Ignite Creation Date:
2025-12-24 @ 1:42 PM
Ignite Modification Date:
2026-02-02 @ 1:53 PM
Study NCT ID:
NCT03008395
Status:
WITHDRAWN
Last Update Posted:
2018-08-03
First Post:
2016-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Empowerment, Motivation and Medical Adherence (EMMA).
Sponsor:
Nova Scotia Health Authority
Organization:
Study Overview
Official Title:
Empowerment, Motivation and Medical Adherence (EMMA). Dialogue Tools for Consultations With Patients With Type 2 Diabetes
Status:
WITHDRAWN
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to secure clinic support for conducting research
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMMA
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: