SMS Reminder to Assess Adherence
Assessment if a Daily SMS (Short Message System) Reminder Improves the Adherence of COPD Patients to Therapy With Spiriva® 18 Microgram
1 other identifier
observational
95
1 country
5
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2011
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedFirst Posted
Study publicly available on registry
March 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedResults Posted
Study results publicly available
December 21, 2012
CompletedJanuary 18, 2013
January 1, 2013
8 months
March 1, 2011
November 20, 2012
January 17, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Change From Baseline in Adherence to Spiriva HandiHaler Over Time
Week 8, Week 12, Week 16, Week 20 and Week 24
Response Rate Regarding Adherence
24 weeks
Patients Compliance With SMS System
24 weeks
Patients Assessment of Usefulness of the SMS System
Visit 2 (12 weeks) and visit 3 (24 weeks)
Physicians Assessment of Usefulness of the SMS System
Visit 2 (12 weeks) and visit 3 (24 weeks)
- +2 more secondary outcomes
Study Arms (2)
SMS group
control group
Interventions
Eligibility Criteria
Patients
You may qualify if:
- Chronic obstructive pulmonary disease (COPD) patients requiring long-acting bronchodilators according to approved Summary of Product Characteristics (SPC) and guidelines
- User of mobile phone
You may not qualify if:
- \- Patients presenting with the general and specific contraindications listed in the Patient Information Leaflet and the SPC
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
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
Boehringer Ingelheim Investigational Site 5
Lübeck, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim Call Center
- Organization
- Boehringer Ingelheim Pharmaceuticals
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2011
First Posted
March 4, 2011
Study Start
March 1, 2011
Primary Completion
November 1, 2011
Last Updated
January 18, 2013
Results First Posted
December 21, 2012
Record last verified: 2013-01