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NCT Number: NCT06811103

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Paris Saint Joseph

Paris, 75014, France

Location status: Recruiting

Location contact

Juliette COURTIADE MAHLER, PhD

CONTACT

[email protected]

+3344127963

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

patient reported outcome

Other

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 outcomes

  1. influences on decision making (MacCAT-T)

    Time frame: enrollment

    The primary objective is to identify the socio-demographic, cognitive, educational, and medical factors that influence overall decision-making autonomy in chronic pain patients who are seeking treatment for the first time as assessed with the MacArthur Competence Assessment Tool-Treatment (MacCAT-T)

Study contacts

Contact information is provided by the study sponsor or research team.

Marguerite D'USSEL, MD

CONTACT

[email protected]

+33144127147

Sponsors and collaborators

Lead sponsor

Fondation Hôpital Saint-Joseph

Other

Registry information

Acronym: DEDICATE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 6, 2025
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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