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

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Other: Cell Phone

• Registration Number: NCT02935439
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2016-10
• Study First Submitted: 2016-10-13
• Study First Submitted QC: 2016-10-13
• Last Update Submitted: 2016-10-13
• Study First Posted: 2016-10-17
• Last Update Posted: 2016-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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.

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Exclusion Criteria

• Previous history of unstable coronary syndromes
• History of end-stage heart failure or heart transplantation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cell-Phone Intervention Arm	Cell Phone	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.

Primary Outcome Measures

Name	Time	Method
Self-Efficacy for Managing Chronic Disease	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 Outcome Measures

Name	Time	Method
European Heart Failure Self-Care Behavior Scale	90 days	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.
Minnesota Living with Heart Failure Questionnaire	90 days	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.
Health Distress Scale	90 days	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.
Communication with Physicians	90 days	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.
Shortness of Breath Visual Numeric	90 days	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.
Dutch Heart Failure Knowledge Scale	90 days	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.
Fatigue Visual Numeric	90 days	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.
Heart Failure Self-Efficacy Scale-30	90 days	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.
The Medical Outcome Study 36-Item Short Form	90 days	36-item quality of life instrument used to evaluate perception of general health status, functional ability, and well-being.
Usability survey	90 days	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.

Trial Locations

Locations (1)

Miami VA Healthcare System; 🇺🇸 Miami, Florida, United States