SMS Reminder to Assess Adherence

January 17, 2013 updated by: Boehringer Ingelheim

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Purpose:

Study Design:

observational

Study Type

Observational

Enrollment (Actual)

95

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Boehringer Ingelheim Investigational Site 1
      • Cottbus, Germany
        • Boehringer Ingelheim Investigational Site 2
      • Hamburg, Germany
        • Boehringer Ingelheim Investigational Site 3
      • Koblenz, Germany
        • Boehringer Ingelheim Investigational Site 4
      • Lübeck, Germany
        • Boehringer Ingelheim Investigational Site 5

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
control group
Procedure: control group
no daily SMS to remind of treatment with tiotropium
SMS group
Procedure: SMS reminder
daily SMS in the SMS group to remind of treatment with tiotropium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to Spiriva HandiHaler Over Time
Time Frame: 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.
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
Time Frame: 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.
Week 8, Week 12, Week 16, Week 20 and Week 24
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.
24 weeks
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.
24 weeks
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.
Visit 2 (12 weeks) and visit 3 (24 weeks)
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.
Visit 2 (12 weeks) and visit 3 (24 weeks)
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)
Visit 2 (12 weeks) and visit 3 (24 weeks)
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.
Visit 2 (12 weeks) and visit 3 (24 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ACTUAL)

November 1, 2011

Study Registration Dates

First Submitted

March 1, 2011

First Submitted That Met QC Criteria

March 3, 2011

First Posted (ESTIMATE)

March 4, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

January 18, 2013

Last Update Submitted That Met QC Criteria

January 17, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 205.474

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pulmonary Disease, Chronic Obstructive

Clinical Trials on SMS reminder

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe