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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06337682
Other study ID # CB_CY_P09_23_11
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 2016
Est. completion date June 2024

Study information

Verified date March 2024
Source University of Leeds
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 3000
Est. completion date June 2024
Est. primary completion date January 2020
Accepts healthy volunteers
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United Kingdom Academic Unit for Ageing and Stroke Research Bradford West Yorkshire

Sponsors (2)

Lead Sponsor Collaborator
University of Leeds Bradford Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other change in systolic pressure following care home admission 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) 12 months before admission for the first measure and 12 months after admission for the second measure.
Primary 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 from the point of admission up to 12 months following admission
Primary 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 6 months before admission to 6 months following admission
Primary Injurious falls one year incidence of a fall resulting in hospital attendance in those entering a care home from the point of admission up to 12 months after admission
Secondary Prevalence of hypertension the proportion of individuals in the care home cohort with a diagnosis of hypertension at the point of care home admission at the day of admission to a care home (this will vary between each individual)
Secondary Antihypertensive medication the number and type of antihypertensive medication prescribed at the point of admission at the day of admission to a care home (this will vary between each individual)
Secondary 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) 12 months following admission
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