NCT03149510

Brief Summary

In the United States, about 40 percent of heart failure (HF) patients are readmitted within 1-year following their first admission for HF and hospitalization accounts for approximately 70 percent of the costs of HF management. As a result, the management of HF patients is evolving from the traditional model of face-to-face follow-up visits toward a proactive real-time technological model of assisting patients with monitoring and self-management while in the community. The investigators plan to test the impact of a mobile application on clinical outcomes in HF.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 6, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 11, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

April 2, 2020

Status Verified

April 1, 2020

Enrollment Period

2.2 years

First QC Date

April 20, 2017

Last Update Submit

April 1, 2020

Conditions

Heart Failure

Keywords

mobile applicationmHealth

Outcome Measures

Primary Outcomes (1)

  • Minnesota Living with Heart Failure Questionnaire (MLHFQ)

    MLHFQ is a quality of life questionnaire for heart failure.

    Change from Baseline MLHFQ at Week 12

Secondary Outcomes (3)

  • Self-Care Heart Failure Index (SCHFI)

    Change from Baseline SCHFI at Week 12

  • Hospitalizations

    Over 12 weeks

  • Mortality

    Over 12 weeks

Study Arms (2)

Mobile Application

EXPERIMENTAL

Participants will be using a mobile application, activity monitor and scale.

Behavioral: Mobile Application

Control Group

NO INTERVENTION

Participants will receive standard of care.

Interventions

Mobile ApplicationBEHAVIORAL

Participants will use the mobile application daily to assess heart failure symptoms.

Mobile Application

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old or older
  • Left ventricular ejection fraction \</= 40% or an LVEF \> 40% (with left atrial size \>40mm or BNP \> 200 pg/ml or NT-proBNP \> 800 pg/ml)
  • Admitted for acutely decompensated heart failure or recently discharged in the past 4 weeks.
  • Smartphone (iOS or Android) with home wifi

You may not qualify if:

  • Unstable coronary syndrome within 8 weeks (unstable angina, NSTEMI, STEMI)
  • Primary valvular heart disease
  • Known pericardial disease (Sarcoidosis, amyloidosis, rheumatoid arthritis, lupus)
  • Uncorrected thyroid disease
  • Advanced renal disease (dialysis or creatinine \>4.0 mg/dL)
  • End-stage HF (hospice candidate, home milrinone or dobutamine)
  • Active cancer
  • Pulmonary fibrosis
  • Discharge to a setting other than home

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48109-2054, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (3)

  • Dorsch MP, Farris KB, Bleske BE, Koelling TM. A web application for self-monitoring improves symptoms in chronic systolic heart failure. Telemed J E Health. 2015 Apr;21(4):267-70. doi: 10.1089/tmj.2014.0095. Epub 2015 Feb 5.

    PMID: 25654615BACKGROUND

  • Bleske BE, Dillman NO, Cornelius D, Ward JK, Burson SC, Diez HL, Pickworth KK, Bennett MS, Nicklas JM, Dorsch MP. Heart failure assessment at the community pharmacy level: a feasibility pilot study. J Am Pharm Assoc (2003). 2014 Nov-Dec;54(6):634-41. doi: 10.1331/JAPhA.2014.14039.

    PMID: 25379983BACKGROUND

  • Dorsch MP, Farris KB, Rowell BE, Hummel SL, Koelling TM. The Effects of the ManageHF4Life Mobile App on Patients With Chronic Heart Failure: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Dec 7;9(12):e26185. doi: 10.2196/26185.

    PMID: 34878990DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Todd M Koelling, MD

    University of Michigan Heart Failure Program

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Internal Medicine

Study Record Dates

First Submitted

April 20, 2017

First Posted

May 11, 2017

Study Start

March 6, 2017

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

April 2, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)