NCT02077686

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

A Prospective Multi-center Evaluation of a Diabetes Education Module Specifically Addressing the Topic "Diabetes and Travel" in a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 262 (actual)
• Sponsor: Forschungsinstitut der Diabetes Akademie Mergentheim · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-02-01
• Primary completion: 2019-01-01
• Completion: 2019-07-01
• First posted: 2014-03-04
• Last updated: 2019-08-09

Locations

4 sites across 1 country: Germany