Empowerment, Motivation and Medical Adherence (EMMA).

Sponsor

Nova Scotia Health Authority (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03008395

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type2 Diabetes Mellitus	Behavioral: EMMA Other: Treatment as Usual	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2017

Anticipated Primary Completion Date :

Aug 1, 2018

Anticipated Study Completion Date :

Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EMMA These participants will receive diabetes self-management education using the dialogue tools, which emphasize empowerment and use the principles of motivational communication and behaviour modification. There will be a series of four visits using the dialogue tools to guide the patient toward meaningful self-management tasks. This is not the typical approach, where providers tell the patient the behaviours they, not the patient, consider priorities. This intervention will evaluate if medical outcomes (A1c) and adherence are improved using a patient-centered not a clinician-cantered approach in individuals with poor diabetes control.	Behavioral: EMMA Dialogue tools will be used to develop personally relevant behavioural goals consistent with diabetes self-management
Active Comparator: Treatment as Usual The participants will receive standard diabetes education via group and individual sessions with certified diabetes educators. In this method the patient is provided structured education in which there is an emphasis on covering clinician-determined aspects of diabetes knowledge and self-management. The emphasis vis on diabetes educator recommendations.	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. Other Names: Standard Diabetes Education

Arm

Intervention/Treatment

Experimental: EMMA

These participants will receive diabetes self-management education using the dialogue tools, which emphasize empowerment and use the principles of motivational communication and behaviour modification. There will be a series of four visits using the dialogue tools to guide the patient toward meaningful self-management tasks. This is not the typical approach, where providers tell the patient the behaviours they, not the patient, consider priorities. This intervention will evaluate if medical outcomes (A1c) and adherence are improved using a patient-centered not a clinician-cantered approach in individuals with poor diabetes control.

Behavioral: EMMA

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

Active Comparator: Treatment as Usual

The participants will receive standard diabetes education via group and individual sessions with certified diabetes educators. In this method the patient is provided structured education in which there is an emphasis on covering clinician-determined aspects of diabetes knowledge and self-management. The emphasis vis on diabetes educator recommendations.

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.

Other Names:

Standard Diabetes Education

Outcome Measures

Primary Outcome Measures

Hemoglobin A1c [12 months]
Hemoglobin A1c is a blood test that is considered to be the gold standard of diabetes control

Secondary Outcome Measures

WHO-QoL Scale [12 months]
The validated WHO quality of life self-report index will be used to assess quality of life
Support for autonomous control over diabetes [12 months]
The validated Healthcare Climate Questionnaire (HCCQ), measures the support for autonomy from healthcare professionals experienced by the patient
Self-management of diabetes [12 Months]
The validated self-report scale, Treatment Self-Regulation Questionnaire (TSRQ), measures the patient's motivation for health behaviour change
Self-Efficacy at diabetes self-management [12 Months]
The validated self-report scale, the Perceived Competence in Diabetes (PCD), measures the patient's experience of competence in diabetes self-management
Diabetes Distress [12 Months]
The validated scale, the Diabetes Distress Scale (DDS) measures the experience of the burden of diabetes in everyday life

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Nova Scotia Health Authority

Investigators

Principal Investigator: Michael Vallis, PhD, Lead, Behaviour Change Institute, NSHA and Associate Professor, Family Medicine, Dalhousie University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Michael Vallis, Lead, Behaviour Change Institute and Associate Professor, Family Medicine, Dalhousie University, Nova Scotia Health Authority

ClinicalTrials.gov Identifier:

NCT03008395

Other Study ID Numbers:

NSHABCIEMMA

First Posted:

Jan 2, 2017

Last Update Posted:

Aug 3, 2018

Last Verified:

Aug 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Aug 3, 2018