DiabetesPhase 3MIDASNCT00754741
Multi-arm Intervention Diabetes Adherence Study
A Phase 3 study testing Adherence information and Adherence information plus motivational interviewing in people with Diabetes, run by Henry Ford Health System at 1 site in United States.
Trial summary
The purpose of this study is to compare the effectiveness of two different interventions to improve adherence to diabetes medications among patients with diabetes and poor metabolic control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Adherence information and Adherence information plus motivational interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,692 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Dec 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- At least 2 dispensings for oral medications used to treat diabetes and dyslipidemia in the last 18 month.
- At least one laboratory result for both glycated hemoglobin and LDL-cholesterol in the last 6 months.
- Average HbA1c ≥ 7% OR an average LDL ≥ 100 mg/d
- Continuous health plan enrollment currently and in the previous calendar year with no more than a 1 month lapse of coverage, and benefits that include both medical and pharmacy coverage.
Who cannot join
- Patients who have been institutionalized in a nursing home or in a long-term care facility for more than 3 months in the preceding 18 month period.
- Participation in a disease management program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase III Clinical Trial of the Effectiveness of Adherence Data and Motivational Interviewing to Improve Medication Adherence and Both Glycated Hemoglobin and Cholesterol Control
The purpose of this study is to compare the effectiveness of two different interventions to improve adherence to diabetes medications among patients with diabetes and poor metabolic control.
Read the detailed description
Nonadherence to medications is common among patients with diabetes and contributes to suboptimal control of glycemic and lipid plasma levels. Adherence is not routinely measured in clinical practice because no valid, feasible methods have been readily available. The lack of medication adherence information contributes to clinician failure to identify and address patient nonadherence and to clinical inertia and poor health outcomes.
Existing electronic prescribing systems hold the potential to display medication adherence information. We propose a 3-arm randomized clinical trial to test the effectiveness of providing primary care physicians (PCPs) with both adherence measurements and an adherence clinic to improve adherence to diabetic and lipid-lowering drugs. This adherence clinic will consist of a pharmacist and nurse trained in motivational interviewing (Ml) techniques to improve adherence to medications.
Adherence indices will be generated by linking e-prescribing information with pharmacy data. The trial will be conducted among 1,436 patients with diabetes and poor blood glycemic and/or lipid control. Patients will be randomized to one of the following three study arms: 1) Usual care - PCPs will write prescriptions electronically but will not be provided patient adherence information or Ml support; 2) Intervention - PCPs will be provided adherence information and prompts electronically when using the electronic prescribing system; and 3) Intervention - PCPs will be provided adherence information and prompts electronically when using the electronic prescribing system plus physicians and patients will receive support from an adherence clinic.
Our intervention uses as theoretical behavioral framework elements of the Chronic Care Model, Self-Determination Theory, and the Health Belief Model. The study will use qualitative methods to guide intervention design and implementation and will include both process evaluation and treatment fidelity measures. The intervention will be tailored to patients' adherence and goal levels. The study will also evaluate the cost effectiveness of the intervention. Patients will be followed for 36 months. The introduction of sustainable medication adherence monitoring in clinical practice holds great potential to improve health outcomes among patients with diabetes.
- Conditions
- Diabetes
- Being tested
- Adherence information, Adherence information plus motivational interviewing
- Keywords
- medication adherence, motivational interviewing
- Medical subject headings
- Diabetes Mellitus, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adherence informationBehavioural
Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
Adherence information plus motivational interviewingBehavioural
Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm |
| Adherence | Active comparator | Not described Receives: Behavioral: Adherence information |
| Adherence Plus | Active comparator | Not described Receives: Behavioral: Adherence information plus motivational interviewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated Hemoglobin Levels
Measured: at 18 months post randomization
LDL-cholesterol Levels
Measured: at 18 months post randomization
Secondary outcomes (12)
Adherence to Oral Anti-diabetic Medications
Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at "6 months post randomization" represented use beginning at 3 months post-randomization and ending at 6 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date.
Measured: at 6 months post randomization
Adherence to Lipid-lowering Drugs
Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at "6 months post randomization" represented use beginning at 3 months post-randomization and ending at 6 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date.
