Endocrine System DiseasesNCT01318564
Diabetic Treatment Adherence
An observational study of Endocrine System Diseases, run by M.D. Anderson Cancer Center at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endocrine System Diseases
- What is being tested?
- Metformin and Questionnaires
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2011to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: General Internal Medicine/Ambulatory Clinics at UT MD Anderson Cancer Center in Houston, Texas Kelsey-Seybold Outpatient Clinics in Houston, Texas
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Kelsey Seybold Clinics
Houston, Texas, 77025
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Treatment Adherence With Compliance Prompting Packaging
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.
Read the detailed 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.
- Conditions
- Endocrine System Diseases
- Being tested
- Metformin, Questionnaires
- Keywords
- Type II Diabetes, Unit dose packaging devices, Metformin, Lisinopril, Enalapril, Atorvastatin, Lipitor, Simvastatin, Aspirin, Questionnaires
- Medical subject headings
- Endocrine System Diseases, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
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).
QuestionnairesBehavioural
Also called Surveys
Completion on Day 1 and after Month 3. Each questionnaire to take about 30 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Unit-dose - Pill Bottle | Unit-dose (blister) packages used first week, followed second week by pill bottles usage. Receives: Drug: Metformin; Behavioral: Questionnaires | |
| Group 2: Pill Bottle - Unit Dose | Pill bottle usage the first week followed second week by Unit-dose (blister) packages. Receives: Drug: Metformin; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endocrine System DiseasesStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Maria Suarez-Almazor, MD,PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01318564
- Sponsor's protocol ID
- 2008-0242
- Other IDs
- U18HS016093
- Status last verified
- Sep 2016
- First submitted
- 16 Mar 2011
- Last updated
- 12 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Adherence With Compliance Prompting Packaging
- ClinicalTrials.gov ID
- NCT01318564
- Acronym / sponsor ID
- 2008-0242
- Conditions
- Endocrine System Diseases
- Keywords
- Type II Diabetes, Unit dose packaging devices, Metformin, Lisinopril, Enalapril, Atorvastatin, Lipitor, Simvastatin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Mar 2011
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 18 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Unit-dose - Pill Bottle | – | Drug: Metformin, Behavioral: QuestionnairesUnit-dose (blister) packages used first week, followed second week by pill bottles usage. |
| Group 2: Pill Bottle - Unit Dose | – | Drug: Metformin, Behavioral: QuestionnairesPill bottle usage the first week followed second week by Unit-dose (blister) packages. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- General Internal Medicine/Ambulatory Clinics at UT MD Anderson Cancer Center in Houston, Texas Kelsey-Seybold Outpatient Clinics in Houston, Texas
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- Dementia
- Patients receiving current intravenous chemotherapy
- Pregnancy
- Patients residing in a nursing home
- Treatment with any type of Insulin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin500 - 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). | Drug | Group 1: Unit-dose - Pill Bottle, Group 2: Pill Bottle - Unit Dose |
| QuestionnairesAlso: SurveysCompletion on Day 1 and after Month 3. Each questionnaire to take about 30 minutes to complete. | Behavioural | Group 1: Unit-dose - Pill Bottle, Group 2: Pill Bottle - Unit Dose |
Primary outcome
Patients' Adherence to Unit Dose Packaging Devices
Time frame: 12 weeks
Taking information from the electronic monitor device packages, adherence considered as a ratio of prescribed doses to doses taken.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2016.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Suarez-Almazor, MD,PHD principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endocrine System Diseases, run by M.D. Anderson Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' Adherence to Unit Dose Packaging Devices (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2016.