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

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Other: Control Group; Behavioral: ASMART

• Registration Number: NCT01626053
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-03
• Primary Completion: 2011-03
• Study Completion: 2011-06
• Status Verified: 2012-06
• Study First Submitted: 2012-06-07
• Study First Submitted QC: 2012-06-21
• Last Update Submitted: 2012-06-21
• Study First Posted: 2012-06-22
• Last Update Posted: 2012-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
control group	Control Group	-
lifestyle counseling	ASMART	These participant received the ASMART interventions.

Primary Outcome Measures

Name	Time	Method
Changes in A1c levels for pretest and post test (Preset baseline and post-test 2 years	Pretest / posttest	Statistical analysis involved comparing pretest and psttest HbA1c levels for the experimental group and the control group

Trial Locations

Locations (1)

Northern Lakes Medicine; 🇺🇸 Warsaw, Indiana, United States