Measured: at 6 months post randomization
Cardiovascular Morbidity and Mortality (Exploratory)
Measured: at 24 months post randomization
Glycated Hemoglobin Levels
Measured: at 6 months post randomization
LDL Cholesterol Levels
Measured: at 6 months post randomization
Glycated Hemoglobin Levels
Measured: at 12 months post randomization
LDL Cholesterol Levels
Measured: at 12 months post randomization
Adherence to Oral Anti-diabetic Medications
Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at "12 months post randomization" represented use beginning at 9 months post-randomization and ending at 12 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date.
Measured: at 12 months post randomization
Adherence to Oral Anti-diabetic Medications
Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at "18 months post randomization" represented use beginning at 15 months post-randomization and ending at 18 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date.
Measured: at 18 months post randomization
Adherence to Lipid-lowering Drugs
Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at "12 months post randomization" represented use beginning at 9 months post-randomization and ending at 12 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date.
Measured: at 12 months post randomization
Adherence to Lipid-lowering Drugs
Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at "18 months post randomization" represented use beginning at 15 months post-randomization and ending at 18 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date.
Measured: at 18 months post randomization
Cardiovascular Morbidity and Mortality (Exploratory)
Measured: at 36 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2008 (estimated)
- Study startJul 2008
- Primary completionApr 2010
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,692 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, keoki williams, Henry Ford Health System
- Investigators
- Janis Campbell, RN, Study director, Henry Ford Health SystemManel Pladeval, MD, MS, Principal investigator, Henry Ford HospitalL. Keoki Williams, MD, MPH, Principal investigator, Henry Ford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00754741
- Sponsor's protocol ID
- DK64695
- Other IDs
- R01DK064695, 5R01DK064695-06
- Acronym
- MIDAS
- Status last verified
- Apr 2015
- First submitted
- 16 Sep 2008
- Last updated
- 8 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Pladevall M, Williams LK, Potts LA, Divine G, Xi H, Lafata JE. Clinical outcomes and adherence to medications measured by claims data in patients with diabetes. Diabetes Care. 2004 Dec;27(12):2800-5. doi: 10.2337/diacare.27.12.2800.
PubMed 15562188Heisler M, Hogan MM, Hofer TP, Schmittdiel JA, Pladevall M, Kerr EA. When more is not better: treatment intensification among hypertensive patients with poor medication adherence. Circulation. 2008 Jun 3;117(22):2884-92. doi: 10.1161/CIRCULATIONAHA.107.724104. Epub 2008 May 27.
PubMed 18506011Schmittdiel JA, Uratsu CS, Karter AJ, Heisler M, Subramanian U, Mangione CM, Selby JV. Why don't diabetes patients achieve recommended risk factor targets? Poor adherence versus lack of treatment intensification. J Gen Intern Med. 2008 May;23(5):588-94. doi: 10.1007/s11606-008-0554-8. Epub 2008 Mar 4.
PubMed 18317847Choudhry NK, Patrick AR, Antman EM, Avorn J, Shrank WH. Cost-effectiveness of providing full drug coverage to increase medication adherence in post-myocardial infarction Medicare beneficiaries. Circulation. 2008 Mar 11;117(10):1261-8. doi: 10.1161/CIRCULATIONAHA.107.735605. Epub 2008 Feb 19.
PubMed 18285564Ho PM, Magid DJ, Shetterly SM, Olson KL, Peterson PN, Masoudi FA, Rumsfeld JS. Importance of therapy intensification and medication nonadherence for blood pressure control in patients with coronary disease. Arch Intern Med. 2008 Feb 11;168(3):271-6. doi: 10.1001/archinternmed.2007.72.
PubMed 18268167Odegard PS, Capoccia K. Medication taking and diabetes: a systematic review of the literature. Diabetes Educ. 2007 Nov-Dec;33(6):1014-29; discussion 1030-1. doi: 10.1177/0145721707308407.
PubMed 18057270Williams LK, Joseph CL, Peterson EL, Wells K, Wang M, Chowdhry VK, Walsh M, Campbell J, Rand CS, Apter AJ, Lanfear DE, Tunceli K, Pladevall M. Patients with asthma who do not fill their inhaled corticosteroids: a study of primary nonadherence. J Allergy Clin Immunol. 2007 Nov;120(5):1153-9. doi: 10.1016/j.jaci.2007.08.020. Epub 2007 Oct 22.
