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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02935439
Enrollment
61
Registered
2016-10-17
Start date
2011-02-28
Completion date
2011-12-31
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Mobile Phone, Self-efficacy, Quality of Life, Knowledge, Feasibility

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.

Interventions

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

Sponsors

James and Esther King Biomedical Research Program
CollaboratorOTHER
University of Miami
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Self-Efficacy for Managing Chronic Disease90 daysThis 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

MeasureTime frameDescription
Communication with Physicians90 daysThis 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.
Fatigue Visual Numeric90 daysThis 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.
Shortness of Breath Visual Numeric90 daysThis 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.
Heart Failure Self-Efficacy Scale-3090 days30-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.
Health Distress Scale90 daysThis 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.
Dutch Heart Failure Knowledge Scale90 days15-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.
Minnesota Living with Heart Failure Questionnaire90 days21-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.
The Medical Outcome Study 36-Item Short Form90 days36-item quality of life instrument used to evaluate perception of general health status, functional ability, and well-being.
Usability survey90 days31-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.
European Heart Failure Self-Care Behavior Scale90 days12-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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026