Contact information
Type
Scientific
Primary contact
Prof Tom Fahey
ORCID ID
Contact details
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
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
FJH/LETT196/#15542
Study information
Scientific title
Acronym
The HyDRA trial - Hypertension Decision Reinforcing Aid
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/01/2006
Overall trial end date
30/06/2007
Reason abandoned
Participant recruitment issue/lack of funding
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
3500 (allowing for non response)
Participant 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
Recruitment start date
01/01/2006
Recruitment end date
30/06/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Tayside Centre for General Practice
Dundee
DD2 4BF
United Kingdom
Sponsor information
Organisation
University of Dundee (UK)
Sponsor details
Research and Innovation Services
Dundee
DD1 4HN
United Kingdom
+44 (0)1382 344664
eresearch@dundee.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
The Stroke Association, UK (Reference number: TSA 2004/04)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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