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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Other: Cell Phone

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33125
      • Miami VA Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: Cell Phone; Participants responded to questions about their heart failure symptoms using a cell phone.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Efficacy for Managing Chronic Disease	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.	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Distress Scale	This was used from the Chronic disease self-management program scales. (http://patienteducation.stanford.edu/research). Measures the distress associated with health problems over the last month. Using a Likert scale with item scores ranging from 0 to 5, scale score is the mean of the four items.	90 days
Communication with Physicians	This was used from the Chronic disease self-management program scales. (http://patienteducation.stanford.edu/research). Measures key behaviors to assess how well patients communicate with their healthcare providers. Using a Likert scale with item scores ranging from 0 to 5, scale score is the mean of the three items.	90 days
Fatigue Visual Numeric	This was used from the Chronic disease self-management program scales. (http://patienteducation.stanford.edu/research). Assesses self-reported fatigue in the past 2 weeks. This visual numeric scale is a modified version of the visual analog scale. It uses 10 bars of different heights and shading intensity.	90 days
Shortness of Breath Visual Numeric	This was used from the Chronic disease self-management program scales. (http://patienteducation.stanford.edu/research). Assesses self-reported shortness of breath in the past 2 weeks.	90 days
Heart Failure Self-Efficacy Scale-30	30-item scale developed for self-efficacy with heart failure overall and with medications, diet, symptoms, activity, and heart failure readmission. Using a Likert scale with item scores ranging from 0 to 10, scale score is the mean of the items.	90 days
European Heart Failure Self-Care Behavior Scale	12-item questionnaire assesses self-care behavior of patients with heart failure. Using a Likert scale with item scores ranging from 1 to 5, scale score is the sum of responses.	90 days
Dutch Heart Failure Knowledge Scale	15-item questionnaire assesses heart failure knowledge in general, knowledge on heart failure treatment (including diet and fluid restriction) and heart failure symptoms and symptom recognition. Each correct answer gets one point and total score ranges from 0 to 15.	90 days
Minnesota Living with Heart Failure Questionnaire	21-item questionnaire assesses HF specific quality of life, using a 6-point Likert scale with item scores ranging from 0 to 5, scale score is the sum of responses.	90 days
The Medical Outcome Study 36-Item Short Form	36-item quality of life instrument used to evaluate perception of general health status, functional ability, and well-being.	90 days
Usability survey	31-item scale developed for this study to assess the participants' satisfaction with 7 aspects of the intervention using a 7-point Likert scale with item scores ranging from 1 to 7 (7 being best), and total score is the mean of responses. Patients were also asked open-ended questions in order to obtain an in-depth understanding of individual experiences, perceptions, concerns and feedback.	90 days

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: James and Esther King Biomedical Research Program
• Investigators: Principal Investigator: Stuti Dang, MD, MPH, University of Miami

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: October 13, 2016
• First Submitted That Met QC Criteria: October 13, 2016
• First Posted (Estimate): October 17, 2016

Study Record Updates

• Last Update Posted (Estimate): October 17, 2016
• Last Update Submitted That Met QC Criteria: October 13, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Feasibility; Quality of Life; Self-efficacy; Mobile Phone; Knowledge
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 20091057; 09KC-01 (Other Grant/Funding Number: James and Esther King Biomedical Research Program)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No