TIPTOE SWAP: Addressing the challenges of including older adults in digitally enabled and decentralised trials
Background
Clinical trials are increasingly being delivered outside of hospitals or research centres. In these ‘decentralised trials’, some or all trial-related activities take place at other locations, such as the person’s own home, or online such as via a study website or an app. However, digitally enabled trials can exclude people who don’t have access to the internet, lack confidence online, or have security concerns.
Older adults, particularly those with multiple long-term conditions (MLTCs) are known to be under-represented in clinical trials. As older adults may be less likely to engage with digital methods, decentralised trials could potentially further exclude them.
TIPTOE SWAP
TIPTOE is a randomised controlled trial evaluating a self-management support intervention for older adults with knee and/or hip osteoarthritis and MLTCs. Participants are recruited through several methods including self-referral via the trial website, and can provide consent, complete questionnaires, and receive the intervention remotely if they wish. In order to minimise the barriers to including older people with MLTCs in TIPTOE, we embedded a ‘Study Within a Project’ (SWAP).
The aim of the SWAP was to identify barriers to inclusion, rapidly develop tailored approaches to support recruitment, and provide methodological guidance for future trials.
It had three phases:
- Pre-trial: questionnaires and process mapping with site teams helped understand local populations and map the different recruitment pathways into the study.
- During the pilot phase: interviews with recruiting staff explored their attitudes, skills and confidence when recruiting under-served populations.
- Transition to the main trial: interviews with trial participants, particularly from under-served groups, explored their experiences of taking part.
Key recommendations
1. Ensure a person-centred approach
Create opportunities to build connections between participants and the research team such as providing telephone support. Additional resources and time should be built into the funding application.
2. Get the messaging right
Participant-facing materials should be designed to be accessible, balanced, and convey key information such as the purpose of the trial and both digital and non-digital options for participating. Diverse public involvement contributors can ensure that the right message is being conveyed in the best way for this population.
3. Consider intersectionality and digital positionality
Other factors can affect older adults’ ability and willingness to engage with the study beyond digital access, such as a fear of being scammed. Consider strategies such as text messages being sent by GPs rather than an unknown source.
4. Provide flexible support options
Older adults may have individual support needs that should be accommodated wherever possible. Flexible options should be built in, such as enabling verbal consent or nominating a support person to assist with completing forms.
5. Avoid losing people through the ‘cracks’
Multi-stage processes for recruiting participants (e.g. expression of interest, consent, baseline data) means opportunities for ‘losing’ participants. Consider how to streamline processes and track participants, which may require more frequent communication with participants with implications for data management resourcing.
Read more about the TIPTOE SWAP: https://link.springer.com/article/10.1186/s13063-026-09907-w
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