EMMA: Empowerment, Motivation and Medical Adherence

Diabetes Mellitus, Type 2 Clinical Trial

— EMMA  

Official title:

EMMA: Empowerment, Motivation and Medical Adherence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02295696
• Other study ID #: grhu
• Status: Recruiting
• Phase: N/A
• First received: November 5, 2014
• Last updated: November 20, 2014
• Start date: November 2014
• Est. completion date: November 2017

Study information

• Verified date: November 2014
• Source: Steno Diabetes Center
• Contact: Gitte R Husted, PhD
• Phone: 4530753035
• Email: grhu[@]steno.dk
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: November 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• EMMA
Consultations using dialogue tools

Locations

Country	Name	City	State
Denmark	Gitte R Husted	Gentofte

Sponsors (1)

Lead Sponsor	Collaborator
Steno Diabetes Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No