Clinical trial NCT02295696: EMMA: Empowerment, Motivation and Medical Adherence
Official title: EMMA: Empowerment, Motivation and Medical Adherence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Adults, dialogue tools, outpatient clinic visits
Lead sponsor: Steno Diabetes Center Copenhagen
Sponsor class: OTHER
First posted: 2014-11-20
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: HbA1c
timeFrame: Baseline, 4½ month and 6 months after end of intervention period
Secondary outcomes:
measure: Self-management
timeFrame: Baseline, 4½ month and 6 months after end of intervention period
measure: Self-management
timeFrame: Baseline, 4½ month and 6 months after end of intervention period
measure: Self-management
timeFrame: Baseline, 4½ month and 6 months after end of intervention period
measure: Self-management
timeFrame: Baseline, 4½ month and 6 months after end of intervention period
measure: Self-management
timeFrame: Baseline, 4½ month and 6 months after end of intervention period
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: Gitte R Husted
Study officials:
affiliation: Steno Diabetes Center, Denmark
name: Gitte R Husted, PhD
role: PRINCIPAL_INVESTIGATOR
References: