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Clinical Trials/NCT02935439
NCT02935439
Completed
Not Applicable

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

University of Miami1 site in 1 country61 target enrollmentFebruary 2011
ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
University of Miami
Enrollment
61
Locations
1
Primary Endpoint
Self-Efficacy for Managing Chronic Disease
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
February 2011
End Date
December 2011
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Stuti Dang MD

Clinical Associate Professor

University of Miami

Eligibility Criteria

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

Outcomes

Primary Outcomes

Self-Efficacy for Managing Chronic Disease

Time Frame: 90 days

This was used from the Chronic disease self-management program scales. (http://patienteducation.stanford.edu/research). Well-validated scale rating patient's confidence in managing chronic illness. It covers several areas of chronic diseases including symptom control, role functions, emotional functioning, and communicating with physicians. The English version has 6-items, while the Spanish version has 4-items.16 Using a Likert scale with item scores ranging from 1 to 10; scale score is the mean of the items.

Secondary Outcomes

  • European Heart Failure Self-Care Behavior Scale(90 days)
  • Minnesota Living with Heart Failure Questionnaire(90 days)
  • Health Distress Scale(90 days)
  • Communication with Physicians(90 days)
  • Shortness of Breath Visual Numeric(90 days)
  • Dutch Heart Failure Knowledge Scale(90 days)
  • The Medical Outcome Study 36-Item Short Form(90 days)
  • Fatigue Visual Numeric(90 days)
  • Heart Failure Self-Efficacy Scale-30(90 days)
  • Usability survey(90 days)

Study Sites (1)

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