Ignite Creation Date:
2024-05-06 @ 7:40 AM
Last Modification Date:
2024-10-26 @ 11:50 AM
Study NCT ID:
NCT02571309
Status:
COMPLETED
Last Update Posted:
2019-02-21
First Post:
2015-09-20
Brief Title:
Asthmatuner a Self-management App for Asthma A Randomized Controlled Multicentre Trial
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
Asthmatuner a Self-management App for Asthma
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Asthmatuner
Brief Summary:
Primary aim Evaluating the effect of Asthmatuner on patients self-reported asthma control test ACTC-ACTcompared 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 femalesmales 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 Lindgrens Childrens Hospital Karolinska University Hospital and 2 adolescents and adults from the primary health care sector in Stockholm Sweden The asthma control test ACTC-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 11 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 ACTC-ACT and HR-QoL PAQLQMini-AQLQ Results will be summarized at each management period as mean scores and analysed by paired t-tests
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 femalesmales 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 Lindgrens Childrens Hospital Karolinska University Hospital and 2 adolescents and adults from the primary health care sector in Stockholm Sweden The asthma control test ACTC-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 11 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 ACTC-ACT and HR-QoL PAQLQMini-AQLQ Results will be summarized at each management period as mean scores and analysed by paired t-tests
Detailed Description:
2 Background Clinical gaps hamper proper asthma management and leads to delayed or undiagnosed disease poor adherence to treatment inadequate self-care abilities inadequate understanding of disease severity poor patient education inadequate measurement of lung function and inconsistent evaluation of symptoms To improve the patients ability to self-manage and to overcome clinical gaps evidence emphasizes clinics to offer comprehensive patient education The national Finish asthma programme 1994-2004 focused on applying effective strategies of asthma management as a result patients self-management was improved and cost-effective through limited demands on the health-care and social security system
Novel applications embodied in smartphones are straightforward alternative to facilitate health care and support patients with hands-on guidance for self-management of asthma Asthmatuner is a smartphone app that enables evaluation of lung function and symptoms The app provides patients with a daily treatment plan adjusted for symptoms and lung function Additionally information is accessible and can be assessed by health care providers through a back-end system Future versions of Asthmatuner will be enabled through patients own medical record Self-management apps with hands-on guidance for self-management of asthma present a promising future for closing clinical gaps but the overall benefits of using the service in the treatment of asthma need comprehensive evaluation that answers scientific questions and end-user opinions
3 Aims The primary aim is to evaluate Asthmatuner and the clinical effect on patients self-reported asthma control test scores of ACTC-ACT
The secondary aim is to evaluate the effect on patients and HR-QoL and medical adherence
Primary outcomes The primary outcome will be scores of ACTC-ACT and Paediatric asthma quality of life questionnaire PAQLQ or Mini-Asthma Quality of Life Questionnaire Mini-AQLQ
Secondary outcomes The secondary outcomes are scores of Medicine adherence report scale MARS and costs of prescribed dose and type of control medication and total amount of direct and indirect costs for patientcaregiver
4 Material and methods Study design Multicenter randomized controlled physician blinded crossover trial where study participants were randomized to start with AsthmaTuner or conventional treatment and a washout period between treatments Figure 1 Primary outcome of asthma control test ACT or Childhood Asthma Control Test C-ACT were measured two times in each treatment period at baseline and at follow-up visit equal or more than 8 weeks after treatment started The participating centers were recommended to comply with Swedish national treatment and management of asthma which closely resemble with Global Initiative for Asthma GINA A study nurse at each site performed the randomization by open a sealed envelope indicating the start of either AsthmaTuner or conventional treatment The physician was blinded for the order of given treatments when one paper personalized treatment plan and one individual treatment plan for AsthmaTuner were arranged to each patient according to levels of controlled partly controlled and uncontrolled asthma The regional board of Ethical Committee in Stockholm number 20151527-311 and 20161546-32 and Swedish Medical Products Agency number 51-2016-19829 both approved the study The study was registered at ClinicalTrialgov
Intervention Asthmatuner is a CE-marked cloud-based system with healthcare interface and a downloaded patient app Android or iOS The intended use of Asthmatuner is to automate and facilitate self-management of asthma by letting patient register symptoms and to measure forced expiratory volume in one second FEV1 with a Bluetooth spirometer MIR SmartOne The patient receives an immediate feedback on asthma control and treatment recommendation with an image of the correct inhaler to use and the dose Asthma control is defined based on to GINA and a summary of lung function liter to percentage of personalized best FEV1 using cutoff equal or less than 80 and asthma symptoms last week in terms of need for recue medication more than twice daytime symptoms nocturnal symptomsawakenings and limitation of activities Furthermore Asthmatuner offers patient and asthma care provider a longitudinal data view of prescribed treatments lung function and experienced symptoms
Study subjects children from 6 years and adults with doctors diagnosis of asthma and ACT or C-ACT score below 20 points were included in the region of Stockholm Sweden The study was conducted in the primary health care sector and in asthma clinics specialised for children and adolescents in Stockholm Patients were included at Liljeholmen Health Care Centre Sophiahemmet Health Care Centre and Astrid Lindgren Childrens Hospital Lung- and Allergy Department in Solna and Children and Adolescents Health Care Department in Huddinge during the years of 2016-2018 Exclusion criteria were other ongoing comorbidity impairing the asthma control participation in other drug trial and a patient or all caregivers in case the patient is a child incapable to read Swedish
Data collection
Questionnaires
A health questionnaire completed at the first visit will provide information regarding asthma medical history health utilization annual income and employment status
ACT will be used to assess asthma control in patients 12 years or older and C-ACT in children of age 6 to 11 years A mean score equal or below 19 indicates uncontrolled asthma Scores above 19 defines asthma to be controlled in both tests
HR-QoL will be applied in patients from 6 to 11 years of age using the validated Swedish translated Paediatric Asthma Quality of Life Questionnaire PAQLQ and the mini Asthma Quality of Life Questionnaire mini-AQLQ in patients from 12 years of age
Self-reported medication adherence will be measured with five-item MARS developed to assess adherence with asthma medication The MARS comprises statements about medication use behaviors The patient is asked to answer each behavior with a score between 1-5 based on of following alternatives always often sometimes rarely or never A mean MARS score will then be calculated and a score of 45 or greater indicates good adherence
Time consume utility and satisfaction using Asthmatuner will be asked patientcaregiver nurses and physicians in relation to applied management
Power analysis The power analysis is based on our previous analysis of ACTC-ACT and HR-QoL scores in schoolchildren with uncontrolled severe asthma 21 The scores for severe uncontrolled asthma were on average for ACT 17 SD 33 and for PAQLQ 54 SD 077 Thus an estimated improvement of ACT from 17 to 19 two points or PAQLQ from 54 to 59 05 points requires 38-43 patients in each group Asthmatuner vs conventional management to attain an 80 power at 5 significance level
Visit 1 Eligibility of participants will be checked The patient will be given information about the study procedures and must sign the informed consent form At the visit the following procedures will be conducted and documented
Demographic data
Body height and weight
Medical history about allergy and asthma will be obtained with health questionnaire
Asthma control will be assessed with ACT or C-ACT
HR-QoL Mini-AQLQ or PAQLQ
MARS questionnaire
Lung function dynamic spirometry including forced vital capacity FVC forced expiratory volume in one second FEV1 FEV1FVC forced expiratory flow after 50 of vital capacity FEF50
Randomization to Asthmatuner - conventional self-management or conventional - Asthmatuner
Prescribe and apply treatment plan Asthmatuner or Conventional
Control of inhalation technique
At visit 2 the following procedures will be conducted and documented
ACTC-ACT
HR-QoL Mini-AQLQPAQLQ
MARS
Lung function dynamic spirometry FVC FEV1 FEV1FVC and FEF50
Revise treatment plan if necessary Asthmatuner or Conventional
Revision of adverse events
At visit 3 the following procedures will be conducted and documented
ACTC-ACT
HR-QoL Mini-AQLQPAQLQ
MARS
Lung function dynamic spirometry FVC FEV1 FEV1FVC and FEF50
Prescribe and apply treatment plan Asthmatuner or Conventional
Control of inhalation technique
Revision of adverse events
At visit 4 the following procedures will be conducted and documented
ACTC-ACT
HR-QoL Mini-AQLQ or PAQLQ
MARS
Lung function dynamic spirometry including forced vital capacity FVC forced expiratory volume in one second FEV1 FEV1FVC forced expiratory flow after 50 of vital capacity FEF50
Revision of adverse events
45 Statistical analysis The study hypothesis will be tested by examining patients change from baseline in asthma control ACTC-ACT HR-QoL PAQLQMini-AQLQ and in MARS scores between asthma management groups Results will be summarized between each group as mean scores and analysed by paired t-tests
48 Withdrawal A patient should be withdrawn from the trial if in the opinion of the investigator it is medically necessary or if it is the wish of the patient In any circumstances the reasons for withdrawal should be documented in the Study termination report Participants who discontinue from the study for any reason will be replaced
49 Safety
An adverse event AE is any untoward medical occurrence in participants using or not using Asthmatuner AE include the following
All suspect adverse reaction
All reactions from medical overdose abuse withdrawal sensitivity or toxicity
Apparently unrelated illness including the worsening of a preexisting illness
Injury or accident
Abnormalities in physiological testing or physical examination
Laboratory abnormalities that require clinical intervention or further investigation unless they are associated with an already reported clinical event
Preexisting conditions In this trial a preexisting condition ie asthma should not be reported as an adverse event unless the condition worsens or episodes increases ie exacerbations in the frequency during the adverse event reporting period
Procedures Diagnostics and therapeutic non-invasive and invasive procedures such as surgery should not be reported as adverse events However the medical condition for which the procedure was performed should be reported if it meets the definition of an AE The AE reporting period begins upon starting the use of Asthmatuner or conventional management visit 1
Each participant will be questioned about AE for each visit 2 and 3 All AE that occur in the trial should be reported to investigator and specified in the participants medical journal and in a separate AE form with following information
Type of AE
Date and time of AE
Association with Asthmatuner NoYesUnknown
Gravity Serious or Non-serious
Reporting time
Follow-up resolved or unresolved
Gravity
Each AE is to be classified by the investigator as serious or non-serious This classification of the gravity of the event determines the reporting procedure to be followed An AE that meets one or more of the following criteria is classified as serious
Death
Life-threatening
Hospitalization
Persistent or significant disabilityincapacity
Congenital anomalybirth defect All serious AE should directly be reported to investigator
50 Ethics The trial will be performed in accordance with the World Medical Assembly Helsinki recommendations guiding physicians in biomedical research involving human subjects 26 It is the responsibility of the investigators to obtain approval of the trial from regional ethic committee
It is the responsibility of the investigators to give each patient prior to inclusion in the trial full adequate information regarding the trial and the procedures The patient must be informed about their right to withdraw from the trial at any time Written patient information must be given to each patient before enrollment In addition it is the responsibility of the investigator to obtain signed informed consent from all participants
Novel applications embodied in smartphones are straightforward alternative to facilitate health care and support patients with hands-on guidance for self-management of asthma Asthmatuner is a smartphone app that enables evaluation of lung function and symptoms The app provides patients with a daily treatment plan adjusted for symptoms and lung function Additionally information is accessible and can be assessed by health care providers through a back-end system Future versions of Asthmatuner will be enabled through patients own medical record Self-management apps with hands-on guidance for self-management of asthma present a promising future for closing clinical gaps but the overall benefits of using the service in the treatment of asthma need comprehensive evaluation that answers scientific questions and end-user opinions
3 Aims The primary aim is to evaluate Asthmatuner and the clinical effect on patients self-reported asthma control test scores of ACTC-ACT
The secondary aim is to evaluate the effect on patients and HR-QoL and medical adherence
Primary outcomes The primary outcome will be scores of ACTC-ACT and Paediatric asthma quality of life questionnaire PAQLQ or Mini-Asthma Quality of Life Questionnaire Mini-AQLQ
