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EMMA: Empowerment, Motivation and Medical Adherence

EMMA: Empowerment, Motivation and Medical Adherence

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02295696
Acronym
EMMA
Enrollment
270
Registered
2014-11-20
Start date
2014-11-30
Completion date
2017-11-30
Last updated
2014-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

Adults, dialogue tools, outpatient clinic visits

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.

Interventions

BEHAVIORALEMMA

Consultations using dialogue tools

Sponsors

Steno Diabetes Center Copenhagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
HbA1cBaseline, 4½ month and 6 months after end of intervention periodChange from baseline in HbA1c at 4½ month which is maintained or improved at 6 months

Secondary

MeasureTime frameDescription
Self-managementBaseline, 4½ month and 6 months after end of intervention periodChange 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

Countries

Denmark

Contacts

Primary ContactGitte R Husted, PhD
grhu@steno.dk4530753035
Backup ContactBjarne B Jensen, Professor
bjbj@steno.dk4544436449

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026