Back to resultsOptimization of the Care Pathway for Patients With Chronic Pain: Assessing the Value of Integrating Sleep Specialists (DOLOREPIT)
Primary Purpose
Chronic Pain
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Standard pain management combined with sleep disorder management
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Pain
Eligibility Criteria
Inclusion Criteria: First consultation at the pain management center Patient with chronic pain as defined by the "Haute Autorité de Santé". The pain must have several of the following characteristics: Persistence or recurrence Duration beyond what is usual for the presumed initial cause, especially if the pain has been evolving for more than 3 months; Inadequate response to treatment; Important and progressive deterioration of the patient's functional and interpersonal abilities in activities of daily living at home, school, or work due to the pain. Patients with chronic primary pain (according to the typology defined by the International Classification of Diseases-11) and classified into one of the 4 following categories: Chronic generalized pain Complex regional pain syndrome Chronic primary headache or orofacial pain Chronic primary musculoskeletal pain Pittsburgh Sleep Quality Index (PSQI) must be completed by the patient and the score must be available (for randomization purposes) Have access to an internet connection as a self-administered questionnaire is to complete online, and at least have access to the online platform for CBT treatment if insomnia is detected Affiliation to a French social security system Free informed consent Exclusion Criteria: Patients undergoing cancer treatment or who have completed treatment within the last 2 years Patient with a chronic inflammatory disease (e.g. rheumatoid arthritis, ankylosing spondylitis, chronic inflammatory bowel disease, Horton's disease, Wegener's disease, myositis, Still's disease, lupus erythematosus, etc.) Immunocompromised patient Patient with severe psychiatric pathology that does not allow study follow-up (at the discretion of the investigator) Patient already treated for a sleep disorder by a sleep specialist (the only prescription of hypnotics is not considered as a criterion of non-inclusion) Patient follow-up difficult (for geographic motives or other reasons) Patient under judicial protection of incapable adults or guardianship Refusal to participate in the research
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Reinforced sleep program
Standard care
Arm Description
standard pain management + sleep disorders management
Control group: standard pain management
Outcomes
Primary Outcome Measures
The primary endpoint is the Mental Composite Score (MCS) of the Short Form 36 Health Survey (SF-36) questionnaire
It's a scientifically validated multidimensional scale that provides a generic score for assessing quality of life, regardless of pathology, age or gender. The 36 items of this questionnaire evaluate 8 dimensions: physical activity; limitations due to physical condition; physical pain; perceived health; vitality; life and relationships with others; limitations due to physical condition; psychological health, as well as a separate dimension on the evaluation of perceived health compared to one year earlier. An average score range from 0 to 100 and can be calculated according to an established algorithm. A high score means good health and absence of pain.
Secondary Outcome Measures
The Physical Composite Score (PCS) of the Short Form 36 Health Survey (SF-36) questionnaire
It's a scientifically validated multidimensional scale that provides a generic score for assessing quality of life, regardless of pathology, age or gender. The 36 items of this questionnaire evaluate 8 dimensions: physical activity; limitations due to physical condition; physical pain; perceived health; vitality; life and relationships with others; limitations due to physical condition; psychological health, as well as a separate dimension on the evaluation of perceived health compared to one year earlier. An average score range from 0 to 100 and can be calculated according to an established algorithm. A high score means good health and absence of pain.
The score of the French version of the Brief Pain Inventory (BPI).
This questionnaire assesses the patient's pain experience and the impact of pain on the patient's daily behavior. It evaluates seven general aspects of the patient's life, divided into fifteen items: activity, mood, walking ability, work, relationships, sleep and enjoyment of life. The score ranges from 0 to 10 with 0 = no pain and 10= worst pain.
The score of the French version of the McGill pain questionnaire (MPQ)
This questionnaire assesses the sensory and emotional dimensions of the patient's pain. It is composed of sixteen items, the first eight of which characterize pain from a sensory point of view, and the following eight from an affective point of view.
Each item is scored from 0 to 4, with 0 corresponding to "no pain", 1 to "mild pain", 2 to "moderate pain", 3 to "severe pain" and 4 to "extremely severe pain".
The score of Hospital anxiety and depression scale (HADS)
This questionnaire can be used to detect anxiety or depression. For each component (seven items for the "anxiety" component and seven items for the "depression" component), the score obtained is analyzed. A score less than or equal to 7 indicates no symptomatology, a score between 8 and 10 indicates doubtful symptomatology, and a score greater than or equal to 11 indicates definite symptomatology.
The score of the French version of Pittsburgh Sleep Quality Index (PSQI)
This is a generic nineteen-item questionnaire for measuring sleep problems. A PSQI score less than or equal to 5 designates "good sleepers", while a score strictly greater than 5 designates "poor sleepers".
The score of the Epworth Sleepiness scale
This scale is made up of 8 questions and the final score obtained ranges from 0 to 24: [0-6] = Absence of drowsiness; [7-9] = contentious score which may indicate a pathological condition; [10-24] = Risk of pathological drowsiness.
