Condition category
Circulatory System
Date applied
31/08/2005
Date assigned
21/09/2005
Last edited
05/07/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

Publication citations

Additional files

Editorial Notes