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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02935439
• Other study ID #: 20091057
• Secondary ID: 09KC-01
• Status: Completed
• Phase: N/A
• First received: October 13, 2016
• Last updated: October 13, 2016
• Start date: February 2011
• Est. completion date: December 2011

Study information

• Verified date: October 2016
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Cell Phone
Participants responded to questions about their heart failure symptoms using a cell phone.

Locations

Country	Name	City	State
United States	Miami VA Healthcare System	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	James and Esther King Biomedical Research Program

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No