The score of the Patient Global Impression of Change (PGIC) scale
This scale is used to assess the evolution of the patient's state of health in terms of activity limitation, symptoms, emotions and quality of life. This scale ranges from 1 "greatly improved" to 7 "greatly worsened", for which the patient is asked to choose the phrase that best represents the changes in his or her overall health.
The drug consumption, particularly analgesics, antidepressants, benzodiazepines and related hypnotics
INN , dosage and duration
The cost-utility ratio for the medico-economic impact of the care pathway
The costs avoided in terms of drug consumption, as well as changes in patients' quality of life at different stages.
The score of the International Restless legs syndrome (IRLS) questionnaire
The latter assesses the severity of RLS according to four levels: for a score between 0 and 10, the disorder is mild; between 11 and 20, moderate; between 21 and 30, severe; between 31 and 40, very severe.
For the experimental group, the average apnea-hypopnea index (AHI)
It represents the average frequency of apneas and hypopneas per hour of sleep. There are three levels of apnea and hypopnea severity. The mild degree corresponds to respiratory incidents of between 5 and 15 per hour, the moderate degree corresponds to respiratory incidents between 15 and 30 per hour, and the severe degree indicates more than 30 respiratory events per hour.
For the experimental group, the score of the insomnia severity index (ISI)
This validated self-questionnaire consists of 7 questions designed to assess the nature of insomnia, sleep satisfaction, day-to-day functioning and anxiety about sleep disorders. Each of the 7 items is evaluated on a 5-point Likert scale (from 0 to 4). The total score is obtained by adding together the scores of the 7 items . The total score ranges from 0 to 28: [0-7] = No insomnia; [8- 14] = Subclinical insomnia (mild); [15-21] = Clinical insomnia (moderate); [22-28] = Clinical insomnia (severe).
Full Information
NCT ID
NCT06052384
First Posted
September 11, 2023
Last Updated
September 25, 2023
Sponsor
Centre Hospitalier Emile Roux
1. Study Identification
Unique Protocol Identification Number
NCT06052384
Brief Title
Optimization of the Care Pathway for Patients With Chronic Pain: Assessing the Value of Integrating Sleep Specialists
Acronym
DOLOREPIT
Official Title
Optimisation du Parcours de Soins Des Patients Atteints de Douleurs Chroniques : étude randomisée évaluant l'intérêt de l'intégration Des spécialistes du Sommeil
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
April 2027 (Anticipated)
Study Completion Date
April 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Emile Roux
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
DOLOREPIT is an interventional, RIPH 2, multicenter, randomized, controlled, open-label study comparing two care pathways for the management of patients with chronic pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
664 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Reinforced sleep program
Arm Type
Experimental
Arm Description
standard pain management + sleep disorders management
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Control group: standard pain management
Intervention Type
Other
Intervention Name(s)
Standard pain management combined with sleep disorder management
Intervention Description
Standard pain management combined with sleep disorder management at M3, M6, and M12
Primary Outcome Measure Information:
Title
The primary endpoint is the Mental Composite Score (MCS) of the Short Form 36 Health Survey (SF-36) questionnaire
Description
It's a scientifically validated multidimensional scale that provides a generic score for assessing quality of life, regardless of pathology, age or gender. The 36 items of this questionnaire evaluate 8 dimensions: physical activity; limitations due to physical condition; physical pain; perceived health; vitality; life and relationships with others; limitations due to physical condition; psychological health, as well as a separate dimension on the evaluation of perceived health compared to one year earlier. An average score range from 0 to 100 and can be calculated according to an established algorithm. A high score means good health and absence of pain.
Time Frame
Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)
Secondary Outcome Measure Information:
Title
The Physical Composite Score (PCS) of the Short Form 36 Health Survey (SF-36) questionnaire
Description
It's a scientifically validated multidimensional scale that provides a generic score for assessing quality of life, regardless of pathology, age or gender. The 36 items of this questionnaire evaluate 8 dimensions: physical activity; limitations due to physical condition; physical pain; perceived health; vitality; life and relationships with others; limitations due to physical condition; psychological health, as well as a separate dimension on the evaluation of perceived health compared to one year earlier. An average score range from 0 to 100 and can be calculated according to an established algorithm. A high score means good health and absence of pain.
Time Frame
Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)
Title
The score of the French version of the Brief Pain Inventory (BPI).
Description
This questionnaire assesses the patient's pain experience and the impact of pain on the patient's daily behavior. It evaluates seven general aspects of the patient's life, divided into fifteen items: activity, mood, walking ability, work, relationships, sleep and enjoyment of life. The score ranges from 0 to 10 with 0 = no pain and 10= worst pain.
Time Frame
Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)
Title
The score of the French version of the McGill pain questionnaire (MPQ)
Description
This questionnaire assesses the sensory and emotional dimensions of the patient's pain. It is composed of sixteen items, the first eight of which characterize pain from a sensory point of view, and the following eight from an affective point of view.
Each item is scored from 0 to 4, with 0 corresponding to "no pain", 1 to "mild pain", 2 to "moderate pain", 3 to "severe pain" and 4 to "extremely severe pain".
