Pulmonary Disease, Chronic Obstructive
Conditions
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
Interventions
PROCEDURESMS reminder
daily SMS in the SMS group to remind of treatment with tiotropium
PROCEDUREcontrol group
no daily SMS to remind of treatment with tiotropium
Sponsors
Boehringer Ingelheim
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Germany
Participant flow
Recruitment details
Patients who participated in this study had to have access to a mobile phone since a SMS (short message service) / IVR (interactive voice response) system was used to remind to medication intake and to evaluate the adherence to Spiriva HandiHaler.
Pre-assignment details
Non-interventional controlled pilot study with two parallel groups.
Participants by arm
| Arm | Count |
|---|---|
| SMS Reminder Group Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler. | 48 |
| Control Group Control group with same medication but not receiving reminder SMS. | 47 |
| Total | 95 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Other | 1 | 0 |
Baseline characteristics
| Characteristic | SMS Reminder Group | Control Group | Total |
|---|---|---|---|
| Age Continuous | 62.6 Years STANDARD_DEVIATION 7.3 | 63.2 Years STANDARD_DEVIATION 8.1 | 62.9 Years STANDARD_DEVIATION 7.7 |
| Sex: Female, Male Female | 15 Participants | 17 Participants | 32 Participants |
| Sex: Female, Male Male | 33 Participants | 30 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 48 | 0 / 47 |
| serious Total, serious adverse events | 2 / 48 | 2 / 47 |
Outcome results
Primary
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.
Time frame: Baseline, Week 8, Week 12, Week 16, Week 20 and Week 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SMS Reminder Group | Adherence to Spiriva HandiHaler Over Time | Baseline | 99.0 Percentage of applications | Standard Deviation 5.4 |
| SMS Reminder Group | Adherence to Spiriva HandiHaler Over Time | Week 8 (N=28, 29) | 99.5 Percentage of applications | Standard Deviation 2.7 |
| SMS Reminder Group | Adherence to Spiriva HandiHaler Over Time | Week 12 (N=20, 30) | 100.0 Percentage of applications | Standard Deviation 0 |
| SMS Reminder Group | Adherence to Spiriva HandiHaler Over Time | Week 16 (N=25, 29) | 100.0 Percentage of applications | Standard Deviation 0 |
| SMS Reminder Group | Adherence to Spiriva HandiHaler Over Time | Week 20 (N=27, 29) | 100.0 Percentage of applications | Standard Deviation 0 |
| SMS Reminder Group | Adherence to Spiriva HandiHaler Over Time | Week 24 (N=26, 30) | 99.5 Percentage of applications | Standard Deviation 2.8 |
| Control Group | Adherence to Spiriva HandiHaler Over Time | Week 20 (N=27, 29) | 95.1 Percentage of applications | Standard Deviation 18.8 |
| Control Group | Adherence to Spiriva HandiHaler Over Time | Baseline | 96.2 Percentage of applications | Standard Deviation 12.5 |
| Control Group | Adherence to Spiriva HandiHaler Over Time | Week 16 (N=25, 29) | 96.1 Percentage of applications | Standard Deviation 14.2 |
| Control Group | Adherence to Spiriva HandiHaler Over Time | Week 8 (N=28, 29) | 99.5 Percentage of applications | Standard Deviation 2.7 |
| Control Group | Adherence to Spiriva HandiHaler Over Time | Week 24 (N=26, 30) | 95.7 Percentage of applications | Standard Deviation 18.4 |
| Control Group | Adherence to Spiriva HandiHaler Over Time | Week 12 (N=20, 30) | 98.6 Percentage of applications | Standard Deviation 7.8 |
Secondary
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.
Time frame: Week 8, Week 12, Week 16, Week 20 and Week 24
Population: FAS. Only subjects who responded to the SMS/ IVR system were considered in this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SMS Reminder Group | Change From Baseline in Adherence to Spiriva HandiHaler Over Time | Week 16 (N=20, 20) | 0.0 Percent change | Standard Deviation 0 |
| SMS Reminder Group | Change From Baseline in Adherence to Spiriva HandiHaler Over Time | Week 20 (N=20, 21) | 0.0 Percent change | Standard Deviation 0 |
| SMS Reminder Group | Change From Baseline in Adherence to Spiriva HandiHaler Over Time | Week 12 (N=15, 23) | 0.0 Percent change | Standard Deviation 0 |
| SMS Reminder Group | Change From Baseline in Adherence to Spiriva HandiHaler Over Time | Week 24 (N=21, 23) | 0.0 Percent change | Standard Deviation 0 |
| SMS Reminder Group | Change From Baseline in Adherence to Spiriva HandiHaler Over Time | Week 8 | 0.6 Percent change | Standard Deviation 3 |
| Control Group | Change From Baseline in Adherence to Spiriva HandiHaler Over Time | Week 24 (N=21, 23) | -1.2 Percent change | Standard Deviation 9.5 |
| Control Group | Change From Baseline in Adherence to Spiriva HandiHaler Over Time | Week 8 | 3.7 Percent change | Standard Deviation 12.3 |
| Control Group | Change From Baseline in Adherence to Spiriva HandiHaler Over Time | Week 12 (N=15, 23) | 2.5 Percent change | Standard Deviation 16.5 |
| Control Group | Change From Baseline in Adherence to Spiriva HandiHaler Over Time | Week 20 (N=20, 21) | -1.4 Percent change | Standard Deviation 11 |
| Control Group | Change From Baseline in Adherence to Spiriva HandiHaler Over Time | Week 16 (N=20, 20) | 0.7 Percent change | Standard Deviation 22 |
Secondary
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.
Time frame: Visit 2 (12 weeks) and visit 3 (24 weeks)
Population: FAS for SMS reminder group only
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SMS Reminder Group | Patients Assessment of Usefulness of the SMS System | Very helpful (week 12) | 12.8 Percentage of participants |
| SMS Reminder Group | Patients Assessment of Usefulness of the SMS System | Helpful (week 12) | 61.7 Percentage of participants |
| SMS Reminder Group | Patients Assessment of Usefulness of the SMS System | Not helpful (week 12) | 23.4 Percentage of participants |
| SMS Reminder Group | Patients Assessment of Usefulness of the SMS System | Missing (week 12) | 2.1 Percentage of participants |
| SMS Reminder Group | Patients Assessment of Usefulness of the SMS System | Very helpful (week 24), N=45 | 8.9 Percentage of participants |
| SMS Reminder Group | Patients Assessment of Usefulness of the SMS System | Helpful (week 24), N=45 | 53.3 Percentage of participants |
| SMS Reminder Group | Patients Assessment of Usefulness of the SMS System | Not helpful (week 24), N=45 | 33.3 Percentage of participants |
| SMS Reminder Group | Patients Assessment of Usefulness of the SMS System | Missing (week 24), N=45 | 4.4 Percentage of participants |
Secondary
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.
Time frame: 24 weeks
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SMS Reminder Group | Patients Compliance With SMS System | 55.0 Percentage of participants answers | Standard Deviation 39.8 |
| Control Group | Patients Compliance With SMS System | 64.1 Percentage of participants answers | Standard Deviation 38.3 |
Secondary
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.
