Clinical Trial

DEterminants of Decisional Autonomy In Chronic Pain Patients and Assessment of Treatment Effectiveness

Study acronym: DEDICATE
Recruiting
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Summary
Chronic pain is defined as an unpleasant sensory and emotional experience that persists for three months or more, affecting 20-30% of the global adult population. It can arise from primary conditions or as a consequence of diseases and is a significant source of disability. Chronic pain is no longer merely a symptom but often a disease itself, with neurological and psychosocial mechanisms. The biopsychosocial model introduced by George Engel in 1977 helps to consider the biological, psychological, social, and societal dimensions of chronic pain. Patients with chronic pain must adapt to new circumstances, acquiring new knowledge and coping skills to reach a new homeostasis. The goal is not necessarily pain elimination but enabling patients to manage their pain and continue daily activities effectively. International guidelines suggest a patient-centered, interdisciplinary approach to managing chronic pain, with an emphasis on empowering patients, motivating them, and involving them in decision-making. Autonomy in decision-making is crucial in this context, encompassing both negative freedom (absence of external constraints) and positive freedom (the ability to make choices and realize one's potential). However, chronic pain can limit cognitive and functional abilities, potentially impeding a patient's autonomy. Research indicates that a significant proportion of chronic pain patients experience a deficit in decision-making autonomy. This mixed-methods study aims to explore the determinants of decision-making autonomy in chronic pain patients and its impact on their treatment. Using the MacCAT-T assessment tool, which evaluates understanding, reasoning, appreciation, and choice expression, the study will examine the relationship between patients' autonomy levels and their health outcomes. The study will also assess how clinicians perceive patients' autonomy compared to the tool's findings.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-01-30.
Status change: Not Yet Recruiting → Recruiting 2025-06-18
Trial Details
NCT Number NCT06811103
Lead Sponsor Fondation Hôpital Saint-Joseph
Conditions Chronic Pain
Enrollment 200 participants
Start Date 2025-03-01
Primary Completion 2027-03-01 (estimated)
Study Completion 2027-10-30 (estimated)
Updated on ClinicalTrials.gov 2025-06-24