Constitution and Analysis of a Cohort of Patients Followed in Pain Clinics and at Home in Real Life

Insurance Daily News

2021 MAY 26 (NewsRx) -- By a News Reporter-Staff News Editor at Insurance Daily News -- Staff editors report on the newly launched clinical trial, NCT04880096, which has the following summary description: “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.”

As a matter of record, on May 11, 2021, NewsRx staff editors report that the available information provided by University Hospital, Clermont-Ferrand on this trial include:

Tracking Information

Trial Identifier	NCT04880096
First Submitted Date	May 5, 2021
First Posted Date	May 10, 2021
Results First Submitted Date	Not Provided
Results First Posted Date	Not Provided
Last Update Submitted Date	May 5, 2021
Last Update Posted Date	May 10, 2021
Primary Completion Date	June 1, 2026
Start Date	June 1, 2021
Current Primary Outcome Measures	•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.).
Current Secondary Outcome Measures	•Multivariate descriptive analyses [ Time Frame: 5 years ] -- Study the relationships between the measured criteria
	•Longitudinal analyses [ Time Frame: 5 years ] -- Describe the distribution and temporal evolution of the measured variables
Other Outcome Measures	Not Provided
Change History	Complete list of historical revisions of study NCT04880096

Descriptive Information

Brief Title	Cohort of Chronic Pain Patients
Official Title	Constitution and Analysis of a Cohort of Patients Followed in Pain Clinics and at Home in Real Life
Brief 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. 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 Type	Observational
Study Phase	Not Provided
Study Design	Observational Model: Cohort
	Time Perspective: Prospective
Condition	Chronic Pain
Intervention	•Other: eDOL
	e-health tool (mobile app for patients and web platform for caregivers in pain clinics)
Study Arms	•chronic pain patients
	All adult patients followed-up in participating pain clinics
	Interventions:
	⚬Other: eDOL

Recruitment Information

Recruitment Status	Not yet recruiting
Estimated Enrollment	5000
Estimated Completion Date	June 1, 2026
Primary Completion Date	June 1, 2026 (Final data collection date for primary outcome measure)
Eligibility	Inclusion Criteria:
	•All patients with chronic pain
	•patients equipped and regular users of a smartphone
	•Non-opposition to participation in the study Exclusion Criteria:
	•Patient unable to understand or answer questionnaires
Sex/Gender	Sexes Eligible for Study: All
Ages	18 years and older
Accepts Healthy Volunteers	Not Provided
Contacts	Primary contact: Lise Laclautre, 04 73 75 11 95, [email protected]
Listed Location Countries	France
Removed Location Countries

Administrative Information

NCT Number	NCT04880096
Other Study ID Numbers	RNI 2020 AUTHIER
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
Plan to Share Data	Not Provided
Plan to Share Data (IPD) Description	Not Provided
Responsible Party	University Hospital, Clermont-Ferrand
Collaborators	Institut ANALGESIA
Investigators	Not Provided
Information Provided By	University Hospital, Clermont-Ferrand
Verification Date	May 2021