Pulmonary Disease, Chronic ObstructiveNCT01308476

SMS Reminder to Assess Adherence

An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 5 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: SMS reminder
Type of treatment: Surgery or procedure
How many people: 95 participants
Where: 5 sitesGermany
Study dates: Mar 2011to Nov 2011
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients

Who may be able to join

Chronic obstructive pulmonary disease (COPD) patients requiring long-acting bronchodilators according to approved Summary of Product Characteristics (SPC) and guidelines
User of mobile phone

Who cannot join

Patients presenting with the general and specific contraindications listed in the Patient Information Leaflet and the SPC

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Germany5 sites

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

Other trials in Germany

About this study

Official title: 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

the SMS group receiving a daily SMS - a reminder to inhale Spiriva® 18 Microgram
the control group not receiving a daily SMS reminder

Read the detailed description

Purpose:

Study Design:

observational

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: SMS reminder, control group
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SMS reminderProcedure or surgery
daily SMS in the SMS group to remind of treatment with tiotropium
control groupProcedure or surgery
no daily SMS to remind of treatment with tiotropium

Study groups in NCT01308476
Study group	Role	What they receive
SMS group		Not described Receives: Procedure: SMS reminder
control group		Not described Receives: Procedure: control group

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, Week 8, Week 12, Week 16, Week 20 and Week 24

Secondary outcomes (7)

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.
Measured: Week 8, Week 12, Week 16, Week 20 and Week 24
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.
Measured: 24 weeks
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.
Measured: 24 weeks
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.
Measured: Visit 2 (12 weeks) and visit 3 (24 weeks)
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.
Measured: Visit 2 (12 weeks) and visit 3 (24 weeks)
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)
Measured: Visit 2 (12 weeks) and visit 3 (24 weeks)
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.
Measured: Visit 2 (12 weeks) and visit 3 (24 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2011Nov 2011

First posted4 Mar 2011 (estimated)
Study startMar 2011
Primary completionNov 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Time perspective: Prospective
Enrolment: 95 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01308476
Sponsor's protocol ID: 205.474
Status last verified: Jan 2013
First submitted: 1 Mar 2011
Last updated: 18 Jan 2013
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment if a Daily SMS (Short Message System) Reminder Improves the Adherence of COPD Patients to Therapy With Spiriva® 18 Microgram
ClinicalTrials.gov ID: NCT01308476
Acronym / sponsor ID: 205.474
Conditions: Pulmonary Disease, Chronic Obstructive
Study type: Observational
Recruitment status: Completed
Enrolment: 95 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Mar 2011
Primary completion: Nov 2011 (actual)
First posted: 4 Mar 2011 (estimated)
Results: Posted 21 Dec 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

6 months open label non-interventional observational study acc to § 4, section 23 and § 67, section 6 German Medicines Act with two parallel groups

the SMS group receiving a daily SMS - a reminder to inhale Spiriva® 18 Microgram
the control group not receiving a daily SMS reminder

Detailed description

Purpose:

Study Design:

observational

Study design

Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
SMS group	–	Procedure: SMS reminder
control group	–	Procedure: control group

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients

Key inclusion criteria (2 listed)

Chronic obstructive pulmonary disease (COPD) patients requiring long-acting bronchodilators according to approved Summary of Product Characteristics (SPC) and guidelines
User of mobile phone

Key exclusion criteria (1 listed)

Patients presenting with the general and specific contraindications listed in the Patient Information Leaflet and the SPC

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SMS reminderdaily SMS in the SMS group to remind of treatment with tiotropium	Procedure or surgery	SMS group
control groupno daily SMS to remind of treatment with tiotropium	Procedure or surgery	control group

Primary outcome

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.

7 secondary outcomes

Change From Baseline in Adherence to Spiriva HandiHaler Over Time
Time frame: Week 8, Week 12, Week 16, Week 20 and Week 24
Response Rate Regarding Adherence
Time frame: 24 weeks
Patients Compliance With SMS System
Time frame: 24 weeks
Patients Assessment of Usefulness of the SMS System
Time frame: 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)
Physicians Recommendation of the SMS System
Time frame: 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)

Results and safety

Results posted to the registry on 21 Dec 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SMS Reminder Group	48	45
Control Group	47	45

Primary outcome: Adherence to Spiriva HandiHaler Over Time

Time frame: Baseline, Week 8, Week 12, Week 16, Week 20 and Week 24. Mean (Standard Deviation). Unit: Percentage of applications

Measure	SMS Reminder Group n = 28	Control Group n = 26
Baseline	99.0 (5.4)	96.2 (12.5)
Week 8 (N=28, 29)	99.5 (2.7)	99.5 (2.7)
Week 12 (N=20, 30)	100.0 (0.0)	98.6 (7.8)
Week 16 (N=25, 29)	100.0 (0.0)	96.1 (14.2)
Week 20 (N=27, 29)	100.0 (0.0)	95.1 (18.8)
Week 24 (N=26, 30)	99.5 (2.8)	95.7 (18.4)

Population analysed: Full Analysis Set (FAS) is defined as all treated patients who additionally met the study diagnosis (Chronic Obstructive Pulmonary Disease (COPD) requiring long-acting anticholinergics) and who had evaluable data in at least one effectiveness endpoint. Only subjects who responded to the SMS/ IVR system were considered in this analysis.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SMS Reminder Group	2 of 48 (4.2%)	0 of 48 (0%)	Not reported
Control Group	2 of 47 (4.3%)	0 of 47 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Characteristics and Outcomes of Patients Admitted to ICU for a Severe Acute Exacerbation of COPD.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 5 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence to Spiriva HandiHaler Over Time (time frame: Baseline, Week 8, Week 12, Week 16, Week 20 and Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01308476.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2013; AzTrials last refreshed its copy on 28 Oct 2026.