SMS Reminder to Assess Adherence

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Boehringer Ingelheim Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01308476

First received: March 1, 2011

Last updated: January 17, 2013

Last verified: January 2013

History of Changes

Results First Received: November 20, 2012

Study Type:	Observational
Study Design:	Time Perspective: Prospective
Condition:	Pulmonary Disease, Chronic Obstructive
Interventions:	Procedure: SMS reminder Procedure: control group

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Non-interventional controlled pilot study with two parallel groups.

Reporting Groups

	Description
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.

Participant Flow: Overall Study

	SMS Reminder Group	Control Group
STARTED	48 ^[1]	47 ^[1]
COMPLETED	45	45
NOT COMPLETED	3	2
Lost to Follow-up	2	2
Unknown	1	0

[1]	Entered and treated.

Baseline Characteristics

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Reporting Groups

	Description
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.
Total	Total of all reporting groups

Baseline Measures

	SMS Reminder Group	Control Group	Total
Number of Participants [units: participants]	48	47	95
Age [units: Years] Mean ± Standard Deviation	62.6 ± 7.3	63.2 ± 8.1	62.9 ± 7.7
Gender [units: Participants]
Female	15	17	32
Male	33	30	63

Outcome Measures

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1. Primary:

Adherence to Spiriva HandiHaler Over Time [ Time Frame: Baseline, Week 8, Week 12, Week 16, Week 20 and Week 24 ]

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2. Secondary:

Change From Baseline in Adherence to Spiriva HandiHaler Over Time [ Time Frame: Week 8, Week 12, Week 16, Week 20 and Week 24 ]

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3. Secondary:

Response Rate Regarding Adherence [ Time Frame: 24 weeks ]

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4. Secondary:

Patients Compliance With SMS System [ Time Frame: 24 weeks ]

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5. Secondary:

Patients Assessment of Usefulness of the SMS System [ Time Frame: Visit 2 (12 weeks) and visit 3 (24 weeks) ]

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6. Secondary:

Physicians Assessment of Usefulness of the SMS System [ Time Frame: Visit 2 (12 weeks) and visit 3 (24 weeks) ]

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7. Secondary:

Physicians Recommendation of the SMS System [ Time Frame: Visit 2 (12 weeks) and visit 3 (24 weeks) ]

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8. Secondary:

Patients Satisfaction With SMS System [ Time Frame: Visit 2 (12 weeks) and visit 3 (24 weeks) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com

No publications provided

Responsible Party:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01308476 History of Changes
Other Study ID Numbers:	205.474
Study First Received:	March 1, 2011
Results First Received:	November 20, 2012
Last Updated:	January 17, 2013
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

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