NCT01626053

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P75+ for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Mar 2009

Typical duration for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 7, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 22, 2012

Completed
Last Updated

June 22, 2012

Status Verified

June 1, 2012

Enrollment Period

2 years

First QC Date

June 7, 2012

Last Update Submit

June 21, 2012

Conditions

Keywords

psychologicalinterventionstages of changemotivational interviewingcoping skillsHbA1Cpsychological testingintegrated carebehavioral health

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 INTERVENTION
Other: Control Group

lifestyle counseling

EXPERIMENTAL

These participant received the ASMART interventions.

Behavioral: ASMART

Interventions

ASMARTBEHAVIORAL

Motivational Interviewing, Stages of Change, Psychological Testing, Bio-psychosocial assessment, responsive diabetes education, support, Cognitive-behavioral interventions

lifestyle counseling

no intervention

control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Northern Lakes Medicine

Warsaw, Indiana, 46580, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Kevin W Roberts, PsyD

    Grace College

    PRINCIPAL INVESTIGATOR
  • Dana L Coates, D.O.

    Kosciusko Community Hospital

    STUDY DIRECTOR

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

Locations