Clinical trial NCT02077686: Diabetes and Travel: Evaluation of a Diabetes Education Module - a Randomized Controlled Trial (PRIMO_Travel)
Official title: A Prospective Multi-center Evaluation of a Diabetes Education Module Specifically Addressing the Topic "Diabetes and Travel" in a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: diabetes
education
randomized
prospective
Lead sponsor: Forschungsinstitut der Diabetes Akademie Mergentheim
Sponsor class: OTHER
First posted: 2014-03-04
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline in diabetes-specific empowerment on the adapted Diabetes Empowerment Scale at the 2-week and 6-month follow-up
timeFrame: Baseline, 2-week follow-up , 6-month follow-up
Secondary outcomes:
measure: 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
timeFrame: baseline, 2-week follow-up, 6-month follow-up
measure: Change from baseline in glycemic control (HbA1c) at the 2-week and 6-month follow-up
timeFrame: baseline, 2-week follow-up, 6-month follow-up
measure: Change from baseline in health-related quality of life on the EQ-5D at the 2-week and 6-month follow-up
timeFrame: baseline, 2-week follow-up, 6-month follow-up
measure: Change from baseline in quality of life on the WHO-5 at the 2-week and 6-month follow-up
timeFrame: baseline, 2-week follow-up, 6-month follow-up
measure: Change from baseline in self-efficacy on the General Self-Efficacy Scale (GSE) the 2-week and 6-month follow-up
timeFrame: baseline, 2-week follow-up, 6-month follow-up
measure: Change from baseline in general diabetes-distress at the 2-week and 6-month follow-up
timeFrame: baseline, 2-week follow-up, 6-month follow-up
measure: Change from baseline in depressive symptoms on the CES-D at the 2-week and 6-month follow-up
timeFrame: baseline, 2-week follow-up, 6-month follow-up
Other outcomes:
Locations:
city: Bad Mergentheim
country: Germany
facility: Research Institute of the Diabetes Academy Mergentheim (FIDAM)
city: Hamburg
country: Germany
facility: Zentrum für Diabetologie Bergedorf
city: Ludwigsburg
country: Germany
facility: Diabeteszentrum Ludwigsburg
city: Neuss
country: Germany
facility: Diabetologische Schwerpunktpraxis Neuss
Study officials:
affiliation: Forschungsinstitut der Diabetes Akademie Mergentheim
name: Norbert Hermanns, PhD
role: PRINCIPAL_INVESTIGATOR
References: