Asthma Self-management Via Application of Telehealth

NCT02017795 | Unknown DMC

• 1 other identifier: H13-02666
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Asthma; Mixed Asthma With Acute Exacerbation

Keywords

asthma, mixed asthma, telehealth, action plan, exacerbation

Outcome Measures

Primary Outcomes (1)

• 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.

  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 outcomes will be collected during the follow-up period (12 months after intervention). Cost-effectiveness will be assessed through decision-analytic modeling.

Study Arms (2)

SMS-Web eAAP group

EXPERIMENTAL

electronic asthma action plan (eAAP) group

Other: electronic asthma action plan (eAAP)

regular-care group

ACTIVE COMPARATOR

written asthma action plan (WAAP) group

Other: written asthma action plan (WAAP)

Interventions

electronic asthma action plan (eAAP) OTHER

An electronic asthma action plan (eAAP) will be provided to intervention group

SMS-Web eAAP group

written asthma action plan (WAAP) OTHER

A written asthma action plan will be given to control group arm

regular-care group

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

• University of British Columbia: lead
• Pfizer: collaborator
• Providence Health & Services: collaborator

Study Sites (1)

Centre for Clinical Epidemiology and Evaluation, Vancouver Coastal Health Research Institute

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Related Links

• University of British Columbia Centre for Lung Health
• Institute of Heart and Lung Health

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Mark J FitzGerald, M.D.

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2013
• First Posted: December 23, 2013
• Study Start: August 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 27, 2016

Record last verified: 2016-05

Locations

CA (1)