Trial Information

Treatment Adherence With Compliance Prompting Packaging

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.