- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06337682
Blood Pressure Management in the Care Home Population (BPITCH)
March 22, 2024 updated by: Oliver Todd, University of Leeds
Describing the Management of Hypertension in a UK Care Home Population
The UK care home population is projected to increase significantly over the coming decades.
A high proportion of individuals in a care home have multiple long-term conditions and take large amounts of prescribed medication.
This means they are routinely excluded from research studies and so there is little evidence on which to base treatment of long-term conditions such as high blood pressure.
Furthermore, given that 1 in 4 people admitted into a care home die within 1 year, the benefit of treating high blood pressure to reduce the risk of heart attack or stroke must be balanced with the need to optimise quality of life.
The aim of this study is to describe the health and social characteristics of the UK care home population with a particular focus on the management of blood pressure in the population.
It is hoped that the findings of this study will help inform future research into the management of chronic conditions in care home residents.
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
The investigators will use the connected Bradford dataset to examine UK electronic health records to describe the UK care home population and management of hypertension in this population.
The sample will include all adults aged 65 and over who have been admitted into a care home between January 2016 and December 2019.
The investigators will extract data at the time of care home admission including age, sex, ethnicity, coded diagnosis of hypertension, indices of frailty and risk of falls as well as comorbidities relevant to cardiovascular risk and falls risk.
Analysis will include looking at the prevalence of hypertension amongst the care home population, describing treatment patterns (i.e.
number and type of prescribed anti-hypertensive medications, frequency of blood pressure monitoring) and the proportion of patients with blood pressure controlled according to National Institute of Health and Care Excellence (NICE) guidelines.
The investigators will also look to establish whether there are any changes in the number and type of prescribed antihypertensive medication before and after admission to a care home (i.e.
intensification of pharmacological therapy or deprescribing) and whether this differs amongst different subgroups of populations including patients with terminal illness and stroke diagnosis.
The investigators will also estimate frequency of falls in the year following care home admission.
Study Type
Observational
Enrollment (Estimated)
3000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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West Yorkshire
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Bradford, West Yorkshire, United Kingdom, BD9 6RJ
- Academic Unit for Ageing and Stroke Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Care home residents in the Bradford metropolitan area.
The Bradford population has high levels of deprivation and ethnic diversity; a large proportion of the population identify as Pakistani ethnicity.
Description
Inclusion Criteria:
- registered to a GP practice contributing to the Connected Bradford dataset at the point of admission
- a recorded length of stay in a care home of longer than six weeks
- recorded social care entry for nursing or residential care in the Bradford council social care data.
Exclusion Criteria:
- no exclusion criteria applied to keep the sample representative of the real-world care home population.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Care home cohort
Individuals aged 65 or over registered to a GP practice which is part of the Connected Bradford Database who have been admitted to a CH between January 2016 and January 2020, with a recorded length of stay more than 6 weeks, will be included in the study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency of blood pressure measurements
Time Frame: from the point of admission up to 12 months following admission
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the proportion of individuals entering a care home, with a diagnosis of hypertension, have their blood pressure measured in the year following admission
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from the point of admission up to 12 months following admission
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change in antihypertensive medication
Time Frame: 6 months before admission to 6 months following admission
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change in the number or type of antihypertensive mediation from six months before care home admission to six months following care home admission
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6 months before admission to 6 months following admission
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Injurious falls
Time Frame: from the point of admission up to 12 months after admission
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one year incidence of a fall resulting in hospital attendance in those entering a care home
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from the point of admission up to 12 months after admission
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of hypertension
Time Frame: at the day of admission to a care home (this will vary between each individual)
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the proportion of individuals in the care home cohort with a diagnosis of hypertension at the point of care home admission
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at the day of admission to a care home (this will vary between each individual)
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Antihypertensive medication
Time Frame: at the day of admission to a care home (this will vary between each individual)
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the number and type of antihypertensive medication prescribed at the point of admission
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at the day of admission to a care home (this will vary between each individual)
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Blood pressure treatment
Time Frame: 12 months following admission
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of those with a diagnosis of hypertension and a blood pressure value recorded in the 12 months after admission, proportion a blood pressure value below the target set by the National Institute for Health and Care Excellence (i.e. for those aged 80 and over 150/90 and those aged below 80 years 140/90)
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12 months following admission
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in systolic pressure following care home admission
Time Frame: 12 months before admission for the first measure and 12 months after admission for the second measure.
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the difference between systolic blood pressure recorded before care home admission (defined as less than 12 months for care home admission) and systolic blood pressure recorded after care home admission (blood pressure recorded within 12 months following admission)
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12 months before admission for the first measure and 12 months after admission for the second measure.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Actual)
January 1, 2020
Study Completion (Estimated)
June 1, 2024
Study Registration Dates
First Submitted
March 14, 2024
First Submitted That Met QC Criteria
March 22, 2024
First Posted (Actual)
March 29, 2024
Study Record Updates
Last Update Posted (Actual)
March 29, 2024
Last Update Submitted That Met QC Criteria
March 22, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CB_CY_P09_23_11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
using anonymised routine health data so cannot be shared.
Will share code used to identify cohort with identifiers removed
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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