AgingBPITCHNCT06337682
Blood Pressure Management in the Care Home Population
An observational study of Aging and Hypertension, run by University of Leeds at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aging, Hypertension
- How many people
- 3,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2016to Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Older adult
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.
Who may be able to join
- 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.
Who cannot join
- no exclusion criteria applied to keep the sample representative of the real-world care home population.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Academic Unit for Ageing and Stroke Research
Bradford, West Yorkshire, BD9 6RJ
About this study
Official title: 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.
Read the 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.
- Conditions
- Aging, Hypertension
- Keywords
- Nursing Home, Residential Home, Deprescribing
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of blood pressure measurements
the proportion of individuals entering a care home, with a diagnosis of hypertension, have their blood pressure measured in the year following admission
Measured: from the point of admission up to 12 months following admission
change in antihypertensive medication
change in the number or type of antihypertensive mediation from six months before care home admission to six months following care home admission
Measured: 6 months before admission to 6 months following admission
Injurious falls
one year incidence of a fall resulting in hospital attendance in those entering a care home
Measured: from the point of admission up to 12 months after admission
Secondary outcomes (3)
Prevalence of hypertension
the proportion of individuals in the care home cohort with a diagnosis of hypertension at the point of care home admission
Measured: at the day of admission to a care home (this will vary between each individual)
Antihypertensive medication
the number and type of antihypertensive medication prescribed at the point of admission
Measured: at the day of admission to a care home (this will vary between each individual)
Blood pressure treatment
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)
Measured: 12 months following admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study startJan 2016
- Primary completionJan 2020
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- Bradford Teaching Hospitals NHS Foundation Trust
- Responsible party
- Principal investigator, Oliver Todd, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06337682
- Sponsor's protocol ID
- CB_CY_P09_23_11
- Acronym
- BPITCH
- Status last verified
- Mar 2024
- First submitted
- 14 Mar 2024
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: using anonymised routine health data so cannot be shared. Will share code used to identify cohort with identifiers removed
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Describing the Management of Hypertension in a UK Care Home Population
- ClinicalTrials.gov ID
- NCT06337682
- Acronym / sponsor ID
- BPITCH / CB_CY_P09_23_11
- Conditions
- Aging, Hypertension
- Keywords
- Nursing Home, Residential Home, Deprescribing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- Bradford Teaching Hospitals NHS Foundation Trust
- Study start
- Jan 2016 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jun 2024 (estimated)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- no exclusion criteria applied to keep the sample representative of the real-world care home population.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of blood pressure measurements
Time frame: from the point of admission up to 12 months following admission
the proportion of individuals entering a care home, with a diagnosis of hypertension, have their blood pressure measured in the year following admission
change in antihypertensive medication
Time frame: 6 months before admission to 6 months following admission
change in the number or type of antihypertensive mediation from six months before care home admission to six months following care home admission
Injurious falls
Time frame: from the point of admission up to 12 months after admission
one year incidence of a fall resulting in hospital attendance in those entering a care home
3 secondary outcomes
Prevalence of hypertension
Time frame: at the day of admission to a care home (this will vary between each individual)
Antihypertensive medication
Time frame: at the day of admission to a care home (this will vary between each individual)
Blood pressure treatment
Time frame: 12 months following admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Individual participant dataSharing planned: No. using anonymised routine health data so cannot be shared. Will share code used to identify cohort with identifiers removed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging and Hypertension, run by University of Leeds at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of blood pressure measurements (time frame: from the point of admission up to 12 months following admission). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2024.