EMMA: Empowerment, Motivation and Medical Adherence (EMMA)

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

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: EMMA

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 270
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gitte R Husted, PhD; Phone Number: 4530753035; Email: grhu@steno.dk
• Study Contact Backup: Name: Bjarne B Jensen, Professor; Phone Number: 4544436449; Email: bjbj@steno.dk

Study Locations

• Denmark
  • Gentofte, Denmark, 2820
    • Recruiting
    • Gitte R Husted
    • Contact: Gitte R Husted, PhD; Phone Number: 4530753035; Email: grhu@steno.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Intervention arm : EMMA consultations	Behavioral: EMMA; Consultations using dialogue tools
No Intervention: Control group; Control arm: Usual care/consultations

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Steno Diabetes Center Copenhagen
• Investigators: Principal Investigator: Gitte R Husted, PhD, Steno Diabetes Center, Denmark

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): November 1, 2017

Study Registration Dates

• First Submitted: November 5, 2014
• First Submitted That Met QC Criteria: November 19, 2014
• First Posted (Estimate): November 20, 2014

Study Record Updates

• Last Update Posted (Estimate): November 21, 2014
• Last Update Submitted That Met QC Criteria: November 20, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Adults, dialogue tools, outpatient clinic visits
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: grhu