AsthmaasthmaNCT02017795
Asthma Self-management Via Application of Telehealth
A study testing electronic asthma action plan (eAAP) and written asthma action plan (WAAP) in people with Asthma and Mixed Asthma With Acute Exacerbation, run by University of British Columbia at 1 site in Canada.
Trial summary
Objectives: The disease being studied is asthma. The main objective of this study is to assess the feasibility of the recruitment goals and also the logistical issues related to use of tele-health technology in developing electronic asthma action plan (eAAP) and communicate with asthma patients in a time period of 24… Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Asthma, Mixed Asthma With Acute Exacerbation
- What is being tested?
- electronic asthma action plan (eAAP) and written asthma action plan (WAAP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2014to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physician diagnosed asthma.
- A history of an asthma exacerbation requiring oral corticosteroids or admission to Emergency Department/hospital in the previous year.
- Ability to understand English and follow the material included in the two different interventions.
- Ownership of a mobile phone with the capacity to support text messaging.
- Patients on maintenance inhaled corticosteroids alone or with a combination inhaler. Subjects on other controller therapies will not be excluded as long as they fulfill these inclusion criteria.
- -
Who cannot join
- Inability to provide written informed consent.
- A history of smoking cigarettes for greater than ten pack years.
- Not owning a mobile cell phone.
- Subjects only taking a reliever medication and on no controller medication.
- A history of significant co morbid disease judged by the investigator to preclude enrolment.
- A history of an asthma exacerbation requiring oral corticosteroids in the previous six weeks.
- Plans to move out of the study area in the next year. -
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre for Clinical Epidemiology and Evaluation, Vancouver Coastal Health Research Institute
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: Managing Asthma With Tele-health Technology: A Feasibility Study
Objectives:
The disease being studied is asthma. The main objective of this study is to assess the feasibility of the recruitment goals and also the logistical issues related to use of tele-health technology in developing electronic asthma action plan (eAAP) and communicate with asthma patients in a time period of 24 months. The goals are: 1) enable asthma patients to self-manage their asthma symptoms. The secondary, 2) help care providers to intervene appropriately based on the patient's health status. The secondary objective is to explore the cost-benefit and cost-effectiveness of the proposed technology. Our research group proposes to complete a feasibility study, with an interim analysis for a formal power calculation and then acquire ethics to report these results and study design with anticipated publication prior to proceeding with a full randomized controlled trial to assess the efficacy of this intervention. The outcome measure will be assessed and data will be presented in a 24-month time frame.
Read more
Aims and goals:
The main aim of our proposed study is to assist asthma patients to practice asthma self-management at home that will eventually enable them to control their asthma, and specifically, prevent asthma exacerbation. Therefore, the ultimate goal of our proposed study is to improve patient health outcome via enhancing patient-physician interaction and using a more practical asthma action plan model (eAAP) that could be followed easily by the patient and their doctor.
Our hypothesis is that asthma patients who have access to the electronic online action plan complimented by weekly text messages to reinforce adherence will have a reduced rate of asthma exacerbation. We further hypothesize that these subjects will have an improvement in secondary measures including quality of life, better asthma control and patient satisfaction. We also anticipate that such an approach in asthma management will be cost-effective as outlined below.
Read the detailed description
In our study design we propose to use a web-based application and inform asthma patients through weekly Text Message (SMS) reminders to take their controller medication regularly and also a message to visit the web-based e-AAP and assess the current level of asthma control. This will be a two-way interaction and personalized feedback protocol to monitor patients at home and during daily activities. We will use an adequate sample size to provide an interim analysis of efficacy and the subsequent total number of subjects that will need to be enrolled. Each patient (in the relevant group, as explained below) will have his/her own profile, which will enable us to send and receive personalized (exchange) information using a web application process via cell phones. This approach will allow interaction between patient and asthma care counselor/ provider aiming to improve asthma control.
This study will test the hypothesis that using mobile phone reminder messages and web-based monitoring, as part of a structured care plan, will improve clinical outcomes; namely reduction in the rate of exacerbation, in patients with asthma. We also aim to explore the cost-effectiveness of this technology. Our research group proposes to complete a feasibility study, with an interim analysis for a formal power calculation and then acquire ethics to report these results and study design with anticipated publication prior to proceeding with a full randomized controlled trial to assess the efficacy of this intervention. We predict that using a combination of Internet and SMS messaging technology will empower patients to manage their asthma and eventually prevent asthma exacerbation based on their personalized action plan as well as a SMS application. We plan to compare the web-based/SMS reminder method with written action plan approach in a 24-month time frame, as explained later in this proposal.
- Conditions
- Asthma, Mixed Asthma With Acute Exacerbation
- Being tested
- electronic asthma action plan (eAAP), written asthma action plan (WAAP)
- Keywords
- asthma, mixed asthma, telehealth, action plan, exacerbation
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electronic asthma action plan (eAAP)Other
An electronic asthma action plan (eAAP) will be provided to intervention group
written asthma action plan (WAAP)Other
A written asthma action plan will be given to control group arm
| Study group | Role | What they receive |
|---|---|---|
| SMS-Web eAAP group | Experimental | electronic asthma action plan (eAAP) group Receives: Other: electronic asthma action plan (eAAP) |
| regular-care group | Active comparator | written asthma action plan (WAAP) group Receives: Other: written asthma action plan (WAAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the rate of asthma exacerbations
Tracking outcomes: All subjects will be asked to contact the study coordinator in the event of an asthma exacerbation. Subjects will also be seen at six and 12 months post intervention for the evaluation of health care utilization and record their asthma exacerbations. In addition, at this time baseline questionnaires will be repeated. They will also receive a telephone contact at three and nine months to document any recent exacerbations which they may have failed to call in with regard.
Measured: Number of asthma exacerbations will be assessed by Global Initiative for Asthma (GINA) standard assessment tool for 12 months post-intervention
Secondary outcomes (1)
the cost-effectiveness and cost-benefit of applying the SMS and web combination technology
Economic evaluation of health technologies is concerned with the trade-off between the incremental costs and incremental effectiveness of technologies and therefore requires collecting information on both costs and effectiveness at the individual level. The interventions in each arm of the trial are based on getting feedback from patients and as such substantial amount of information on the use of controller medications and asthma exacerbations will be collected. At month 6 and 12 after the intervention, participants will be invited to the study center for a detailed interview during which we will collect information on asthma-related resource use in the previous 6 months and will estimate participants' quality of life. As a surrogate for adherence, we will track prescriptions refills before and during the study using access to patient's PharmaNET data; which is feasible in BC, Canada.
Measured: Economic outcomes will be collected during the follow-up period (12 months after intervention). Cost-effectiveness will be assessed through decision-analytic modeling.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startAug 2014
- Primary completionJun 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, Providence Health & Services
- Responsible party
- Sponsor
- Investigators
- Mark J FitzGerald, M.D., Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02017795
- Sponsor's protocol ID
- H13-02666
- Acronym
- asthma
- Status last verified
- May 2016
- First submitted
- 29 Nov 2013
- Last updated
- 27 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Asthma With Tele-health Technology: A Feasibility Study
- ClinicalTrials.gov ID
- NCT02017795
- Acronym / sponsor ID
- asthma / H13-02666
- Conditions
- Asthma, Mixed Asthma With Acute Exacerbation
- Keywords
- asthma, mixed asthma, telehealth, action plan, exacerbation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Pfizer, Providence Health & Services
- Study start
- Aug 2014
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 23 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives:
The disease being studied is asthma. The main objective of this study is to assess the feasibility of the recruitment goals and also the logistical issues related to use of tele-health technology in developing electronic asthma action plan (eAAP) and communicate with asthma patients in a time period of 24 months. The goals are: 1) enable asthma patients to self-manage their asthma symptoms. The secondary, 2) help care providers to intervene appropriately based on the patient's health status. The secondary objective is to explore the cost-benefit and cost-effectiveness of the proposed technology. Our research group proposes to complete a feasibility study, with an interim analysis for a formal power calculation and then acquire ethics to report these results and study design with anticipated publication prior to proceeding with a full randomized controlled trial to assess the efficacy of this intervention. The outcome measure will be assessed and data will be presented in a 24-month time frame.
Aims and goals:
The main aim of our proposed study is to assist asthma patients to practice asthma self-management at home that will eventually enable them to control their asthma, and specifically, prevent asthma exacerbation. Therefore, the ultimate goal of our proposed study is to improve patient health outcome via enhancing patient-physician interaction and using a more practical asthma action plan model (eAAP) that could be followed easily by the patient and their doctor.
Our hypothesis is that asthma patients who have access to the electronic online action plan complimented by weekly text messages to reinforce adherence will have a reduced rate of asthma exacerbation. We further hypothesize that these subjects will have an improvement in secondary measures including quality of life, better asthma control and patient satisfaction. We also anticipate that such an approach in asthma management will be cost-effective as outlined below.
Detailed description
In our study design we propose to use a web-based application and inform asthma patients through weekly Text Message (SMS) reminders to take their controller medication regularly and also a message to visit the web-based e-AAP and assess the current level of asthma control. This will be a two-way interaction and personalized feedback protocol to monitor patients at home and during daily activities. We will use an adequate sample size to provide an interim analysis of efficacy and the subsequent total number of subjects that will need to be enrolled. Each patient (in the relevant group, as explained below) will have his/her own profile, which will enable us to send and receive personalized (exchange) information using a web application process via cell phones. This approach will allow interaction between patient and asthma care counselor/ provider aiming to improve asthma control.
This study will test the hypothesis that using mobile phone reminder messages and web-based monitoring, as part of a structured care plan, will improve clinical outcomes; namely reduction in the rate of exacerbation, in patients with asthma. We also aim to explore the cost-effectiveness of this technology. Our research group proposes to complete a feasibility study, with an interim analysis for a formal power calculation and then acquire ethics to report these results and study design with anticipated publication prior to proceeding with a full randomized controlled trial to assess the efficacy of this intervention. We predict that using a combination of Internet and SMS messaging technology will empower patients to manage their asthma and eventually prevent asthma exacerbation based on their personalized action plan as well as a SMS application. We plan to compare the web-based/SMS reminder method with written action plan approach in a 24-month time frame, as explained later in this proposal.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMS-Web eAAP group | Experimental | Other: electronic asthma action plan (eAAP)electronic asthma action plan (eAAP) group |
| regular-care group | Active comparator | Other: written asthma action plan (WAAP)written asthma action plan (WAAP) group |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Physician diagnosed asthma.
- A history of an asthma exacerbation requiring oral corticosteroids or admission to Emergency Department/hospital in the previous year.
- Ability to understand English and follow the material included in the two different interventions.
- Ownership of a mobile phone with the capacity to support text messaging.
- Patients on maintenance inhaled corticosteroids alone or with a combination inhaler. Subjects on other controller therapies will not be excluded as long as they fulfill these inclusion criteria.
Key exclusion criteria (7 listed)
- Inability to provide written informed consent.
- A history of smoking cigarettes for greater than ten pack years.
- Not owning a mobile cell phone.
- Subjects only taking a reliever medication and on no controller medication.
- A history of significant co morbid disease judged by the investigator to preclude enrolment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electronic asthma action plan (eAAP)An electronic asthma action plan (eAAP) will be provided to intervention group | Other | SMS-Web eAAP group |
| written asthma action plan (WAAP)A written asthma action plan will be given to control group arm | Other | regular-care group |
Primary outcome
Reduction in the rate of asthma exacerbations
Time frame: Number of asthma exacerbations will be assessed by Global Initiative for Asthma (GINA) standard assessment tool for 12 months post-intervention
Tracking outcomes: All subjects will be asked to contact the study coordinator in the event of an asthma exacerbation. Subjects will also be seen at six and 12 months post intervention for the evaluation of health care utilization and record their asthma exacerbations. In addition, at this time baseline questionnaires will be repeated. They will also receive a telephone contact at three and nine months to document any recent exacerbations which they may have failed to call in with regard.
1 secondary outcome
the cost-effectiveness and cost-benefit of applying the SMS and web combination technology
Time frame: Economic outcomes will be collected during the follow-up period (12 months after intervention). Cost-effectiveness will be assessed through decision-analytic modeling.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2016.
- University of British Columbia Centre for Lung HealthLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark J FitzGerald, M.D. principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electronic asthma action plan (eAAP) and written asthma action plan (WAAP) in people with Asthma and Mixed Asthma With Acute Exacerbation, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in the rate of asthma exacerbations (time frame: Number of asthma exacerbations will be assessed by Global Initiative for Asthma (GINA) standard assessment tool for 12 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2016.