SMS Reminder to Assess Adherence
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01308476
First received: March 1, 2011
Last updated: January 17, 2013
Last verified: January 2013
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Purpose
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
| Condition | Intervention |
|---|---|
|
Pulmonary Disease, Chronic Obstructive |
Procedure: SMS reminder Procedure: control group |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Assessment if a Daily SMS (Short Message System) Reminder Improves the Adherence of COPD Patients to Therapy With Spiriva® 18 Microgram |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- Adherence to Spiriva HandiHaler Over Time [ Time Frame: Baseline, Week 8, Week 12, Week 16, Week 20 and Week 24 ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Change From Baseline in Adherence to Spiriva HandiHaler Over Time [ Time Frame: Week 8, Week 12, Week 16, Week 20 and Week 24 ] [ Designated as safety issue: No ]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.
- Response Rate Regarding Adherence [ Time Frame: 24 weeks ]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.
- Patients Compliance With SMS System [ Time Frame: 24 weeks ]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.
- Patients Assessment of Usefulness of the SMS System [ Time Frame: Visit 2 (12 weeks) and visit 3 (24 weeks) ]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.
- Physicians Assessment of Usefulness of the SMS System [ Time Frame: Visit 2 (12 weeks) and visit 3 (24 weeks) ]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.
- Physicians Recommendation of the SMS System [ Time Frame: Visit 2 (12 weeks) and visit 3 (24 weeks) ]Only physicians of patients in the SMS reminder group were asked if they would recommend the SMS system (no, yes, don't know)
- Patients Satisfaction With SMS System [ Time Frame: Visit 2 (12 weeks) and visit 3 (24 weeks) ]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.
| Enrollment: | 95 |
| Study Start Date: | March 2011 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| SMS group |
Procedure: SMS reminder
daily SMS in the SMS group to remind of treatment with tiotropium
|
| control group |
Procedure: control group
no daily SMS to remind of treatment with tiotropium
|
Detailed Description:
Purpose:
Study Design:
observational
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01308476
Locations
| Germany | |
| 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 | |
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
Related Info 
No publications provided
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01308476 History of Changes |
| Other Study ID Numbers: | 205.474 |
| Study First Received: | March 1, 2011 |
| Results First Received: | November 20, 2012 |
| Last Updated: | January 17, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Chronic Disease Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive |
Disease Attributes Pathologic Processes Respiratory Tract Diseases Lung Diseases, Obstructive |
ClinicalTrials.gov processed this record on May 19, 2013