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Clinical worsening intervention for Heart Failure

Phase 3
Waitlist Available
Led By Michael Dorsch, PharmD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial will test two different ways of using a mobile app to help heart failure patients.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 ]
Secondary outcome measures
All-Cause Mortality [ Time Frame: Baseline up to Week 12 ]
Change from baseline in health-related quality of life [ Time Frame: Baseline, Week 12 ]
Heart failure-related hospitalizations [ Time Frame: Baseline to Week 12 ]

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Dietary Sodium and Clinical WorseningExperimental Treatment2 Interventions
Full access to all content in the control, dietary sodium, and clinical worsening interventions.
Group II: Dietary Sodium InterventionExperimental Treatment1 Intervention
The dietary sodium intervention facilitates lower sodium choices using tailored push notifications.
Group III: Clinical Worsening InterventionExperimental Treatment1 Intervention
The clinical worsening intervention promotes self-monitoring and self-management and is linked tailored push notifications.
Group IV: Control GroupPlacebo Group1 Intervention
Standard heart failure educational information.

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,653 Previous Clinical Trials
28,004,913 Total Patients Enrolled
41 Trials studying Heart Failure
213,203 Patients Enrolled for Heart Failure
University of MichiganLead Sponsor
1,780 Previous Clinical Trials
6,364,473 Total Patients Enrolled
24 Trials studying Heart Failure
12,024 Patients Enrolled for Heart Failure
Michael Dorsch, PharmDPrincipal Investigator - University of Michigan
University of Michigan

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many test subjects are required for this research?

"That is right, the online information indicates that this study is looking for 500 individuals to participate and it has 9 different locations. The original posting was on 6/14/2021 with the most recent update on 3/21/2022."

Answered by AI

Where are patients able to take part in this trial?

"Currently, this study is operational at 9 sites. They are situated in Atlanta, Saint Louis and Detroit along with 6 other cities. If you choose to participate in this trial, try and select the location that is closest to you to reduce travel time."

Answered by AI

Has the FDA given their blessing to this Clinical worsening intervention?

"There is existing clinical data that supports the efficacy of this intervention, and thus it has been given a safety score of 3."

Answered by AI

Are there any available positions for patients who want to enroll in this clinical trial?

"That is correct. The clinicaltrials.gov website indicates that this trial is still actively looking for participants. This research was originally posted on June 14th, 2021 and was most recently updated on March 21st, 2022. Currently, they are trying to enroll 500 patients from 9 different locations."

Answered by AI

Who else is applying?

What state do they live in?
Missouri
How old are they?
65+
What site did they apply to?
Washington University in St. Louis
What portion of applicants met pre-screening criteria?
Met criteria
~17 spots leftby Mar 2025