Condition category
Circulatory System
Date applied
18/06/2010
Date assigned
18/06/2010
Last edited
27/08/2014
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

Mr Bob Scott

ORCID ID

Contact details

Barts and The London NHS Trust
ASCOT Clinic
William Harvey Research Institute
Charterhouse Square
London
EC1M 6BQ
United Kingdom
+44 (0)20 7882 5649
b.scott@qmul.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

6727

Study information

Scientific title

Acronym

HiLo

Study hypothesis

This is a 2 x 2 factorial design complex health services intervention research trial which examines the influence of none, either or both of two interventions designed to help primary care clinicians improve the blood pressure and cholesterol control of patients at high risk of cardiovascular events over 12 months. One intervention explores expertise sharing whilst the other explores protocol adherence by clinicians.

Ethics approval

Not provided at time of registration

Study design

Single-centre randomised interventional prevention, process of care and treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Condition

Topic: Cardiovascular, Diabetes Research Network, Primary Care Research Network for England; Subtopic: Both, Not Assigned, Cardiovascular (all Subtopics); Disease: Diabetic Control, Cardiovascular, All Diseases

Intervention

1. Case management
2. Protocol-based treatment suggestions
3. Clinical educational support
4. Expertise sharing

Follow-up length: 12 months

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Change in blood pressure (BP) treatment at 1 year

Secondary outcome measures

1. Change in lipid treatment at 1 year
2. Change in systolic blood pressure (BP) at 1 year
3. Change in total cholesterol at 1 year

Overall trial start date

01/06/2006

Overall trial end date

01/08/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Elevated systolic blood pressure greater than or equal to 160 mmHg within the last 12 months
2. Elevated total cholesterol greater than or equal to 5 mmol/l
3. Patients in secondary prevention, or risk equivalent, or hypertensives in primary prevention at more than 20% 10-year cardiovascular disease (CVD) risk by QRISK2 or Framingham equations
4. Male and female, lower age limit of 40 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 10000; UK sample size: 10000

Participant exclusion criteria

Compelling reasons to avoid increase in blood pressure or lipid-lowering medication, such as severe debilitating illness or terminal cancer

Recruitment start date

01/06/2006

Recruitment end date

01/08/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Barts and The London NHS Trust
London
EC1M 6BQ
United Kingdom

Sponsor information

Organisation

William Harvey Research Institute (UK)

Sponsor details

Barts and The London
Queen Mary's School of Medicine and Dentistry
Rutland Place
Charterhouse Square
London
EC1M 6BQ
United Kingdom

Sponsor type

Research organisation

Website

http://www.whri.qmul.ac.uk/

Funders

Funder type

Hospital/treatment centre

Funder name

City and Hackney Teaching Primary Care Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Merck Schering-Plough (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Pfizer (UK)

Alternative name(s)

Pfizer Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Funder name

Tower Hamlets Primary Care Trust (UK)

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