Diabetic Treatment Adherence
Treatment Adherence With Compliance Prompting Packaging
2 other identifiers
observational
28
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2011
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 16, 2011
CompletedFirst Posted
Study publicly available on registry
March 18, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedSeptember 12, 2016
September 1, 2016
5.4 years
March 16, 2011
September 9, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patients' Adherence to Unit Dose Packaging Devices
Taking information from the electronic monitor device packages, adherence considered as a ratio of prescribed doses to doses taken.
12 weeks
Study Arms (2)
Group 1: Unit-dose - Pill Bottle
Unit-dose (blister) packages used first week, followed second week by pill bottles usage.
Group 2: Pill Bottle - Unit Dose
Pill bottle usage the first week followed second week by Unit-dose (blister) packages.
Interventions
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).
Completion on Day 1 and after Month 3. Each questionnaire to take about 30 minutes to complete.
Eligibility Criteria
General Internal Medicine/Ambulatory Clinics at UT MD Anderson Cancer Center in Houston, Texas Kelsey-Seybold Outpatient Clinics in Houston, Texas
You may qualify if:
- Adults of 18 years or older.
- 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.
You may not qualify if:
- Dementia
- Patients receiving current intravenous chemotherapy
- Pregnancy
- Patients residing in a nursing home
- Treatment with any type of Insulin
- Patients wanting to continue to use pill organizers for monitored medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Kelsey Seybold Clinics
Houston, Texas, 77025, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
Biospecimen
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.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria Suarez-Almazor, MD,PHD
M.D. Anderson Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2011
First Posted
March 18, 2011
Study Start
March 1, 2011
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
September 12, 2016
Record last verified: 2016-09