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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01626053
First Posted: June 22, 2012
Last Update Posted: June 22, 2012
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.
Collaborators:
K21 Health Foundation
Kosciusko County Health Department
Information provided by (Responsible Party):
KRJG Services Inc.
  Purpose
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 Intervention
Type 2 Diabetes Mellitus Behavioral: ASMART Other: Control Group

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by KRJG Services Inc.:

Primary Outcome Measures:
  • 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


Enrollment: 182
Study Start Date: March 2009
Study Completion Date: June 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

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 Submitted: June 7, 2012
First Posted: June 22, 2012
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