ClinicalTrials.gov
ClinicalTrials.gov Menu

The Efficacy and Treatment Adherence With an Integrated Program on HbA1c Scores in Patients With Type 2 Diabetes (ASMART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01626053
Recruitment Status : Completed
First Posted : June 22, 2012
Last Update Posted : June 22, 2012
Sponsor:
Collaborators:
K21 Health Foundation
Kosciusko County Health Department
Information provided by (Responsible Party):
KRJG Services Inc.

Brief Summary:
It is hypothesized for this study that the coupling of the Millon Behavioral Medicine Diagnostic, biopsychosocial evaluation, motivational interviewing, relapse prevention, and ongoing support can produce improved outcomes with diabetics who have previously been unsuccessful with the traditional care. This study examined the relationship between patients' HbA1c levels and patients' involvement in the ASMART program, a multifaceted program involving psychological intervention. The study was conducted through the Kosciusko Health Department and funded by K21 Health Foundation.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Behavioral: ASMART Other: Control Group Not Applicable

Detailed Description:
The study involved 182 Type 2 Diabetes patients with an HbA1c score above 7, reflecting poor control of diabetes. The experimental group consisted of 124 patients who joined the ASMART program, while the control group consisted of 60 patients who continued to receive traditional care. Statistical analysis involved comparing pretest & posttest HbA1c levels for the experimental group and the control group.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Efficacy and Treatment Adherence With an Integrated Program on HbA1c Scores in Patients With Type 2 Diabetes
Study Start Date : March 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: control group Other: Control Group
no intervention
Experimental: lifestyle counseling
These participant received the ASMART interventions.
Behavioral: ASMART
Motivational Interviewing, Stages of Change, Psychological Testing, Bio-psychosocial assessment, responsive diabetes education, support, Cognitive-behavioral interventions



Primary Outcome Measures :
  1. Changes in A1c levels for pretest and post test (Preset baseline and post-test 2 years [ Time Frame: Pretest / posttest ]
    Statistical analysis involved comparing pretest and psttest HbA1c levels for the experimental group and the control group



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 Diabetes patients with an HbA1c score over 7

Exclusion Criteria:

  • No Type 1 patients
  • No children under the age of 18

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01626053


Locations
United States, Indiana
Northern Lakes Medicine
Warsaw, Indiana, United States, 46580
Sponsors and Collaborators
KRJG Services Inc.
K21 Health Foundation
Kosciusko County Health Department
Investigators
Principal Investigator: Kevin W Roberts, PsyD Grace College
Study Director: Dana L Coates, D.O. Kosciusko Community Hospital

Responsible Party: KRJG Services Inc.
ClinicalTrials.gov Identifier: NCT01626053     History of Changes
Other Study ID Numbers: ASMART-01
2008-4-03 ( Other Grant/Funding Number: K21 Health Foundation )
First Posted: June 22, 2012    Key Record Dates
Last Update Posted: June 22, 2012
Last Verified: June 2012

Keywords provided by KRJG Services Inc.:
psychological
intervention
stages of change
motivational interviewing
coping skills
HbA1C
psychological testing
integrated care
behavioral health

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