Trial Outcomes & Findings for SMS Reminder to Assess Adherence (NCT NCT01308476)
NCT ID: NCT01308476
Last Updated: 2013-01-18
Results Overview
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.
COMPLETED
95 participants
Baseline, Week 8, Week 12, Week 16, Week 20 and Week 24
2013-01-18
Participant Flow
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.
Non-interventional controlled pilot study with two parallel groups.
Participant milestones
| Measure |
SMS Reminder Group
Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
|
Control Group
Control group with same medication but not receiving reminder SMS.
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
47
|
|
Overall Study
COMPLETED
|
45
|
45
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
SMS Reminder Group
Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
|
Control Group
Control group with same medication but not receiving reminder SMS.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Other
|
1
|
0
|
Baseline Characteristics
SMS Reminder to Assess Adherence
Baseline characteristics by cohort
| Measure |
SMS Reminder Group
n=48 Participants
Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
|
Control Group
n=47 Participants
Control group with same medication but not receiving reminder SMS.
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
62.6 Years
STANDARD_DEVIATION 7.3 • n=39 Participants
|
63.2 Years
STANDARD_DEVIATION 8.1 • n=41 Participants
|
62.9 Years
STANDARD_DEVIATION 7.7 • n=35 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=39 Participants
|
17 Participants
n=41 Participants
|
32 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=39 Participants
|
30 Participants
n=41 Participants
|
63 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 8, Week 12, Week 16, Week 20 and Week 24Population: 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.
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.
Outcome measures
| Measure |
Control Group
n=26 Participants
Control group with same medication but not receiving reminder SMS.
|
SMS Reminder Group
n=28 Participants
Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
|
|---|---|---|
|
Adherence to Spiriva HandiHaler Over Time
Baseline
|
96.2 Percentage of applications
Standard Deviation 12.5
|
99.0 Percentage of applications
Standard Deviation 5.4
|
|
Adherence to Spiriva HandiHaler Over Time
Week 12 (N=20, 30)
|
98.6 Percentage of applications
Standard Deviation 7.8
|
100.0 Percentage of applications
Standard Deviation 0.0
|
|
Adherence to Spiriva HandiHaler Over Time
Week 16 (N=25, 29)
|
96.1 Percentage of applications
Standard Deviation 14.2
|
100.0 Percentage of applications
Standard Deviation 0.0
|
|
Adherence to Spiriva HandiHaler Over Time
Week 20 (N=27, 29)
|
95.1 Percentage of applications
Standard Deviation 18.8
|
100.0 Percentage of applications
Standard Deviation 0.0
|
|
Adherence to Spiriva HandiHaler Over Time
Week 24 (N=26, 30)
|
95.7 Percentage of applications
Standard Deviation 18.4
|
99.5 Percentage of applications
Standard Deviation 2.8
|
|
Adherence to Spiriva HandiHaler Over Time
Week 8 (N=28, 29)
|
99.5 Percentage of applications
Standard Deviation 2.7
|
99.5 Percentage of applications
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Week 8, Week 12, Week 16, Week 20 and Week 24Population: FAS. Only subjects who responded to the SMS/ IVR system were considered in this analysis.
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.
Outcome measures
| Measure |
Control Group
n=23 Participants
Control group with same medication but not receiving reminder SMS.
|
SMS Reminder Group
n=23 Participants
Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
|
|---|---|---|
|
Change From Baseline in Adherence to Spiriva HandiHaler Over Time
Week 8
|
3.7 Percent change
Standard Deviation 12.3
|
0.6 Percent change
Standard Deviation 3.0
|
|
Change From Baseline in Adherence to Spiriva HandiHaler Over Time
Week 12 (N=15, 23)
|
2.5 Percent change
Standard Deviation 16.5
|
0.0 Percent change
Standard Deviation 0.0
|
|
Change From Baseline in Adherence to Spiriva HandiHaler Over Time
Week 24 (N=21, 23)
|
-1.2 Percent change
Standard Deviation 9.5
|
0.0 Percent change
Standard Deviation 0.0
|
|
Change From Baseline in Adherence to Spiriva HandiHaler Over Time
Week 16 (N=20, 20)
|
0.7 Percent change
Standard Deviation 22.0
|
0.0 Percent change
Standard Deviation 0.0
|
|
Change From Baseline in Adherence to Spiriva HandiHaler Over Time
Week 20 (N=20, 21)
|
-1.4 Percent change
Standard Deviation 11.0
|
0.0 Percent change
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: FAS
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.
Outcome measures
| Measure |
Control Group
n=45 Participants
Control group with same medication but not receiving reminder SMS.
|
SMS Reminder Group
n=47 Participants
Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
|
|---|---|---|
|
Response Rate Regarding Adherence
no (not adherent)
|
35.6 Percentage of participants
|
44.7 Percentage of participants
|
|
Response Rate Regarding Adherence
yes (adherent)
|
64.4 Percentage of participants
|
55.3 Percentage of participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: FAS
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.
Outcome measures
| Measure |
Control Group
n=45 Participants
Control group with same medication but not receiving reminder SMS.
|
SMS Reminder Group
n=47 Participants
Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
|
|---|---|---|
|
Patients Compliance With SMS System
|
64.1 Percentage of participants answers
Standard Deviation 38.3
|
55.0 Percentage of participants answers
Standard Deviation 39.8
|
SECONDARY outcome
Timeframe: Visit 2 (12 weeks) and visit 3 (24 weeks)Population: FAS for SMS reminder group only
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.
