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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG062582-01A1 | U.S. NIH Grant/Contract | View source |
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Slow recruitment - DSMB decision
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group 'A' | Sham Comparator | Standard heart failure educational information. |
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| Dietary Sodium Intervention 'B' | Experimental | The dietary sodium intervention facilitates lower sodium choices using tailored push notifications. |
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| Clinical Worsening Intervention 'C' | Experimental | The clinical worsening intervention promotes self-monitoring and self-management and is linked tailored push notifications. |
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| Dietary Sodium and Clinical Worsening 'D' | Experimental | Full access to all content in the control, dietary sodium, and clinical worsening interventions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| All-Cause Mortality [ Time Frame: Baseline up to Week 12 ] | Time to all-cause mortality will be analyzed up to week 12. | 12 weeks |
| Heart Failure-related Hospitalizations [ Time Frame: Baseline up to Week 12 ] |
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Inclusion Criteria:
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
A valid email address
Fluent in spoken and written English
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Dorsch, PharmD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Stanford University |
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.
No later than 3 years after the end of the study or 2 years after the main paper reporting the results of the trial, whichever comes first.
Researchers at institutions with a Federal Wide Assurance will be able to gain access to repository data by submitting a data access request in accordance with applicable policies.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Standard heart failure educational information. Educational content: Standard heart failure educational information and a daily symptom survey. |
| FG001 | Dietary Sodium Intervention |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 27, 2022 | May 3, 2024 |
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| Clinical worsening intervention | Behavioral | 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. |
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| Educational content | Behavioral | Standard heart failure educational information and a daily symptom survey. |
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Time to first heart-failure related hospitalization will be analyzed up to week 12.
| 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. | 12 weeks |
| Stanford |
| California |
| 94305 |
| United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Atlanta VA Health Care System | Decatur | Georgia | 30033 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Henry Ford Hospital System | Detroit | Michigan | 48202 | United States |
| Washington University in St. Louis | St Louis | Missouri | 63130 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23284 | United States |
The dietary sodium intervention facilitates lower sodium choices using tailored push notifications.
Sodium intervention: The sodium dietary intervention provides uses location services to determine when a participant is at home, arrives at a grocery store or arrives at a restaurant. The user receives a tailored message to assist with making dietary choices based on sodium content.
| FG002 | Clinical Worsening Intervention | The clinical worsening intervention promotes self-monitoring and self-management and is linked tailored push notifications. Clinical worsening intervention: 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. |
| FG003 | Dietary Sodium and Clinical Worsening | Full access to all content in the control, dietary sodium, and clinical worsening interventions. Sodium intervention: The sodium dietary intervention provides uses location services to determine when a participant is at home, arrives at a grocery store or arrives at a restaurant. The user receives a tailored message to assist with making dietary choices based on sodium content. Clinical worsening intervention: 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Standard heart failure educational information. Educational content: Standard heart failure educational information and a daily symptom survey. |
| BG001 | Dietary Sodium Intervention | The dietary sodium intervention facilitates lower sodium choices using tailored push notifications. Sodium intervention: The sodium dietary intervention provides uses location services to determine when a participant is at home, arrives at a grocery store or arrives at a restaurant. The user receives a tailored message to assist with making dietary choices based on sodium content. |
| BG002 | Clinical Worsening Intervention | The clinical worsening intervention promotes self-monitoring and self-management and is linked tailored push notifications. Clinical worsening intervention: 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. |
| BG003 | Dietary Sodium and Clinical Worsening | Full access to all content in the control, dietary sodium, and clinical worsening interventions. Sodium intervention: The sodium dietary intervention provides uses location services to determine when a participant is at home, arrives at a grocery store or arrives at a restaurant. The user receives a tailored message to assist with making dietary choices based on sodium content. Clinical worsening intervention: 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Subjects randomized to the Dietary intervention only (n=20) + those randomized to both interventions (n=18) vs Subjects randomized to the Clinical Worsening intervention only (n=12) + those randomized to Neither intervention (n=12) | Posted | Number | Total number of wins | 12 weeks |
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| Primary | 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. | Subjects randomized to the Clinical Worsening intervention only (n=12) + those randomized to both interventions (n=18) vs Subjects randomized to the Dietary intervention only (n=20) + those randomized to Neither intervention (n=12) | Posted | Number | Total number of wins | 12 weeks |
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| Secondary | All-Cause Mortality [ Time Frame: Baseline up to Week 12 ] | Time to all-cause mortality will be analyzed up to week 12. | no deaths in the study and this outcome could not be assessed | Posted | 12 weeks |
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| Secondary | 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. | Subjects randomized to the Dietary intervention only (n=20) + those randomized to both interventions (n=18) vs Subjects randomized to the Clinical Worsening intervention only (n=12) + those randomized to Neither intervention (n=12) | Posted | Mean | Standard Deviation | Days since randomization | 12 weeks |
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| Secondary | 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. | Subjects randomized to the Dietary intervention only (n=20) + those randomized to both interventions (n=18) vs Subjects randomized to the Clinical Worsening intervention only (n=12) + those randomized to Neither intervention (n=12) | Posted | Mean | Standard Deviation | Points on MLHFQ scale | 12 weeks |
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| Secondary | 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. | Subjects randomized to the Clinical Worsening intervention only (n=12) + those randomized to both interventions (n=18) vs Subjects randomized to the Dietary intervention only (n=20) + those randomized to Neither intervention (n=12) | Posted | Mean | Standard Deviation | Days since randomization | 12 weeks |
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| Secondary | 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. | Subjects randomized to the Clinical Worsening intervention only (n=12) + those randomized to both interventions (n=18) vs Subjects randomized to the Dietary intervention only (n=20) + those randomized to Neither intervention (n=12) | Posted | Mean | Standard Deviation | Points on MLHFQ scale | 12 Weeks |
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The adverse event data were collected from September of 2021 to June of 2022, so a total of 9 months. Each participants was assessed for AEs for the follow-up period of 12 weeks from baseline.
