Mobile Phone Text for Optimizing Asthma Treatment
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
SMS support
Sponsored by

About this trial
This is an interventional supportive care trial for Asthma
Eligibility Criteria
Inclusion Criteria:
- asthmatics
Exclusion Criteria:
- below 18 and above 45
- COPD patients
- no mobile phone
- not using the prescribed asthma inhalation medication
Sites / Locations
- University of Copenhagen
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SMS intervention
Arm Description
Outcomes
Primary Outcome Measures
Asthma control test
EQ-5D
Use of health services
Use of preventive medicine
Secondary Outcome Measures
Full Information
NCT ID
NCT00917410
First Posted
June 5, 2009
Last Updated
June 9, 2009
Sponsor
University of Copenhagen
Collaborators
MedicoMonitor Aps, The Ministry of Health and Prevention, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT00917410
Brief Title
Mobile Phone Text for Optimizing Asthma Treatment
Official Title
Assessment of the Health Related Effects of Compliance Optimization in Asthma Through Use of SMS (Short Message System) - A Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Copenhagen
Collaborators
MedicoMonitor Aps, The Ministry of Health and Prevention, Denmark
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
244 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SMS intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
SMS support
Intervention Description
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).
Primary Outcome Measure Information:
Title
Asthma control test
Title
EQ-5D
Time Frame
0, 45, 90 days
Title
Use of health services
Time Frame
0, 45, 90 days
Title
Use of preventive medicine
Time Frame
0, 45, 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
asthmatics
Exclusion Criteria:
below 18 and above 45
COPD patients
no mobile phone
not using the prescribed asthma inhalation medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claus Møldrup, PhD
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Copenhagen
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
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Mobile Phone Text for Optimizing Asthma Treatment
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