Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06402409
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-03
Brief Title:
Exploring Multimorbidity in Patients With Spinal Pain
Sponsor:
Jacob Christiansen Gandløse
Organization:
Aalborg University Hospital
Study Overview
Official Title:
Workpackage 1 Baseline Prevalence and Implications of Multimorbidity for the Management of Spinal Pain Workpackage 2 The Influence of Multimorbidity Treatment Burden on Long-term Prognosis of Individuals With Spinal Pain
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Spinal pain is frequently accompanied by other chronic conditions multimorbidity and the predicted rise in multimorbidity prevalence emphasizes the need for studies to understand its impact on patients with chronic pain conditions
Therefore the aims of the two studies are to
Work package 1 - Determine prevalence of multimorbidity among patients with spinal pain referred to hospital outpatient clinics Examine associations with relevant health-related factors and cover the significance of multimorbidity in the diagnostic process referral patterns and healthcare utilization
Work package 2 Examine the association between treatment burden arising from multimorbidity and patient prognosis in structured rehabilitation
Across both work packages data will be derived from individuals initially referred to the Department of Rheumatology at Aalborg University Hospital AaUH or the Medical Spine Clinic in Silkeborg MSCS
Therefore the aims of the two studies are to
Work package 1 - Determine prevalence of multimorbidity among patients with spinal pain referred to hospital outpatient clinics Examine associations with relevant health-related factors and cover the significance of multimorbidity in the diagnostic process referral patterns and healthcare utilization
Work package 2 Examine the association between treatment burden arising from multimorbidity and patient prognosis in structured rehabilitation
Across both work packages data will be derived from individuals initially referred to the Department of Rheumatology at Aalborg University Hospital AaUH or the Medical Spine Clinic in Silkeborg MSCS
Detailed Description:
Background
Spinal pain is frequently accompanied by other chronic conditions multimorbidity and the predicted rise in multimorbidity prevalence emphasizes the need for studies to understand its impact on patients with chronic pain conditions
Objectives
Work package 1 Determine prevalence of multimorbidity among patients with spinal pain referred to hospital outpatient clinics Examine associations with various health-related factors and cover the significance of multimorbidity in the diagnostic process referral patterns and healthcare utilization
Work package 2 Examine the association between treatment burden arising from multimorbidity and patient prognosis in structured rehabilitation
Methods
The project consists of two work packages A cross sectional study Work package 1 and a prospective observational cohort study Work package 2
Across both work packages data will be derived from individuals initially referred to the Department of Rheumatology at Aalborg University Hospital AaUH or the Medical Spine Clinic in Silkeborg MSCS In work package 1 patients with scheduled appointments at the Departments are identified via the hospitals electronic booking system Secure questionnaires are sent via E-Boks
Data for the work packages will be collected through the hospitals electronic journal systems patient-reported outcome measures PROMs and external danish registers PROMS will be collected with REDCap at baseline and 3 6 and 12 months after the initial consultation in the outpatient clinics The patients unique civil registration number CPR will be linked to external Danish registries facilitated by the Danish Civil Registration System CRS
Variables
Electronic questionnaires Name CPR number Marital status Height and weight Smoking and alcohol habits and PROMS elaborated elsewhere
Medical records Past and current medication use referral source general practitioner specialist hospital Past treatment attempts physiotherapy chiropractic etc Information on any scans performed if any Signs of radiculopathy Number of consultations
External registries
The Danish Civil Registration System Age sex Migration status Vital status
The Danish National Patient Registry Concurrent diseases ICD-10 codes Period from referral date to treatment start date Start and end dates of outpatient treatment
The Danish National Prescription Registry All dispensed medications from Danish pharmacies ATC codes
The Population Education Register Highest completed level of education short medium long
DREAM database Income status and public financial support
Statistical considerations
Work package 1 A cross-sectional study
Prevalence of multimorbidity and frequency of other diseases will be reported as percentages and total counts and presented in a table Regression analysis will be emplyed to determine whether the number of chronic conditions or specific clusters of chronic conditions are associated with the primary outcome EQ-5D-5L other patient-reported measures and use of healthcare services Additionally patients will be divided into groups categorized by the Multimorbidity Treatment Burden Questionnaire following the classification established by Duncan et al These categories will divide participants into four distinct categories no burden score 0 low burden score 10 medium burden score 10-22 and high burden score 22 Analysis of Covariance ANCOVA will be employed to determine whether there are statistically significant differences in EQ-5D-5L scores between the groups while accounting for potential confounding covariates Individual plots will be generated to visually depict the distribution of patient scores on EQ-5D-5L and Brief Pain Inventory across the four groups
Work package 2 An observational prospective cohort study
As in work package 1 patients will be categorized into groups based on their baseline treatment burden Mixed model with repeated measures will be utilized to determine whether there are statistically significant differences in EQ-5D-5L scores and BPI-scores between groups over time baseline 3-6-12 months follow-up while accounting for potential confounding covariates Line graphs with error bars will be generated to visually depict the changes in EQ-5D-5L and BPI across the four groups
For both workpackages missing data will be addressed by multiple imputation or other means if not deemed appropiate The imputation model will be informed by existing literature and by a dropout analysis In addition the selection of covariates for inclusion in the statistical models will be guided by current evidence and clinical reasoning to account for potential confounding factors
In assessing the prevalence of multimorbidity it is defined as the presence of two concurrent chronic diseases in a single individual To discern which ICD-10 codes correspond to chronic health conditions a unique script has been devised This script draws from previous studies particularly those focused on determining multimorbidity prevalence and incorporates recommendations from international consensus on multimorbidity measurement in research The validation of ICD-10 codes in the Danish National Patient Registry DNPR and the Primary Care Referral Registry PCRR has been systematically conducted across various diagnoses and studies affirming their accuracy for research purposes
Spinal pain is frequently accompanied by other chronic conditions multimorbidity and the predicted rise in multimorbidity prevalence emphasizes the need for studies to understand its impact on patients with chronic pain conditions
Objectives
Work package 1 Determine prevalence of multimorbidity among patients with spinal pain referred to hospital outpatient clinics Examine associations with various health-related factors and cover the significance of multimorbidity in the diagnostic process referral patterns and healthcare utilization
Work package 2 Examine the association between treatment burden arising from multimorbidity and patient prognosis in structured rehabilitation
Methods
The project consists of two work packages A cross sectional study Work package 1 and a prospective observational cohort study Work package 2
Across both work packages data will be derived from individuals initially referred to the Department of Rheumatology at Aalborg University Hospital AaUH or the Medical Spine Clinic in Silkeborg MSCS In work package 1 patients with scheduled appointments at the Departments are identified via the hospitals electronic booking system Secure questionnaires are sent via E-Boks
Data for the work packages will be collected through the hospitals electronic journal systems patient-reported outcome measures PROMs and external danish registers PROMS will be collected with REDCap at baseline and 3 6 and 12 months after the initial consultation in the outpatient clinics The patients unique civil registration number CPR will be linked to external Danish registries facilitated by the Danish Civil Registration System CRS
Variables
Electronic questionnaires Name CPR number Marital status Height and weight Smoking and alcohol habits and PROMS elaborated elsewhere
Medical records Past and current medication use referral source general practitioner specialist hospital Past treatment attempts physiotherapy chiropractic etc Information on any scans performed if any Signs of radiculopathy Number of consultations
External registries
The Danish Civil Registration System Age sex Migration status Vital status
The Danish National Patient Registry Concurrent diseases ICD-10 codes Period from referral date to treatment start date Start and end dates of outpatient treatment
The Danish National Prescription Registry All dispensed medications from Danish pharmacies ATC codes
The Population Education Register Highest completed level of education short medium long
DREAM database Income status and public financial support
Statistical considerations
Work package 1 A cross-sectional study
Prevalence of multimorbidity and frequency of other diseases will be reported as percentages and total counts and presented in a table Regression analysis will be emplyed to determine whether the number of chronic conditions or specific clusters of chronic conditions are associated with the primary outcome EQ-5D-5L other patient-reported measures and use of healthcare services Additionally patients will be divided into groups categorized by the Multimorbidity Treatment Burden Questionnaire following the classification established by Duncan et al These categories will divide participants into four distinct categories no burden score 0 low burden score 10 medium burden score 10-22 and high burden score 22 Analysis of Covariance ANCOVA will be employed to determine whether there are statistically significant differences in EQ-5D-5L scores between the groups while accounting for potential confounding covariates Individual plots will be generated to visually depict the distribution of patient scores on EQ-5D-5L and Brief Pain Inventory across the four groups
Work package 2 An observational prospective cohort study
As in work package 1 patients will be categorized into groups based on their baseline treatment burden Mixed model with repeated measures will be utilized to determine whether there are statistically significant differences in EQ-5D-5L scores and BPI-scores between groups over time baseline 3-6-12 months follow-up while accounting for potential confounding covariates Line graphs with error bars will be generated to visually depict the changes in EQ-5D-5L and BPI across the four groups
For both workpackages missing data will be addressed by multiple imputation or other means if not deemed appropiate The imputation model will be informed by existing literature and by a dropout analysis In addition the selection of covariates for inclusion in the statistical models will be guided by current evidence and clinical reasoning to account for potential confounding factors
In assessing the prevalence of multimorbidity it is defined as the presence of two concurrent chronic diseases in a single individual To discern which ICD-10 codes correspond to chronic health conditions a unique script has been devised This script draws from previous studies particularly those focused on determining multimorbidity prevalence and incorporates recommendations from international consensus on multimorbidity measurement in research The validation of ICD-10 codes in the Danish National Patient Registry DNPR and the Primary Care Referral Registry PCRR has been systematically conducted across various diagnoses and studies affirming their accuracy for research purposes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None