Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
28 participants
OBSERVATIONAL
2011-03-31
2016-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Enhancing Diabetes Management Approaches for Patients With Uncontrolled Diabetes
NCT05912647
The Medication Adherence Program
NCT00838344
Multi-arm Intervention Diabetes Adherence Study
NCT00754741
Impact of Accu-Chek 360 in Veterans With Type 2 Diabetes
NCT00824694
Improving Medication Adherence Among Underserved Patients With Type 2 Diabetes
NCT02409329
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Some people find it difficult to take drugs on the proper schedule. For this reason, researchers want to learn if a different kind of drug packaging can help patients take their drugs more easily.
In unit-dose packaging, each pill is packaged in its own plastic bubble (called a "blister") on a package that has a calendar on it. This is designed to make it easier to keep track of when the pills should be taken.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will keep taking the same drugs that you are taking now. You will also keep taking those drugs on the same schedule that your doctor prescribed. The specific "study drugs" you may be taking are metformin, lisinopril, enalapril, atorvastatin, simvastatin, and aspirin.
You will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. You have an equal chance of being assigned to either group.
Group 1 will receive their study drugs in unit-dose packages (also called "reminder blister packages") from Visit 1 to Visit 2.
Group 2 will receive their study drugs in pill bottles from Visit 1 to Visit 2.
Data Collection on Pill Usage:
There are electronic sensors on each blister package and pill bottle. If you are using blister packages (Group 1), the sensors will record the dates and times that you remove pills from the blisters. If you are using pill bottles (Group 2), the sensors will record the dates and times that you open the bottles.
It is important that you do not remove the pills too early before your dose (for example, the night before), so that the proper time is recorded.
You should return the empty blister packages or bottles to the clinic at each study visit. When you return the empty packaging, researchers will be able to collect the data that the sensors recorded (times and dates).
Study Visits:
On Day 1 and after Month 3, you will complete a questionnaire. It includes questions about your overall health, daily activities, and moods. There are also questions about how you take your drugs and how you feel about your diabetes drugs such as metformin. This questionnaire should take about 30-45 minutes to complete.
Researchers will record the results of your routine blood sugar level tests performed on Day 1 and after Month 3. Researchers will also record the results of your routine cholesterol level blood tests on Day 1 and after Month 3. The purpose is to learn how the drugs may impact your health status.
At each visit your blood pressure will be measured 3 times. This will take about 15 min. If your questionnaire responses show that you may be having emotional difficulties or depression, you will receive contact information for the counseling staff in case you would like to speak with a counselor.
Study Databases:
Your questionnaire and blood test data will be kept confidential and will only be used for this study. The same is true for the pill/package usage data recorded by the electronic sensors.
The study data will be entered into password-protected databases. In the databases, your name and other identifying information will not be used. Instead, your study identification (ID) number will be used.
Length of Study Participation:
Your study participation will be over after you complete the questionnaire after Month 3.
This is an investigational study. Unit-dose packaging is an FDA-approved type of packing for certain other drugs. At this time and for these particular drugs, unit-dose packaging is only being used in research.
Up to 120 patients will take part in this study.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1: Unit-dose - Pill Bottle
Unit-dose (blister) packages used first week, followed second week by pill bottles usage.
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).
Questionnaires
Completion on Day 1 and after Month 3. Each questionnaire to take about 30 minutes to complete.
Group 2: Pill Bottle - Unit Dose
Pill bottle usage the first week followed second week by Unit-dose (blister) packages.
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).
Questionnaires
Completion on Day 1 and after Month 3. Each questionnaire to take about 30 minutes to complete.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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).
Questionnaires
Completion on Day 1 and after Month 3. Each questionnaire to take about 30 minutes to complete.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Agency for Healthcare Research and Quality (AHRQ)
FED
M.D. Anderson Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Maria Suarez-Almazor, MD,PHD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kelsey Seybold Clinics
Houston, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
University of Texas MD Anderson Cancer Center Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2008-0242
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.