Using Conversation Maps to Reinforce Self-Care - Full Text View

Sponsor:	Joslin Diabetes Center
Collaborator:	American Diabetes Association
Information provided by:	Joslin Diabetes Center
ClinicalTrials.gov Identifier:	NCT00895986

Purpose

Many people with type 2 diabetes are not able to keep their blood glucose in good control. Improving blood glucose control and maintaining that improvement is important for diabetes patients because doing so delays the onset and progression of severe complications of diabetes. Although educational programs may be helpful, their effect is not always long-lasting. This project is studying whether the Conversation Maps program (an interactive diabetes education program) reinforces diabetes education and information and thus helps type 2 diabetes patients take better care of their diabetes and blood glucose levels. Half of the patients will attend the Conversation Maps program and half of the patients will attend an educational program about blood pressure and cholesterol. Also, all patients will come in for 4 or 5 appointments to complete surveys and other tests and have their blood drawn. The group of patients who attend the Conversation Maps program will be compared to the group of patients who attend the blood pressure and cholesterol program to see if the educational programs helped diabetes patients to improve their diabetes control and quality of life and to maintain that improvement over time.

Condition	Intervention
Diabetes Mellitus, Type 2	Behavioral: Conversation Maps Diabetes Education Behavioral: Heart Healthy Living Diabetes Education

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Achieving and Maintaining Glycemic Control: Using Conversation Maps to Reinforce Self-Care

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2

U.S. FDA Resources

Further study details as provided by Joslin Diabetes Center:

Primary Outcome Measures:

Improved frequency of recommended self-care behaviors (Self-Care Inventory-R) [ Time Frame: 3, 6, and 12 months post intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

HbA1c [ Time Frame: 3, 6, and 12 months post intervention ] [ Designated as safety issue: No ]
Diabetes Quality of Life (scale) [ Time Frame: 3, 6, and 12 months post intervention ] [ Designated as safety issue: No ]
Major mediating/moderating variables include Problem Areas in Diabetes, Brief Symptom Inventory, Coping Styles, and Confidence in Diabetes [ Time Frame: 3, 6, and 12 months post intervention ] [ Designated as safety issue: No ]

Estimated Enrollment:	168
Study Start Date:	December 2008
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Conversation Maps Diabetes Education	Behavioral: Conversation Maps Diabetes Education The Conversation Maps program is a set of innovative, interactive diabetes education tools developed by the Healthy Interactions, Inc (Healthy I) and endorsed by the American Diabetes Association. It consists of four conversation maps covering: 1) Diabetes Overview, 2) Diabetes and Healthy Eating, 3) Blood Glucose and Monitoring, and 4) The Natural Course of Diabetes (a fifth map covering gestational diabetes will not be used in this study), and a program manual to help educators successfully implement the program.
Experimental: 2 Heart Healthy Living Diabetes Education	Behavioral: Heart Healthy Living Diabetes Education The Joslin Clinic offers a series of two 120-minute classes specifically for people with diabetes that address dyslipidemia and blood pressure problems. A registered nurse and/or a registered dietitian teach the classes, which have a formal written curriculum, including PowerPoint slides.

Arms

Assigned Interventions

Experimental: 1

Conversation Maps Diabetes Education

Behavioral: Conversation Maps Diabetes Education

The Conversation Maps program is a set of innovative, interactive diabetes education tools developed by the Healthy Interactions, Inc (Healthy I) and endorsed by the American Diabetes Association. It consists of four conversation maps covering: 1) Diabetes Overview, 2) Diabetes and Healthy Eating, 3) Blood Glucose and Monitoring, and 4) The Natural Course of Diabetes (a fifth map covering gestational diabetes will not be used in this study), and a program manual to help educators successfully implement the program.

Experimental: 2

Heart Healthy Living Diabetes Education

Behavioral: Heart Healthy Living Diabetes Education

The Joslin Clinic offers a series of two 120-minute classes specifically for people with diabetes that address dyslipidemia and blood pressure problems. A registered nurse and/or a registered dietitian teach the classes, which have a formal written curriculum, including PowerPoint slides.

Eligibility

Ages Eligible for Study:	25 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ages 25-75 years
Diagnosis of type 2 diabetes mellitus
Two A1c levels ≥7.0 % (above ADA target)
2 years since initial diagnosis. This will provide a minimum of two-years experience with diabetes treatment. Also, excluding those who are newly diagnosed will prevent improvement due to newly prescribed medications from confounding study results.
Attended one of Joslin's group education programs or comparable 3-hour (or more) educational programs and/or appointments

Exclusion Criteria:

Severe complications of diabetes including renal disease (microalbumin >300 ug/mg), severe peripheral diabetic neuropathy and/or severe peripheral vascular disease, symptomatic severe autonomic neuropathy, that may place participants at risk when increasing activity levels.
Proliferative diabetic retinopathy based on dilated eye examination within one year of study entry. Patients whose eye disease is successfully treated will be included.
Current or planned pregnancy
A1c levels less than 7.0% (normal range 4.0 - 6.0%) and A1c levels greater than 14%.
A history of severe, unstable myocardial infarction, congestive heart failure or other severe cardiac disease, or severe hypertension (systolic ≥160 mmHg or diastolic ≥ 90 mmHg) (increased risk when mildly increasing physical activity).
A diagnosis of bipolar disorder, schizophrenia, mental retardation, organic mental disorder, and alcohol or drug abuse will be excluded, as well as patients currently undergoing psychiatric treatment. These exclusions are being made to avoid confounds due to concurrent changes in mental status and the effects of ongoing psychiatric treatment.
Used Conversation Maps as an educational tool
Started a new diabetes medication (pills or insulin) in past three months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00895986

Contacts

Contact: Brittney Hultgren

617-732-2403

brittney.hultgren@joslin.harvard.edu

Locations

United States, Massachusetts
Joslin Diabetes Center	Recruiting
Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Joslin Diabetes Center

American Diabetes Association

Investigators

Principal Investigator:

Katie Weinger, EdD, RN

Joslin Diabetes Center

More Information

No publications provided

Responsible Party:	Katie Weinger, EdD, RN, Joslin Diabetes Center
ClinicalTrials.gov Identifier:	NCT00895986 History of Changes
Other Study ID Numbers:	ADA 7-08-CR-62, CHS #08-07
Study First Received:	May 7, 2009
Last Updated:	January 24, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Joslin Diabetes Center:

Diabetes
Education

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on February 09, 2012