Multi-arm Intervention Diabetes Adherence Study

NCT00754741 | Completed Phase 3 Results DMC

• 3 other identifiers: DK64695R01DK0646955R01DK064695-06
• Study Type: interventional
• Target: 1,692
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes

Keywords

medication adherence; motivational interviewing

Outcome Measures

Primary Outcomes (2)

• Glycated Hemoglobin Levels

  at 18 months post randomization

• LDL-cholesterol Levels

  at 18 months post randomization

Secondary Outcomes (12)

• Adherence to Oral Anti-diabetic Medications

  at 6 months post randomization

• Adherence to Lipid-lowering Drugs

  at 6 months post randomization

• Cardiovascular Morbidity and Mortality (Exploratory)

  at 24 months post randomization

• Glycated Hemoglobin Levels

  at 6 months post randomization

• LDL Cholesterol Levels

  at 6 months post randomization

Study Arms (3)

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

Interventions

Adherence information BEHAVIORAL

Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.

Adherence

Adherence information plus motivational interviewing BEHAVIORAL

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.

Adherence Plus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Related Publications (18)

• 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.

  PMID: 15562188 BACKGROUND

• Heisler 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.

  PMID: 18506011 BACKGROUND

• Schmittdiel 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.

  PMID: 18317847 BACKGROUND

• Choudhry 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.

  PMID: 18285564 BACKGROUND

• Ho 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.

  PMID: 18268167 BACKGROUND

• Odegard 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.

  PMID: 18057270 BACKGROUND

• Williams 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.

  PMID: 17936894 BACKGROUND

• Piette 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.

  PMID: 17586735 BACKGROUND

• Borrelli 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.

  PMID: 17904625 BACKGROUND

• West 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.

  PMID: 17337504 BACKGROUND

• Munro 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.

  PMID: 17561997 BACKGROUND

• Channon 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.

  PMID: 17351283 BACKGROUND

• van 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.

  PMID: 17439645 BACKGROUND

• Grant 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.

  PMID: 17259469 BACKGROUND

• Williams 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.

  PMID: 17208598 BACKGROUND

• Ho PM, Rumsfeld JS, Masoudi FA, McClure DL, Plomondon ME, Steiner JF, Magid DJ. Effect of medication nonadherence on hospitalization and mortality among patients with diabetes mellitus. Arch Intern Med. 2006 Sep 25;166(17):1836-41. doi: 10.1001/archinte.166.17.1836.

  PMID: 17000939 BACKGROUND

• Miller NH, Hill M, Kottke T, Ockene IS. The multilevel compliance challenge: recommendations for a call to action. A statement for healthcare professionals. Circulation. 1997 Feb 18;95(4):1085-90. doi: 10.1161/01.cir.95.4.1085.

  PMID: 9054774 BACKGROUND

• Haynes RB, Ackloo E, Sahota N, McDonald HP, Yao X. Interventions for enhancing medication adherence. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD000011. doi: 10.1002/14651858.CD000011.pub3.

  PMID: 18425859 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Medication Adherence

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: L. Keoki Williams, MD, MPH
• Organization: Henry Ford Health System

chphsr@hfhs.org

313-874-5454

Study Officials

• Janis Campbell, RN

  Henry Ford Health System

  STUDY DIRECTOR

• Manel Pladeval, MD, MS

  Henry Ford Hospital

  PRINCIPAL INVESTIGATOR

• L. Keoki Williams, MD, MPH

  Henry Ford Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: September 16, 2008
• First Posted: September 18, 2008
• Study Start: July 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: December 1, 2012
• Last Updated: May 8, 2015
• Results First Posted: April 22, 2015

Record last verified: 2015-04

Locations

US (1)