Secondary outcomes The secondary outcomes are scores of Medicine adherence report scale MARS and costs of prescribed dose and type of control medication and total amount of direct and indirect costs for patientcaregiver
4 Material and methods Study design Multicenter randomized controlled physician blinded crossover trial where study participants were randomized to start with AsthmaTuner or conventional treatment and a washout period between treatments Figure 1 Primary outcome of asthma control test ACT or Childhood Asthma Control Test C-ACT were measured two times in each treatment period at baseline and at follow-up visit equal or more than 8 weeks after treatment started The participating centers were recommended to comply with Swedish national treatment and management of asthma which closely resemble with Global Initiative for Asthma GINA A study nurse at each site performed the randomization by open a sealed envelope indicating the start of either AsthmaTuner or conventional treatment The physician was blinded for the order of given treatments when one paper personalized treatment plan and one individual treatment plan for AsthmaTuner were arranged to each patient according to levels of controlled partly controlled and uncontrolled asthma The regional board of Ethical Committee in Stockholm number 20151527-311 and 20161546-32 and Swedish Medical Products Agency number 51-2016-19829 both approved the study The study was registered at ClinicalTrialgov
Intervention Asthmatuner is a CE-marked cloud-based system with healthcare interface and a downloaded patient app Android or iOS The intended use of Asthmatuner is to automate and facilitate self-management of asthma by letting patient register symptoms and to measure forced expiratory volume in one second FEV1 with a Bluetooth spirometer MIR SmartOne The patient receives an immediate feedback on asthma control and treatment recommendation with an image of the correct inhaler to use and the dose Asthma control is defined based on to GINA and a summary of lung function liter to percentage of personalized best FEV1 using cutoff equal or less than 80 and asthma symptoms last week in terms of need for recue medication more than twice daytime symptoms nocturnal symptomsawakenings and limitation of activities Furthermore Asthmatuner offers patient and asthma care provider a longitudinal data view of prescribed treatments lung function and experienced symptoms
Study subjects children from 6 years and adults with doctors diagnosis of asthma and ACT or C-ACT score below 20 points were included in the region of Stockholm Sweden The study was conducted in the primary health care sector and in asthma clinics specialised for children and adolescents in Stockholm Patients were included at Liljeholmen Health Care Centre Sophiahemmet Health Care Centre and Astrid Lindgren Childrens Hospital Lung- and Allergy Department in Solna and Children and Adolescents Health Care Department in Huddinge during the years of 2016-2018 Exclusion criteria were other ongoing comorbidity impairing the asthma control participation in other drug trial and a patient or all caregivers in case the patient is a child incapable to read Swedish
Data collection
Questionnaires
A health questionnaire completed at the first visit will provide information regarding asthma medical history health utilization annual income and employment status
ACT will be used to assess asthma control in patients 12 years or older and C-ACT in children of age 6 to 11 years A mean score equal or below 19 indicates uncontrolled asthma Scores above 19 defines asthma to be controlled in both tests
HR-QoL will be applied in patients from 6 to 11 years of age using the validated Swedish translated Paediatric Asthma Quality of Life Questionnaire PAQLQ and the mini Asthma Quality of Life Questionnaire mini-AQLQ in patients from 12 years of age
Self-reported medication adherence will be measured with five-item MARS developed to assess adherence with asthma medication The MARS comprises statements about medication use behaviors The patient is asked to answer each behavior with a score between 1-5 based on of following alternatives always often sometimes rarely or never A mean MARS score will then be calculated and a score of 45 or greater indicates good adherence
Time consume utility and satisfaction using Asthmatuner will be asked patientcaregiver nurses and physicians in relation to applied management
Power analysis The power analysis is based on our previous analysis of ACTC-ACT and HR-QoL scores in schoolchildren with uncontrolled severe asthma 21 The scores for severe uncontrolled asthma were on average for ACT 17 SD 33 and for PAQLQ 54 SD 077 Thus an estimated improvement of ACT from 17 to 19 two points or PAQLQ from 54 to 59 05 points requires 38-43 patients in each group Asthmatuner vs conventional management to attain an 80 power at 5 significance level
Visit 1 Eligibility of participants will be checked The patient will be given information about the study procedures and must sign the informed consent form At the visit the following procedures will be conducted and documented
Demographic data
Body height and weight
Medical history about allergy and asthma will be obtained with health questionnaire
Asthma control will be assessed with ACT or C-ACT
HR-QoL Mini-AQLQ or PAQLQ
MARS questionnaire
Lung function dynamic spirometry including forced vital capacity FVC forced expiratory volume in one second FEV1 FEV1FVC forced expiratory flow after 50 of vital capacity FEF50
Randomization to Asthmatuner - conventional self-management or conventional - Asthmatuner
Prescribe and apply treatment plan Asthmatuner or Conventional
Control of inhalation technique
At visit 2 the following procedures will be conducted and documented
ACTC-ACT
HR-QoL Mini-AQLQPAQLQ
MARS
Lung function dynamic spirometry FVC FEV1 FEV1FVC and FEF50
Revise treatment plan if necessary Asthmatuner or Conventional
Revision of adverse events
At visit 3 the following procedures will be conducted and documented
ACTC-ACT
HR-QoL Mini-AQLQPAQLQ
MARS
Lung function dynamic spirometry FVC FEV1 FEV1FVC and FEF50
Prescribe and apply treatment plan Asthmatuner or Conventional
Control of inhalation technique
Revision of adverse events
At visit 4 the following procedures will be conducted and documented
ACTC-ACT
HR-QoL Mini-AQLQ or PAQLQ
MARS
Lung function dynamic spirometry including forced vital capacity FVC forced expiratory volume in one second FEV1 FEV1FVC forced expiratory flow after 50 of vital capacity FEF50
Revision of adverse events
45 Statistical analysis The study hypothesis will be tested by examining patients change from baseline in asthma control ACTC-ACT HR-QoL PAQLQMini-AQLQ and in MARS scores between asthma management groups Results will be summarized between each group as mean scores and analysed by paired t-tests
48 Withdrawal A patient should be withdrawn from the trial if in the opinion of the investigator it is medically necessary or if it is the wish of the patient In any circumstances the reasons for withdrawal should be documented in the Study termination report Participants who discontinue from the study for any reason will be replaced
49 Safety
An adverse event AE is any untoward medical occurrence in participants using or not using Asthmatuner AE include the following
All suspect adverse reaction
All reactions from medical overdose abuse withdrawal sensitivity or toxicity
Apparently unrelated illness including the worsening of a preexisting illness
Injury or accident
Abnormalities in physiological testing or physical examination
Laboratory abnormalities that require clinical intervention or further investigation unless they are associated with an already reported clinical event
Preexisting conditions In this trial a preexisting condition ie asthma should not be reported as an adverse event unless the condition worsens or episodes increases ie exacerbations in the frequency during the adverse event reporting period
Procedures Diagnostics and therapeutic non-invasive and invasive procedures such as surgery should not be reported as adverse events However the medical condition for which the procedure was performed should be reported if it meets the definition of an AE The AE reporting period begins upon starting the use of Asthmatuner or conventional management visit 1
Each participant will be questioned about AE for each visit 2 and 3 All AE that occur in the trial should be reported to investigator and specified in the participants medical journal and in a separate AE form with following information
Type of AE
Date and time of AE
Association with Asthmatuner NoYesUnknown
Gravity Serious or Non-serious
Reporting time
Follow-up resolved or unresolved
Gravity
Each AE is to be classified by the investigator as serious or non-serious This classification of the gravity of the event determines the reporting procedure to be followed An AE that meets one or more of the following criteria is classified as serious
Death
Life-threatening
Hospitalization
Persistent or significant disabilityincapacity
Congenital anomalybirth defect All serious AE should directly be reported to investigator
50 Ethics The trial will be performed in accordance with the World Medical Assembly Helsinki recommendations guiding physicians in biomedical research involving human subjects 26 It is the responsibility of the investigators to obtain approval of the trial from regional ethic committee
It is the responsibility of the investigators to give each patient prior to inclusion in the trial full adequate information regarding the trial and the procedures The patient must be informed about their right to withdraw from the trial at any time Written patient information must be given to each patient before enrollment In addition it is the responsibility of the investigator to obtain signed informed consent from all participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None