Empowerment, Motivation and Medical Adherence (EMMA).

Type2 Diabetes Mellitus Clinical Trial

— EMMA  

Official title:

Empowerment, Motivation and Medical Adherence (EMMA). Dialogue Tools for Consultations With Patients With Type 2 Diabetes

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03008395
• Other study ID #: NSHABCIEMMA
• Status: Withdrawn
• Phase: N/A
• Start date: October 2017
• Est. completion date: August 2018

Study information

• Verified date: August 2018
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Outcomes in type 2 diabetes are largely achieved by self-management efforts by individuals living with diabetes. Diabetes self-management is typically provided using the principles of adult education. Current evidence suggests that standard educational interventions are suboptimal. This study evaluates a novel approach to diabetes self-management using dialogue tools based on empowerment and motivational communication methods. The approach evaluated in this study is called EMMA: empowerment, motivation and medical adherence. Participants will be randomized to EMMA and treatment as usual, treated for a period of 4 months and evaluated over a period of 12 months.

Description:

The management of type 2 diabetes (T2D) is experienced by many patients as being very complex. This is especially true when diabetes management includes multiple medical interventions such as oral agents and injectable medication (insulin, GLP-1; DPP-4s) in combination with diabetes specific behaviours such as blood glucose monitoring and foot care as well as healthy lifestyle behaviours such as physical activity and healthy eating. Studies show that 40-50 % of patients with T2D have suboptimal adherence to self-management recommendations. In general, it is estimated that about half of patients with chronic diseases do not take their medications as prescribed. Suboptimal medical adherence drives poor glycemic control as well as poor quality of life for an individual patient not to mention increased health care costs due to comorbidities, reduced work function and hospital admissions.

Suboptimal adherence may be driven by numerous factors, including lack of symptoms of TD2 (perceived nonseriousness of the disease), side-effects of treatments (GI distress associated with metformin, weight gain associated with insulin) in conjunction with a complex dosing regimen, lack of knowledge or belief in the efficiency of the medication, lack of motivation, cultural factors as well as poor instruction and judgmental communication between the healthcare professional and patient.

There is a need for new methods to understand the drivers of nonadherence and support the patient to proactively self-manage their TD2. There is also a need for new tools (i.e., knowledge translation methods) to support healthcare professionals to engage patients based on dialogue (collaboration) and active patient involvement (self-management), to overcome the barriers to adherence and thereby improve their ability to obtain good glycemic control. The purpose of this study is to evaluate a self-management support intervention called EMMA: Empowerment, motivation & medical adherence.

EMMA is a concept consisting of a number of dialogue tools for use in diabetes consultations (see below). The concept was, in its original form tested, in a feasibility study (N = 19 T2D) in 2011-12. The study showed significant reduction in HbA1c (EMMA: median decrease of 2.0 mmol / mol (-1.0 to 3.0) versus control: median increase 2.5 mmol / mol (-2.0 to -4.5) p = 0.05) (Varming 2012; Andrésdóttir 2014). The investigators have been collaborating with the Danish group who have developed the EMMA protocol and have developed training programs to support the diabetes educator in the delivery of the intervention. The use of the EMMA method is very consistent with motivational communication and behaviour change counselling. The investigators plan to conduct a small scale randomized comparison trial of the EMMA method with diabetes services at the NSHA Central Zone.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adults with type 2 diabetes = 18 years

• Type 2 diabetes = 1 years

• HbA1c = 8 % at the last three visits before randomization

• On oral or injectable medications (insulin, GLP-1; DPP-4)

• Can speak, read and understand English

Exclusion Criteria:

• Participation in other clinical intervention studies during the trial period

• Receiving psychological or psychiatric treatment for a mental health disorder

• Severely impaired vision or blindness

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes Mellitus

Intervention

Behavioral:
• EMMA
Dialogue tools will be used to develop personally relevant behavioural goals consistent with diabetes self-management

