Improving Compliance With Metformin - Tabular View

Tracking Information

First Received Date ^ICMJE

July 3, 2001

Last Updated Date

September 21, 2009

Start Date ^ICMJE

October 1999

Primary Completion Date

January 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00018616 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Improving Compliance With Metformin

Official Title ^ICMJE

Improving Compliance With Metformin

Brief Summary

This is a randomized controlled trial of adherence. The study involves monitoring and managing focused intervention in patients prescribed metformin.

Detailed Description

The active intervention, MEMS Feedback, involves review of patients' medication-taking over the preceding weeks

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Diabetes

Intervention ^ICMJE

Behavioral: MEMS caps

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2005

Primary Completion Date

January 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Metformin has been prescribed
Willing to use medication containers with MEMS caps
Capable of giving informed consent

Exclusion Criteria:

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00018616

Responsible Party

Rosen, Marc - Principal Investigator, Department of Veterans Affairs

Study ID Numbers ^ICMJE

MHBS-047-98F

Study Sponsor ^ICMJE

Department of Veterans Affairs

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Marc I. Rosen, MD

VA Connecticut Health Care System (West Haven)

Information Provided By

Department of Veterans Affairs

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP