Facilitating patient self-management in chronic disease: integrating electronic personal health records and ongoing communication into a web-based self-management tool
| ISRCTN | ISRCTN34326236 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34326236 |
| Secondary identifying numbers | 179464; MOP-89859 |
- Submission date
- 23/03/2009
- Registration date
- 07/04/2009
- Last edited
- 05/12/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof Sarah Ahmed
Scientific
Scientific
3654 Prom Sir-William-Osler
Montreal
H3G 1Y5
Canada
| Phone | +1 (0)514 398 4400 ext. 00531 |
|---|---|
| sara.ahmed@mcgill.ca |
Study information
| Study design | Multicentre two-armed randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| 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(s) | McGill Institutional Review Board (IRB), 18/02/2009, ref: A10-E36-08B |
| 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 |
| Primary outcome measure | 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 study start date | 30/03/2009 |
| Overall study end date | 30/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 96 patients |
| 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 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
Study participating centre
3654 Prom Sir-William-Osler
Montreal
H3G 1Y5
Canada
H3G 1Y5
Canada
Sponsor information
McGill University (Canada)
University/education
University/education
Faculty of Medicine
McIntyre Medical Building
3655 Promenade Sir William Osler
Montreal, Quebec
H3G 1Y6
Canada
| Phone | +1 (0)514 398 1768 |
|---|---|
| researchsec.med@mcgill.ca | |
| Website | http://www.mcgill.ca/medicine/ |
"ROR" |
https://ror.org/01pxwe438 |
Funders
Funder type
Government
Canadian Institutes of Health Research (Canada) (ref: MOP-89859)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
- Location
- Canada
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 14/12/2011 | Yes | No | |
| Results article | results | 01/12/2016 | Yes | No |
Editorial Notes
05/12/2016: Publication reference added.
