Diabetes Mellitus, Type 2EMMANCT02295696
EMMA: Empowerment, Motivation and Medical Adherence
A study testing EMMA in people with Diabetes Mellitus, Type 2, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
Trial summary
EMMA: Empowerment, Motivation and Medical Adherence. A consultation program based on dialogue tools for adults with poorly regulated Type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- EMMA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2014to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participating in other intervention research projects during the trial period
- Being treated by a psychiatrist or psychologist during the period
- Reduced sight or blindness
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Gitte R Husted
Gentofte Municipality, 2820
Gitte R Husted, PhD, 4530753035, grhu@steno.dk
About this study
EMMA: Empowerment, Motivation and Medical Adherence. A consultation program based on dialogue tools for adults with poorly regulated Type 2 diabetes.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- EMMA
- Keywords
- Adults, dialogue tools, outpatient clinic visits
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMMABehavioural
Consultations using dialogue tools
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intervention arm : EMMA consultations Receives: Behavioral: EMMA |
| Control group | No intervention | Control arm: Usual care/consultations |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Change from baseline in HbA1c at 4½ month which is maintained or improved at 6 months
Measured: Baseline, 4½ month and 6 months after end of intervention period
Secondary outcomes (5)
Self-management
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
Measured: Baseline, 4½ month and 6 months after end of intervention period
Self-management
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
Measured: Baseline, 4½ month and 6 months after end of intervention period
Self-management
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
Measured: Baseline, 4½ month and 6 months after end of intervention period
Self-management
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
Measured: Baseline, 4½ month and 6 months after end of intervention period
Self-management
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
Measured: Baseline, 4½ month and 6 months after end of intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionAug 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gitte Reventlov Husted, Steno Diabetes Center Copenhagen
- Investigators
- Gitte R Husted, PhD, Principal investigator, Steno Diabetes Center, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295696
- Sponsor's protocol ID
- grhu
- Acronym
- EMMA
- Status last verified
- Nov 2014
- First submitted
- 5 Nov 2014
- Last updated
- 21 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMMA: Empowerment, Motivation and Medical Adherence
- ClinicalTrials.gov ID
- NCT02295696
- Acronym / sponsor ID
- EMMA / grhu
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Adults, dialogue tools, outpatient clinic visits
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 20 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: EMMAIntervention arm : EMMA consultations |
| Control group | No intervention | –Control arm: Usual care/consultations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Participating in other intervention research projects during the trial period
- Being treated by a psychiatrist or psychologist during the period
- Reduced sight or blindness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMMAConsultations using dialogue tools | Behavioural | Intervention group |
Primary outcome
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
5 secondary outcomes
Self-management
Time frame: Baseline, 4½ month and 6 months after end of intervention period
Self-management
Time frame: Baseline, 4½ month and 6 months after end of intervention period
Self-management
Time frame: Baseline, 4½ month and 6 months after end of intervention period
Self-management
Time frame: Baseline, 4½ month and 6 months after end of intervention period
Self-management
Time frame: Baseline, 4½ month and 6 months after end of intervention period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gitte R Husted, PhD principal investigator
Steno Diabetes Center, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMMA in people with Diabetes Mellitus, Type 2, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gitte R Husted, PhD (4530753035, grhu@steno.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: Baseline, 4½ month and 6 months after end of intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2014.