PubMed 17936894Piette JD. Interactive behavior change technology to support diabetes self-management: where do we stand? Diabetes Care. 2007 Oct;30(10):2425-32. doi: 10.2337/dc07-1046. Epub 2007 Jun 22. No abstract available.
PubMed 17586735Borrelli B, Riekert KA, Weinstein A, Rathier L. Brief motivational interviewing as a clinical strategy to promote asthma medication adherence. J Allergy Clin Immunol. 2007 Nov;120(5):1023-30. doi: 10.1016/j.jaci.2007.08.017. Epub 2007 Sep 29.
PubMed 17904625West DS, DiLillo V, Bursac Z, Gore SA, Greene PG. Motivational interviewing improves weight loss in women with type 2 diabetes. Diabetes Care. 2007 May;30(5):1081-7. doi: 10.2337/dc06-1966. Epub 2007 Mar 2.
PubMed 17337504Munro S, Lewin S, Swart T, Volmink J. A review of health behaviour theories: how useful are these for developing interventions to promote long-term medication adherence for TB and HIV/AIDS? BMC Public Health. 2007 Jun 11;7:104. doi: 10.1186/1471-2458-7-104.
PubMed 17561997Channon SJ, Huws-Thomas MV, Rollnick S, Hood K, Cannings-John RL, Rogers C, Gregory JW. A multicenter randomized controlled trial of motivational interviewing in teenagers with diabetes. Diabetes Care. 2007 Jun;30(6):1390-5. doi: 10.2337/dc06-2260. Epub 2007 Mar 10.
PubMed 17351283van Dulmen S, Sluijs E, van Dijk L, de Ridder D, Heerdink R, Bensing J. Patient adherence to medical treatment: a review of reviews. BMC Health Serv Res. 2007 Apr 17;7:55. doi: 10.1186/1472-6963-7-55.
PubMed 17439645Grant R, Adams AS, Trinacty CM, Zhang F, Kleinman K, Soumerai SB, Meigs JB, Ross-Degnan D. Relationship between patient medication adherence and subsequent clinical inertia in type 2 diabetes glycemic management. Diabetes Care. 2007 Apr;30(4):807-12. doi: 10.2337/dc06-2170. Epub 2007 Jan 26.
PubMed 17259469Williams LK, Joseph CL, Peterson EL, Moon C, Xi H, Krajenta R, Johnson R, Wells K, Booza JC, Tunceli K, Lafata JE, Johnson CC, Ownby DR, Enberg R, Pladevall M. Race-ethnicity, crime, and other factors associated with adherence to inhaled corticosteroids. J Allergy Clin Immunol. 2007 Jan;119(1):168-75. doi: 10.1016/j.jaci.2006.09.029. Epub 2006 Nov 2.
PubMed 17208598
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Clinical Trial of the Effectiveness of Adherence Data and Motivational Interviewing to Improve Medication Adherence and Both Glycated Hemoglobin and Cholesterol Control
- ClinicalTrials.gov ID
- NCT00754741
- Acronym / sponsor ID
- MIDAS / DK64695
- Conditions
- Diabetes
- Keywords
- medication adherence, motivational interviewing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,692 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jul 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 18 Sep 2008 (estimated)
- Results
- Posted 22 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the effectiveness of two different interventions to improve adherence to diabetes medications among patients with diabetes and poor metabolic control.
Detailed description
Nonadherence to medications is common among patients with diabetes and contributes to suboptimal control of glycemic and lipid plasma levels. Adherence is not routinely measured in clinical practice because no valid, feasible methods have been readily available. The lack of medication adherence information contributes to clinician failure to identify and address patient nonadherence and to clinical inertia and poor health outcomes.
Existing electronic prescribing systems hold the potential to display medication adherence information. We propose a 3-arm randomized clinical trial to test the effectiveness of providing primary care physicians (PCPs) with both adherence measurements and an adherence clinic to improve adherence to diabetic and lipid-lowering drugs. This adherence clinic will consist of a pharmacist and nurse trained in motivational interviewing (Ml) techniques to improve adherence to medications.