Time Frame
Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)
Title
The score of Hospital anxiety and depression scale (HADS)
Description
This questionnaire can be used to detect anxiety or depression. For each component (seven items for the "anxiety" component and seven items for the "depression" component), the score obtained is analyzed. A score less than or equal to 7 indicates no symptomatology, a score between 8 and 10 indicates doubtful symptomatology, and a score greater than or equal to 11 indicates definite symptomatology.
Time Frame
Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)
Title
The score of the French version of Pittsburgh Sleep Quality Index (PSQI)
Description
This is a generic nineteen-item questionnaire for measuring sleep problems. A PSQI score less than or equal to 5 designates "good sleepers", while a score strictly greater than 5 designates "poor sleepers".
Time Frame
Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)
Title
The score of the Epworth Sleepiness scale
Description
This scale is made up of 8 questions and the final score obtained ranges from 0 to 24: [0-6] = Absence of drowsiness; [7-9] = contentious score which may indicate a pathological condition; [10-24] = Risk of pathological drowsiness.
Time Frame
Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)
Title
The score of the Patient Global Impression of Change (PGIC) scale
Description
This scale is used to assess the evolution of the patient's state of health in terms of activity limitation, symptoms, emotions and quality of life. This scale ranges from 1 "greatly improved" to 7 "greatly worsened", for which the patient is asked to choose the phrase that best represents the changes in his or her overall health.
Time Frame
Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)
Title
The drug consumption, particularly analgesics, antidepressants, benzodiazepines and related hypnotics
Description
INN , dosage and duration
Time Frame
Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)
Title
The cost-utility ratio for the medico-economic impact of the care pathway
Description
The costs avoided in terms of drug consumption, as well as changes in patients' quality of life at different stages.
Time Frame
Change from baseline (Day 0) at Month 6
Title
The score of the International Restless legs syndrome (IRLS) questionnaire
Description
The latter assesses the severity of RLS according to four levels: for a score between 0 and 10, the disorder is mild; between 11 and 20, moderate; between 21 and 30, severe; between 31 and 40, very severe.
Time Frame
At the 1st sleep consultation (Month 1) then at Month 6 and Month 12
Title
For the experimental group, the average apnea-hypopnea index (AHI)
Description
It represents the average frequency of apneas and hypopneas per hour of sleep. There are three levels of apnea and hypopnea severity. The mild degree corresponds to respiratory incidents of between 5 and 15 per hour, the moderate degree corresponds to respiratory incidents between 15 and 30 per hour, and the severe degree indicates more than 30 respiratory events per hour.
Time Frame
at start of ventilation (continuous positive airway pressure), then for periods Month 3-Month 6 and Month 6-Month 12
Title
For the experimental group, the score of the insomnia severity index (ISI)
Description
This validated self-questionnaire consists of 7 questions designed to assess the nature of insomnia, sleep satisfaction, day-to-day functioning and anxiety about sleep disorders. Each of the 7 items is evaluated on a 5-point Likert scale (from 0 to 4). The total score is obtained by adding together the scores of the 7 items . The total score ranges from 0 to 28: [0-7] = No insomnia; [8- 14] = Subclinical insomnia (mild); [15-21] = Clinical insomnia (moderate); [22-28] = Clinical insomnia (severe).
Time Frame
At the 1st sleep consultation (Month 1) then at Month 6 and Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
First consultation at the pain management center
Patient with chronic pain as defined by the "Haute Autorité de Santé". The pain must have several of the following characteristics:
Persistence or recurrence
Duration beyond what is usual for the presumed initial cause, especially if the pain has been evolving for more than 3 months;
Inadequate response to treatment;
Important and progressive deterioration of the patient's functional and interpersonal abilities in activities of daily living at home, school, or work due to the pain.
Patients with chronic primary pain (according to the typology defined by the International Classification of Diseases-11) and classified into one of the 4 following categories:
Chronic generalized pain
Complex regional pain syndrome
Chronic primary headache or orofacial pain
Chronic primary musculoskeletal pain
Pittsburgh Sleep Quality Index (PSQI) must be completed by the patient and the score must be available (for randomization purposes)
Have access to an internet connection as a self-administered questionnaire is to complete online, and at least have access to the online platform for CBT treatment if insomnia is detected
Affiliation to a French social security system
Free informed consent
Exclusion Criteria:
Patients undergoing cancer treatment or who have completed treatment within the last 2 years
Patient with a chronic inflammatory disease (e.g. rheumatoid arthritis, ankylosing spondylitis, chronic inflammatory bowel disease, Horton's disease, Wegener's disease, myositis, Still's disease, lupus erythematosus, etc.)
Immunocompromised patient
Patient with severe psychiatric pathology that does not allow study follow-up (at the discretion of the investigator)
Patient already treated for a sleep disorder by a sleep specialist (the only prescription of hypnotics is not considered as a criterion of non-inclusion)
Patient follow-up difficult (for geographic motives or other reasons)
Patient under judicial protection of incapable adults or guardianship
Refusal to participate in the research
12. IPD Sharing Statement
Learn more about this trial
Optimization of the Care Pathway for Patients With Chronic Pain: Assessing the Value of Integrating Sleep Specialists
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