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Trial record 47 of 662 for:    SMS

SMS Reminder to Assess Adherence

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ClinicalTrials.gov Identifier: NCT01308476
Recruitment Status : Completed
First Posted : March 4, 2011
Results First Posted : December 21, 2012
Last Update Posted : January 18, 2013
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Observational
Study Design Time Perspective: Prospective
Condition Pulmonary Disease, Chronic Obstructive
Interventions Procedure: SMS reminder
Procedure: control group
Enrollment 95
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.
Arm/Group Title SMS Reminder Group Control Group
Hide Arm/Group Description Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler. Control group with same medication but not receiving reminder SMS.
Period Title: Overall Study
Started 48 [1] 47 [1]
Completed 45 45
Not Completed 3 2
Reason Not Completed
Lost to Follow-up             2             2
Other             1             0
[1]
Entered and treated.
Arm/Group Title SMS Reminder Group Control Group Total
Hide Arm/Group Description Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler. Control group with same medication but not receiving reminder SMS. Total of all reporting groups
Overall Number of Baseline Participants 48 47 95
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 48 participants 47 participants 95 participants
62.6  (7.3) 63.2  (8.1) 62.9  (7.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 47 participants 95 participants
Female
15
  31.3%
17
  36.2%
32
  33.7%
Male
33
  68.8%
30
  63.8%
63
  66.3%
1.Primary Outcome
Title Adherence to Spiriva HandiHaler Over Time
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description

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/Group Title SMS Reminder Group Control Group
Hide Arm/Group Description:
Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
Control group with same medication but not receiving reminder SMS.
Overall Number of Participants Analyzed 28 26
Mean (Standard Deviation)
Unit of Measure: Percentage of applications
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)
2.Secondary Outcome
Title Change From Baseline in Adherence to Spiriva HandiHaler Over Time
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Only subjects who responded to the SMS/ IVR system were considered in this analysis.
Arm/Group Title SMS Reminder Group Control Group
Hide Arm/Group Description:
Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
Control group with same medication but not receiving reminder SMS.
Overall Number of Participants Analyzed 23 23
Mean (Standard Deviation)
Unit of Measure: Percent change
Week 8 0.6  (3.0) 3.7  (12.3)
Week 12 (N=15, 23) 0.0  (0.0) 2.5  (16.5)
Week 16 (N=20, 20) 0.0  (0.0) 0.7  (22.0)
Week 20 (N=20, 21) 0.0  (0.0) -1.4  (11.0)
Week 24 (N=21, 23) 0.0  (0.0) -1.2  (9.5)
3.Secondary Outcome
Title Response Rate Regarding Adherence
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title SMS Reminder Group Control Group
Hide Arm/Group Description:
Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
Control group with same medication but not receiving reminder SMS.
Overall Number of Participants Analyzed 47 45
Measure Type: Number
Unit of Measure: Percentage of participants
yes (adherent) 55.3 64.4
no (not adherent) 44.7 35.6
4.Secondary Outcome
Title Patients Compliance With SMS System
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title SMS Reminder Group Control Group
Hide Arm/Group Description:
Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
Control group with same medication but not receiving reminder SMS.
Overall Number of Participants Analyzed 47 45
Mean (Standard Deviation)
Unit of Measure: Percentage of participants answers
55.0  (39.8) 64.1  (38.3)
5.Secondary Outcome
Title Patients Assessment of Usefulness of the SMS System
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS for SMS reminder group only
Arm/Group Title SMS Reminder Group Control Group
Hide Arm/Group Description:
Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
Control group with same medication but not receiving reminder SMS.
Overall Number of Participants Analyzed 47 0
Measure Type: Number
Unit of Measure: Percentage of participants
Very helpful (week 12) 12.8
Helpful (week 12) 61.7
Not helpful (week 12) 23.4
Missing (week 12) 2.1
Very helpful (week 24), N=45 8.9
Helpful (week 24), N=45 53.3
Not helpful (week 24), N=45 33.3
Missing (week 24), N=45 4.4
6.Secondary Outcome
Title Physicians Assessment of Usefulness of the SMS System
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS for SMS reminder group only
Arm/Group Title SMS Reminder Group Control Group
Hide Arm/Group Description:
Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
Control group with same medication but not receiving reminder SMS.
Overall Number of Participants Analyzed 47 0
Measure Type: Number
Unit of Measure: Percentage of participants
Very helpful (week 12) 6.4
Helpful (week 12) 87.2
Not helpful (week 12) 6.4
Missing (week 12) 0.0
Very helpful (week 24), N=45 11.1
Helpful (week 24), N=45 80.0
Not helpful (week 24), N=45 6.7
Missing (week 24), N=45 2.2
7.Secondary Outcome
Title Physicians Recommendation of the SMS System
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS for SMS reminder group only
Arm/Group Title SMS Reminder Group Control Group
Hide Arm/Group Description:
Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
Control group with same medication but not receiving reminder SMS.
Overall Number of Participants Analyzed 47 0
Measure Type: Number
Unit of Measure: Percentage of participants
No (week 12) 8.5
Yes (week 12) 70.2
Don't know (week 12) 21.3
No (week 24), N=45 8.9
Yes (week 24), N=45 64.4
Don't know (week 24), N=45 26.7
8.Secondary Outcome
Title Patients Satisfaction With SMS System
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS for SMS reminder group only
Arm/Group Title SMS Reminder Group Control Group
Hide Arm/Group Description:
Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
Control group with same medication but not receiving reminder SMS.
Overall Number of Participants Analyzed 47 0
Measure Type: Number
Unit of Measure: Percantage of participants
Very good (week 12) 23.4
Good (week 12) 42.6
Satisfactory (week 12) 21.3
Sufficient (week 12) 6.4
Deficient (week 12) 2.1
Insufficient (week 12) 4.3
Very good (week 24), N=45 15.6
Good (week 24), N=45 37.8
Satisfactory (week 24), N=45 28.9
Sufficient (week 24), N=45 11.1
Deficient (week 24), N=45 4.4
Insufficient (week 24), N=45 2.2
Time Frame 24 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SMS Reminder Group Control Group
Hide Arm/Group Description Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler. Control group with same medication but not receiving reminder SMS.
All-Cause Mortality
SMS Reminder Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
SMS Reminder Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   2/48 (4.17%)   2/47 (4.26%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bronchial carcinoma  1  1/48 (2.08%)  0/47 (0.00%) 
Nervous system disorders     
Syncope  1  0/48 (0.00%)  1/47 (2.13%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  0/48 (0.00%)  1/47 (2.13%) 
Nasal septum deviation  1  1/48 (2.08%)  0/47 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SMS Reminder Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/48 (0.00%)   0/47 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01308476     History of Changes
Other Study ID Numbers: 205.474
First Submitted: March 1, 2011
First Posted: March 4, 2011
Results First Submitted: November 20, 2012
Results First Posted: December 21, 2012
Last Update Posted: January 18, 2013