The Efficacy and Treatment Adherence With an Integrated Program on HbA1c Scores in Patients With Type 2 Diabetes
ASMART
2 other identifiers
interventional
182
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes-mellitus
Started Mar 2009
Typical duration for not_applicable type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 7, 2012
CompletedFirst Posted
Study publicly available on registry
June 22, 2012
CompletedJune 22, 2012
June 1, 2012
2 years
June 7, 2012
June 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
control group
NO INTERVENTIONlifestyle counseling
EXPERIMENTALThese participant received the ASMART interventions.
Interventions
Motivational Interviewing, Stages of Change, Psychological Testing, Bio-psychosocial assessment, responsive diabetes education, support, Cognitive-behavioral interventions
Eligibility Criteria
You may qualify if:
- Type 2 Diabetes patients with an HbA1c score over 7
You may not qualify if:
- No Type 1 patients
- No children under the age of 18
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- KRJG Services Inc.lead
- K21 Health Foundationcollaborator
- Kosciusko County Health Departmentcollaborator
Study Sites (1)
Northern Lakes Medicine
Warsaw, Indiana, 46580, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin W Roberts, PsyD
Grace College
- STUDY DIRECTOR
Dana L Coates, D.O.
Kosciusko Community Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2012
First Posted
June 22, 2012
Study Start
March 1, 2009
Primary Completion
March 1, 2011
Study Completion
June 1, 2011
Last Updated
June 22, 2012
Record last verified: 2012-06