio") of Time to All-cause Mortality, Time to Heart Failure Hospital Readmission, and Decline in Health-related Quality of Life (HRQOL) [ Time Frame: Baseline up to Week 12 ]
Time to all-cause mortality (ACM), time to heart failure hospital readmission (HFHR), and decline in quality of life will be analyzed using the Finkelstein-Schoenfeld method. The method combines these three endpoints in a hierarchical fashion using ACM first, HRHR second, and change in HRQOL third. The method pairs every participant receiving the clinical worsening intervention with every participant not receiving the clinical worsening intervention within each stratum. Within each pairing, a +1 is assigned to the "better" participant, -1 to the "worse" participant, and 0 if they are "tied". The comparison begins with ACM. Tied pairings are then compared using HFHR. Any remaining tied pairings are compared using change in HRQOL. A 'Win' represents a participant doing better within each pairing (receiving +1) based on the hierarchical comparison. The reported unit is the total "wins" for each intervention group from performing such a hierarchical comparison across all strata.
Measured: 12 weeks
Secondary outcomes (3)
All-Cause Mortality [ Time Frame: Baseline up to Week 12 ]
Time to all-cause mortality will be analyzed up to week 12.
Measured: 12 weeks
Heart Failure-related Hospitalizations [ Time Frame: Baseline up to Week 12 ]
Time to first heart-failure related hospitalization will be analyzed up to week 12.
Measured: 12 weeks
Change From Baseline in Health-related Quality of Life [ Time Frame: Baseline up to Week 12 ]
Change from baseline to week 12 in health-related quality of life as measured by the Minnesota Living with Heart Failure Questionnaire.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start14 Jun 2021
- Primary completion8 May 2023
- Study completion17 May 2023
Why it stopped: Slow recruitment - DSMB decision
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 Heart FailureStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Michael Dorsch, University of Michigan
- Investigators
- Michael Dorsch, PharmD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755816
- Sponsor's protocol ID
- HUM00181316
- Other IDs
- R01AG062582-01A1
- Status last verified
- Aug 2024
- First submitted
- 27 Jan 2021
- Last updated
- 17 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The aim is to prepare data for deposit into the National Institute on Aging supported National Archive of Computerized Data on Aging data repository. The de-identified analytic data will be prepared as SAS transport files or ASCII comma-delimited files with accompanying codebooks that describe the data and data structure. The redaction will employ best practices and will be consistent with National Institute on Aging data sharing policies.
Publications
Dorsch MP, Ali MS, Krambrink A, Kolenic G, Ganai S, Arzac J, Zhang X, Greer KM, Shah AJ, Cowger JA, Ewald G, Rodgers JE, Dixon DL, Koelling TM, Hummel SL. The ManageHF Just-in-Time Adaptive Mobile App Interventions to Promote Self-Management and Improve Outcomes in Heart Failure: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2026 Jul 28;14:e74121. doi: 10.2196/74121.
PubMed 42520258
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multifaceted Adaptive Mobile Application to Promote Self-management and Improve Outcomes in Heart Failure
- ClinicalTrials.gov ID
- NCT04755816
- Acronym / sponsor ID
- HUM00181316
- Conditions
- Heart Failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment - DSMB decision
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 8 May 2023 (actual)
- Study completion
- 17 May 2023 (actual)
- First posted
- 16 Feb 2021 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the effectiveness of two contextual just-in-time adaptive interventions (JITAIs) delivered via a mobile app for heart failure patients.
Detailed description
The Manage HF study is a multicenter 12-week randomized controlled double-blind 2x2 factorial clinical trial. This study will investigate the effectiveness of two contextual just-in-time adaptive interventions (JITAIs) delivered via a mobile app for heart failure patients. The clinical worsening intervention targets self-management of behaviors to prevent worsening of a patient's heart failure symptoms. The dietary sodium intervention promotes lower sodium intake. Eligible participants will be randomized to the dietary sodium intervention, the clinical worsening intervention, both interventions, or no intervention in a 1:1:1:1 manner, stratified by site, gender, and HF type (HFpEF versus HFrEF).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Group 'A' | Sham comparator | Behavioral: Educational contentStandard heart failure educational information. |
| Dietary Sodium Intervention 'B' | Experimental | Behavioral: Sodium interventionThe dietary sodium intervention facilitates lower sodium choices using tailored push notifications. |
| Clinical Worsening Intervention 'C' | Experimental | Behavioral: Clinical worsening interventionThe clinical worsening intervention promotes self-monitoring and self-management and is linked tailored push notifications. |
| Dietary Sodium and Clinical Worsening 'D' | Experimental | Behavioral: Sodium intervention, Behavioral: Clinical worsening interventionFull access to all content in the control, dietary sodium, and clinical worsening interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 years and older at screening
- Currently admitted or discharged from the hospital within the last 14 days with a diagnosis of acute or acute on chronic decompensated HF.
