EMMA: Empowerment, Motivation and Medical Adherence

Study Overview
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Brief Summary
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EMMA: Empowerment, Motivation and Medical Adherence. A consultation program based on dialogue tools for adults with poorly regulated Type 2 diabetes.

Detailed Description
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Traditionally, the success of patients to manage their diabetes has been judged by their ability to adhere to a prescribed therapeutic regimen, and efforts have been spent developing strategies to promote adherence. It is estimated that 20% to 50% of patients with chronic conditions are not adherent to their prescribed medication regimen, with non-adherence being defined as <80% adherence to prescribed, relevant medication. The treatment regimen often comprises several elements such as poly-pharmacy including insulin administration, self-monitoring of blood glucose, diet and physical exercise. It is thus not just a matter of 'taking a pill or not' but implies lifestyle changes, knowledge and competence, and internal motivation for self-management. The investigators developed a consultation program based on dialogue tools. The EMMA program aims to support medication adherence and blood glucose control by facilitating rapport, exploring patient concerns and challenges, enabling knowledge exchange and supporting goal-setting and action-planning. A pilot test of the program appeared feasible and acceptable to patients and health care professionals and showed significant decrease on HbA1c. EMMA is now ready to be tested in a randomized controlled study (RCT) study.

Official Title
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EMMA: Empowerment, Motivation and Medical Adherence

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: EMMA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults Type 2 diabetes ≥ 18 år Type 2 diabetes ≥ 1 år HbA1c ≥ 64 mmol/mol (≥ 8%) at the last three measures before randomisation Taking medication for Type 2 diabetes • - Speak, read and understands Danish Exclusion Criteria: Participating in other intervention research projects during the trial period Being treated by a psychiatrist or psychologist during the period Reduced sight or blindness

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Intervention arm : EMMA consultations | Behavioral: EMMA<br>* Consultations using dialogue tools<br>|
| No Intervention: Control group<br>Control arm: Usual care/consultations | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Change from baseline in HbA1c at 4½ month which is maintained or improved at 6 months | Baseline, 4½ month and 6 months after end of intervention period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-management | Change from baseline in Self-management skills at 4½ month assessed by increase in the Perceived Competence In Diabetes (PCD scale) which is maintained or improved at 6 months | Baseline, 4½ month and 6 months after end of intervention period | 
| Self-management | Change from baseline in Self-management skills at 4½ month assessed by increase in the Health Care Climate Questionnaire (HCCC scale) which is maintained or improved at 6 months | Baseline, 4½ month and 6 months after end of intervention period | 
| Self-management | Change from baseline in Self-management skills at 4½ month assessed by decrease in the Problem Areas in Diabetes Questionnaire (PAID scale) which is maintained or improved at 6 months | Baseline, 4½ month and 6 months after end of intervention period | 
| Self-management | Change from baseline in Self-management skills at 4½ month assessed by increase in The WHO5 Wellbeing Questionnaire (WHO5 scale) which is maintained or improved at 6 months | Baseline, 4½ month and 6 months after end of intervention period | 
| Self-management | Change from baseline in Self-management skills at 4½ month assessed by increase in the Treament Self-Regulation Questionnaire (TSRQ scale) which is maintained or improved at 6 months | Baseline, 4½ month and 6 months after end of intervention period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adults, dialogue tools, outpatient clinic visits