SMS Reminder to Assess Adherence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01308476
First received: March 1, 2011
Last updated: January 17, 2013
Last verified: January 2013
  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

  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

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:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
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 July 24, 2014