Diabetic Treatment Adherence

Endocrine System Diseases Clinical Trial

Official title:

Treatment Adherence With Compliance Prompting Packaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01318564
• Other study ID #: 2008-0242
• Secondary ID: U18HS016093
• Status: Completed
• Phase: N/A
• First received: March 16, 2011
• Last updated: September 9, 2016
• Start date: March 2011
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Description:

Study Background:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Endocrine System Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Kelsey Seybold Clinics	Houston	Texas
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

External Links

•   University of Texas MD Anderson Cancer Center Website