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

Type 2 Diabetes Mellitus Clinical Trial

— ASMART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01626053
• Other study ID #: ASMART-01
• Secondary ID: 2008-4-03
• Status: Completed
• Phase: N/A
• First received: June 7, 2012
• Last updated: June 21, 2012
• Start date: March 2009
• Est. completion date: June 2011

Study information

• Verified date: June 2012
• Source: KRJG Services Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: June 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• ASMART
Motivational Interviewing, Stages of Change, Psychological Testing, Bio-psychosocial assessment, responsive diabetes education, support, Cognitive-behavioral interventions

Other:
• Control Group
no intervention

Locations

Country	Name	City	State
United States	Northern Lakes Medicine	Warsaw	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
KRJG Services Inc.	K21 Health Foundation, Kosciusko County Health Department

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in A1c levels for pretest and post test (Preset baseline and post-test 2 years	Statistical analysis involved comparing pretest and psttest HbA1c levels for the experimental group and the control group	Pretest / posttest	No