Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02571309
Recruitment Status : Completed
First Posted : October 8, 2015
Last Update Posted : February 21, 2019
Sponsor:
Collaborator:
Stockholm County Council, Sweden
Information provided by (Responsible Party):
Björn Nordlund, Karolinska Institutet

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.


Condition or disease Intervention/treatment Phase
Asthma Device: Asthmatuner Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Asthmatuner a Self-management App for Asthma
Study Start Date : August 2016
Actual Primary Completion Date : August 2018
Actual Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Smartphone app - Asthmatuner

The 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
Device: Asthmatuner
Asthmatuner is an app for self-management of asthma.

Conventional
Conventional 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.
Device: Asthmatuner
Asthmatuner is an app for self-management of asthma.




Primary Outcome Measures :
  1. Asthma control [ Time Frame: 8 weeks ]
    Asthma control test

  2. Health-related quality of life [ Time Frame: 8 weeks ]
    Pediatric asthma quality of life questionnaire/Mini-asthma quality of life quest.

  3. Adverse events [ Time Frame: 8 weeks ]
    revision of adverse events


Secondary Outcome Measures :
  1. Medical adherence [ Time Frame: 8 weeks ]
    MARS Medicine adherence report scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Consent to participate is voluntary.
  • Age > 6 years
  • Diagnosed asthma
  • Asthma control score (ACT/C-ACT) less than 20

Exclusion Criteria:

  • Ongoing comorbidity affecting the health status of asthma
  • Asthma control score (ACT/C-ACT) equal or more than 20
  • Participation in other drug trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02571309


Locations
Layout table for location information
Sweden
Capio Ringen
Stockholm, Stockholm County, Sweden
Sponsors and Collaborators
Karolinska Institutet
Stockholm County Council, Sweden
Additional Information:
Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Björn Nordlund, PhD RN, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02571309    
Other Study ID Numbers: Medituner-001
First Posted: October 8, 2015    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Björn Nordlund, Karolinska Institutet:
Self-management
Asthma
Patient education
Health literacy
Health-related quality of life
Asthma control
Adherence
Additional relevant MeSH terms:
Layout table for MeSH terms
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases