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

NCT ID: NCT02077686

Last Updated: 2019-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 262 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2019-07-31

Brief 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 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.

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Education - Diabetes and Travel

Patients randomized to this arm, will participate immediately in the education module "Diabetes and Travel"

Group Type: EXPERIMENTAL

Education - Diabetes and Travel

Intervention Type: BEHAVIORAL

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.

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Forschungsinstitut der Diabetes Akademie Mergentheim

OTHER

Sponsor Role: lead

Responsible Party

Norbert Hermanns

Head of the Research Institut Diabetes Academy Mergentheim

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Norbert Hermanns, PhD

Role: PRINCIPAL_INVESTIGATOR

Forschungsinstitut der Diabetes Akademie Mergentheim

Locations

Research Institute of the Diabetes Academy Mergentheim (FIDAM)

Bad Mergentheim, , Germany

Zentrum für Diabetologie Bergedorf

Hamburg, , Germany

Diabeteszentrum Ludwigsburg

Ludwigsburg, , Germany

Diabetologische Schwerpunktpraxis Neuss

Neuss, , Germany

Countries

Germany

Other Identifiers

NH022014_2

Identifier Type: -

Identifier Source: org_study_id