A Novel Fully Integrated Mobile Management Solution Using Cell Phone Technology for Heart Failure

NCT ID: NCT02935439

Last Updated: 2016-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-12-31

Brief Summary

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The purpose of this research study is to learn about the use of a cell phone for monitoring patients with heart failure. Participants will be asked questions about their heart failure daily and participants will need to answer them. The investigator will try to assess if the questions are easily understood by the participants. The investigator will also assess if the phone-based system for monitoring is easy to use by the participants. The investigator will also assess if the daily questions and interactions increase the self-efficacy, knowledge, and quality of life of participants related to their heart failure.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Cell-Phone Intervention Arm

A standard cell phone system sent web-browser messages daily to ask about their weight and symptoms of heart failure. Participants received up to 3 daily messages 15 minutes apart at a time of their choosing for 90 days. Participants were given a mobile phone for the 90 day period and a weight scale.

Group Type ACTIVE_COMPARATOR

Cell Phone

Intervention Type OTHER

Participants responded to questions about their heart failure symptoms using a cell phone.

Usual Care

Usual Care participants continued to receive care in the Heart Failure Clinic. All subjects were enrolled in the study for 90 days. Participants were given a weight scale.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cell Phone

Participants responded to questions about their heart failure symptoms using a cell phone.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Have a diagnosis of heart failure
* Have an anticipated survival ≥ 6 months
* Receive care at the University of Miami or Jackson Healthcare system
* 18 years or older
* Able to communicate in English and/or Spanish
* Able to operate a cell phone, read, understand, and respond to the questions on the cell phone, and are able to use the weight scale.

Exclusion Criteria

* Previous history of unstable coronary syndromes
* History of end-stage heart failure or heart transplantation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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James and Esther King Biomedical Research Program

OTHER

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Stuti Dang MD

Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stuti Dang, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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Miami VA Healthcare System

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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09KC-01

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

20091057

Identifier Type: -

Identifier Source: org_study_id

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