The Efficacy and Treatment Adherence With an Integrated Program on HbA1c Scores in Patients With Type 2 Diabetes (ASMART)
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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|
- 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
|Study Start Date:||March 2009|
|Study Completion Date:||June 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
|No Intervention: control group||
Other: Control Group
Experimental: lifestyle counseling
These participant received the ASMART interventions.
Motivational Interviewing, Stages of Change, Psychological Testing, Bio-psychosocial assessment, responsive diabetes education, support, Cognitive-behavioral interventions
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01626053
|United States, Indiana|
|Northern Lakes Medicine|
|Warsaw, Indiana, United States, 46580|
|Principal Investigator:||Kevin W Roberts, PsyD||Grace College|
|Study Director:||Dana L Coates, D.O.||Kosciusko Community Hospital|