- Based on one of the EF criteria (LVEF within 12 months of randomization. BNP or NT-proBNP criteria within 30 days prior to randomization):
- Have a personal physician for follow-up
- A smartphone with a compatible Apple or Android operating system installed and able to download and use ManageHF including accepting all permissions
Key exclusion criteria (12 listed)
- Contraindication to recommending a sodium restriction diet
- Scheduled intervention for primary valvular heart disease will occur during the study period.
- Cardiac resynchronization therapy (CRT) within 3 months prior to screening or current plan to implant CRT device during the study period.
- Dialysis
- Previous cardiac transplantation or implantation of a ventricular assistance device or similar device.
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 |
|---|---|---|
| Sodium interventionThe sodium dietary intervention provides the user with a tailored message to assist with making dietary choices based on sodium content when they arrive at a grocery store or restaurant. | Behavioural | Dietary Sodium Intervention 'B', Dietary Sodium and Clinical Worsening 'D' |
| Clinical worsening interventionThe intervention adapts to the participant's reported symptoms and provides feedback with a global health status indicator (HSI). Users will receive tailored push notification based on their HSI status. | Behavioural | Clinical Worsening Intervention 'C', Dietary Sodium and Clinical Worsening 'D' |
| Educational contentStandard heart failure educational information and a daily symptom survey. | Behavioural | Control Group 'A' |
Primary outcome
Hierarchical Combination ("Win Ratio") of Time to All-cause Mortality, Time to Heart Failure Hospital Readmission, and Decline in Health-related Quality of Life (HRQOL) [ Time Frame: Baseline up to Week 12 ]
Time frame: 12 weeks
Time to all-cause mortality (ACM), time to heart failure hospital readmission (HFHR), and decline in quality of life will be analyzed using the Finkelstein-Schoenfeld method. The method combines these three endpoints in a hierarchical fashion using ACM first, HRHR second, and change in HRQOL third. The method pairs every participant receiving the diet intervention with every participant not receiving the diet intervention within each stratum. Within each pairing, a +1 is assigned to the "better" participant, -1 to the "worse" participant, and 0 if they are "tied". The comparison begins with ACM. Tied pairings are then compared using HFHR. Any remaining tied pairings are compared using change in HRQOL. A 'Win' represents a participant doing better within each pairing (receiving +1) based on the hierarchical comparison. The reported unit is the total "wins" for each intervention group from performing such a hierarchical comparison across all strata.
Hierarchical Combination ("Win Ratio") of Time to All-cause Mortality, Time to Heart Failure Hospital Readmission, and Decline in Health-related Quality of Life (HRQOL) [ Time Frame: Baseline up to Week 12 ]
Time frame: 12 weeks
Time to all-cause mortality (ACM), time to heart failure hospital readmission (HFHR), and decline in quality of life will be analyzed using the Finkelstein-Schoenfeld method. The method combines these three endpoints in a hierarchical fashion using ACM first, HRHR second, and change in HRQOL third. The method pairs every participant receiving the clinical worsening intervention with every participant not receiving the clinical worsening intervention within each stratum. Within each pairing, a +1 is assigned to the "better" participant, -1 to the "worse" participant, and 0 if they are "tied". The comparison begins with ACM. Tied pairings are then compared using HFHR. Any remaining tied pairings are compared using change in HRQOL. A 'Win' represents a participant doing better within each pairing (receiving +1) based on the hierarchical comparison. The reported unit is the total "wins" for each intervention group from performing such a hierarchical comparison across all strata.
3 secondary outcomes
All-Cause Mortality [ Time Frame: Baseline up to Week 12 ]
Time frame: 12 weeks
Heart Failure-related Hospitalizations [ Time Frame: Baseline up to Week 12 ]
Time frame: 12 weeks
Change From Baseline in Health-related Quality of Life [ Time Frame: Baseline up to Week 12 ]
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42520258Dorsch MP, Ali MS, Krambrink A, Kolenic G, Ganai S, Arzac J, Zhang X, Greer KM, Shah AJ, Cowger JA, Ewald G, Rodgers JE, Dixon DL, Koelling TM, Hummel SL. The ManageHF Just-in-Time Adaptive Mobile App Interventions to Promote Self-Management and Improve Outcomes in Heart Failure: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2026 Jul 28;14:e74121. doi: 10.2196/74121.
- Individual participant dataSharing planned: Yes. The aim is to prepare data for deposit into the National Institute on Aging supported National Archive of Computerized Data on Aging data repository. The de-identified analytic data will be prepared as SAS transport files or ASCII comma-delimited files with accompanying codebooks that describe the data and data structure. The redaction will employ best practices and will be consistent with National Institute on Aging data sharing policies.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
Michael Dorsch, PharmD principal investigator
University of Michigan
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sodium intervention, Clinical worsening intervention and Educational content in people with Heart Failure, run by University of Michigan at 9 sites 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 9 inclusion and 12 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: stopped early, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). 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?
Hierarchical Combination ("Win Ratio") of Time to All-cause Mortality, Time to Heart Failure Hospital Readmission, and Decline in Health-related Quality of Life (HRQOL) [ Time Frame: Baseline up to Week 12 ] (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 NCT04755816, 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 17 Sep 2026.