The University of Sheffield
RHABIT Project Protocol Version 2.0.docx (166.9 kB)
Download file

Recording Harms in Behavioural change Intervention Trials (RHABIT) Project Protocol

Download (166.9 kB)
posted on 2023-06-23, 09:19 authored by Diana PapaioannouDiana Papaioannou, Sienna Hamer-KiwaczSienna Hamer-Kiwacz, Cara MooneyCara Mooney, Kirsty Sprange, Gwenllian Moody, Cindy CooperCindy Cooper, Alicia O'CathainAlicia O'Cathain

This is the protocol for the RHABIT (Recording Harms in Behavioural change Intervention Trials) project and describes the research taking place, including the methods that will be used in the study as well as the planned outputs.

The aim of the RHABIT project is to collaborate across several CTUs to determine appropriate practice for the collection and recording of harms in BCI trials to develop principles, considerations, and recommendations. It consists of 4 work packages (WP): WP1 Scoping review of literature to identify definitions, typologies, instruments, and suggested principles for recording harms in behavioural change intervention (BCI) trials; WP2 Qualitative interviews with clinical trials unit (CTU) and NIHR investigators involved in designing and delivering BCI trials; WP3 Workshop(s) to review guidance for recording harms in BCI trials; and WP4 Suggested principles and considerations for harms recording in BCI trials.

ScHARR REC Ref. 044669  


NIHR CTU Support Funding



  • The project has ethical approval and the number is included in the description field


  • The data complies with the institution and funders' policies on access and sharing

Sharing and access restrictions

  • The data can be shared openly

Data description

  • The file formats are open or commonly used

Methodology, headings and units

  • Headings and units are explained in the files

Usage metrics

    Design, Trials and Statistics