Chronic Paine-DOL cohortNCT04880096
Cohort of Chronic Pain Patients
An observational study of Chronic Pain, run by University Hospital, Clermont-Ferrand at 22 sites in France.
Trial summary
Chronic pain affects approximately 20% of adults, 50% of the elderly population and over 1.5 billion people worldwide. Societal and economic issues are also crucial, as 60% of people with pain are less able or unable to work and 20% say they have lost their jobs because of pain. 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?
- eDOL
- How many people
- 5,000 participants
- Where
- 22 sitesFrance
- Study dates
- 14 Sep 2021to 14 Sep 2031
- 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
- Adult, Older adult
Study population: Patiant with chronic pain
Who may be able to join
- All patients with chronic pain
- patients equipped and regular users of a smartphone
- Non-opposition to participation in the study
Who cannot join
- Patient unable to understand or answer questionnaires
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
22 sites in 1 country
France22 sites, 22 recruiting
- Recruiting
CHU Amiens
Amiens, 80054
Eric SERRA
- Not yet recruiting
CH Bayeux
Bayeux, 14400
Lauriane FOUREL
- Not yet recruiting
CHU bordeaux
Bordeaux, 33000
Virginie CORAND
- Recruiting
APHP Ambroise Paré
Boulogne-Billancourt, IDF, 92100
Nadine ATTAL
- Recruiting
Hospices civils Lyon
Bron, 69500
Christian GOV
- Recruiting
CHU de Clermont-Ferrand - Service de Neurologie
Clermont-Ferrand, AURA, 63000
Xavier MOISSET
- Recruiting
Clermont-Ferrand University Hospital
Clermont-Ferrand, AURA, 63000
Lise laclautre, 04 73 75 11 95, promo_interne_drci@chu-clermontferrand.fr
Nicolas AUTHIER
- Recruiting
CHU Grenoble
Grenoble, 38700
Marie FROST
- Recruiting
CHU Limoges
Limoges, 87000
Pascale VERGNE-SALLE
- Recruiting
Ch Lons Le Saunier
Lons-le-Saunier, 39000
Laurent BALP
- Not yet recruiting
CHU Montepllier
Montpellier
Patrick GINIES
- Recruiting
CHU Nantes
Nantes, 44093
Julien NIZARD
- Recruiting
CHU Nîmes
Nîmes, 30029
François JESRYKA
- Recruiting
APHP Saint Antoine
Paris, IDF, 75012
Françoise LAROCHE
- Recruiting
APHP Cochin
Paris, IDF, 75014
Serge PERROT
- Recruiting
Groupe Hospitalier Paris Saint Joseph
Paris, IDf, 75014
Marguerite D'USSEL
- Recruiting
CHU Rennes
Rennes, 35000
akexandre MENET
- Recruiting
Chu Rouen
Rouen, 76000
Rodrigue DELEENS
- Recruiting
CHU Saint Etienne
Saint-Etienne, 42270
Christelle CREACH
- Recruiting
Hôpital Civil de Strasbourg
Strasbourg
Eric SALVAT
- Recruiting
Chu Toulouse
Toulouse, 31300
Nathalie CANTAGREL
- Recruiting
CH Voiron
Voiron, 38500
Gérard MICK
About this study
Official title: Constitution and Analysis of a Cohort of Patients Followed in Pain Clinics and at Home in Real Life
Chronic pain affects approximately 20% of adults, 50% of the elderly population and over 1.5 billion people worldwide. Societal and economic issues are also crucial, as 60% of people with pain are less able or unable to work and 20% say they have lost their jobs because of pain. The overall cost of chronic pain is estimated at around 300 billion euros in the EU. Unfortunately, current treatments for chronic pain have limited effectiveness and important adverse effects. Pain clinics, which support the most complex and refractory cases of chronic pain, as well as general practitioners and patients expect improvements, both in terms of therapeutic efficacy and organization of care.
In order to allow the characterization and a personalized follow-up of chronic pain patients, we have created e-DOL, a smartphone application for patients and a web platform for healthcare professionals in pain clinics. The purpose of this study is to create an e-cohort for the research, and characterization and follow-up of chronic pain patients.
Read the detailed description
This first French e-cohort of chronic pain patients will allow real-life follow-up in order to generate big data including various information on chronic pain, associated-comorbidities, pain impacts on sleep, activity and psycho-emotional parameters, sociodemographic characteristics and pain treatments.
These data will be collected with he eDOL tool (smartphone application for patients and web platform for caregivers in pain clinics), integrating numerous repeatable questionnaires, weekly barometers, a therapeutic education module and a conversational agent (chat bot).
All of these data will also be linked with French health insurance care data in order to get an overview of comorbidities and patient care consumption in a medico-economic approach.
The study will include 20 pain clinics and a minimum of 5000 patients followed for 24 months.
- Conditions
- Chronic Pain
- Being tested
- eDOL
- Keywords
- Chronic Pain, e-Health
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eDOLOther
e-health tool (mobile app for patients and web platform for caregivers in pain clinics)
| Study group | Role | What they receive |
|---|---|---|
| chronic pain patients | All adult patients followed-up in participating pain clinics Receives: Other: eDOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
multidimensional characterisation of chronic pain patients
Multimodal exploratory analysis of the determinants and repercussions of chronic pain, and their evolution in a real-life context, taking into account all environmental events likely to influence chronic pain (treatments, history, co-morbidities, etc.).
