Improving Diabetes Outcomes With Activity, Nutrition and Medication

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT00179374
First received: September 13, 2005
Last updated: April 27, 2009
Last verified: April 2009
  Purpose

This study has the following specific aims:

  1. A tailored telephone intervention will significantly improve medication adherence compared to a standard care intervention.
  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. To conduct cost evaluations for the telephone intervention vs. standard care.

Condition Intervention
Diabetes Mellitus, Type 2
Behavioral: Tailored telephone intervention of education
Behavioral: Print educational intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Improving Diabetes Medication Adherence and Outcomes

Resource links provided by NLM:


Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:
  • Medication adherence [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Metabolic control (measured by HbA1c) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes in self-care behaviors including diet and exercise [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Cost evaluations [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 556
Study Start Date: July 2003
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Tailored telephone intervention plus mailed print educational materials
Behavioral: Tailored telephone intervention of education
Tailored telephone intervention to promote metabolic control of diabetes
Active Comparator: 2
print intervention with no telephone component
Behavioral: Print educational intervention
diabetes educational materials by mail

Detailed Description:

Metabolic control of type 2 diabetes and prevention of its complications are related to management of blood glucose and other factors. Medication and lifestyle modifications are integral to most self-management plans; however, adherence remains a great challenge. Many patients have abnormal HbA1c, blood pressure and lipid values, and are at greater risk for complications. This study is to evaluate the effectiveness and costs of a tailored, telephone intervention to promote adherence in middle-aged and older adults with type-2 diabetes who are members of a union/employer-sponsored health benefit plan. The target population includes English- and Spanish-speaking individuals from the health plan database.

This study has the following specific aims:

  1. A tailored telephone intervention will significantly improve medication adherence compared to a standard care intervention.
  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. To conduct cost evaluations for the telephone intervention vs. standard care. The study design is a randomized, controlled intervention trial with masking; the individual is the unit of sampling, assignment and analysis. After eligibility is assessed and consent is obtained by telephone, patients will be randomized to either the telephone intervention or standard are. Study outcomes will be medication adherence as measured from pharmacy records and metabolic control (HbA1c). A total of 556 patients with type 2 diabetes wil be randomized, which will provide 80% power to detect a statistically significant difference in HbA1c of at least 0.3%, and over 95% power to detect a difference in filled prescriptions. Telephone surveys will provide data on self-care behaviors including diet and exercise, risk perceptions, and depressive symptoms. Cost data will be collected using standardized methods. Study results will inform implementation of practical, nurse-managed interventions to improve medication adherence and metabolic control in diverse, middle-aged and older, type 2 diabetes patients, while linking changes in medication adherence to lifestyle modification for diet and physical activity.
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Currently in a diabetes education program
  • Will lose health care eligibility within a year
  • Unable to receive phone calls or mail
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00179374

Locations
United States, New York
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
Investigators
Principal Investigator: Elizabeth A Walker, DNSc, RN Albert Einstein College of Medicine of Yeshiva University
Principal Investigator: Hillel W Cohen, DrPH, MPH Albert Einstein College of Medicine of Yeshiva University
  More Information

No publications provided

Responsible Party: Elizabeth A. Walker, PhD, Principal Investigator, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT00179374     History of Changes
Other Study ID Numbers: #2003-068, 1 R18 DK062038-01A1
Study First Received: September 13, 2005
Last Updated: April 27, 2009
Health Authority: United States: Federal Government

Keywords provided by Albert Einstein College of Medicine of Yeshiva University:
Medication adherence
Self-care behaviors
Telephonic intervention
Diabetes
Nutrition
Exercise

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 28, 2014