The number of participants at risk for All-Cause Mortality is zero because there were no deaths reported in the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Standard heart failure educational information. Educational content: Standard heart failure educational information and a daily symptom survey. | 0 | 12 | 5 | 12 | 3 | 12 |
| EG001 | Dietary Sodium Intervention | The dietary sodium intervention facilitates lower sodium choices using tailored push notifications. Sodium intervention: The sodium dietary intervention provides uses location services to determine when a participant is at home, arrives at a grocery store or arrives at a restaurant. The user receives a tailored message to assist with making dietary choices based on sodium content. | 0 | 20 | 9 | 20 | 4 | 20 |
| EG002 | Clinical Worsening Intervention | The clinical worsening intervention promotes self-monitoring and self-management and is linked tailored push notifications. Clinical worsening intervention: 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. | 0 | 12 | 4 | 12 | 3 | 12 |
| EG003 | Dietary Sodium and Clinical Worsening | Full access to all content in the control, dietary sodium, and clinical worsening interventions. Sodium intervention: The sodium dietary intervention provides uses location services to determine when a participant is at home, arrives at a grocery store or arrives at a restaurant. The user receives a tailored message to assist with making dietary choices based on sodium content. Clinical worsening intervention: 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. | 0 | 18 | 6 | 18 | 2 | 18 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inpatient hospitalization or prolongation of existing hospitalization | Blood and lymphatic system disorders | Systematic Assessment | SAE were not monitored with regard to specific adverse event terms |
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| Inpatient hospitalization or prolongation of existing hospitalization | Cardiac disorders | Systematic Assessment | SAE were not monitored with regard to specific adverse event terms |
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| Inpatient hospitalization or prolongation of existing hospitalization | Endocrine disorders | Systematic Assessment | SAE were not monitored with regard to specific adverse event terms |
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| Inpatient hospitalization or prolongation of existing hospitalization | Gastrointestinal disorders | Systematic Assessment | SAE were not monitored with regard to specific adverse event terms |
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| Inpatient hospitalization or prolongation of existing hospitalization | Infections and infestations | Systematic Assessment | SAE were not monitored with regard to specific adverse event terms |
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| Inpatient hospitalization or prolongation of existing hospitalization | Injury, poisoning and procedural complications | Systematic Assessment | SAE were not monitored with regard to specific adverse event terms |
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| Inpatient hospitalization or prolongation of existing hospitalization | Musculoskeletal and connective tissue disorders | Systematic Assessment | SAE were not monitored with regard to specific adverse event terms |
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| Inpatient hospitalization or prolongation of existing hospitalization | Investigations | Systematic Assessment | As other. SAE were not monitored with regard to specific adverse event terms |
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| Inpatient hospitalization or prolongation of existing hospitalization | Psychiatric disorders | Systematic Assessment | SAE were not monitored with regard to specific adverse event terms |
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| Inpatient hospitalization or prolongation of existing hospitalization | Renal and urinary disorders | Systematic Assessment | SAE were not monitored with regard to specific adverse event terms |
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| Inpatient hospitalization or prolongation of existing hospitalization | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | SAE were not monitored with regard to specific adverse event terms |
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| Life Threatening | Cardiac disorders | Systematic Assessment | SAE were not monitored with regard to specific adverse event terms |
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| Other | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | SAE were not monitored with regard to specific adverse event terms |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperkalemia (Potassium > 6.0 meq/dl or requiring change in therapy) | Renal and urinary disorders | Systematic Assessment |
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| Symptomatic bradycardia | Cardiac disorders | Systematic Assessment |
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| Symptomatic hypotension | Blood and lymphatic system disorders | Systematic Assessment |
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| Worsening renal function (increase in creatinine by 0.5 mg/dl from last visit or requiring change in | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. MICHAEL DORSCH | University of Michigan College of Pharmacy | 734/647-1452 | mdorsch@umich.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 23, 2023 | May 3, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 23, 2022 | May 3, 2024 | ICF_002.pdf |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Change in MLHFQ from Baseline to 12 Weeks |
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| Overall (across 3 outcomes) |
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| OG001 | No Clinical Worsening Intervention | Access to all content in the control, and dietary sodium. This includes group A and B. Educational content: Standard heart failure educational information and a daily symptom survey. Sodium intervention: The sodium dietary intervention provides uses location services to determine when a participant is at home, arrives at a grocery store or arrives at a restaurant. The user receives a tailored message to assist with making dietary choices based on sodium content. |
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| OG003 | Dietary Sodium and Clinical Worsening | Full access to all content in the control, dietary sodium, and clinical worsening interventions. Sodium intervention: The sodium dietary intervention provides uses location services to determine when a participant is at home, arrives at a grocery store or arrives at a restaurant. The user receives a tailored message to assist with making dietary choices based on sodium content. Clinical worsening intervention: 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. |
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