SMS Reminder to Assess Adherence

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Procedure: SMS reminder; Procedure: control group

• Registration Number: NCT01308476
• Lead Sponsor: Boehringer Ingelheim

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

Detailed Description

Purpose:

Study Design:

observational

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-01
• Study First Submitted QC: 2011-03-03
• Study First Posted: 2011-03-04
• Primary Completion: 2011-11
• Results First Submitted: 2012-11-20
• Results First Submitted QC: 2012-11-20
• Results First Posted: 2012-12-21
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-17
• Last Update Posted: 2013-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SMS group	SMS reminder	-
control group	control group	-

Primary Outcome Measures

Name	Time	Method
Adherence to Spiriva HandiHaler Over Time	Baseline, Week 8, Week 12, Week 16, Week 20 and Week 24	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

Name	Time	Method
Change From Baseline in Adherence to Spiriva HandiHaler Over Time	Week 8, Week 12, Week 16, Week 20 and Week 24	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	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	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	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	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	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	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.

Trial Locations

Locations (5)

Boehringer Ingelheim Investigational Site 3; 🇩🇪 Hamburg, Germany

Boehringer Ingelheim Investigational Site 1; 🇩🇪 Berlin, Germany

Boehringer Ingelheim Investigational Site 5; 🇩🇪 Lübeck, Germany

Boehringer Ingelheim Investigational Site 2; 🇩🇪 Cottbus, Germany

Boehringer Ingelheim Investigational Site 4; 🇩🇪 Koblenz, Germany