Mobile Phone Text for Optimizing Asthma Treatment

Asthma Clinical Trial

Official title:

Assessment of the Health Related Effects of Compliance Optimization in Asthma Through Use of SMS (Short Message System) - A Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00917410
• Other study ID #: UC-SMS-01
• Status: Completed
• Phase: N/A
• First received: June 5, 2009
• Last updated: June 9, 2009
• Start date: November 2007
• Est. completion date: May 2008

Study information

• Verified date: June 2009
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

The study aims at providing information on how the Short Message Service (SMS) tool influences self-management in asthma patients and to assess the resulting health related effect. A wide range of models and theories exist in the compliance area, such as technical models, communication models, cognitive models and self-management models and theories. The use of some of these theories and models will serve as theoretical and explanatory tools for studying how and why the SMS tool influences the patient's self-management.

Objective:

The objective of this study is to assess the health-related effects of a SMS compliance and monitoring system for optimized asthma treatment in a controlled trial setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• asthmatics

Exclusion Criteria:

• below 18 and above 45

• COPD patients

• no mobile phone

• not using the prescribed asthma inhalation medication

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• SMS support
The intervention consisted of sequences of SMS messages sent to the intervention group, each containing 2 or 3 monitoring questions and one reminder to take the preventive medication. The SMS sequence was as follows. Remember to take your preventive asthma medication (sent at 8.00 am). Were you awakened during the night due to your asthma? Answer YES or NO. How many times have you taken your asthma attack medication during the last 24 hours? Answer a number. What was your peak flow this morning? Answer a number (optional, depending on the participant's use of a spirometer prior to the study).

Locations

Country	Name	City	State
Denmark	University of Copenhagen	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
University of Copenhagen	MedicoMonitor Aps, The Ministry of Health and Prevention, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma control test			No
Primary	EQ-5D		0, 45, 90 days	No
Primary	Use of health services		0, 45, 90 days	No
Primary	Use of preventive medicine		0, 45, 90 days	No