Other:
• Treatment as Usual
Participants randomized to this intervention will receive standard diabetes education sessions. These include group education session and follow up session based on clinician-generated recommendations.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nova Scotia Health Authority

References & Publications (29)

Aikens JE, Piette JD. Longitudinal association between medication adherence and glycaemic control in Type 2 diabetes. Diabet Med. 2013 Mar;30(3):338-44. doi: 10.1111/dme.12046. — View Citation

Anderson RM, Funnell MM, Aikens JE, Krein SL, Fitzgerald JT, Nwankwo R, Tannas CL, Tang TS. Evaluating the Efficacy of an Empowerment-Based Self-Management Consultant Intervention: Results of a Two-Year Randomized Controlled Trial. Ther Patient Educ. 2009 Jun 1;1(1):3-11. — View Citation

Cushing A, Metcalfe R. Optimizing medicines management: From compliance to concordance. Ther Clin Risk Manag. 2007 Dec;3(6):1047-58. — View Citation

Funnell M. Beyond the data: moving towards a new DAWN in diabetes. Diabet Med. 2013 Jul;30(7):765-6. doi: 10.1111/dme.12244. — View Citation

Gaede P, Vedel P, Larsen N, Jensen GV, Parving HH, Pedersen O. Multifactorial intervention and cardiovascular disease in patients with type 2 diabetes. N Engl J Med. 2003 Jan 30;348(5):383-93. — View Citation

Gaver, B, Dunne, T, Pacenti, E. Design Cultural Probes. Interactions. 1999; 6(1):21-29

Grabowski, D, Jensen, BB, Willaing, I, Zoffmann, V, Schiøtz, M. Sundhedspædagogik in patientuddannelse. A literature-based review of selected health education principles used in patient education. 2010; Steno Diabetes Center

Hansen, UM, Engelund, G, à Rogvi, S, Willaing, I (2014). The Balancing Person: an innovative approach to person-centered education in chronic illness. The European Journal of Person Centered Healthcare vol 2(3): 290-302

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. Review. Update in: Cochrane Database Syst Rev. 2014;11:CD000011. — View Citation

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. — View Citation

Jensen ML, Jørgensen ME, Hansen EH, Aagaard L, Carstensen B. A multistate model and an algorithm for measuring long-term adherence to medication: a case of diabetes mellitus type 2. Value Health. 2014 Mar;17(2):266-74. doi: 10.1016/j.jval.2013.11.014. — View Citation

Kerse N, Buetow S, Mainous AG 3rd, Young G, Coster G, Arroll B. Physician-patient relationship and medication compliance: a primary care investigation. Ann Fam Med. 2004 Sep-Oct;2(5):455-61. — View Citation

Kvale,S. Interviews: an introduction to qualitative research interviewing. 1996. Thousand Oaks, CA; London, Sage

Linn AJ, van Weert JC, Schouten BC, Smit EG, van Bodegraven AA, van Dijk L. Words that make pills easier to swallow: a communication typology to address practical and perceptual barriers to medication intake behavior. Patient Prefer Adherence. 2012;6:871-85. doi: 10.2147/PPA.S36195. Epub 2012 Dec 11. — View Citation

Manca A, Hawkins N, Sculpher MJ. Estimating mean QALYs in trial-based cost-effectiveness analysis: the importance of controlling for baseline utility. Health Econ. 2005 May;14(5):487-96. — View Citation

Osterberg L, Blaschke T. Adherence to medication. N Engl J Med 2005; 353(5):487-497 among patients with type 2 diabetes. Diabetologia. 2010; 53(Suppl. 1):1067

Peyrot M, Rubin RR. Behavioral and psychosocial interventions in diabetes: a conceptual review. Diabetes Care. 2007 Oct;30(10):2433-40. Epub 2007 Jul 31. Review. — View Citation

