NCT02935439

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Feb 2011

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2016

Completed
Last Updated

October 17, 2016

Status Verified

October 1, 2016

Enrollment Period

10 months

First QC Date

October 13, 2016

Last Update Submit

October 13, 2016

Conditions

Heart Failure

Keywords

Mobile PhoneSelf-efficacyQuality of LifeKnowledgeFeasibility

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Health Distress Scale

    90 days

  • Communication with Physicians

    90 days

  • Fatigue Visual Numeric

    90 days

  • Shortness of Breath Visual Numeric

    90 days

  • Heart Failure Self-Efficacy Scale-30

    90 days

  • +5 more secondary outcomes

Study Arms (2)

Cell-Phone Intervention Arm

ACTIVE COMPARATOR

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

Usual Care

NO INTERVENTION

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.

Interventions

Cell PhoneOTHER

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

Cell-Phone Intervention Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have a diagnosis of heart failure
  • Have an anticipated survival ≥ 6 months
  • Receive care at the University of Miami or Jackson Healthcare system
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Miami VA Healthcare System

Miami, Florida, 33125, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Stuti Dang, MD, MPH

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

October 13, 2016

First Posted

October 17, 2016

Study Start

February 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

October 17, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)