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Diabetes MellitusPRIMO_SocialNCT02076555

Diabetes and Social Issues: Evaluation of a Diabetes Education Module

A study testing Education - Diabetes and Social Issues in people with Diabetes Mellitus, run by Forschungsinstitut der Diabetes Akademie Mergentheim at 4 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a multi-center, randomized prospective trial with a 6-month follow up. A newly developed treatment and education module will be tested compared to a waiting-list control group. The module covers the topic "diabetes and social issues". Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diabetes Mellitus
What is being tested?
Education - Diabetes and Social Issues
Could I receive a placebo?
No, everyone receives an active treatment
How many people
256 participants
Where
4 sitesGermany
Study dates
Feb 2014to Jul 2019
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Intensive insulin treatment
  • specific interest in "Diabetes and Social Issues"
  • wish to participate in group education
  • informed consent
  • fluent in reading and speaking German language

Who cannot join

  • diabetes duration < 4 week
  • severe organic disease (e.g. terminal renal disease, cancer with poor prognosis)
  • current treatment of a mental disease
  • cognitive impairment
  • dementia
  • pregnancy

Trial locations and contacts

4 sites in 1 country.

Germany4 sites

  • Research Institute of the Diabetes Academy Mergentheim (FIDAM)

    Bad Mergentheim, 97980

  • Zentrum für Diabetologie Bergedorf

    Hamburg, 21029

  • Diabeteszentrum Ludwigsburg

    Ludwigsburg, 71634

  • Diabetologische Schwerpunktpraxis Neuss

    Neuss, 41462

Other trials in Germany

About this study

Official title: A Prospective Multi-center Evaluation of a Diabetes Education Module Specifically Addressing the Topic "Diabetes and Social Issues" in a Randomized Controlled Trial

This study is a multi-center, randomized prospective trial with a 6-month follow up. A newly developed treatment and education module will be tested compared to a waiting-list control group. The module covers the topic "diabetes and social issues". Primary outcome variable is diabetes-specific empowerment regarding diabetes and social issues. Secondary outcome variables are: diabetes-related distress, health-related quality of life, depressive symptoms, self-care behavior, and glycemic control.

Read the detailed description

The module consists of one lesson (duration: 90 minutes). The module is derived from the empowerment approach and is based on the previously evaluated education and treatment program for type 1 diabetes: PRIMAS (NCT01220557). The module is designed as a group session held by a trained diabetes educator. Patients are randomized either to the immediate participation in the module or to the control group. Control group is a waiting-list control group. Patients in this waiting-list control group get the education after the completion of the 6-month follow-up.

Being tested
Education - Diabetes and Social Issues
Keywords
diabetes, education, randomized, prospective
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Education - Diabetes and Social IssuesBehavioural

    Based on the treatment and education programme PRIMAS a problem-specific education module regarding "Diabetes and Social Issues" was created. The module covers specific and detailed aspects of the topic "social issues" such as driver licence, hypoglycemia when driving, and the pass for severly handicapped persons. With this module, a more comprehensive education of patients with specific interest is possible.

Study groups in NCT02076555
Study groupRoleWhat they receive
Education - Diabetes and Social IssuesExperimentalPatients randomized to this arm, will participate immediately in the education module "Diabetes and Social Issues"
Receives: Behavioral: Education - Diabetes and Social Issues
Waiting-list control groupNo interventionPatients in the control group will get the education with the education module after completion of the 6-month follow-up

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in diabetes-specific empowerment on the adapted Diabetes Empowerment Scale at the 2-week and 6-month follow-up

    The Diabetes Empowerment Scale was specifically adjusted to cover the topic "social issues". Psychometric criteria for these adjusted scale were evaluated in an independent study

    Measured: Baseline, 2-week follow-up , 6-month follow-up

Secondary outcomes (7)

  1. Change from baseline in problem-specific distress on the adapted Problem Areas in Diabetes (PAID) Scale at the 2-week and 6-month follow-up

    The PAID scale was specifically adapted to cover the topic "social issues". Psychometric quality was assessed in an independent study

    Measured: baseline, 2-week follow-up, 6-month follow-up

  2. Change from baseline in glycemic control (HbA1c) at the 2-week and 6-month follow-up

    HbA1c will be analyzed in a central laboratory.

    Measured: baseline, 2-week follow-up, 6-month follow-up

  3. Change from baseline in health-related quality of life on the EQ-5D at the 2-week and 6-month follow-up

    Measured: baseline, 2-week follow-up, 6-month follow-up

  4. Change from baseline in quality of life on the WHO-5 at the 2-week and 6-month follow-up

    Measured: baseline, 2-week follow-up, 6-month follow-up

  5. Change from baseline in self-efficacy on the General Self-Efficacy Scale (GSE) the 2-week and 6-month follow-up

    Measured: baseline, 2-week follow-up, 6-month follow-up

  6. Change from baseline in general diabetes-distress at the 2-week and 6-month follow-up

    Measured: baseline, 2-week follow-up, 6-month follow-up

  7. Change from baseline in depressive symptoms on the CES-D at the 2-week and 6-month follow-up

    Measured: baseline, 2-week follow-up, 6-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionJan 2019
  4. Study completionJul 2019

Resources

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
256 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02076555
Sponsor's protocol ID
NH022014_3
Acronym
PRIMO_Social
Status last verified
Aug 2019
First submitted
28 Feb 2014
Last updated
9 Aug 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Education - Diabetes and Social Issues in people with Diabetes Mellitus, run by Forschungsinstitut der Diabetes Akademie Mergentheim at 4 sites in Germany.

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 5 inclusion and 6 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: finished, as of the sponsor's last update on 9 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in diabetes-specific empowerment on the adapted Diabetes Empowerment Scale at the 2-week and 6-month follow-up (time frame: Baseline, 2-week follow-up , 6-month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02076555.

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 9 Aug 2019.

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