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The Effects of Self-monitoring With a Mobile Application in Heart Failure

Primary Purpose

Heart Failure

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Mobile Application

About this trial

This is an interventional other trial for Heart Failure focused on measuring mobile application, mHealth

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

45 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

Exclusion Criteria:

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

Sites / Locations

University of Michigan
University of Michigan Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mobile Application

Control Group

Arm Description

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

Participants will receive standard of care.

Outcomes

Primary Outcome Measures

Minnesota Living with Heart Failure Questionnaire (MLHFQ)

MLHFQ is a quality of life questionnaire for heart failure.

Secondary Outcome Measures

Self-Care Heart Failure Index (SCHFI)

SCHFI is a survey of heart failure patient self-management.

Hospitalizations

Admission to the hospital while enrolled in the trial.

Mortality

Death while enrolled in the trial.

Full Information

NCT ID

NCT03149510

First Posted

April 20, 2017

Last Updated

April 1, 2020

Sponsor

University of Michigan

1. Study Identification

Unique Protocol Identification Number

NCT03149510

Brief Title

The Effects of Self-monitoring With a Mobile Application in Heart Failure

Official Title

A Patient-centered Mobile Intervention to Promote Self-management and Improve Patient Outcomes in Chronic Heart Failure

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

March 6, 2017 (Actual)

Primary Completion Date

April 30, 2019 (Actual)

Study Completion Date

April 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

HF patients with a reduced ejection fraction will be randomized to the mobile application versus placebo for 12 weeks. The mobile application will provide the participants with a reminder to perform self-monitoring, a health status indicator and heart failure education for self-management. All participants will complete the Minnesota Living with Heart Failure Questionnaire and Self-Care Heart Failure Index. Hospital admissions and mortality will also be collected.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

Keywords

mobile application, mHealth

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

83 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mobile Application

Arm Type

Experimental

Arm Description

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

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

Participants will receive standard of care.

Intervention Type

Behavioral

Intervention Name(s)

Mobile Application

Intervention Description

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

Primary Outcome Measure Information:

Title

Minnesota Living with Heart Failure Questionnaire (MLHFQ)

Description

MLHFQ is a quality of life questionnaire for heart failure.

Time Frame

Change from Baseline MLHFQ at Week 12

Secondary Outcome Measure Information:

Title

Self-Care Heart Failure Index (SCHFI)

Description

SCHFI is a survey of heart failure patient self-management.

Time Frame

Change from Baseline SCHFI at Week 12

Title

Hospitalizations

Description

Admission to the hospital while enrolled in the trial.

Time Frame

Over 12 weeks

Title

Mortality

Description

Death while enrolled in the trial.

Time Frame

Over 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 45 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Todd M Koelling, MD

Organizational Affiliation

University of Michigan Heart Failure Program

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109-2054

Country

United States

Facility Name

University of Michigan Health System

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25654615

Citation

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.

Results Reference

background

PubMed Identifier

25379983

Citation

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.

Results Reference

background

PubMed Identifier

34878990

Citation

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.

Results Reference

derived

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The Effects of Self-monitoring With a Mobile Application in Heart Failure

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