Patient and public involvement and engagement

Study delivery has benefited from lay members of the project management group, which allowed an integrated approach to redesign. Their previous experience and insight have been invaluable when commenting on important issues, offering a patient perspective to all elements of the redesign including: patient access to technology, use of personal protective equipment (PPE), optimising reminder texts (to mitigate attrition) and improving the participant documents and resources. As acknowledged by the NIHR,15 patient and public involvement and engagement (PPIE) has been essential in successfully adapting the study for remote delivery during the pandemic and beyond.

The considerable time delays caused by COVID-19 restrictions along with the numerous amendments contributed to the significant increase in workload for the research team; arguably this disproportionately impacts on lay members whose continued involvement is no longer commensurate with initial commitment expectations. Interestingly, similar difficulties have resulted in many COVID-19 trials sacrificing valuable PPIE to meet time constraint pressures.16 We have been extremely fortunate with the loyalty and commitment received from our public members and would advise anyone embarking on a funded research path to ensure they select these members with care. The importance of careful ongoing consideration of this aspect is reiterated in the UK-wide vision for the future of clinical research delivery which identifies the need to strengthen PPIE in research.14

Changes to trial protocol and governance

As a result of COVID-19 restrictions, alterations had to be made to the study protocol, along with ethical amendments and this inevitably introduced significant delay to delivery of the study.17 One major alteration involved moving all contact to remote means wherever possible, including the screening, baseline and follow-up visits. This clearly aligns with the DHSC’s fourth key theme to ensure that research is enabled by data and digital tools.14 This meant an additional remote appointment had to be added to screen and check patient eligibility, and clinic BP measurements were replaced by participant home BP readings using Omron M3 Intellisense machines, resulting in increased study costs. Also, this raised potential concerns regarding the accuracy of using this type of BP monitor:18 despite the device being validated19 and the use of remotely observed BP measurements by a trained healthcare professional (HCP).

As a result of social distancing guidelines, participants were asked to carry out home BP readings with the investigator via video call. This was to ensure accurate home BP measurements according to National Institute for Health and Care Excellence guidelines.6 The disadvantage of this approach was that participants needed access to technology which PPIE advised to avoid. Implementing this major change in delivery required additional equipment, such as webcam access, instructional resources (eg, videos) and alternative arrangements for those without IT access or ability, that is, free provision of smart technology or an additional visit. Thus, there were further logistical and cost implications associated with continued attempts to avoid inequity of access.

Due to reduced face-to-face contact with participants, it was necessary to develop a remote reminder system to mitigate increased risk of drop out. The sending of the messages was completely automated and made use of an SMS API provided by a large provider, with this system now reusable for future studies.

Adaptation of participant identification searches and recruitment

The pandemic made recruitment more challenging for several reasons including a reduction of patients identified with stage 1 hypertension on GP records, reduced access to GP administrative staff and less provision of research active staff in primary care.

Searches of GP records yielded considerably fewer patients than pilot work had indicated. This is primarily attributed to: reduced attendances at GP clinics, suspension of routine health checks (eg, well man over 50), reduced recording of hypertension in primary care (suspension of some indicators in the quality and outcomes framework) and lack of repeat attendance for suspected hypertension. This hypothesis is supported by the findings of Dale et al,10 who demonstrate a considerable reduction in numbers treated for incident hypertension during the pandemic. Anecdotal evidence also suggests that because GPs were concerned about being able to follow patients up (during the pandemic), many were commenced on antihypertensive medication immediately following diagnosis rather than allowing a period of lifestyle modification as per hypertension guidelines.6 Since our study recruited untreated hypertensives, this rendered them ineligible. In future, initiatives such as rollout of the NHS community pharmacy BP check service20 may mean potential participants for hypertension studies are identified outside the GP setting and supports the need for a more data-enabled research environment.14

As a result of persistent difficulties with recruiting in primary care, the study was approved for delivery in all NHS settings with additional direct to patient advertising. This targeted potential participants geographically via Facebook social media within reasonable travel distance of a research site. In addition, those displaying interest in subjects that may predispose them to being attracted to the study were targeted. Users seeing the advert could click through to a prescreening survey to find out whether they were eligible to take part in the study and register their details.21 This led to a greater number of potential participants (75% of those randomised) without involving any NHS staff time. This method also elicited a lower percentage of screen failures compared with GP screening and mail out (31% screen failure rate for direct advertising compared with 67% for mail out). Key learning has been the effectiveness of the prescreening survey in significantly reducing staff time (up to 12 hours of screening patient lists before mailout) and screen failure rates.

Adaptations to consent

The requirement to reduce face-to-face contact with participants meant that, although consent remained a requirement, this process had to be managed virtually with the HCP on the video call and participants completing and signing an online form. In line with the drive for research to be enabled by digital tools,14 this data are now captured straight into Qualtrics (online system), which is directly accessible by the research team. This allowed more efficient and accurate data handling without the need to transfer data from paper to database. In general, this worked well; however, there were some cases where it did not, primarily because patients were unable to access both Microsoft Teams and Qualtrics simultaneously.

Changes to the intervention: prescription and development of IE training

The IE intervention used is a wall squat (figure 1) protocol, which involves leaning against a wall and squatting at an individual specific (knee joint) angle prescribed to elicit the required exercise intensity based on HR.22

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Figure 1

Isometric wall squat exercise.

To accurately prescribe an individual specific wall squat angle, participants must complete at least three-stages of a five-stage incremental IE test (IIET).23 It was originally intended to subjectively preassess each patient’s physical ability to meet this requirement during the initial face-to-face screening visit. However, since this was replaced with a remote screening visit, it was not possible to complete this capability assessment in person. As such, we had to develop a simple protocol to be completed remotely via video call. This protocol tested the participant’s ability to reach an approximation of their personalised IE training angle and hold for 60 s. The easy-to-follow instructions allow participants to carry out the test independently. Delivering the test remotely required additional risk assessment, the translation of safety considerations into the home (eg, a nearby chair for support), along with additional online instructional materials.

The IIET stayed the same apart from the time delay of having to establish the status of the exercise type as non-aerosol generating; expert consensus from the Physiological Society was not available until 20 May 2020.24 However, new PPE considerations had to be implemented immediately in line with government guidelines.25 This had numerous implications, not least equipment costs and additional time considerations during face-to-face testing.

Impact of COVID-19 on NHS primary care staff participation

It was originally planned to recruit 2–4 primary care sites in the Southeast based on feasibility searches performed before the pandemic. Between November 2019 and February 2020, one site had committed in principle as a research site. The onset of COVID-19 and unprecedented demands on the NHS, in particular, primary care, led to initial difficulties in identifying principal investigators at prospective sites due to uncertainty of workload. Identification of appropriate HCPs with the capacity to deliver the intervention was already a challenge. This was exacerbated by the fact that GP principal investigators were focused on the COVID-19 response and, later, COVID-19 intervention studies and vaccination.

Embedding clinical research in the NHS is a key theme in the vision of The Future of UK Clinical Research Delivery.14 To create a research-positive culture in which all health and care staff feel empowered to support and participate in clinical research as part of their job role, much greater funding and resourcing of primary care would be necessary. To try and mitigate this in the current study, we were forced to approach sites further afield and would strongly recommend overplanning the number of sites in future exercise-based studies.