6 months open label non-interventional observational study acc to § 4, section 23 and § 67, section 6 German Medicines Act with two parallel groups 1. the SMS group receiving a daily SMS - a reminder to inhale Spiriva® 18 Microgram 2. the control group not receiving a daily SMS reminder
Purpose: Study Design: observational
Study Type
OBSERVATIONAL
Enrollment
95
daily SMS in the SMS group to remind of treatment with tiotropium
no daily SMS to remind of treatment with tiotropium
Boehringer Ingelheim Investigational Site 1
Berlin, Germany
Boehringer Ingelheim Investigational Site 2
Cottbus, Germany
Boehringer Ingelheim Investigational Site 3
Hamburg, Germany
Boehringer Ingelheim Investigational Site 4
Koblenz, Germany
Adherence to Spiriva HandiHaler Over Time
Adherence was defined as percentage of documented applications of Spiriva HandiHaler as compared to the regularly planned seven applications during the week before questioning the patients. Patients in the SMS reminder group and in the control group were asked via SMS how often they had used Spiriva HandiHaler during the last week and were requested to call the IVR system to provide their response. Baseline was defined as week 4.
Time frame: Baseline, Week 8, Week 12, Week 16, Week 20 and Week 24
Change From Baseline in Adherence to Spiriva HandiHaler Over Time
Adherence was defined as percentage of documented applications of Spiriva HandiHaler as compared to the regularly planned seven applications during the week before questioning the patients. Patients in the SMS reminder group and in the control group were asked via SMS how often they had used Spiriva HandiHaler during the last week and were requested to call the IVR system to provide their response. Baseline was defined as week 4.
Time frame: Week 8, Week 12, Week 16, Week 20 and Week 24
Response Rate Regarding Adherence
Adherence was dichotomised into yes and no at the end of study depending on whether the percentage of adherence was at least 80 percent or less than 80 percent, respectively. Patients who did not respond to the SMS/ IVR system to provide information about the actual number of inhalations were considered with 0 percent adherence.
Time frame: 24 weeks
Patients Compliance With SMS System
Compliance was defined as the percentage of patients answers to the IVR system as compared to the number of SMS automatically sent to the patients by the SMS/ IVR system asking for the number of Spiriva HandiHaler applications.
Time frame: 24 weeks
Patients Assessment of Usefulness of the SMS System
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Boehringer Ingelheim Investigational Site 5
Lübeck, Germany
Only patients in the SMS reminder group were asked to assess the usefulness of the SMS system by the categories very helpful, helpful and not helpful.
Time frame: Visit 2 (12 weeks) and visit 3 (24 weeks)
Physicians Assessment of Usefulness of the SMS System
Only physicians of patients in the SMS reminder group were asked to assess the usefulness of the SMS system by the categories very helpful, helpful and not helpful.
Time frame: Visit 2 (12 weeks) and visit 3 (24 weeks)
Physicians Recommendation of the SMS System
Only physicians of patients in the SMS reminder group were asked if they would recommend the SMS system (no, yes, don't know)
Time frame: Visit 2 (12 weeks) and visit 3 (24 weeks)
Patients Satisfaction With SMS System
Only patients in the SMS group were asked to assess their satisfaction with the SMS system by assigning German school grades 1=very good, 2=good, 3=satisfactory, 4=sufficient, 5=deficient, 6=insufficient.
Time frame: Visit 2 (12 weeks) and visit 3 (24 weeks)