Heart FailureNCT01829152
Verizon Wireless - Sarasota Memorial Hospital Converged Health Management (CHM) For Heart Failure
A study testing CHM in people with Heart Failure, run by Verizon Wireless at 1 site in United States.
Trial summary
The primary objective is to evaluate the impact on heart failure related quality of life when integrating a mobile health system, Verizon Wireless's Converged Health Management (CHM), into a subject's self-management of their heart failure (HF) as well as in the medical management of HF by the subjects' clinical team. 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?
- CHM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Oct 2014
- 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
- Adult (≥ 18 years of age)
- A least 1 prior hospitalization within the past 12 months for HF based upon the presence of at least 1 symptom (dyspnea, orthopnea, or edema) AND at least 1 sign (rales, peripheral edema, ascites, or pulmonary vascular congestion on chest radiography)AND treatment with a loop diuretic during the hospital stay OR Symptoms of New York Hospital Association (NYHA) Class 2+ symptoms: dyspnea, fatigue, or chest pain with normal physical activity (class II), less than ordinary activity (class III) or at rest (class IV).
- Information may be provided by subject self-report obtained during the initial screening process and/or by medical record confirmation. Compliance with all eligibility criteria will be confirmed at the initial study visit before subject is presented with the ICF.
- Receiving care at the SMH HF Clinic and assessed by the clinic at least twice. (Those who were seen in person on their first visit and then followed-up by telephone thereafter will be considered eligible).
- Able to provide contact information for someone who agrees to provide information about the subject if the subject is not available to do so.
- Capability of understanding and willingness to comply with the protocol and study requirements, assessed according to the Principal Investigator's judgment.
- Ability to understand and willingness to sign a written informed consent document, assessed according to the Principal Investigator's judgment.
Who cannot join
- Decline to participate in the study
- Reside in an area with limited to no Verizon Wireless coverage as determined by VZ using the VZ zip code coverage analysis technology.
- Scheduled procedure for left ventricular device implantation, or listed for potential cardiac transplant
- Current resident of a long-term care or skilled nursing facility
- Currently receiving palliative or hospice care
- Human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) based on past medical history or subject self-report
Show all 14Show fewer
- Dialysis-dependent, end-stage renal disease
- A concurrent physical condition (including rare or chronic diseases such as sickle cell anemia or cystic fibrosis) or mental health condition (including dementia, schizophrenia, or other mental illness) that in the view of the Principal Investigator would compromise the subject's ability to fulfill the protocol requirements or affect the subject's safety during the study
- Are unable or unwilling to comply with the study requirements as instructed including coming to the SMH HF clinic for the 2 study visits.
- For subjects in the Intervention Group that are:
- Unable or unwilling to return to the SMH clinic to receive their training, devices and study material after signing the informed consent form and being randomized into the Intervention Group;
- Unable or unwilling to use the biometric devices and CHM at least one time per day.
- Are pregnant or planning to become pregnant during the study.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Sarasota Memorial Hospital Heart Failure Clinic
Sarasota, Florida, 34239
About this study
The primary objective is to evaluate the impact on heart failure related quality of life when integrating a mobile health system, Verizon Wireless's Converged Health Management (CHM), into a subject's self-management of their heart failure (HF) as well as in the medical management of HF by the subjects' clinical team.
- Conditions
- Heart Failure
- Being tested
- CHM
- Keywords
- heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHMDevice
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Subjects in the Control Group will receive Heart Failure care as routinely delivered by the SMH HF clinicians according to their standards of care. |
| CHM Intervention Group | Experimental | The Intervention Group subjects will receive Converged Health Management (CHM) in addition to continuing to receive care as routinely delivered by the SMH HF clinicians. Receives: Device: CHM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life, as measured by subject response to the Minnesota Living with Heart Failure Questionnaire (MLWHF).
Measured: 6 months
Secondary outcomes (1)
To assess the impact of the CHM intervention on the subjects' medication adherence as gathered from the Morisky Medication Adherence questionnaire.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startDec 2013
- Primary completionSep 2014 (estimated)
- Study completionOct 2014 (estimated)
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.
- 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
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Verizon Wireless
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kirk Voelker, MD, Principal investigator, Sarasota Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01829152
- Sponsor's protocol ID
- SARHF-0319
- Status last verified
- Jul 2014
- First submitted
- 8 Apr 2013
- Last updated
- 28 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verizon Wireless - Sarasota Memorial Hospital Converged Health Management (CHM) For Heart Failure
- ClinicalTrials.gov ID
- NCT01829152
- Acronym / sponsor ID
- SARHF-0319
- Conditions
- Heart Failure
- Keywords
- heart failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Verizon WirelessIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 11 Apr 2013 (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 primary objective is to evaluate the impact on heart failure related quality of life when integrating a mobile health system, Verizon Wireless's Converged Health Management (CHM), into a subject's self-management of their heart failure (HF) as well as in the medical management of HF by the subjects' clinical team.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Subjects in the Control Group will receive Heart Failure care as routinely delivered by the SMH HF clinicians according to their standards of care. |
| CHM Intervention Group | Experimental | Device: CHMThe Intervention Group subjects will receive Converged Health Management (CHM) in addition to continuing to receive care as routinely delivered by the SMH HF clinicians. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult (≥ 18 years of age)
- A least 1 prior hospitalization within the past 12 months for HF based upon the presence of at least 1 symptom (dyspnea, orthopnea, or edema) AND at least 1 sign (rales, peripheral edema, ascites, or pulmonary vascular congestion on chest radiography)AND treatment with a loop diuretic during the hospital stay OR Symptoms of New York Hospital Association (NYHA) Class 2+ symptoms: dyspnea, fatigue, or chest pain with normal physical activity (class II), less than ordinary activity (class III) or at rest (class IV).
- Information may be provided by subject self-report obtained during the initial screening process and/or by medical record confirmation. Compliance with all eligibility criteria will be confirmed at the initial study visit before subject is presented with the ICF.
- Receiving care at the SMH HF Clinic and assessed by the clinic at least twice. (Those who were seen in person on their first visit and then followed-up by telephone thereafter will be considered eligible).
- Able to provide contact information for someone who agrees to provide information about the subject if the subject is not available to do so.
Key exclusion criteria (14 listed)
- Decline to participate in the study
- Reside in an area with limited to no Verizon Wireless coverage as determined by VZ using the VZ zip code coverage analysis technology.
- Scheduled procedure for left ventricular device implantation, or listed for potential cardiac transplant
- Current resident of a long-term care or skilled nursing facility
- Currently receiving palliative or hospice care
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 |
|---|---|---|
| CHM | Device | CHM Intervention Group |
Primary outcome
Quality of life, as measured by subject response to the Minnesota Living with Heart Failure Questionnaire (MLWHF).
Time frame: 6 months
1 secondary outcome
To assess the impact of the CHM intervention on the subjects' medication adherence as gathered from the Morisky Medication Adherence questionnaire.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2014.
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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.
Kirk Voelker, MD principal investigator
Sarasota Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHM in people with Heart Failure, run by Verizon Wireless 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 7 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 28 Jul 2014. 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?
Results are not available in the source record.
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?
Quality of life, as measured by subject response to the Minnesota Living with Heart Failure Questionnaire (MLWHF). (time frame: 6 months). 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 28 Jul 2014.