Adherence indices will be generated by linking e-prescribing information with pharmacy data. The trial will be conducted among 1,436 patients with diabetes and poor blood glycemic and/or lipid control. Patients will be randomized to one of the following three study arms: 1) Usual care - PCPs will write prescriptions electronically but will not be provided patient adherence information or Ml support; 2) Intervention - PCPs will be provided adherence information and prompts electronically when using the electronic prescribing system; and 3) Intervention - PCPs will be provided adherence information and prompts electronically when using the electronic prescribing system plus physicians and patients will receive support from an adherence clinic.
Our intervention uses as theoretical behavioral framework elements of the Chronic Care Model, Self-Determination Theory, and the Health Belief Model. The study will use qualitative methods to guide intervention design and implementation and will include both process evaluation and treatment fidelity measures. The intervention will be tailored to patients' adherence and goal levels. The study will also evaluate the cost effectiveness of the intervention. Patients will be followed for 36 months. The introduction of sustainable medication adherence monitoring in clinical practice holds great potential to improve health outcomes among patients with diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm |
| Adherence | Active comparator | Behavioral: Adherence information |
| Adherence Plus | Active comparator | Behavioral: Adherence information plus motivational interviewing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 2 dispensings for oral medications used to treat diabetes and dyslipidemia in the last 18 month.
- At least one laboratory result for both glycated hemoglobin and LDL-cholesterol in the last 6 months.
- Average HbA1c ≥ 7% OR an average LDL ≥ 100 mg/d
- Continuous health plan enrollment currently and in the previous calendar year with no more than a 1 month lapse of coverage, and benefits that include both medical and pharmacy coverage.
Key exclusion criteria (2 listed)
- Patients who have been institutionalized in a nursing home or in a long-term care facility for more than 3 months in the preceding 18 month period.
- Participation in a disease management program
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 |
|---|---|---|
| Adherence informationPhysicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. | Behavioural | Adherence |
| Adherence information plus motivational interviewingPhysicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal. | Behavioural | Adherence Plus |
Primary outcome
Glycated Hemoglobin Levels
Time frame: at 18 months post randomization
LDL-cholesterol Levels
Time frame: at 18 months post randomization
12 secondary outcomes
Adherence to Oral Anti-diabetic Medications
Time frame: at 6 months post randomization
Adherence to Lipid-lowering Drugs
Time frame: at 6 months post randomization
Cardiovascular Morbidity and Mortality (Exploratory)
Time frame: at 24 months post randomization
Glycated Hemoglobin Levels
Time frame: at 6 months post randomization
LDL Cholesterol Levels
Time frame: at 6 months post randomization
Glycated Hemoglobin Levels
Time frame: at 12 months post randomization
LDL Cholesterol Levels
Time frame: at 12 months post randomization
Adherence to Oral Anti-diabetic Medications
Time frame: at 12 months post randomization
Adherence to Oral Anti-diabetic Medications
Time frame: at 18 months post randomization
Adherence to Lipid-lowering Drugs
Time frame: at 12 months post randomization
Adherence to Lipid-lowering Drugs
Time frame: at 18 months post randomization
Cardiovascular Morbidity and Mortality (Exploratory)
Time frame: at 36 months post randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15562188Pladevall M, Williams LK, Potts LA, Divine G, Xi H, Lafata JE. Clinical outcomes and adherence to medications measured by claims data in patients with diabetes. Diabetes Care. 2004 Dec;27(12):2800-5. doi: 10.2337/diacare.27.12.2800.
- Background: PubMed 18506011Heisler M, Hogan MM, Hofer TP, Schmittdiel JA, Pladevall M, Kerr EA. When more is not better: treatment intensification among hypertensive patients with poor medication adherence. Circulation. 2008 Jun 3;117(22):2884-92. doi: 10.1161/CIRCULATIONAHA.107.724104. Epub 2008 May 27.
- Background: PubMed 18317847Schmittdiel JA, Uratsu CS, Karter AJ, Heisler M, Subramanian U, Mangione CM, Selby JV. Why don't diabetes patients achieve recommended risk factor targets? Poor adherence versus lack of treatment intensification. J Gen Intern Med. 2008 May;23(5):588-94. doi: 10.1007/s11606-008-0554-8. Epub 2008 Mar 4.
