Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Medication Adherence With Polyglot Meducation

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Durham VA Medical Center
ClinicalTrials.gov Identifier:
NCT01744392
First received: December 5, 2012
Last updated: May 6, 2014
Last verified: February 2013
  Purpose

The investigators propose a 6 month pre-post, pilot,feasibility study with up to 25 individuals among veterans with cardiovascular disease risk factors including Hypertension (HT), Diabetes Mellitis (DM) and Hyperlipidemia (HL) who receive care from the hospital-based primary care clinics associated with Durham VAMC. The investigators will examine veteran's perception and ease of using an innovative tool to help improve medication adherence to cardiovascular medications. This study aims to focus on patients with multiple chronic conditions and their caregivers to address 1) appropriate use of medications 2)maximize patient self-care and care by families and other caregivers 3) make available a tool for medication management 4) managing complex regimens, and 5) addressing health literacy.


Condition Intervention
Hypertension
Diabetes
Hypercholesterolemia
Behavioral: education intervention

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Evaluate Changes in Medication Adherence and Patient Perspective of Polyglot Systems, Inc's Meducation Technology

Resource links provided by NLM:


Further study details as provided by Durham VA Medical Center:

Primary Outcome Measures:
  • medication adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The primary outcome will be change in self reported medication adherence and pill refill adherence.


Estimated Enrollment: 25
Study Start Date: February 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: education intervention
The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.
Behavioral: education intervention
Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Enrolled in one of three DVAMC Primary Care Clinics affiliated with the hospital for at least one year;
  • At least one visit to a primary care provider (PCP) at Durham VAMC associated primary care clinics in the previous 12 months;
  • Outpatient diagnostic code for hypertension (> 140/90), diabetes and/or hypercholesterolemia
  • Prescription for metoprolol tartrate (twice a day beta blocker, most common 2 day medication prescribed in the VA)
  • Baseline Medication Possession Ratio (MPR) of < 80% indicating medication non adherence
  • More than 9 active medications.

Exclusion Criteria:

  • diagnosed with metastatic cancer,
  • diagnosed with dementia documented in medical record,
  • active diagnosis of psychosis documented in medical record with admission with last 30 days
  • participating in another clinical trial,
  • not currently receiving care at the Durham VAMC
  • resident of a nursing home,
  • hard time seeing type/printing on books, magazines articles, etc.
  • hard time hearing or speaking on the telephone
  • limited/no access to telephone
  • currently a patient in the primary care pharmacist medication management clinic at Durham VAMC
  • plans to move medical care from DVAMC in next 12 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01744392

Locations
United States, North Carolina
Durham VA Medical Center
Durham, North Carolina, United States, 27701
Sponsors and Collaborators
Durham VA Medical Center
Investigators
Principal Investigator: Hayden B Bosworth, PhD Durham VA Medical Center
  More Information

No publications provided

Responsible Party: Durham VA Medical Center
ClinicalTrials.gov Identifier: NCT01744392     History of Changes
Other Study ID Numbers: 01658
Study First Received: December 5, 2012
Last Updated: May 6, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Hypercholesterolemia
Hypertension
Cardiovascular Diseases
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014