Improving Compliance With Metformin | NCT00018616

Studies
Improving Compliance With Metformin

NCT00018616

Sponsor

US Department of Veterans Affairs

Status

Completed

Last Update Posted

Sep 23, 2009Estimated

Enrollment

79Actual

Phase

Phase 2

Conditions

Diabetes

Interventions

MEMS caps

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1999

Primary Completion Date

Jan 2004Actual

Completion Date

Jan 2005Actual

First Submitted Date

Jul 3, 2001

First Submission Date that Met QC Criteria

Jul 4, 2001

First Posted Date

Jul 5, 2001Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2009

Last Update Posted Date

Sep 23, 2009Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

79Actual

Label	Type	Description	Intervention Names
1	Other		Behavioral: MEMS caps

Name	Type	Description	Arm Group Labels	Other Names
MEMS caps	Behavioral		1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marc I. Rosen, MD	VA Connecticut Health Care System (West Haven)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
VA Connecticut Health Care System (West Haven)		West Haven	Connecticut	06516	United States

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D010349	Patient Compliance

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided