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OpenTrials
Completed

NCT Number: NCT01308476

SMS Reminder to Assess Adherence

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

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boehringer Ingelheim Investigational Site 1, Berlin, Germany

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About this study

Purpose:

Study Design:

observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SMS reminder

Procedure

daily SMS in the SMS group to remind of treatment with tiotropium

Control Group

Procedure

no daily SMS to remind of treatment with tiotropium

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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)

  7. 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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
First posted
Mar 4, 2011
Registry last updated
Jan 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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