Table 4.

ACCEPT for a Full-Scale RCT with the iCST App⁴¹

Component of Trial		Monitoring Methods	Amend?	Outcomes
Trial design		Reviewed suitability of and adherence to research protocol.	No	Trial design and related components are appropriate.
Sample size		Tested assumptions within protocol on: number of sites; recruitment rates; retention rates; and SD of primary outcomes.	Yes	Revision necessary in terms of sample size calculation; recruiting capacity; trial period; and funding.
Interventions	Clinical governance	Assessed compliance with formal training in intervention through contact with local PIs.	Yes	Enhance formal training and supervision of local researchers and/or research nurses at each site eg, by additional training visits and/or catch-ups.
	Intervention fidelity	Measured & assessed adherence to intervention through weekly telephone calls and analytics.	Yes	Enhance supervision of intervention using identifiable analytics. Extend the iCST app with more relevant activities and provide more guidance in its use eg, through the involvement of a formal carer.
Participants	Recruitment strategy	Assessed participant flow per recruitment source.	Yes	Refine recruitment strategy eg, by promoting engagement within recruitment sources (eg, memory clinics) and include other sources such as the Alzheimer’s Society.
	Eligibility criteria	Assessed reasons for ineligible participants and any barriers to recruitment.	Yes	Refine eligibility criteria eg, by making the iCST app compatible with a maximum number of devices.
Consent procedures	Participant information sheets (PIS)	Monitored PIS distribution and emergence of questions related to the PIS through contact with PIs at local site.	No	PIS are appropriate.
	Taking informed consent	Monitored consent documentation and appropriateness of forms through contact with PIs at local site.	No	Consent process and accompanying forms are appropriate.
Randomisation process		Checked randomisation procedures including use of Sealed Envelope, randomisation sequences and accessibility by researchers.	No	Randomisation procedure and training of research team are appropriate.
Blinding		Checked occurrences of unblinding by participants and whether unblinded researchers can keep other researchers blind.	Yes	Extend blinding procedures, eg, by checking whether blinded assessors can predict individual allocations.
Data	Data collection	Assessed adherence to assessments and weekly telephone calls/questionnaires.	Yes	Refine schedules to reduce assessment burden and modify outcome measure selection. Enhance training of research team in data collection tools such as outcome measures to minimise errors and missing data.
	Data quality	Tested missing data procedures listed within the analysis plan.	Yes	Refine missing data procedures in case of assessments missing in full eg, through statistical analyses.
	Data management	Tested suitability of trial database, storage of data, related procedures and software.	Yes	Refine trial database and data monitoring procedures considering the amount of data in larger trial.
Research Governance	Research protocol adherence	Tested adherence to research protocol as widely as possible through regular contact with local PIs.	Yes	Enable quality assurance officer (QAO) to test adherence as widely as possible. Refine protocol to enhance quality assurance plan and training of team.
	Adverse events (AE)	Assessed occurrences and severity of AEs, and reporting procedures.	Yes	Refine AE reporting and assessment procedures through the addition of a QAO.
	Health & Safety (H&S)	Monitored H&S procedures, eg, during installation and assessment visits.	No	Refinement to H&S procedures not necessary.
Data analysis		Tested an analysis plan on the obtained data.	Yes	Refine analysis plan to address research aims in full in terms of effectiveness on outcomes.
Trial management		Reviewed role descriptions of research team including at local sites.	Yes	Extension of research team will be necessary through a Trial Steering Committee and a Data Monitoring Committee. Refine roles eg, depending on workloads.

Notes: Adapted from Charlesworth G, Burnell K, Hoe J et al. Acceptance checklist for clinical effectiveness pilot trials: a systematic approach. BMC Med Res Methodol 13, 78 (2013). Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0)⁴¹.