Outcome measures
| Measure |
Control Group
Control group with same medication but not receiving reminder SMS.
|
SMS Reminder Group
n=47 Participants
Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
|
|---|---|---|
|
Patients Assessment of Usefulness of the SMS System
Not helpful (week 12)
|
—
|
23.4 Percentage of participants
|
|
Patients Assessment of Usefulness of the SMS System
Missing (week 12)
|
—
|
2.1 Percentage of participants
|
|
Patients Assessment of Usefulness of the SMS System
Very helpful (week 24), N=45
|
—
|
8.9 Percentage of participants
|
|
Patients Assessment of Usefulness of the SMS System
Helpful (week 24), N=45
|
—
|
53.3 Percentage of participants
|
|
Patients Assessment of Usefulness of the SMS System
Very helpful (week 12)
|
—
|
12.8 Percentage of participants
|
|
Patients Assessment of Usefulness of the SMS System
Helpful (week 12)
|
—
|
61.7 Percentage of participants
|
|
Patients Assessment of Usefulness of the SMS System
Not helpful (week 24), N=45
|
—
|
33.3 Percentage of participants
|
|
Patients Assessment of Usefulness of the SMS System
Missing (week 24), N=45
|
—
|
4.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Visit 2 (12 weeks) and visit 3 (24 weeks)Population: FAS for SMS reminder group only
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.
Outcome measures
| Measure |
Control Group
Control group with same medication but not receiving reminder SMS.
|
SMS Reminder Group
n=47 Participants
Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
|
|---|---|---|
|
Physicians Assessment of Usefulness of the SMS System
Helpful (week 24), N=45
|
—
|
80.0 Percentage of participants
|
|
Physicians Assessment of Usefulness of the SMS System
Not helpful (week 24), N=45
|
—
|
6.7 Percentage of participants
|
|
Physicians Assessment of Usefulness of the SMS System
Missing (week 24), N=45
|
—
|
2.2 Percentage of participants
|
|
Physicians Assessment of Usefulness of the SMS System
Very helpful (week 12)
|
—
|
6.4 Percentage of participants
|
|
Physicians Assessment of Usefulness of the SMS System
Helpful (week 12)
|
—
|
87.2 Percentage of participants
|
|
Physicians Assessment of Usefulness of the SMS System
Not helpful (week 12)
|
—
|
6.4 Percentage of participants
|
|
Physicians Assessment of Usefulness of the SMS System
Missing (week 12)
|
—
|
0.0 Percentage of participants
|
|
Physicians Assessment of Usefulness of the SMS System
Very helpful (week 24), N=45
|
—
|
11.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Visit 2 (12 weeks) and visit 3 (24 weeks)Population: FAS for SMS reminder group only
Only physicians of patients in the SMS reminder group were asked if they would recommend the SMS system (no, yes, don't know)
Outcome measures
| Measure |
Control Group
Control group with same medication but not receiving reminder SMS.
|
SMS Reminder Group
n=47 Participants
Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
|
|---|---|---|
|
Physicians Recommendation of the SMS System
No (week 12)
|
—
|
8.5 Percentage of participants
|
|
Physicians Recommendation of the SMS System
Yes (week 12)
|
—
|
70.2 Percentage of participants
|
|
Physicians Recommendation of the SMS System
Don't know (week 12)
|
—
|
21.3 Percentage of participants
|
|
Physicians Recommendation of the SMS System
No (week 24), N=45
|
—
|
8.9 Percentage of participants
|
|
Physicians Recommendation of the SMS System
Yes (week 24), N=45
|
—
|
64.4 Percentage of participants
|
|
Physicians Recommendation of the SMS System
Don't know (week 24), N=45
|
—
|
26.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Visit 2 (12 weeks) and visit 3 (24 weeks)Population: FAS for SMS reminder group only
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.
Outcome measures
| Measure |
Control Group
Control group with same medication but not receiving reminder SMS.
|
SMS Reminder Group
n=47 Participants
Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
|
|---|---|---|
|
Patients Satisfaction With SMS System
Good (week 24), N=45
|
—
|
37.8 Percantage of participants
|
|
Patients Satisfaction With SMS System
Satisfactory (week 24), N=45
|
—
|
28.9 Percantage of participants
|
|
Patients Satisfaction With SMS System
Sufficient (week 24), N=45
|
—
|
11.1 Percantage of participants
|
|
Patients Satisfaction With SMS System
Very good (week 12)
|
—
|
23.4 Percantage of participants
|
|
Patients Satisfaction With SMS System
Good (week 12)
|
—
|
42.6 Percantage of participants
|
|
Patients Satisfaction With SMS System
Satisfactory (week 12)
|
—
|
21.3 Percantage of participants
|
|
Patients Satisfaction With SMS System
Sufficient (week 12)
|
—
|
6.4 Percantage of participants
|
|
Patients Satisfaction With SMS System
Deficient (week 12)
|
—
|
2.1 Percantage of participants
|
|
Patients Satisfaction With SMS System
Insufficient (week 12)
|
—
|
4.3 Percantage of participants
|
|
Patients Satisfaction With SMS System
Very good (week 24), N=45
|
—
|
15.6 Percantage of participants
|
|
Patients Satisfaction With SMS System
Deficient (week 24), N=45
|
—
|
4.4 Percantage of participants
|
|
Patients Satisfaction With SMS System
Insufficient (week 24), N=45
|
—
|
2.2 Percantage of participants
|
Adverse Events
SMS Reminder Group
Control Group
Serious adverse events
| Measure |
SMS Reminder Group
n=48 participants at risk
Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
|
Control Group
n=47 participants at risk
Control group with same medication but not receiving reminder SMS.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
2.1%
1/48 • 24 weeks
|
0.00%
0/47 • 24 weeks
|
|
Nervous system disorders
Syncope
|
0.00%
0/48 • 24 weeks
|
2.1%
1/47 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/48 • 24 weeks
|
2.1%
1/47 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
2.1%
1/48 • 24 weeks
|
0.00%
0/47 • 24 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER