Asthma Self-management Via Application of Telehealth (asthma)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT02017795
First received: November 29, 2013
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Asthma
Mixed Asthma With Acute Exacerbation
Other: electronic asthma action plan (eAAP)
Other: written asthma action plan (WAAP)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Managing Asthma With Tele-health Technology: A Feasibility Study

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 250
Study Start Date: August 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SMS-Web eAAP group
electronic asthma action plan (eAAP) group
Other: electronic asthma action plan (eAAP)
An electronic asthma action plan (eAAP) will be provided to intervention group
Other Name: electronic asthma action plan (eAAP)
Active Comparator: regular-care group
written asthma action plan (WAAP) group
Other: written asthma action plan (WAAP)
A written asthma action plan will be given to control group arm

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.

  Eligibility

Ages Eligible for Study:   19 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Physician diagnosed asthma.
  2. A history of an asthma exacerbation requiring oral corticosteroids or admission to Emergency Department/hospital in the previous year.
  3. Ability to understand English and follow the material included in the two different interventions.
  4. Ownership of a mobile phone with the capacity to support text messaging.
  5. 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.

    -

Exclusion Criteria:

  1. Inability to provide written informed consent.
  2. A history of smoking cigarettes for greater than ten pack years.
  3. Not owning a mobile cell phone.
  4. Subjects only taking a reliever medication and on no controller medication.
  5. A history of significant co morbid disease judged by the investigator to preclude enrolment.
  6. A history of an asthma exacerbation requiring oral corticosteroids in the previous six weeks.
  7. Plans to move out of the study area in the next year. -
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02017795

Contacts
Contact: Iraj M Poureslami, Ph.D 604-875-4111 ext 61812 iraj.poureslami@ubc.ca
Contact: Mark J FitzGerald, M.D. 604-875-4122 mark.fitzgerald@vch.ca

Locations
Canada, British Columbia
Centre for Clinical Epidemiology and Evaluation, Vancouver Coastal Health Research Institute Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Iraj M Poureslami, Ph.D    604-875-4111 ext 61812    iraj.poureslami@ubc.ca   
Contact: Margie Bell, BSc    604-875-4327    Margie.Bell@vch.ca   
Sub-Investigator: Iraj M Poureslami, Ph.D         
Sub-Investigator: Richard Laster, M.D.         
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Mark J FitzGerald, M.D. University of British Columbia
  More Information

Additional Information:
No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT02017795     History of Changes
Other Study ID Numbers: H13-02666
Study First Received: November 29, 2013
Last Updated: June 19, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
asthma, mixed asthma, telehealth, action plan, exacerbation

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 16, 2014