Diabetic Treatment Adherence

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01318564
First received: March 16, 2011
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

The goal of this clinical research study is to test an investigational type of packaging for diabetes drugs called "unit-dose packaging." Researchers want to learn if unit-dose packaging can help patients with Type II diabetes to take their drugs on the proper schedule.


Condition Intervention
Endocrine System Diseases
Drug: Metformin
Behavioral: Questionnaires

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment Adherence With Compliance Prompting Packaging

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Patients' Adherence to Unit Dose Packaging Devices [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Taking information from the electronic monitor device packages, adherence considered as a ratio of prescribed doses to doses taken.


Biospecimen Retention:   Samples With DNA

A fasting blood sample of 10 ml will be collected 2 days after randomization if the physician considers the test as a standard of care.


Estimated Enrollment: 120
Study Start Date: March 2011
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1: Unit-dose - Pill Bottle
Unit-dose (blister) packages used first week, followed second week by pill bottles usage.
Drug: Metformin
500 - 1000 mg by mouth twice a day with either via a MEMS device pill bottle (medication event monitoring system) or by unit-dosing (blister packaging) with attached Med-ic device (electronic compliance monitoring for blistered medication).
Behavioral: Questionnaires
Completion on Day 1 and after Month 3. Each questionnaire to take about 30 minutes to complete.
Other Name: Surveys
Group 2: Pill Bottle - Unit Dose
Pill bottle usage the first week followed second week by Unit-dose (blister) packages.
Drug: Metformin
500 - 1000 mg by mouth twice a day with either via a MEMS device pill bottle (medication event monitoring system) or by unit-dosing (blister packaging) with attached Med-ic device (electronic compliance monitoring for blistered medication).
Behavioral: Questionnaires
Completion on Day 1 and after Month 3. Each questionnaire to take about 30 minutes to complete.
Other Name: Surveys

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

General Internal Medicine/Ambulatory Clinics at UT MD Anderson Cancer Center in Houston, Texas Kelsey-Seybold Outpatient Clinics in Houston, Texas

Criteria

Inclusion Criteria:

  1. Adults of 18 years or older.
  2. Patients with type II Diabetes taking or eligible to start metformin with at least another medication for hypertension (Lisinopril or Enalapril), hyperlipidemia (atorvastatin or simvastatin) and/or aspirin.

Exclusion Criteria:

  1. Dementia
  2. Patients receiving current intravenous chemotherapy
  3. Pregnancy
  4. Patients residing in a nursing home
  5. Treatment with any type of Insulin
  6. Patients wanting to continue to use pill organizers for monitored medications
  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: NCT01318564

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Maria Suarez-Almazor, MD,PHD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01318564     History of Changes
Other Study ID Numbers: 2008-0242
Study First Received: March 16, 2011
Last Updated: January 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Type II Diabetes
Unit dose packaging devices
Metformin
Lisinopril
Enalapril
Atorvastatin
Lipitor
Simvastatin
Aspirin
Questionnaires

Additional relevant MeSH terms:
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014