Type 2 Diabetes MellitusASMARTNCT01626053
The Efficacy and Treatment Adherence With an Integrated Program on HbA1c Scores in Patients With Type 2 Diabetes
A study testing ASMART in people with Type 2 Diabetes Mellitus, run by KRJG Services Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- ASMART
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 Diabetes patients with an HbA1c score over 7
Who cannot join
- No Type 1 patients
- No children under the age of 18
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- ASMART, Control Group
- Keywords
- psychological, intervention, stages of change, motivational interviewing, coping skills, HbA1C, psychological testing, integrated care, behavioral health
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASMARTBehavioural
Motivational Interviewing, Stages of Change, Psychological Testing, Bio-psychosocial assessment, responsive diabetes education, support, Cognitive-behavioral interventions
Control GroupOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Not described Receives: Other: Control Group |
| lifestyle counseling | Experimental | These participant received the ASMART interventions. Receives: Behavioral: ASMART |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Pretest / posttest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2012 (estimated)
- Study startMar 2009
- Primary completionMar 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- KRJG Services Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- K21 Health Foundation, Kosciusko County Health Department
- Responsible party
- Sponsor
- Investigators
- Kevin W Roberts, PsyD, Principal investigator, Grace CollegeDana L Coates, D.O., Study director, Kosciusko Community Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01626053
- Sponsor's protocol ID
- ASMART-01
- Other IDs
- 2008-4-03
- Acronym
- ASMART
- Status last verified
- Jun 2012
- First submitted
- 7 Jun 2012
- Last updated
- 22 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Treatment Adherence With an Integrated Program on HbA1c Scores in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01626053
- Acronym / sponsor ID
- ASMART / ASMART-01
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- psychological, intervention, stages of change, motivational interviewing, coping skills, HbA1C, psychological testing, integrated care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- KRJG Services Inc.University, hospital or other
- Collaborators
- K21 Health Foundation, Kosciusko County Health Department
- Study start
- Mar 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 22 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | Other: Control Group |
| lifestyle counseling | Experimental | Behavioral: ASMARTThese participant received the ASMART interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Type 2 Diabetes patients with an HbA1c score over 7
Key exclusion criteria (2 listed)
- No Type 1 patients
- No children under the age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASMARTMotivational Interviewing, Stages of Change, Psychological Testing, Bio-psychosocial assessment, responsive diabetes education, support, Cognitive-behavioral interventions | Behavioural | lifestyle counseling |
| Control Groupno intervention | Other | control group |
Primary outcome
Changes in A1c levels for pretest and post test (Preset baseline and post-test 2 years
Time frame: Pretest / posttest
Statistical analysis involved comparing pretest and psttest HbA1c levels for the experimental group and the control group
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin W Roberts, PsyD principal investigator
Grace College
Dana L Coates, D.O. study director
Kosciusko Community Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASMART in people with Type 2 Diabetes Mellitus, run by KRJG Services Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in A1c levels for pretest and post test (Preset baseline and post-test 2 years (time frame: Pretest / posttest). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2012.