SMS Reminder to Assess Adherence

Study Overview
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Brief Summary
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6 months open label non-interventional observational study acc to § 4, section 23 and § 67, section 6 German Medicines Act with two parallel groups the SMS group receiving a daily SMS - a reminder to inhale Spiriva® 18 Microgram the control group not receiving a daily SMS reminder

Detailed Description
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Purpose: Study Design: observational

Official Title
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Assessment if a Daily SMS (Short Message System) Reminder Improves the Adherence of COPD Patients to Therapy With Spiriva® 18 Microgram

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Procedure: SMS reminder
* Procedure: control group


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Chronic obstructive pulmonary disease (COPD) patients requiring long-acting bronchodilators according to approved Summary of Product Characteristics (SPC) and guidelines User of mobile phone Exclusion criteria: - Patients presenting with the general and specific contraindications listed in the Patient Information Leaflet and the SPC

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SMS group<br> | Procedure: SMS reminder<br>* daily SMS in the SMS group to remind of treatment with tiotropium<br>|
| control group<br> | Procedure: control group<br>* no daily SMS to remind of treatment with tiotropium<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, Week 8, Week 12, Week 16, Week 20 and Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 24 weeks | 
| Patients Assessment of Usefulness of the SMS System | 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. | 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. | 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) | 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. | Visit 2 (12 weeks) and visit 3 (24 weeks) |