The Efficacy and Treatment Adherence With an Integrated Program on HbA1c Scores in Patients With Type 2 Diabetes (ASMART)
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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 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
| 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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| 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 |
More Information
No publications provided
| Responsible Party: | KRJG Services Inc. |
| ClinicalTrials.gov Identifier: | NCT01626053 History of Changes |
| Other Study ID Numbers: | ASMART-01, 2008-4-03 |
| Study First Received: | June 7, 2012 |
| Last Updated: | June 21, 2012 |
| Health Authority: | United States: Institutional Review Board |
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 |
ClinicalTrials.gov processed this record on June 18, 2013