Chronic PainCOADOLNCT06811077
Evaluation of Individual Health Coaching Sessions Provided by a Patient Expert As Part of Therapeutic Education for Patients Registered At the Chronic Pain Consultation
An observational study of Chronic Pain, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Chronic pain is defined as a persistent sensory and emotional experience, lasting for more than three months, and often resistant to treatment. It can result from various conditions, including life-threatening diseases, accidents, or therapeutic procedures like surgery or chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- individual coaching
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 3 Feb 2025to 15 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients followed in chronic pain consultations referred to the therapeutic education workshops
Who may be able to join
- Patient aged ≥ 18 years
- Patients followed in chronic pain consultations referred to the therapeutic education workshops
- Patient affiliated with a health insurance plan
- French-speaking patient
- Patient capable of giving oral, informed, and explicit consent
Who cannot join
- Patient with psychiatric disorders making inclusion in group workshops impossible
- Patient unwilling to participate in individual coaching sessions Patient under guardianship or curatorship Patient deprived of liberty Patient under legal protection Pregnant or breastfeeding patient
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Saint Joseph
Paris, France, 75014
juliette COURTIADE MAHLER, PhD, +3344127963, jcourtiade@ghpsj.fr
About this study
Official title: As Part of Therapeutic Education for Patients Registered At the Chronic Pain Consultation
Chronic pain is defined as a persistent sensory and emotional experience, lasting for more than three months, and often resistant to treatment. It can result from various conditions, including life-threatening diseases, accidents, or therapeutic procedures like surgery or chemotherapy. Chronic pain significantly impacts a patient's physical and psychological well-being, often leading to body image issues and functional deterioration in daily activities, both at home and at work or school. The World Health Organization recognized chronic pain as a disease in 2019. Chronic pain patients must adapt to their condition, acquiring new skills and knowledge through therapeutic education. Group sessions, a key part of therapeutic education, help break the isolation felt by many patients, fostering shared experiences and mutual support. Since 2015, the Saint-Joseph Hospital's chronic pain consultation has offered group education workshops, inspired by those at the Pitié-Salpêtrière hospital in Paris. However, many patients struggle to apply new skills independently after these workshops. In response, individualized coaching was introduced in 2020. This approach, led by a health coach who is also an expert patient, provides personalized support to help patients set and achieve realistic goals, fostering active engagement in their lives through tailored strategies and ongoing support.
The main aim of this pilot study is to assess the quantitative and qualitative contribution of personalized support by an "expert patient" chronic pain coach (individual coaching), on the functional and emotional impact and emotional impact of their pain, in patients followed up in a chronic pain consultation and having group therapeutic education workshops.
- Conditions
- Chronic Pain
- Being tested
- individual coaching
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
individual coachingOther
in addition to group therapeutic education, the patient participates to individual coaching session and answers several Patient Reported Outcome to assess his wellbeing
| Study group | Role | What they receive |
|---|---|---|
| individual coaching | Not described Receives: Other: individual coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
BPI (Brief Pain Inventotry )
evaluation of functional and emotional impact of pain assess with the Brief Pain inventory on a scale from 0 to 10
Measured: enrollment, 4, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start3 Feb 2025
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06811077
- Sponsor's protocol ID
- COADOL
- Acronym
- COADOL
- Status last verified
- Feb 2025
- First submitted
- 30 Jan 2025
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- As Part of Therapeutic Education for Patients Registered At the Chronic Pain Consultation
- ClinicalTrials.gov ID
- NCT06811077
- Acronym / sponsor ID
- COADOL / COADOL
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic pain is defined as a persistent sensory and emotional experience, lasting for more than three months, and often resistant to treatment. It can result from various conditions, including life-threatening diseases, accidents, or therapeutic procedures like surgery or chemotherapy. Chronic pain significantly impacts a patient's physical and psychological well-being, often leading to body image issues and functional deterioration in daily activities, both at home and at work or school. The World Health Organization recognized chronic pain as a disease in 2019. Chronic pain patients must adapt to their condition, acquiring new skills and knowledge through therapeutic education. Group sessions, a key part of therapeutic education, help break the isolation felt by many patients, fostering shared experiences and mutual support. Since 2015, the Saint-Joseph Hospital's chronic pain consultation has offered group education workshops, inspired by those at the Pitié-Salpêtrière hospital in Paris. However, many patients struggle to apply new skills independently after these workshops. In response, individualized coaching was introduced in 2020. This approach, led by a health coach who is also an expert patient, provides personalized support to help patients set and achieve realistic goals, fostering active engagement in their lives through tailored strategies and ongoing support.
The main aim of this pilot study is to assess the quantitative and qualitative contribution of personalized support by an "expert patient" chronic pain coach (individual coaching), on the functional and emotional impact and emotional impact of their pain, in patients followed up in a chronic pain consultation and having group therapeutic education workshops.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| individual coaching | – | Other: individual coaching |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients followed in chronic pain consultations referred to the therapeutic education workshops
Key inclusion criteria (5 listed)
- Patient aged ≥ 18 years
- Patients followed in chronic pain consultations referred to the therapeutic education workshops
- Patient affiliated with a health insurance plan
- French-speaking patient
- Patient capable of giving oral, informed, and explicit consent
Key exclusion criteria (2 listed)
- Patient with psychiatric disorders making inclusion in group workshops impossible
- Patient unwilling to participate in individual coaching sessions Patient under guardianship or curatorship Patient deprived of liberty Patient under legal protection Pregnant or breastfeeding patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| individual coachingin addition to group therapeutic education, the patient participates to individual coaching session and answers several Patient Reported Outcome to assess his wellbeing | Other | individual coaching |
Primary outcome
BPI (Brief Pain Inventotry )
Time frame: enrollment, 4, 6 and 12 months
evaluation of functional and emotional impact of pain assess with the Brief Pain inventory on a scale from 0 to 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Fondation Hôpital Saint-Joseph at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne COUTAUX, Dr (+33144123193, acoutaux@ghpsj.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BPI (Brief Pain Inventotry ) (time frame: enrollment, 4, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.