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Verizon Wireless - Sarasota Memorial Hospital Converged Health Management (CHM) For Heart Failure

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ClinicalTrials.gov Identifier: NCT01829152
Recruitment Status : Unknown
Verified July 2014 by Verizon Wireless.
Recruitment status was:  Active, not recruiting
First Posted : April 11, 2013
Last Update Posted : July 28, 2014
Sponsor:
Information provided by (Responsible Party):
Verizon Wireless

Tracking Information
First Submitted Date  ICMJE April 8, 2013
First Posted Date  ICMJE April 11, 2013
Last Update Posted Date July 28, 2014
Study Start Date  ICMJE December 2013
Estimated Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2013)
Quality of life, as measured by subject response to the Minnesota Living with Heart Failure Questionnaire (MLWHF). [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2013)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Verizon Wireless - Sarasota Memorial Hospital Converged Health Management (CHM) For Heart Failure
Official Title  ICMJE Verizon Wireless - Sarasota Memorial Hospital Converged Health Management (CHM) For Heart Failure
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Heart Failure
Intervention  ICMJE Device: CHM
Study Arms  ICMJE
  • No Intervention: Control
    Subjects in the Control Group will receive Heart Failure care as routinely delivered by the SMH HF clinicians according to their standards of care.
  • Experimental: CHM Intervention Group
    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.
    Intervention: Device: CHM
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 8, 2013)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2014
Estimated Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Adult (≥ 18 years of age)
  2. 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.

  3. 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).
  4. Able to provide contact information for someone who agrees to provide information about the subject if the subject is not available to do so.
  5. Capability of understanding and willingness to comply with the protocol and study requirements, assessed according to the Principal Investigator's judgment.
  6. Ability to understand and willingness to sign a written informed consent document, assessed according to the Principal Investigator's judgment.

Exclusion Criteria:

  1. Decline to participate in the study
  2. Reside in an area with limited to no Verizon Wireless coverage as determined by VZ using the VZ zip code coverage analysis technology.
  3. Scheduled procedure for left ventricular device implantation, or listed for potential cardiac transplant
  4. Current resident of a long-term care or skilled nursing facility
  5. Currently receiving palliative or hospice care
  6. Human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) based on past medical history or subject self-report
  7. Dialysis-dependent, end-stage renal disease
  8. 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
  9. Are unable or unwilling to comply with the study requirements as instructed including coming to the SMH HF clinic for the 2 study visits.
  10. For subjects in the Intervention Group that are:

    1. 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;
    2. Unable or unwilling to use the biometric devices and CHM at least one time per day.
  11. Are pregnant or planning to become pregnant during the study.

    -

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01829152
Other Study ID Numbers  ICMJE SARHF-0319
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Verizon Wireless
Study Sponsor  ICMJE Verizon Wireless
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kirk Voelker, MD Sarasota Memorial Hospital
PRS Account Verizon Wireless
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP