SMS Reminder to Assess Adherence

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01308476
• Other study ID #: 205.474
• Status: Completed
• Phase: N/A
• First received: March 1, 2011
• Last updated: January 17, 2013
• Start date: March 2011

Study information

• Verified date: January 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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

Description:

Purpose:

Study Design:

observational

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Disease
• Pulmonary Disease, Chronic Obstructive

Intervention

Procedure:
• SMS reminder
daily SMS in the SMS group to remind of treatment with tiotropium
• control group
no daily SMS to remind of treatment with tiotropium

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)