NCT05889403

Brief Summary

Patient autonomy is recognized throughout the world, by caregivers, as a value. The idea of autonomy has been the keystone of the changes accomplished in the contemporary history of health law. It is about respect for everyone to have their own health and to choose the options that correspond to their wishes, their values or their life projects. The recently revised definition of pain specifies that it is "an unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage". In this, pain is always a personal experience that is influenced to varying degrees by biological, psychological and social factors. The High Authority of Health considers pain as chronic is considered when it is persistent or recurrent beyond what is usual for its presumed initial cause (most often beyond 3 months), that it responds harm to treatment and that they induce a significant and progressive deterioration of functional and relational capacities. Chronic pain confines patients on a psychosocial level. It is no longer just a symptom, it is even a disease in its own right since 2019 with the new classification of diseases proposed by the World Health Organization.In France, chronic pain concerns 31.7% of French people regardless of its intensity, and 19.9% of French people for moderate to severe pain, which represents 13 million people in total. As with any chronic disease, the patient suffering from persistent pain must develop the ability to adapt to cope with the new situation with which he is confronted. He must be able to acquire knowledge and new know-how related to his pathology and thus finally find a new homeostasis, a new state of health having integrated "the pathological state". In France, chronic pain concerns 31.7% of French people regardless of its intensity, and 19.9% of French people for moderate to severe pain, which represents 13 million people in total. As with any chronic disease, the patient suffering from persistent pain must develop the ability to adapt to cope with the new situation with which he is confronted. He must be able to acquire knowledge and new know-how related to his pathology and thus finally find a new homeostasis, a new state of health having integrated "the pathological state".In France, chronic pain concerns 31.7% of French people regardless of its intensity, and 19.9% of French people for moderate to severe pain, which represents 13 million people in total. As with any chronic disease, the patient suffering from persistent pain must develop the ability to adapt to cope with the new situation with which he is confronted. He must be able to acquire knowledge and new know-how related to his pathology and thus finally find a new homeostasis, a new state of health having integrated "the pathological state". In current practice, this skill is assessed in case of doubt (generally when there is uncertainty about the patient's understanding of the issues and his involvement in the therapeutic project) intuitively, by following a Socratic questioning or from grids like the MacCAT-T. In the pain center, investigators use the MacCAT-T but investigators have not yet systematically measured the benefit and the cost of using this questionnaire in everyday practice. In particular, investigators want to know if the skill is not overestimated by the doctor in charge of the patient.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 5, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

June 5, 2023

Status Verified

May 1, 2023

Enrollment Period

3 months

First QC Date

May 26, 2023

Last Update Submit

May 26, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Measurement of patient autonomy

    This outcome corresponds to the analysis of the distribution (means, standard deviations, medians, etc.) of MacCAT-T subscores (understanding, evaluation, appreciation and reasoning) of patients just after the pain consultation, where the personalized therapeutic plan was offered to them. analysis of the distribution (means, standard deviations, medians, etc.) of MacCAT-T subscores (understanding, evaluation, appreciation and reasoning) of patients just after the pain consultation, where the personalized therapeutic plan was offered to them

    Day 1

Secondary Outcomes (1)

  • Good capacity for evaluation by the investigators of the autonomy of their patient

    Day 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient coming in 1st chronic pain consultation

You may qualify if:

  • Patient whose age ≥ 18 years
  • Patient coming in 1st chronic pain consultation
  • French-speaking patient

You may not qualify if:

  • Patient with a significant visual or auditory deficit
  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under legal protection
  • Patient objects to the use of their data for this research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Hôpital Saint-Joseph

Paris, 75014, France

Location

Related Publications (7)

  • Raja SN, Carr DB, Cohen M, Finnerup NB, Flor H, Gibson S, Keefe FJ, Mogil JS, Ringkamp M, Sluka KA, Song XJ, Stevens B, Sullivan MD, Tutelman PR, Ushida T, Vader K. The revised International Association for the Study of Pain definition of pain: concepts, challenges, and compromises. Pain. 2020 Sep 1;161(9):1976-1982. doi: 10.1097/j.pain.0000000000001939.

    PMID: 32694387BACKGROUND
  • Treede RD, Rief W, Barke A, Aziz Q, Bennett MI, Benoliel R, Cohen M, Evers S, Finnerup NB, First MB, Giamberardino MA, Kaasa S, Kosek E, Lavand'homme P, Nicholas M, Perrot S, Scholz J, Schug S, Smith BH, Svensson P, Vlaeyen JWS, Wang SJ. A classification of chronic pain for ICD-11. Pain. 2015 Jun;156(6):1003-1007. doi: 10.1097/j.pain.0000000000000160. No abstract available.

    PMID: 25844555BACKGROUND
  • Bouhassira D, Lanteri-Minet M, Attal N, Laurent B, Touboul C. Prevalence of chronic pain with neuropathic characteristics in the general population. Pain. 2008 Jun;136(3):380-387. doi: 10.1016/j.pain.2007.08.013. Epub 2007 Sep 20.

    PMID: 17888574BACKGROUND
  • Engel GL. The need for a new medical model: a challenge for biomedicine. Science. 1977 Apr 8;196(4286):129-36. doi: 10.1126/science.847460.

    PMID: 847460BACKGROUND
  • Grisso T, Appelbaum PS, Hill-Fotouhi C. The MacCAT-T: a clinical tool to assess patients' capacities to make treatment decisions. Psychiatr Serv. 1997 Nov;48(11):1415-9. doi: 10.1176/ps.48.11.1415.

    PMID: 9355168BACKGROUND
  • Raffard S, Lebrun C, Laraki Y, Capdevielle D. Validation of the French Version of the MacArthur Competence Assessment Tool for Treatment (MacCAT-T) in a French Sample of Individuals with Schizophrenia: Validation de la version francaise de l'instrument d'evaluation des competences MacArthur-traitement (MacCAT-T) dans un echantillon francais de personnes souffrant de schizophrenie. Can J Psychiatry. 2021 Apr;66(4):395-405. doi: 10.1177/0706743720966443. Epub 2020 Oct 16.

    PMID: 33064578BACKGROUND
  • Etchells E, Darzins P, Silberfeld M, Singer PA, McKenny J, Naglie G, Katz M, Guyatt GH, Molloy DW, Strang D. Assessment of patient capacity to consent to treatment. J Gen Intern Med. 1999 Jan;14(1):27-34. doi: 10.1046/j.1525-1497.1999.00277.x.

    PMID: 9893088BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2023

First Posted

June 5, 2023

Study Start

February 15, 2023

Primary Completion

May 15, 2023

Study Completion

December 31, 2023

Last Updated

June 5, 2023

Record last verified: 2023-05

Locations