Condition category
Respiratory
Date applied
23/03/2009
Date assigned
07/04/2009
Last edited
24/04/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Sarah Ahmed

ORCID ID

Contact details

3654 Prom Sir-William-Osler
Montreal
H3G 1Y5
Canada
+1 514 398 4400 ext. 00531
sara.ahmed@mcgill.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

179464; MOP-89859

Study information

Scientific title

Facilitating patient self-management in chronic disease: integrating electronic personal health records and ongoing communication into a web-based self-management tool - a multicentre, two-armed randomised controlled trial

Acronym

Study hypothesis

Higher rates of usage of the web-based self-management tool will be associated with greater improvements in asthma-related quality of life and asthma control.

Ethics approval

McGill Institutional Review Board (IRB) gave approval on the 18th February 2009 (ref: A10-E36-08B)

Study design

Multicentre two-armed randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Asthma

Intervention

Intervention group: access to the web-based self-management tool including personal asthma profile, educational material, communication and feedback with the healthcare team, telephone follow-up by the study nurse
Control group: usual care and follow-up

Duration: 6 months

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Asthma Specific Health-Related Quality of Life, measures four functional impairments at baseline and at the end of the study
2. Asthma control, defined as the excess use of rescue fast-acting bronchodilators (beta-2-agonists) (FABA) at baseline and at the end of the study

Secondary outcome measures

1. Technology Acceptance Measure (TAM): to evaluate intention to use the system and perceived benefits at the end of the study
2. Usage rates of the system, assessed by examining automated audit trails which will include the frequency of use defined as the number of minutes patients spent logged into the system/week
3. Patterns usage
4. Asthma Self-Efficacy, using a rating scale an overall mean score is calculated that can range from 1 (no confidence) to 5 (very confident), measured at baseline and at the end of the study
5. Medication adherence, evaluated by comparing medications prescribed to medications dispensed based on the prescription claims file
6. Healthcare utilisation: asthma-related emergency room (ER) visits/hospitalisations

Overall trial start date

30/03/2009

Overall trial end date

30/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male and female patients over the age of 18 years suffering from asthma
2. Have full health insurance coverage from Régie de l'assurance maladie du Québec (RAMQ)
3. Physicians are actively using the asthma decision support system
4. In poor control despite being prescribed appropriate therapy and a written action plan. Specifically, poor control is defined as those patients who have had a respiratory-related emergency room (ER) visit or excessive beta-2-agonist use in the six months before recruitment.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

96 patients

Participant exclusion criteria

1. Aged over 60 years
2. Serious medical diagnosis such as lung cancer
3. Severely limited mobility preventing patients from leaving home

Recruitment start date

30/03/2009

Recruitment end date

30/12/2011

Locations

Countries of recruitment

Canada

Trial participating centre

3654 Prom Sir-William-Osler
Montreal
H3G 1Y5
Canada

Sponsor information

Organisation

McGill University (Canada)

Sponsor details

Faculty of Medicine
McIntyre Medical Building
3655 Promenade Sir William Osler
Montreal
Quebec
H3G 1Y6
Canada
+1 514 398 1768
researchsec.med@mcgill.ca

Sponsor type

University/education

Website

http://www.mcgill.ca/medicine/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (Canada) (ref: MOP-89859)

Alternative name(s)

Instituts de Recherche en Santé du Canada, CIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Canada

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 study protocol in http://www.ncbi.nlm.nih.gov/pubmed/22168530

Publication citations

  1. Study protocol

    Ahmed S, Bartlett SJ, Ernst P, Paré G, Kanter M, Perreault R, Grad R, Taylor L, Tamblyn R, Effect of a web-based chronic disease management system on asthma control and health-related quality of life: study protocol for a randomized controlled trial., Trials, 2011, 12, 260, doi: 10.1186/1745-6215-12-260.

Additional files

Editorial Notes