Time frame: Visit 2 (12 weeks) and visit 3 (24 weeks)
Population: FAS for SMS reminder group only
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SMS Reminder Group | Patients Satisfaction With SMS System | Very good (week 12) | 23.4 Percantage of participants |
| SMS Reminder Group | Patients Satisfaction With SMS System | Good (week 12) | 42.6 Percantage of participants |
| SMS Reminder Group | Patients Satisfaction With SMS System | Satisfactory (week 12) | 21.3 Percantage of participants |
| SMS Reminder Group | Patients Satisfaction With SMS System | Sufficient (week 12) | 6.4 Percantage of participants |
| SMS Reminder Group | Patients Satisfaction With SMS System | Deficient (week 12) | 2.1 Percantage of participants |
| SMS Reminder Group | Patients Satisfaction With SMS System | Insufficient (week 12) | 4.3 Percantage of participants |
| SMS Reminder Group | Patients Satisfaction With SMS System | Very good (week 24), N=45 | 15.6 Percantage of participants |
| SMS Reminder Group | Patients Satisfaction With SMS System | Good (week 24), N=45 | 37.8 Percantage of participants |
| SMS Reminder Group | Patients Satisfaction With SMS System | Satisfactory (week 24), N=45 | 28.9 Percantage of participants |
| SMS Reminder Group | Patients Satisfaction With SMS System | Sufficient (week 24), N=45 | 11.1 Percantage of participants |
| SMS Reminder Group | Patients Satisfaction With SMS System | Deficient (week 24), N=45 | 4.4 Percantage of participants |
| SMS Reminder Group | Patients Satisfaction With SMS System | Insufficient (week 24), N=45 | 2.2 Percantage of participants |
Secondary
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.
Time frame: Visit 2 (12 weeks) and visit 3 (24 weeks)
Population: FAS for SMS reminder group only
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SMS Reminder Group | Physicians Assessment of Usefulness of the SMS System | Very helpful (week 12) | 6.4 Percentage of participants |
| SMS Reminder Group | Physicians Assessment of Usefulness of the SMS System | Helpful (week 12) | 87.2 Percentage of participants |
| SMS Reminder Group | Physicians Assessment of Usefulness of the SMS System | Not helpful (week 12) | 6.4 Percentage of participants |
| SMS Reminder Group | Physicians Assessment of Usefulness of the SMS System | Missing (week 12) | 0.0 Percentage of participants |
| SMS Reminder Group | Physicians Assessment of Usefulness of the SMS System | Very helpful (week 24), N=45 | 11.1 Percentage of participants |
| SMS Reminder Group | Physicians Assessment of Usefulness of the SMS System | Helpful (week 24), N=45 | 80.0 Percentage of participants |
| SMS Reminder Group | Physicians Assessment of Usefulness of the SMS System | Not helpful (week 24), N=45 | 6.7 Percentage of participants |
| SMS Reminder Group | Physicians Assessment of Usefulness of the SMS System | Missing (week 24), N=45 | 2.2 Percentage of participants |
Secondary
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)
Time frame: Visit 2 (12 weeks) and visit 3 (24 weeks)
Population: FAS for SMS reminder group only
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SMS Reminder Group | Physicians Recommendation of the SMS System | No (week 12) | 8.5 Percentage of participants |
| SMS Reminder Group | Physicians Recommendation of the SMS System | Yes (week 12) | 70.2 Percentage of participants |
| SMS Reminder Group | Physicians Recommendation of the SMS System | Don't know (week 12) | 21.3 Percentage of participants |
| SMS Reminder Group | Physicians Recommendation of the SMS System | No (week 24), N=45 | 8.9 Percentage of participants |
| SMS Reminder Group | Physicians Recommendation of the SMS System | Yes (week 24), N=45 | 64.4 Percentage of participants |
| SMS Reminder Group | Physicians Recommendation of the SMS System | Don't know (week 24), N=45 | 26.7 Percentage of participants |
Secondary
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.
Time frame: 24 weeks
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SMS Reminder Group | Response Rate Regarding Adherence | yes (adherent) | 55.3 Percentage of participants |
| SMS Reminder Group | Response Rate Regarding Adherence | no (not adherent) | 44.7 Percentage of participants |
| Control Group | Response Rate Regarding Adherence | yes (adherent) | 64.4 Percentage of participants |
| Control Group | Response Rate Regarding Adherence | no (not adherent) | 35.6 Percentage of participants |