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

Diabetes Mellitus Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02077686
• Other study ID #: NH022014_2
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: July 2019

Study information

• Verified date: August 2019
• Source: Forschungsinstitut der Diabetes Akademie Mergentheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: July 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
Germany	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

Sponsors (1)

Lead Sponsor	Collaborator
Forschungsinstitut der Diabetes Akademie Mergentheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in diabetes-specific empowerment on the adapted Diabetes Empowerment Scale at the 2-week and 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	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	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
Secondary	Change from baseline in glycemic control (HbA1c) at the 2-week and 6-month follow-up	HbA1c will be analyzed in a central laboratory.	baseline, 2-week follow-up, 6-month follow-up
Secondary	Change from baseline in health-related quality of life on the EQ-5D at the 2-week and 6-month follow-up		baseline, 2-week follow-up, 6-month follow-up
Secondary	Change from baseline in quality of life on the WHO-5 at the 2-week and 6-month follow-up		baseline, 2-week follow-up, 6-month follow-up
Secondary	Change from baseline in self-efficacy on the General Self-Efficacy Scale (GSE) the 2-week and 6-month follow-up		baseline, 2-week follow-up, 6-month follow-up
Secondary	Change from baseline in general diabetes-distress at the 2-week and 6-month follow-up		baseline, 2-week follow-up, 6-month follow-up
Secondary	Change from baseline in depressive symptoms on the CES-D at the 2-week and 6-month follow-up		baseline, 2-week follow-up, 6-month follow-up