Empowerment, Motivation and Medical Adherence (EMMA).

NCT03008395 | Withdrawn

• 1 other identifier: NSHABCIEMMA
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1c

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

  12 months

Secondary Outcomes (5)

• WHO-QoL Scale

  12 months

• Support for autonomous control over diabetes

  12 months

• Self-management of diabetes

  12 Months

• Self-Efficacy at diabetes self-management

  12 Months

• Diabetes Distress

  12 Months

Study Arms (2)

EMMA

EXPERIMENTAL

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

Treatment as Usual

ACTIVE COMPARATOR

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

Interventions

EMMA BEHAVIORAL

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

EMMA

Treatment as Usual OTHER

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.

Also known as: Standard Diabetes Education

Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Related Publications (29)

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  BACKGROUND

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  BACKGROUND

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• 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

  BACKGROUND

• 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.

  BACKGROUND

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  BACKGROUND

MeSH Terms

Interventions

Therapeutics

Study Officials

• Michael Vallis, PhD

  Lead, Behaviour Change Institute, NSHA and Associate Professor, Family Medicine, Dalhousie University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lead, Behaviour Change Institute and Associate Professor, Family Medicine, Dalhousie University

Study Record Dates

• First Submitted: December 29, 2016
• First Posted: January 2, 2017
• Study Start: October 1, 2017
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 3, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share