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Asthmatuner a Self-management App for Asthma: A Randomized Controlled Multicentre Trial

NCT02571309 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2019-02-21

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Asthmatuner

Asthmatuner is an app for self-management of asthma.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2018-08-31
Completion
2019-02-28

Countries

  • Sweden

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02571309 on ClinicalTrials.gov