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Systematic Techniques to Enhance rEtention in Randomised controlled trials: the STEER study protocol.

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Improving clinical trial retention is crucial for reliable results. This study develops theory-informed, participant-centered interventions to boost participant retention and reduce research waste.

Keywords:
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Area of Science:

  • Clinical Trials
  • Behavioral Science
  • Health Research Methodology

Background:

  • Participant non-retention in clinical trials compromises study credibility and clinical impact.
  • Existing retention strategies often lack theoretical grounding and participant involvement.
  • Understanding and addressing the behavioral aspects of non-retention is key.

Purpose of the Study:

  • To develop and pilot theoretically informed, participant-centered interventions to enhance clinical trial retention.
  • To address the lack of theoretical basis and participant involvement in current retention strategies.
  • To reduce research waste by improving participant adherence and data completeness.

Main Methods:

  • Conducting semi-structured interviews to identify barriers and enablers to trial retention using the Theoretical Domains Framework.
  • Employing recognized methodologies for behavior change technique identification and co-producing interventions with end-users.
  • Evaluating intervention acceptability and feasibility through focus groups and developing evaluation and retention frameworks.

Main Results:

  • This study will generate data on stakeholder perspectives regarding trial non-retention.
  • It will identify key behavior change techniques and co-produce relevant interventions.
  • An evaluation framework and an explanatory retention framework will be developed.

Conclusions:

  • This research pioneers the application of a theoretical lens to intervention development for trial retention, grounded in participant experiences.
  • Priority interventions will be identified and developed, contributing to reduced research waste.
  • The study aims to enhance the relevance and acceptability of retention strategies.