Rhee MK, Slocum Pawson & Tilley. Realistic Evaluation. 1997. London: Sage

Rhee MK, Slocum W, Ziemer DC, Culler SD, Cook CB, El-Kebbi IM, Gallina DL, Barnes C, Phillips LS. Patient adherence improves glycemic control. Diabetes Educ. 2005 Mar-Apr;31(2):240-50. — View Citation

Richard C, Lussier MT. MEDICODE: an instrument to describe and evaluate exchanges on medications that occur during medical encounters. Patient Educ Couns. 2006 Dec;64(1-3):197-206. Epub 2006 Jun 16. — View Citation

Skinner TC, Carey ME, Cradock S, Dallosso HM, Daly H, Davies MJ, Doherty Y, Heller S, Khunti K, Oliver L; DESMOND Collaborative. 'Educator talk' and patient change: some insights from the DESMOND (Diabetes Education and Self Management for Ongoing and Newly Diagnosed) randomized controlled trial. Diabet Med. 2008 Sep;25(9):1117-20. doi: 10.1111/j.1464-5491.2008.02492.x. — View Citation

Tang TS, Funnell MM, Gillard M, Nwankwo R, Heisler M. The development of a pilot training program for peer leaders in diabetes: process and content. Diabetes Educ. 2011 Jan-Feb;37(1):67-77. doi: 10.1177/0145721710387308. Epub 2011 Jan 10. — View Citation

Teasdale, T & Svendsen, H. Psykologiske & pædagogiske metoder. Kvalitative og kvantitative forskningsmetoder I praksis. Jensen T.B. and Christensen G (eds.). 2005. Frederiksberg:Roskilde Universitetsforla

Vallis M. Behaviour change counselling--how do I know if I am doing it well? The development of the Behaviour Change Counselling Scale (BCCS). Can J Diabetes. 2013 Feb;37(1):18-26. doi: 10.1016/j.jcjd.2013.01.005. Epub 2013 Mar 14. — View Citation

van Dulmen S. The value of tailored communication for person-centred outcomes. J Eval Clin Pract. 2011 Apr;17(2):381-3. doi: 10.1111/j.1365-2753.2010.01586.x. Epub 2010 Nov 18. — View Citation

Varming, A. Development and usability of a participatory adherence programme aimed at patients with type 2 diabetes in poor glycemic control. 2012. Master thesis (Master of Drug Management), University of Copenhagen

Varming, A., Andrésdóttir, G., Engelund, G., Jelstrup, L., Persson, F. I. EMMA: Empowerment, Motivation & Medical Adherence. Dialogue tools for diabetes consultations. ISBN 978-87-92759-07-8. Steno Diabetes Center. 2013 Gentofte.

Williams A, Manias E, Walker R. Interventions to improve medication adherence in people with multiple chronic conditions: a systematic review. J Adv Nurs. 2008 Jul;63(2):132-43. doi: 10.1111/j.1365-2648.2008.04656.x. Review. — View Citation

World Health Organization. Adherence to long-term therapies: evidence for action. 2003

* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c	Hemoglobin A1c is a blood test that is considered to be the gold standard of diabetes control	12 months
Secondary	WHO-QoL Scale	The validated WHO quality of life self-report index will be used to assess quality of life	12 months
Secondary	Support for autonomous control over diabetes	The validated Healthcare Climate Questionnaire (HCCQ), measures the support for autonomy from healthcare professionals experienced by the patient	12 months
Secondary	Self-management of diabetes	The validated self-report scale, Treatment Self-Regulation Questionnaire (TSRQ), measures the patient's motivation for health behaviour change	12 Months
Secondary	Self-Efficacy at diabetes self-management	The validated self-report scale, the Perceived Competence in Diabetes (PCD), measures the patient's experience of competence in diabetes self-management	12 Months
Secondary	Diabetes Distress	The validated scale, the Diabetes Distress Scale (DDS) measures the experience of the burden of diabetes in everyday life	12 Months