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Recruiting NCT06811103

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

Observational Chronic Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: patient reported outcome.
Who it may be relevant to
Registry conditions: Chronic Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other patient reported outcome
    after enrollment, patient will have to answer to several patient reported outcome (PRO) to evaluate their pain, and well being. They will also answer to the MacCatT PRO to assess their understanding, reasoning, appreciation and choice expression

Primary outcome measures

  • influences on decision making (MacCAT-T) [Time frame: enrollment]

Eligibility criteria

Inclusion criteria

  • Patient aged 18 years or older
  • Patient attending their first consultation for chronic pain between 01/01/2025 and 31/12/2025
  • Francophone patient
  • Patient capable of expressing their non-opposition to participation

Exclusion criteria

  • Patient with significant visual or hearing impairment
  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under judicial protection Patient who opposes the use of their data for this research

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Hôpital Paris Saint Joseph — Paris

Identifiers

NCT: NCT06811103 · DEDICATE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