Hypertension in Dementia - Feasibility Study
Research type
Research Study
Full title
Hypertension in Dementia - Feasibility Study
IRAS ID
127672
Contact name
Veronika van der Wardt
Contact email
Sponsor organisation
University of Nottingham
Research summary
While the benefits of medication against high blood pressure have been established in many large clinical trials, this has never been investigated for people with dementia who consistently have been excluded from these trials. In addition, the risk for harmful side effects, such as falls or effects resulting from taking many medications is larger in people with than without dementia. Therefore, the balance of beneficial and harmful effects of medication against high blood pressure might be different in people with dementia compared to those without dementia. Research has shown that for a significant proportion of people (without dementia) medication against high blood pressure can be withdrawn safely. Considering the larger weight of harmful effects of medication against high blood pressure and that it can be safely withdrawn in a considerable proportion of people, we would like to propose a feasibility study for a withdrawal trial. We will include 40 people with dementia using medication against high blood pressure who have a carer who can act as a consultee. After consenting and an initial assessment of blood pressure, kidney function, depression, independence, quality of life, behavioural problems and cognition, participants will enter a withdrawal programme. During the withdrawal phase, participants will have their blood pressure monitored weekly and monthly thereafter. If blood pressure levels rise beyond the levels currently considered as normal by NHS guidelines, the GP will be informed immediately to recommence blood pressure medication. Falls, syncope, cardiovascular events, GP or nurse visits, hospital and A&E admissions will be recorded. After 6 months the initial assessments will be repeated. Alongside the withdrawal programme, we will assess how participants’ carers feel about consenting and supporting the study, how many GPs support the study, if the study increases GPs’ workload and the how much support we receive from care homes.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
13/WM/0468
Date of REC Opinion
5 Dec 2013
REC opinion
Favourable Opinion