Asthmatuner a Self-management App for Asthma: A Randomized Controlled Multicentre Trial
Asthmatuner
1 other identifier
interventional
77
1 country
1
Brief Summary
Primary aim: Evaluating the effect of Asthmatuner on patients´ self-reported asthma control test (ACT/C-ACT)compared with conventional asthma management. Secondary aim: Evaluating patients´ health-related quality of life (HR-QoL) medical adherence by using Asthmatuner compared with conventional management. Total sample size: Stratified study population consisting of 43 females and males with diagnosed asthma at the age of at least 6 years pediatric specialist care and 43 females/males in primary care. Study design: This is a multi-centre, blinded, randomized controlled, cross-over trial over to at least 16 weeks. Subjects: Two stratified groups of participants with uncontrolled asthma will be recruited; (1) children and adolescents from Astrid Lindgren's Children's Hospital, Karolinska University Hospital, and (2) adolescents and adults from the primary health care sector in Stockholm, Sweden. The asthma control test (ACT/C-ACT) will be applied for evaluation of asthma control, a score less than 20 will be required for inclusion. Intervention: Asthmatuner is an app supporting self-management evaluating symptoms and lung function with external spirometry. The app gathers the information to define patients´ asthma control. Subsequently, Asthmatuner provides the patient with a treatment recommendation based on the individual treatment plan. Procedures: Participants are randomized (1:1) into the one of two-arms of asthma self-management with Asthmatuner - conventional or conventional - Asthmatuner. Questionnaires will collect information about asthma control, HR-QoL, Medicine adherence report scale (MARS) and history of medical health concerning health care utilization and personal costs and income. Analysis: The study hypothesis will be tested by examining difference in patients´ change in asthma control (ACT/C-ACT) and HR-QoL (PAQLQ/Mini-AQLQ). Results will be summarized at each management period as mean scores and analysed by paired t-tests.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable asthma
Started Aug 2016
Typical duration for not_applicable asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2015
CompletedFirst Posted
Study publicly available on registry
October 8, 2015
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2019
CompletedFebruary 21, 2019
February 1, 2019
2 years
September 20, 2015
February 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Asthma control
Asthma control test
8 weeks
Health-related quality of life
Pediatric asthma quality of life questionnaire/Mini-asthma quality of life quest.
8 weeks
Adverse events
revision of adverse events
8 weeks
Secondary Outcomes (1)
Medical adherence
8 weeks
Study Arms (2)
Smartphone app - Asthmatuner
OTHERThe app Asthmatuner contains four different modes; 1. Lung function testing with Bluetooth connection of external spirometry 2. Symptom evaluation 3. Actual treatment plan, based om lung function and symptoms 4. Trend views of lung function, symptoms and asthma control
Conventional
OTHERConventional treatment and Asthmatuner will be stratified and harmonized into categories of asthma management and current state-of-art at each health care centre. Each group harmonized group will include 43 subjects.
Interventions
Asthmatuner is an app for self-management of asthma.
Eligibility Criteria
You may qualify if:
- Consent to participate is voluntary.
- Age \> 6 years
- Diagnosed asthma
- Asthma control score (ACT/C-ACT) less than 20
You may not qualify if:
- Ongoing comorbidity affecting the health status of asthma
- Asthma control score (ACT/C-ACT) equal or more than 20
- Participation in other drug trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska Institutetlead
- Region Stockholmcollaborator
Study Sites (1)
Capio Ringen
Stockholm, Stockholm County, Sweden
Related Publications (10)
Jansson SA, Ronmark E, Forsberg B, Lofgren C, Lindberg A, Lundback B. The economic consequences of asthma among adults in Sweden. Respir Med. 2007 Nov;101(11):2263-70. doi: 10.1016/j.rmed.2007.06.029. Epub 2007 Aug 6.
PMID: 17689234BACKGROUNDBrand PL. The clinician's guide on monitoring children with asthma. Paediatr Respir Rev. 2013 Jun;14(2):119-25. doi: 10.1016/j.prrv.2012.07.001. Epub 2012 Aug 24.
PMID: 23718992BACKGROUNDLiu WT, Huang CD, Wang CH, Lee KY, Lin SM, Kuo HP. A mobile telephone-based interactive self-care system improves asthma control. Eur Respir J. 2011 Feb;37(2):310-7. doi: 10.1183/09031936.00000810. Epub 2010 Jun 18.
PMID: 20562122BACKGROUNDSadatsafavi M, Rousseau R, Chen W, Zhang W, Lynd L, FitzGerald JM. The preventable burden of productivity loss due to suboptimal asthma control: a population-based study. Chest. 2014 Apr;145(4):787-793. doi: 10.1378/chest.13-1619.
PMID: 24337140BACKGROUNDHuman D, Crawley F, IJesselmuiden C. Revised declaration of Helsinki. WMA will continue to revise policy as medicine and research changes. BMJ. 2001 Aug 4;323(7307):283-4. No abstract available.
PMID: 11505938BACKGROUNDNordlund B, Konradsen JR, Pedroletti C, Kull I, Hedlin G. The clinical benefit of evaluating health-related quality-of-life in children with problematic severe asthma. Acta Paediatr. 2011 Nov;100(11):1454-60. doi: 10.1111/j.1651-2227.2011.02359.x. Epub 2011 Jun 16.
PMID: 21595747RESULTFuhrman C, Dubus JC, Marguet C, Delacourt C, Thumerelle C, de Blic J, Delmas MC. Hospitalizations for asthma in children are linked to undertreatment and insufficient asthma education. J Asthma. 2011 Aug;48(6):565-71. doi: 10.3109/02770903.2011.580031. Epub 2011 May 20.
PMID: 21595608RESULTNathan RA, Sorkness CA, Kosinski M, Schatz M, Li JT, Marcus P, Murray JJ, Pendergraft TB. Development of the asthma control test: a survey for assessing asthma control. J Allergy Clin Immunol. 2004 Jan;113(1):59-65. doi: 10.1016/j.jaci.2003.09.008.
PMID: 14713908RESULTLiu AH, Zeiger R, Sorkness C, Mahr T, Ostrom N, Burgess S, Rosenzweig JC, Manjunath R. Development and cross-sectional validation of the Childhood Asthma Control Test. J Allergy Clin Immunol. 2007 Apr;119(4):817-25. doi: 10.1016/j.jaci.2006.12.662. Epub 2007 Mar 13.
PMID: 17353040RESULTZafari Z, Lynd LD, FitzGerald JM, Sadatsafavi M. Economic and health effect of full adherence to controller therapy in adults with uncontrolled asthma: a simulation study. J Allergy Clin Immunol. 2014 Oct;134(4):908-915.e3. doi: 10.1016/j.jaci.2014.04.009. Epub 2014 May 27.
PMID: 24875619RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD RN
Study Record Dates
First Submitted
September 20, 2015
First Posted
October 8, 2015
Study Start
August 1, 2016
Primary Completion
August 1, 2018
Study Completion
February 1, 2019
Last Updated
February 21, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share