Comparing treatments for high blood pressure in older patients with more than one chronic illness

Not Applicable

Completed

• Conditions: Blood pressure treatment in older, multimorbid patients; Circulatory System; Essential (primary) hypertension

• Registration Number: ISRCTN17647940
• Lead Sponsor: niversity of Oxford

Brief Summary

2023 Results article in https://doi.org/10.1097/01.hjh.0000939004.21318.7b (added 16/08/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-01
• Study Completion: 2022-08-31
• Last Update Posted: 28 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

1. Age 65 years or more
2. Having at least three chronic diseases or taking at least five non-antihypertensive drugs
3. Baseline office systolic BP in the range of 115-165 mmHg (or home systolic BP of 110-160 mmHg)
4. Willingness to have anti-hypertensive medication modified (increased, decreased or left unchanged) by trial team for the duration of the trial
5. Willingness to register with the specified on-line pharmacy service to facilitate remote dispensing of anti-hypertensive medication and period sharing of participants prescription list
6. Willingness and ability to monitor BP at home
7. Participant is willing and able to give informed consent for participation in the trial
8. Participant’s or carer’s ability to understand English language is required to operate the IT-enabled (web-based) system

Exclusion Criteria

1. Previous admission to hospital with primary diagnosis of heart failure or known systolic heart failure
2. Self-reported symptomatic orthostatic hypotension
3. Pre-existing anti-hypertensive treatment, or baseline BP prohibit the achievement of the minimum required change in anti-hypertensive drugs defined as:
3.1. Office systolic BP 155 to 165 mmHg and on three or more anti-hypertensive medications
3.2. Office systolic BP 115 to 124 mmHg and no anti-hypertensive medications
4. Routine use of a dosset box or NOMAD box to help manage medications
5. No reliable 4G mobile or WiFi network connectivity at home
6. Lack of uncertainty in the opinion of the Investigator for changing BP drug treatment (e.g., any other significant disease, which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or the participant’s ability to participate in the trial)
7. Current participation in any other research trial that investigates blood pressure management

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Modelled difference in mean change in systolic blood pressure from baseline to end of study between treatment groups and cumulative time-weighted difference in systolic blood pressure between treatment groups, as measured by participants themselves at home using a blood pressure monitor on a weekly basis

Secondary Outcome Measures

Name	Time	Method
1. Counts of each anti-hypertensive drug class for each participant and the average daily dose of all anti-hypertensive drugs for each participant, measured at monthly intervals throughout the study<br>2. Serious adverse events as measured by the incidence of serious adverse events and selected non-serious adverse events with information collated directly from participants and central databases throughout the study<br>3. Acceptability and tolerability of the intervention measured using participant completed health questionnaires (EQ-5D-5L), measures of frailty (PRISMA 7) and drug compliance and a researcher assessment of cognitive function (T-MoCA) completed every 3 months for the duration of the study