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:
Collaborators:
K21 Health Foundation
Kosciusko County Health Department
Information provided by (Responsible Party):
KRJG Services Inc.
ClinicalTrials.gov Identifier:
NCT01626053
First received: June 7, 2012
Last updated: June 21, 2012
Last verified: June 2012

June 7, 2012
June 21, 2012
March 2009
March 2011   (final data collection date for primary outcome measure)
Changes in A1c levels for pretest and post test (Preset baseline and post-test 2 years [ Time Frame: Pretest / posttest ] [ Designated as safety issue: No ]
Statistical analysis involved comparing pretest and psttest HbA1c levels for the experimental group and the control group
Same as current
Complete list of historical versions of study NCT01626053 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Efficacy and Treatment Adherence With an Integrated Program on HbA1c Scores in Patients With Type 2 Diabetes
The Efficacy and Treatment Adherence With an Integrated Program on HbA1c Scores in Patients With Type 2 Diabetes

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Type 2 Diabetes Mellitus
  • Behavioral: ASMART
    Motivational Interviewing, Stages of Change, Psychological Testing, Bio-psychosocial assessment, responsive diabetes education, support, Cognitive-behavioral interventions
  • Other: Control Group
    no intervention
  • No Intervention: control group
    Intervention: Other: Control Group
  • Experimental: lifestyle counseling
    These participant received the ASMART interventions.
    Intervention: Behavioral: ASMART
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
182
June 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01626053
ASMART-01, 2008-4-03
No
KRJG Services Inc.
KRJG Services Inc.
  • K21 Health Foundation
  • Kosciusko County Health Department
Principal Investigator: Kevin W Roberts, PsyD Grace College
Study Director: Dana L Coates, D.O. Kosciusko Community Hospital
KRJG Services Inc.
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP