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

Forschungsinstitut der Diabetes Akademie Mergentheim

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Behavioral: Education - Diabetes and Travel

Study type: Interventional

Funder types: Other

Identifiers

NCT02077686

NH022014_2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 262 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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262 participants in 2 patient groups

Education - Diabetes and Travel

Experimental group

Description:

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

Treatment:

Behavioral: Education - Diabetes and Travel

Waiting-list control group

No Intervention group

Description:

Patients in the control group will get the education with the education module after completion of the 6-month follow-up