EMMA: Empowerment, Motivation and Medical Adherence

Steno Diabetes Centers

Status: Unknown

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: EMMA

Study type: Interventional

Funder types: Other

Identifiers

NCT02295696

grhu

Details and patient eligibility

About

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

Full 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.

Enrollment: 270 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

270 participants in 2 patient groups

Intervention group

Experimental group

Description:

Intervention arm : EMMA consultations

Treatment:

Behavioral: EMMA

Control group

No Intervention group

Description:

Control arm: Usual care/consultations