High blood pressure control and lipid lowering in patients at high cardiovascular risk: a cluster randomised factorial comparison of educational and protocol-based interventions to help primary care teams improve control of patients with poor risk factor control
| ISRCTN | ISRCTN99472145 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99472145 |
| Secondary identifying numbers | 6727 |
- Submission date
- 18/06/2010
- Registration date
- 18/06/2010
- Last edited
- 06/04/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- 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
Mr Bob Scott
Scientific
Scientific
Barts and The London NHS Trust
ASCOT Clinic
William Harvey Research Institute
Charterhouse Square
London
EC1M 6BQ
United Kingdom
| Phone | +44 (0)20 7882 5649 |
|---|---|
| b.scott@qmul.ac.uk |
Study information
| Study design | Single-centre randomised interventional prevention, process of care and treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | High blood pressure control and lipid lowering in patients at high cardiovascular risk: a cluster randomised factorial comparison of educational and protocol-based interventions to help primary care teams improve control of patients with poor risk factor control |
| Study acronym | HiLo |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/06/2006 |
| Completion date | 01/08/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned sample size: 10000; UK sample size: 10000 |
| Key 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 |
| Key exclusion criteria | Compelling reasons to avoid increase in blood pressure or lipid-lowering medication, such as severe debilitating illness or terminal cancer |
| Date of first enrolment | 01/06/2006 |
| Date of final enrolment | 01/08/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Barts and The London NHS Trust
London
EC1M 6BQ
United Kingdom
EC1M 6BQ
United Kingdom
Sponsor information
William Harvey Research Institute (UK)
Research organisation
Research organisation
Barts and The London
Queen Mary's School of Medicine and Dentistry
Rutland Place
Charterhouse Square
London
EC1M 6BQ
United Kingdom
| Website | http://www.whri.qmul.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/0574dzy90 |
Funders
Funder type
Hospital/treatment centre
City and Hackney Teaching Primary Care Trust (UK)
No information available
Merck Schering-Plough (UK)
No information available
Pfizer (UK)
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Pfizer Inc., Pfizer Consumer Healthcare, Davis, Charles Pfizer & Company, Warner-Lambert, King Pharmaceuticals, Wyeth Pharmaceuticals, Seagen
- Location
- United States of America
Tower Hamlets Primary Care Trust (UK)
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 |
Editorial Notes
06/04/2017: No publications found, verifying study status with principal investigator.
