Diabetes and Travel: Evaluation of a Diabetes Education Module - a Randomized Controlled Trial (PRIMO_Travel) (PRIMO_Travel)

August 7, 2019 updated by: Norbert Hermanns, Forschungsinstitut der Diabetes Akademie Mergentheim

A Prospective Multi-center Evaluation of a Diabetes Education Module Specifically Addressing the Topic "Diabetes and Travel" 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 travel". Primary outcome variable is diabetes-specific empowerment regarding diabetes and travel. Secondary outcome variables are: diabetes-related distress, health-related quality of life, depressive symptoms, self-care behavior, and glycemic control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

262

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Mergentheim, Germany, 97980
        • Research Institute of the Diabetes Academy Mergentheim (FIDAM)
      • Hamburg, Germany, 21029
        • Zentrum für Diabetologie Bergedorf
      • Ludwigsburg, Germany, 71634
        • Diabeteszentrum Ludwigsburg
      • Neuss, Germany, 41462
        • Diabetologische Schwerpunktpraxis Neuss

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Waiting-list control group
Patients in the control group will get the education with the education module after completion of the 6-month follow-up
Experimental: Education - Diabetes and Travel
Patients randomized to this arm, will participate immediately in the education module "Diabetes and Travel"
Behavioral: Education - Diabetes and Travel
Based on the treatment and education programme PRIMAS a problem-specific education module regarding "Diabetes and Travel" was created. The module covers specific and detailed aspects of the topic "travel" such as insulin adaption to intercontinental flights, dealing with exotic food, and treatment goals during vacation. With this module, a more comprehensive education of patients with specific interest is possible.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The Diabetes Empowerment Scale was specifically adjusted to cover the topic "travel". Psychometric criteria for these adjusted scale were evaluated in an independent study.
Baseline, 2-week follow-up , 6-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in glycemic control (HbA1c) at the 2-week and 6-month follow-up
Time Frame: baseline, 2-week follow-up, 6-month follow-up
HbA1c will be analyzed in a central laboratory.
baseline, 2-week follow-up, 6-month follow-up
Change from baseline in health-related quality of life on the EQ-5D at the 2-week and 6-month follow-up
Time Frame: baseline, 2-week follow-up, 6-month follow-up
baseline, 2-week follow-up, 6-month follow-up
Change from baseline in quality of life on the WHO-5 at the 2-week and 6-month follow-up
Time Frame: baseline, 2-week follow-up, 6-month follow-up
baseline, 2-week follow-up, 6-month follow-up
Change from baseline in self-efficacy on the General Self-Efficacy Scale (GSE) the 2-week and 6-month follow-up
Time Frame: baseline, 2-week follow-up, 6-month follow-up
baseline, 2-week follow-up, 6-month follow-up
Change from baseline in general diabetes-distress at the 2-week and 6-month follow-up
Time Frame: baseline, 2-week follow-up, 6-month follow-up
baseline, 2-week follow-up, 6-month follow-up
Change from baseline in depressive symptoms on the CES-D at the 2-week and 6-month follow-up
Time Frame: baseline, 2-week follow-up, 6-month follow-up
baseline, 2-week follow-up, 6-month follow-up
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
Time Frame: baseline, 2-week follow-up, 6-month follow-up
The PAID scale was specifically adapted to cover the topic "travel". Psychometric quality was assessed in an independent study
baseline, 2-week follow-up, 6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forschungsinstitut der Diabetes Akademie Mergentheim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

February 28, 2014

First Submitted That Met QC Criteria

February 28, 2014

First Posted (Estimate)

March 4, 2014

Study Record Updates

Last Update Posted (Actual)

August 9, 2019

Last Update Submitted That Met QC Criteria

August 7, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NH022014_2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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