Measured: 5 years
Secondary outcomes (2)
Multivariate descriptive analyses
Study the relationships between the measured criteria
Measured: 5 years
Longitudinal analyses
Describe the distribution and temporal evolution of the measured variables
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start14 Sep 2021
- Primary completion14 Sep 2031 (estimated)
- Study completion14 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Institut ANALGESIA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880096
- Sponsor's protocol ID
- RNI 2020 AUTHIER
- Acronym
- e-DOL cohort
- Status last verified
- Oct 2026
- First submitted
- 5 May 2021
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Delage N, Cantagrel N, Soriot-Thomas S, Frost M, Deleens R, Ginies P, Eschalier A, Corteval A, Laveyssiere A, Phalip J, Bertin C, Pereira B, Chenaf C, Doreau B, Authier N; ePAIN; Kerckhove N. Mobile Health App and Web Platform (eDOL) for Medical Follow-Up of Patients With Chronic Pain: Cohort Study Involving the French eDOL National Cohort After 1 Year. JMIR Mhealth Uhealth. 2024 Jun 12;12:e54579. doi: 10.2196/54579.
PubMed 38865173
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Constitution and Analysis of a Cohort of Patients Followed in Pain Clinics and at Home in Real Life
- ClinicalTrials.gov ID
- NCT04880096
- Acronym / sponsor ID
- e-DOL cohort / RNI 2020 AUTHIER
- Conditions
- Chronic Pain
- Keywords
- Chronic Pain, e-Health
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Institut ANALGESIA
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 14 Sep 2031 (estimated)
- Study completion
- 14 Sep 2031 (estimated)
- First posted
- 10 May 2021 (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 affects approximately 20% of adults, 50% of the elderly population and over 1.5 billion people worldwide. Societal and economic issues are also crucial, as 60% of people with pain are less able or unable to work and 20% say they have lost their jobs because of pain. The overall cost of chronic pain is estimated at around 300 billion euros in the EU. Unfortunately, current treatments for chronic pain have limited effectiveness and important adverse effects. Pain clinics, which support the most complex and refractory cases of chronic pain, as well as general practitioners and patients expect improvements, both in terms of therapeutic efficacy and organization of care.
In order to allow the characterization and a personalized follow-up of chronic pain patients, we have created e-DOL, a smartphone application for patients and a web platform for healthcare professionals in pain clinics. The purpose of this study is to create an e-cohort for the research, and characterization and follow-up of chronic pain patients.
Detailed description
This first French e-cohort of chronic pain patients will allow real-life follow-up in order to generate big data including various information on chronic pain, associated-comorbidities, pain impacts on sleep, activity and psycho-emotional parameters, sociodemographic characteristics and pain treatments.
These data will be collected with he eDOL tool (smartphone application for patients and web platform for caregivers in pain clinics), integrating numerous repeatable questionnaires, weekly barometers, a therapeutic education module and a conversational agent (chat bot).
All of these data will also be linked with French health insurance care data in order to get an overview of comorbidities and patient care consumption in a medico-economic approach.
The study will include 20 pain clinics and a minimum of 5000 patients followed for 24 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronic pain patients | – | Other: eDOLAll adult patients followed-up in participating pain clinics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patiant with chronic pain
Key inclusion criteria (3 listed)
- All patients with chronic pain
- patients equipped and regular users of a smartphone
- Non-opposition to participation in the study
Key exclusion criteria (1 listed)
- Patient unable to understand or answer questionnaires
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 |
|---|---|---|
| eDOLe-health tool (mobile app for patients and web platform for caregivers in pain clinics) | Other | chronic pain patients |
Primary outcome
multidimensional characterisation of chronic pain patients
Time frame: 5 years
Multimodal exploratory analysis of the determinants and repercussions of chronic pain, and their evolution in a real-life context, taking into account all environmental events likely to influence chronic pain (treatments, history, co-morbidities, etc.).
2 secondary outcomes
Multivariate descriptive analyses
Time frame: 5 years
Longitudinal analyses
Time frame: 5 years
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 29 Oct 2026.
- Derived from this study: PubMed 38865173Delage N, Cantagrel N, Soriot-Thomas S, Frost M, Deleens R, Ginies P, Eschalier A, Corteval A, Laveyssiere A, Phalip J, Bertin C, Pereira B, Chenaf C, Doreau B, Authier N; ePAIN; Kerckhove N. Mobile Health App and Web Platform (eDOL) for Medical Follow-Up of Patients With Chronic Pain: Cohort Study Involving the French eDOL National Cohort After 1 Year. JMIR Mhealth Uhealth. 2024 Jun 12;12:e54579. doi: 10.2196/54579.
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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.
22 sites 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 University Hospital, Clermont-Ferrand at 22 sites 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 3 inclusion and 1 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 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites 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 Lise Laclautre (04 73 75 11 95, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
multidimensional characterisation of chronic pain patients (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04880096, which also lists 1 linked publication.
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 29 Oct 2026.