Clinical trial NCT03008395: Empowerment, Motivation and Medical Adherence (EMMA).
Official title: Empowerment, Motivation and Medical Adherence (EMMA). Dialogue Tools for Consultations With Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Type2 Diabetes Mellitus
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2017-01-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: 12 months
Secondary outcomes:
measure: WHO-QoL Scale
timeFrame: 12 months
measure: Support for autonomous control over diabetes
timeFrame: 12 months
measure: Self-management of diabetes
timeFrame: 12 Months
measure: Self-Efficacy at diabetes self-management
timeFrame: 12 Months
measure: Diabetes Distress
timeFrame: 12 Months
Other outcomes:
Locations:
Study officials:
affiliation: Lead, Behaviour Change Institute, NSHA and Associate Professor, Family Medicine, Dalhousie University
name: Michael Vallis, PhD
role: PRINCIPAL_INVESTIGATOR
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