Back to resultsThe Efficacy and Treatment Adherence With an Integrated Program on HbA1c Scores in Patients With Type 2 Diabetes (ASMART)
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ASMART
Control Group
Sponsored by
About this trial
This is an interventional supportive care trial for Type 2 Diabetes Mellitus focused on measuring psychological, intervention, stages of change, motivational interviewing, coping skills, HbA1C, psychological testing, integrated care, behavioral health
Eligibility Criteria
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
Sites / Locations
- Northern Lakes Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control group
lifestyle counseling
Arm Description
These participant received the ASMART interventions.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01626053
First Posted
June 7, 2012
Last Updated
June 21, 2012
Sponsor
KRJG Services Inc.
Collaborators
K21 Health Foundation, Kosciusko County Health Department
1. Study Identification
Unique Protocol Identification Number
NCT01626053
Brief Title
The Efficacy and Treatment Adherence With an Integrated Program on HbA1c Scores in Patients With Type 2 Diabetes
Acronym
ASMART
Official Title
The Efficacy and Treatment Adherence With an Integrated Program on HbA1c Scores in Patients With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KRJG Services Inc.
Collaborators
K21 Health Foundation, Kosciusko County Health Department
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
psychological, intervention, stages of change, motivational interviewing, coping skills, HbA1C, psychological testing, integrated care, behavioral health
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
182 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm Title
lifestyle counseling
Arm Type
Experimental
Arm Description
These participant received the ASMART interventions.
Intervention Type
Behavioral
Intervention Name(s)
ASMART
Intervention Description
Motivational Interviewing, Stages of Change, Psychological Testing, Bio-psychosocial assessment, responsive diabetes education, support, Cognitive-behavioral interventions
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
no intervention
Primary Outcome Measure Information:
Title
Changes in A1c levels for pretest and post test (Preset baseline and post-test 2 years
Description
Statistical analysis involved comparing pretest and psttest HbA1c levels for the experimental group and the control group
Time Frame
Pretest / posttest
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin W Roberts, PsyD
Organizational Affiliation
Grace College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dana L Coates, D.O.
Organizational Affiliation
Kosciusko Community Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Northern Lakes Medicine
City
Warsaw
State/Province
Indiana
ZIP/Postal Code
46580
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Efficacy and Treatment Adherence With an Integrated Program on HbA1c Scores in Patients With Type 2 Diabetes
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