Heart FailureNCT02935439
A Novel Fully Integrated Mobile Management Solution Using Cell Phone Technology for Heart Failure
A study testing Cell Phone in people with Heart Failure, run by University of Miami at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Cell Phone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Previous history of unstable coronary syndromes
- History of end-stage heart failure or heart transplantation
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Heart Failure
- Being tested
- Cell Phone
- Keywords
- Mobile Phone, Self-efficacy, Quality of Life, Knowledge, Feasibility
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cell PhoneOther
Participants responded to questions about their heart failure symptoms using a cell phone.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startFeb 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- James and Esther King Biomedical Research Program
- Responsible party
- Principal investigator, Stuti Dang MD, University of Miami
- Investigators
- Stuti Dang, MD, MPH, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02935439
- Sponsor's protocol ID
- 20091057
- Other IDs
- 09KC-01
- Status last verified
- Oct 2016
- First submitted
- 13 Oct 2016
- Last updated
- 17 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Fully Integrated Mobile Management Solution Using Cell Phone Technology for Heart Failure
- ClinicalTrials.gov ID
- NCT02935439
- Acronym / sponsor ID
- 20091057
- Conditions
- Heart Failure
- Keywords
- Mobile Phone, Self-efficacy, Quality of Life, Knowledge, Feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- James and Esther King Biomedical Research Program
- Study start
- Feb 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 17 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cell-Phone Intervention Arm | Active comparator | Other: Cell PhoneA 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Previous history of unstable coronary syndromes
- History of end-stage heart failure or heart transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cell PhoneParticipants responded to questions about their heart failure symptoms using a cell phone. | Other | Cell-Phone Intervention Arm |
Primary outcome
Self-Efficacy for Managing Chronic Disease
Time frame: 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.
10 secondary outcomes
Health Distress Scale
Time frame: 90 days
Communication with Physicians
Time frame: 90 days
Fatigue Visual Numeric
Time frame: 90 days
Shortness of Breath Visual Numeric
Time frame: 90 days
Heart Failure Self-Efficacy Scale-30
Time frame: 90 days
European Heart Failure Self-Care Behavior Scale
Time frame: 90 days
Dutch Heart Failure Knowledge Scale
Time frame: 90 days
Minnesota Living with Heart Failure Questionnaire
Time frame: 90 days
The Medical Outcome Study 36-Item Short Form
Time frame: 90 days
Usability survey
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuti Dang, MD, MPH principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cell Phone in people with Heart Failure, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Efficacy for Managing Chronic Disease (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2016.