ATEMPT: Antihypertensive Treatment in Elderly Multimorbid Patients V1
Research type
Research Study
Full title
Antihypertensive Treatment in Elderly Multimorbid Patients: a pilot study
IRAS ID
284172
Contact name
Kazem Rahimi
Contact email
Sponsor organisation
N/A
Duration of Study in the UK
1 years, 0 months, 17 days
Research summary
Summary of Research
The beneficial effects of blood pressure (BP) lowering treatment are well understood. However, the importance of BP-lowering treatment in certain patient groups remains uncertain. One such group includes older patients with many underlying health problems, in particular when their blood pressure is not very high. These patients have been underrepresented or excluded in previous research, thus, leaving an important gap in our understanding of treatment effects.One key reason for the existing gap in evidence is the challenge of recruiting sufficiently large numbers of older and multimorbid patients into clinical trials. In this pilot study conducted from one site in Oxford, we aim to address this challenge by recruiting approximately 200 participants aged 65 or over who have at least 3 long-term health conditions or are taking at least 5 medications in addition to any being taken to manage blood pressure. Participants will be randomised to receive up to 2 additional or 2 fewer classes of BP lowering medication over the course of the study with their treatment assessed every 4 weeks with the aim to test whether the intervention can lead to important changes in blood pressure.
The study is designed to minimise the burden of participation to patients. There is no need for clinic attendance. Participation and follow-up will take place at home using a bespoke IT system with much of the data collected remotely. Study staff will be available throughout the study to support participants with the use of the technology and to visit them in their homes, if required. The findings from this study will establish the feasibility of a larger home-based study to assess the effect of treatment changes on patient-important outcomes.
The study is being funded by NIHR Oxford BRC and Oxford Martin School.
Summary of Results
Who carried out the Research?
The ATEMPT study was conducted by researchers at the University of Oxford, with funding from NIHR Oxford BRC, and the Oxford Martin School, Deep Medicine Programme.What was the purpose of the study?
Older patients who have been diagnosed with several medical conditions or take multiple medications per day have been under-represented in previous clinical trials focussing on blood pressure-lowering medication. The Study aimed to assess the effect of different intensities of blood pressure treatment on participants’ blood pressure, adverse events and their quality of life. The Study was a home-based trial that allowed patients to participate from their homes without the need to attend their GPs or outpatient clinic appointments.The ATEMPT trial recruited 230 participants’ with a mean age of 76 years. 118 women and 111 men joined the study, and they were taking a mean of 5.7 medications and were diagnosed with a median of 4 medical conditions. 126 participants were part of the treatment group in which a more blood pressure-lowering tablets were prescribed, and 104 participants belonged to the group in which fewer tablets were prescribed. The difference in systolic blood pressure, which is the first number displayed on your blood pressure monitor, was 11 mmHg between the two groups. There were no differences in quality of life, mobility, and cognitive function that participants kindly completed on the study website or when assessed over the telephone. Some participants who were prescribed new blood pressure-lowering tablets described symptoms, such as dizziness or tiredness, and we cannot be sure of the reasons for that yet. Participants provided the trial with exceptionally positive feedback and particularly enjoyed the chance to participate from their homes without the need to attend appointments elsewhere.
Conclusion
The Study showed that older patients who have several conditions or take multiple medications are willing to join a blood pressure-lowering trial that uses a flexible approach allowing them to participate from their homes. Although there were no routine clinic appointments, patients in the group of more blood pressure-lowering tablets showed a good medication adherence resulting in a substantially lower blood pressure. The results of the questionnaires showed that the increase of blood pressure-lowering medications had no harmful effects on participants’ quality of life, mobility, or cognitive function and there were no severe side effects from the treatment. We could show that patients’ blood pressure can be safely lowered in a home-based clinical trial. A grant application for a large clinical trial has been submitted.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
20/NW/0344
Date of REC Opinion
29 Sep 2020
REC opinion
Further Information Favourable Opinion