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EMMA: Empowerment, Motivation and Medical Adherence (EMMA)

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ClinicalTrials.gov Identifier: NCT02295696
Recruitment Status : Unknown
Verified November 2014 by Gitte Reventlov Husted, Steno Diabetes Center Copenhagen.
Recruitment status was:  Recruiting
First Posted : November 20, 2014
Last Update Posted : November 21, 2014
Sponsor:
Information provided by (Responsible Party):
Gitte Reventlov Husted, Steno Diabetes Center Copenhagen

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: EMMA Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: EMMA: Empowerment, Motivation and Medical Adherence
Study Start Date : November 2014
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : November 2017

Arm Intervention/treatment
Experimental: Intervention group
Intervention arm : EMMA consultations
Behavioral: EMMA
Consultations using dialogue tools

No Intervention: Control group
Control arm: Usual care/consultations



Primary Outcome Measures :
  1. HbA1c [ Time Frame: Baseline, 4½ month and 6 months after end of intervention period ]
    Change from baseline in HbA1c at 4½ month which is maintained or improved at 6 months


Secondary Outcome Measures :
  1. Self-management [ Time Frame: Baseline, 4½ month and 6 months after end of intervention period ]
    Change 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

  2. Self-management [ Time Frame: Baseline, 4½ month and 6 months after end of intervention period ]
    Change from baseline in Self-management skills at 4½ month assessed by increase in the Health Care Climate Questionnaire (HCCC scale) which is maintained or improved at 6 months

  3. Self-management [ Time Frame: Baseline, 4½ month and 6 months after end of intervention period ]
    Change from baseline in Self-management skills at 4½ month assessed by decrease in the Problem Areas in Diabetes Questionnaire (PAID scale) which is maintained or improved at 6 months

  4. Self-management [ Time Frame: Baseline, 4½ month and 6 months after end of intervention period ]
    Change from baseline in Self-management skills at 4½ month assessed by increase in The WHO5 Wellbeing Questionnaire (WHO5 scale) which is maintained or improved at 6 months

  5. Self-management [ Time Frame: Baseline, 4½ month and 6 months after end of intervention period ]
    Change from baseline in Self-management skills at 4½ month assessed by increase in the Treament Self-Regulation Questionnaire (TSRQ scale) which is maintained or improved at 6 months



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02295696


Contacts
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Contact: Gitte R Husted, PhD 4530753035 grhu@steno.dk
Contact: Bjarne B Jensen, Professor 4544436449 bjbj@steno.dk

Locations
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Denmark
Gitte R Husted Recruiting
Gentofte, Denmark, 2820
Contact: Gitte R Husted, PhD    4530753035    grhu@steno.dk   
Sponsors and Collaborators
Steno Diabetes Center Copenhagen
Investigators
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Principal Investigator: Gitte R Husted, PhD Steno Diabetes Center, Denmark
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Responsible Party: Gitte Reventlov Husted, Researcher PhD, Steno Diabetes Center Copenhagen
ClinicalTrials.gov Identifier: NCT02295696    
Other Study ID Numbers: grhu
First Posted: November 20, 2014    Key Record Dates
Last Update Posted: November 21, 2014
Last Verified: November 2014
Keywords provided by Gitte Reventlov Husted, Steno Diabetes Center Copenhagen:
Adults, dialogue tools, outpatient clinic visits
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases