The THINK-TTP Study for Assessing Cognitive Function in Clinical Trials: A Qualitative Research Protocol

Purpose of the Research Immune thrombotic thrombocytopenic purpura (TTP) is a rare, life-threatening condition with long-term impacts on survivors’ health-related quality of life (HRQoL). A top HRQoL concern among TTP survivors is cognitive dysfunction. However, the specific cognitive aspects affected by TTP remain poorly understood. This gap limits the ability to assess cognitive outcomes in clinical trials and hinders the development of targeted interventions. To address this gap, we designed THINK-TTP – a qualitative study designed to identify and characterize cognitive dysfunction experienced by patients with TTP through interviews with patients and patient-observer dyads. Major Findings This protocol describes a multi-site, descriptive, qualitative study of cognitive dysfunction using semi-structured interviews of 24 patient and close observer dyads (48 interviews total). This study is the first step in selection of appropriate clinical outcome assessments that are specific to cognitive dysfunction experienced after a TTP diagnosis. Additional data sources include standardized questionnaires, clinical data, and performance-based cognitive tasks. Conclusions A qualitative study protocol describing procedures for eliciting and documenting patient and observer perspectives on cognitive function facilitates rigor and transparency and enhances clinical trial readiness. After completion, this study will generate foundational evidence to support cognitive function measures tailored to the experiences of people with TTP in clinical trials.