Cluster randomised trial of a computer based decision support system (CDSS) and decision aid for patients with high blood pressure in the community
| ISRCTN | ISRCTN25487120 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25487120 |
| Secondary identifying numbers | FJH/LETT196/#15542 |
- Submission date
- 31/08/2005
- Registration date
- 21/09/2005
- Last edited
- 05/07/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Tom Fahey
Scientific
Scientific
Tayside Centre for General Practice
The Mackenzie Building
University of Dundee
Kirsty Semple Way
Dundee
DD2 4BF
United Kingdom
| t.p.fahey@chs.dundee.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Scientific title | |
| Study acronym | The HyDRA trial - Hypertension Decision Reinforcing Aid |
| Study objectives | High blood pressure (hypertension) is an important public health problem. There is ongoing concern that the benefits demonstrated in randomised trials of antihypertensive drug treatment are not implemented in everyday clinical practice. Community-based studies throughout the world show that blood pressure goals are achieved in only 25-40% of the patients who take antihypertensive drug treatment. A situation that has remained unchanged for the last 30 years. Observational studies have shown that inadequate control of blood pressure is associated with a significant risk of stroke. This study aims to improve the decision aid tool and develop a web-based CDSS which will facilitate individual care of Tayside/Fife hypertensive patients, enabling health professionals to overcome the pre-specified barriers of poor chronic disease management. These include: treating to therapeutic targets; aiding in the practical complexity of treating to target for different chronic disorders (in this situation blood pressure, cholesterol, cardiovascular risk and for diabetic patients, glycaemic treatment goals); and as an aid to structuring clinical care by facilitating registration, recall and regular review and incorporating prompts for effective clinical care. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Hypertension |
| Intervention | The intervention is a computer based decision support system. It incorporates the dual elements of a health professional decision support system and patient decision aid. The key elements will include: web-based, multifaceted intervention modelled on the successful Tayside regional diabetes network (MEMO/DARTS); a health professional element including prompts/reminders; a facility for registration, recall and review of patients, flexibility so that the functions can be 'tailored' to respond to data entry; feedback (at the individual, practice and regional level). Control: usual care As of 02/06/2011 this trial has stopped due to a combination of poor recruitment, funding issues and relocation of the Principal Investigator from Scotland to Ireland in 2006. |
| Intervention type | Other |
| Primary outcome measure | Blood pressure control |
| Secondary outcome measures | 1. Adherence to medication 2. Process measures concerning the management of hypertension in primary care 3. Decision conflict |
| Overall study start date | 01/01/2006 |
| Completion date | 30/06/2007 |
| Reason abandoned (if study stopped) | Participant recruitment issue/lack of funding |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 3500 (allowing for non response) |
| Key inclusion criteria | Patients, if they are aged between 40 to 79 years under treatment for high blood pressure and suffering from uncontrolled high blood pressure in accordance with the British Hypertension Society standard of ≥150/85 mmHg. |
| Key exclusion criteria | 1. Severe hypertension requiring immediate treatment (as determined by the GP) 2. Hypertension associated with pregnancy 3. Inability to understand witten and spoken English 4. Dementia or learning difficulties |
| Date of first enrolment | 01/01/2006 |
| Date of final enrolment | 30/06/2007 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Tayside Centre for General Practice
Dundee
DD2 4BF
United Kingdom
DD2 4BF
United Kingdom
Sponsor information
University of Dundee (UK)
University/education
University/education
Research and Innovation Services
Dundee
DD1 4HN
Scotland
United Kingdom
| Phone | +44 (0)1382 344664 |
|---|---|
| eresearch@dundee.ac.uk | |
"ROR" |
https://ror.org/03h2bxq36 |
Funders
Funder type
Charity
The Stroke Association, UK (Reference number: TSA 2004/04)
No information available
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 |
