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EMMA: Empowerment, Motivation and Medical Adherence

NCT ID: NCT02295696

Last Updated: 2014-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2017-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Intervention group

Intervention arm : EMMA consultations

Group Type EXPERIMENTAL

EMMA

Intervention Type BEHAVIORAL

Consultations using dialogue tools

Control group

Control arm: Usual care/consultations

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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EMMA

Consultations using dialogue tools

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Steno Diabetes Center Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Gitte Reventlov Husted

Researcher PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gitte R Husted, PhD

Role: PRINCIPAL_INVESTIGATOR

Steno Diabetes Center, Denmark

Locations

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Gitte R Husted

Gentofte Municipality, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Gitte R Husted, PhD

Role: CONTACT

[email protected]
4530753035

Bjarne B Jensen, Professor

Role: CONTACT

[email protected]
4544436449

Facility Contacts

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Gitte R Husted, PhD

Role: primary

[email protected]
4530753035

Other Identifiers

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grhu

Identifier Type: -

Identifier Source: org_study_id