- Background: PubMed 18285564Choudhry NK, Patrick AR, Antman EM, Avorn J, Shrank WH. Cost-effectiveness of providing full drug coverage to increase medication adherence in post-myocardial infarction Medicare beneficiaries. Circulation. 2008 Mar 11;117(10):1261-8. doi: 10.1161/CIRCULATIONAHA.107.735605. Epub 2008 Feb 19.
- Background: PubMed 18268167Ho PM, Magid DJ, Shetterly SM, Olson KL, Peterson PN, Masoudi FA, Rumsfeld JS. Importance of therapy intensification and medication nonadherence for blood pressure control in patients with coronary disease. Arch Intern Med. 2008 Feb 11;168(3):271-6. doi: 10.1001/archinternmed.2007.72.
- Background: PubMed 18057270Odegard PS, Capoccia K. Medication taking and diabetes: a systematic review of the literature. Diabetes Educ. 2007 Nov-Dec;33(6):1014-29; discussion 1030-1. doi: 10.1177/0145721707308407.
- Background: PubMed 17936894Williams LK, Joseph CL, Peterson EL, Wells K, Wang M, Chowdhry VK, Walsh M, Campbell J, Rand CS, Apter AJ, Lanfear DE, Tunceli K, Pladevall M. Patients with asthma who do not fill their inhaled corticosteroids: a study of primary nonadherence. J Allergy Clin Immunol. 2007 Nov;120(5):1153-9. doi: 10.1016/j.jaci.2007.08.020. Epub 2007 Oct 22.
- Background: PubMed 17586735Piette JD. Interactive behavior change technology to support diabetes self-management: where do we stand? Diabetes Care. 2007 Oct;30(10):2425-32. doi: 10.2337/dc07-1046. Epub 2007 Jun 22. No abstract available.
- Background: PubMed 17904625Borrelli B, Riekert KA, Weinstein A, Rathier L. Brief motivational interviewing as a clinical strategy to promote asthma medication adherence. J Allergy Clin Immunol. 2007 Nov;120(5):1023-30. doi: 10.1016/j.jaci.2007.08.017. Epub 2007 Sep 29.
- Background: PubMed 17337504West DS, DiLillo V, Bursac Z, Gore SA, Greene PG. Motivational interviewing improves weight loss in women with type 2 diabetes. Diabetes Care. 2007 May;30(5):1081-7. doi: 10.2337/dc06-1966. Epub 2007 Mar 2.
- Background: PubMed 17561997Munro S, Lewin S, Swart T, Volmink J. A review of health behaviour theories: how useful are these for developing interventions to promote long-term medication adherence for TB and HIV/AIDS? BMC Public Health. 2007 Jun 11;7:104. doi: 10.1186/1471-2458-7-104.
- Background: PubMed 17351283Channon SJ, Huws-Thomas MV, Rollnick S, Hood K, Cannings-John RL, Rogers C, Gregory JW. A multicenter randomized controlled trial of motivational interviewing in teenagers with diabetes. Diabetes Care. 2007 Jun;30(6):1390-5. doi: 10.2337/dc06-2260. Epub 2007 Mar 10.
Related trials for Diabetes
RecruitingObservational study
Diabetes and Heart Disease Risk in Blacks
Cardiovascular Diseases, Diabetes
RecruitingObservational study
Genetic Studies of Insulin and Diabetes
Diabetes Mellitus, Severe Insulin Resistance
RecruitingObservational study
Urinary Vitamin C Loss in Diabetic Subjects
Diabetes
Active, not recruitingObservational study
Healthy Aging in Neighborhoods of Diversity Across the Life Span (HANDLS)
Diabetes, Cerebrovascular Disease
Active, not recruiting
Dietary Behavior Intervention in African Americans at Risk for Cardiovascular Disease
Diet, Cooking
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.
Janis Campbell, RN study director
Henry Ford Health System
Manel Pladeval, MD, MS principal investigator
Henry Ford Hospital
L. Keoki Williams, MD, MPH principal investigator
Henry Ford Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adherence information and Adherence information plus motivational interviewing in people with Diabetes, run by Henry Ford Health System 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 4 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 8 May 2015. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Glycated Hemoglobin Levels (time frame: at 18 months post randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00754741, which also lists 18 linked publications.
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 8 May 2015; AzTrials last refreshed its copy on 30 Oct 2026.