NCT02295696

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
270

participants targeted

Target at P75+ for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 20, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

November 21, 2014

Status Verified

November 1, 2014

Enrollment Period

2.8 years

First QC Date

November 5, 2014

Last Update Submit

November 20, 2014

Conditions

Diabetes Mellitus, Type 2

Keywords

Adults, dialogue tools, outpatient clinic visits

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Self-management

    Baseline, 4½ month and 6 months after end of intervention period

  • Self-management

    Baseline, 4½ month and 6 months after end of intervention period

  • Self-management

    Baseline, 4½ month and 6 months after end of intervention period

  • Self-management

    Baseline, 4½ month and 6 months after end of intervention period

  • Self-management

    Baseline, 4½ month and 6 months after end of intervention period

Study Arms (2)

Intervention group

EXPERIMENTAL

Intervention arm : EMMA consultations

Behavioral: EMMA

Control group

NO INTERVENTION

Control arm: Usual care/consultations

Interventions

EMMABEHAVIORAL

Consultations using dialogue tools

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Participating in other intervention research projects during the trial period
  • Being treated by a psychiatrist or psychologist during the period
  • Reduced sight or blindness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gitte R Husted

Gentofte Municipality, 2820, Denmark

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Gitte R Husted, PhD

    Steno Diabetes Center, Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gitte R Husted, PhD

CONTACT

4530753035grhu@steno.dk

Bjarne B Jensen, Professor

CONTACT

4544436449bjbj@steno.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher PhD

Study Record Dates

First Submitted

November 5, 2014

First Posted

November 20, 2014

Study Start

November 1, 2014

Primary Completion

August 1, 2017

Study Completion

November 1, 2017

Last Updated

November 21, 2014

Record last verified: 2014-11

Locations

DK(1)