A Mobile Application to Promote Self-management and Improve Outcomes in Heart Failure

NCT04755816 | Terminated Phase 3 Results DMC

• 2 other identifiers: HUM00181316R01AG062582-01A1
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• All-Cause Mortality [ Time Frame: Baseline up to Week 12 ]

  12 weeks

• Heart Failure-related Hospitalizations [ Time Frame: Baseline up to Week 12 ]

  12 weeks

• Change From Baseline in Health-related Quality of Life [ Time Frame: Baseline up to Week 12 ]

  12 weeks

Study Arms (4)

Control Group 'A'

SHAM COMPARATOR

Standard heart failure educational information.

Behavioral: Educational content

Dietary Sodium Intervention 'B'

EXPERIMENTAL

The dietary sodium intervention facilitates lower sodium choices using tailored push notifications.

Behavioral: Sodium intervention

Clinical Worsening Intervention 'C'

EXPERIMENTAL

The clinical worsening intervention promotes self-monitoring and self-management and is linked tailored push notifications.

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.

Behavioral: Sodium intervention; Behavioral: Clinical worsening intervention

Interventions

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.

Dietary Sodium Intervention 'B'; Dietary Sodium and Clinical Worsening 'D'

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.

Clinical Worsening Intervention 'C'; Dietary Sodium and Clinical Worsening 'D'

Educational content BEHAVIORAL

Standard heart failure educational information and a daily symptom survey.

Control Group 'A'

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of Michigan: lead
• National Institute on Aging (NIA): collaborator

Study Sites (9)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Atlanta VA Health Care System

Decatur, Georgia, 30033, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Hospital System

Detroit, Michigan, 48202, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63130, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. MICHAEL DORSCH
• Organization: University of Michigan College of Pharmacy

mdorsch@umich.edu

734/647-1452

Study Officials

• Michael Dorsch, PharmD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Pharmacy

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 16, 2021
• Study Start: June 14, 2021
• Primary Completion: May 8, 2023
• Study Completion: May 17, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 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.
• Access Criteria: 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.

Locations

US (9)