PERSONAL-COVIDBP [COVID-19]
Research type
Research Study
Full title
Personalised Electronic Record Supported OptimisatioN when ALone for Patients with Hypertension- Pilot Study for Remote Medical Management of Hypertension During the COVID-19 Pandemic
IRAS ID
283209
Contact name
David Collier
Contact email
Sponsor organisation
Queen Mary University of London
Eudract number
2020-002494-10
ISRCTN Number
ISRCTN16393332
Duration of Study in the UK
1 years, 1 months, 1 days
Research summary
Research Summary:
Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus. Hypertension and poor blood pressure control may represent an important factor in determining whether patients with COVID-19 experience a severe illness that requires hospitalisation. Patients with hypertension require long term management. This is very difficult during the COVID-19 crisis with doctors being assigned to COVID-19 related duties and social distancing. To meet this need, the NHS is moving to remote monitoring of patients. There is a need for an approach that minimises direct contact for the safety of both patients and health care professional while ensuring that patients are able to easily access services. This study focuses on the control of blood pressure in hypertensive participants during the COVID-19 pandemic. Patients will use a digital diary to record home BP measurements. Amlodipine as an oral solution will be the study medication. It can be increased in dosage (e.g. 1mg, 2mg, 3mg, 4mg, 5mg, 6mg, 7mg, 8mg, 9mg to a maximum of 10mg per day) to patients whose blood pressure is not adequately controlled. The dose of amlodipine will be personalised by the study doctor to achieve optimal blood pressure control for an individual patient based on blood pressure readings. We will recruit a total of 1000 participants, those with adequate blood pressure control at baseline will be the observational group, with monthly followup calls and record blood pressure and COVID-19 symptoms in a digital diary. \nParticipants with raised blood pressure will be sent liquid amlodipine. The dose will be adjusted during remote consultation with the clinician every 1-2 weeks. Home monitoring may improve blood pressure control. The change in BP in both groups will be reviewed to see if the additional treatment helps to better control blood pressure.Summary of Research:
We remotely recruited 353 participants, started phone diary app-based monitoring of blood pressure and then sorted 343 participants by starting blood pressure control over 5-7 days.For those 181 participants with raised blood pressure (BP), we sent them liquid amlodipine, which was the study medication, to their home. The dose of medication was increased, in small steps, during phone calls every fortnight. The liquid amlodipine dose could be changed to get the best balance of blood pressure control with as few side-effects as possible. The doctor or nurse adjusted dose according to calls with the participant. Using a mobile phone diary App, the doctor or nurse was able to see the BP readings taken by the participant, the dose of drug taken each day and any unwanted effects.
For those 162 participants with good blood pressure (BP) control at the start of the study, they had phone calls every 4 weeks from the study team, to check that their blood pressure control was still good. Twenty four out of the 162 in observation later qualified for extra blood pressure treatment over the 3 months of the study, and for their own safety chose to restart with the liquid amlodipine and join the treatment arm of the study. In this way a total of 205 participants (181 plus 24) were given the liquid amlodipine treatment.
Blood pressure did not change over the three months of observation in the good BP control group, but it fell in those in the amolodipine treatment group by 11mmHg systolic (SBP) and 7mmHg diastolic (DBP). Average BP fell from 142/87 (SBP/DBP) to 131/81 mmHg (95% CI: 6-7) mmHg, p<0.001). This is a significant fall in BP.
Most of the amlodipine treatment group (84%) achieved blood pressure control, most on novel (new) doses of amlodipine between the existing doses (5mg and 10mg), many on very small doses like 1mg.
BP recording was very complete (84%) and 94% reported taking their medication. Most participants completed the trial, 96% (196/205). Treatment was well-tolerated, and nobody left the trial because of side-effects, even if some had to stop the medication.
REC name
London - Dulwich Research Ethics Committee
REC reference
20/HRA/2988
Date of REC Opinion
29 Jun 2020
REC opinion
Further Information Favourable Opinion