NCT00179374

Brief Summary

This study has the following specific aims:

  1. 1.A tailored telephone intervention will significantly improve medication adherence compared to a standard care intervention.
  2. 2.A tailored telephone intervention will significantly improve metabolic control measured by HbA1c compared to a standard care intervention 2a) We will explore ways to link behavior change for medication adherence with lifestyle modification for diet and physical activity.
  3. 3.To conduct cost evaluations for the telephone intervention vs. standard care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
556

participants targeted

Target at P75+ for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jul 2003

Longer than P75 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

April 26, 2018

Status Verified

April 1, 2018

Enrollment Period

5 years

First QC Date

September 13, 2005

Last Update Submit

April 24, 2018

Conditions

Diabetes Mellitus, Type 2

Keywords

Medication adherenceSelf-care behaviorsTelephonic interventionDiabetesNutritionExercise

Outcome Measures

Primary Outcomes (2)

  • Medication adherence

    1 year

  • Metabolic control (measured by HbA1c)

    1 year

Secondary Outcomes (2)

  • Changes in self-care behaviors including diet and exercise

    1 year

  • Cost evaluations

    1 year

Study Arms (2)

1

EXPERIMENTAL

Tailored telephone intervention plus mailed print educational materials

Behavioral: Tailored telephone intervention of education

2

ACTIVE COMPARATOR

print intervention with no telephone component

Behavioral: Print educational intervention

Interventions

Tailored telephone intervention of educationBEHAVIORAL

Tailored telephone intervention to promote metabolic control of diabetes

1
Print educational interventionBEHAVIORAL

diabetes educational materials by mail

2

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes
  • Taking oral diabetes medication
  • At least 40 years old
  • In a union-sponsored health plan with full medication coverage for at least a year
  • Able to understand English or Spanish
  • Informed consent

You may not qualify if:

  • Currently in a diabetes education program
  • Will lose health care eligibility within a year
  • Unable to receive phone calls or mail

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Medication AdherenceDiabetes MellitusMotor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Elizabeth A Walker, DNSc, RN

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

  • Hillel W Cohen, DrPH, MPH

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof., Dept of Medicine

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

July 1, 2003

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

April 26, 2018

Record last verified: 2018-04

Locations

US(1)