E11
Conditions
Interventions
Group 1: The pharmacists of the intervention group intensively guide their participants.
This support includes:
• Data is collected at baseline, after six and after twelve months comprising laboratory
Sponsors
WIPIG - Wissenschaftliches Institut für Prävention im Gesundheitswesen der Bayerischen Landesapothekerkammer
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: •Diagnosis of type 2 diabetes •HbA1c = 7% •BMI = 25 kg/m2 •Age = 18 years •At least one oral antidiabetic drug •Overall at least three prescribed medications for chronic diseases •Ability to fulfill questionnaires independently •Declaration of consent •Ability to understand German in spoken and written form in order to participate in the prevention program
Exclusion criteria
Exclusion criteria: • Inclusion criteria not fulfilled • Declaration of consent withdrawn before collection of baseline data • Treatment exclusively with insulin • Cardiovascular event in the past • Cancer / severe illness • Pregnancy • No recognition of the consequences of the study • Participation in a clinical study in the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycolated hemoglobin: The study will examine if there is a statistically significant difference between the intervention and control group (respectively comparison of baseline and follow-up data) (measurement: Alere AfinionTM AS 100 Analyzer). | — |
Secondary
| Measure | Time frame |
|---|---|
| The data is collected at baseline, after 6 months and after 12 months. • Fasting level of blood glucose: The study will examine if there is a statistically significant difference between intervention and control group (respectively the difference of fasting blood glucose levels between baseline and after twelve months). • Weight: The study will examine if there is a statistically significant difference between intervention and control group in achieving a weight reduction of at least 5 % (using pharmacist’s weighing scale). • Blood pressure: The study will examine if there is a statistically significant difference between intervention and control group (respectively difference of blood pressure between baseline and after twelve months) using pharmacist’s blood pressure monitor. • Gender-specific analysis: The study will examine by evaluating the primary and secondary outcomes if there is a difference between male and female participants. • Physical activity: The study will examine if there is a statistically significant difference between intervention and control group (respectively differences of metabolic rate and level of activity between baseline and after twelve months measured by “Freiburger Fragebogen für körperliche Aktivität“). • Life quality: The study will examine if there is a statistically significant difference between intervention and control group (respectively differences of life quality between baseline and after twelve months measured by EQ-5D-3L). • Adherence: The study will examine if there is a statistically significant difference between intervention and control group (respectively difference of adherence between baseline and after twelve months measured by MARS-D). • Medication: The study will examine, if there is a difference in medication between the intervention and control group (between baseline and after 12 months). • Drug related problems: The study will examine, if there is a statistically significant difference between intervention a | — |
Countries
Germany
Contacts
Public ContactKatja Prax
Professur für Molekulare und Klinische Pharmazie
Outcome results
None listed