Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06544382
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Rehabilitation and Return to Everyday Life for Patients With Long COVID
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Rehabilitation and Return to Everyday Life for Patients With Long COVID
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This non-randomised controlled trial will investigate if patients with long COVID receiving a structured and group-based rehabilitation intervention The Long COVID Rehabilitation Intervention will report a difference in mean change in self-reported mental fatigue measured by Mental Fatigue Scale and will report a mean difference in weeks of sick-leave obtained through the Danish Register for Evaluation of Marginalisation compared to usual practise over a 12-month follow-up period Alongside the effectiveness evaluation a economic evaluation study and process evaluation study will be conducted
Patients from Aarhus Municipality Central Denmark Region Denmark receive The Long COVID Rehabilitation Intervention and will be allocated to the intervention group Patients receiving rehabilitation in the other municipalities of Central Denmark Region Denmark will be allocated to the control group Alongside this a health economic study and a process evaluation study will be conducted
Patients from Aarhus Municipality Central Denmark Region Denmark receive The Long COVID Rehabilitation Intervention and will be allocated to the intervention group Patients receiving rehabilitation in the other municipalities of Central Denmark Region Denmark will be allocated to the control group Alongside this a health economic study and a process evaluation study will be conducted
Detailed Description:
The study is a non-randomised controlled trial with 12-month follow-up Alongside this a health economic study and process evaluation study will be conducted in line with the British Medical Research Councils framework for development and evaluation of complex interventions The study will be reported in three separate scientific papers for each evaluation study
This study aims to evaluate the effectiveness of a structured and group-based rehabilitation intervention called The Long COVID Rehabilitation Intervention with the goal to optimise the rehabilitation of patients experiencing long-term symptoms after COVID-19 long COVID
The primary hypothesis A structured and personalised rehabilitation intervention for patients with long COVID is more effective evaluated on sick leave mental fatigue and disability compared to usual rehabilitation
To evaluate the aim the intervention group patients receiving The Long COVID Rehabilitation Intervention in Aarhus Municipality Central Denmark Region Denmark will be compared to a control group patients receiving rehabilitation in the 18 other municipalities in Central Denmark Region Denmark
The data will be handled in accordance with the World Medical Association Coherence Declaration of Helsinki and with the General Data Protection Regulation The study is approved by the Danish Regional Data Protection Agency Jnr 1-16-02-655-20
The intervention group patients from Aarhus Municipality Central Denmark Region received The Long COVID Rehabilitation Intervention a rehabilitation programme with a duration of minimum 3 months comprising 4-12 individual sessions and 1-4 group-based courses with physiotherapists and occupational therapists The control group patients from the other 18 municipalities in Central Denmark region received the rehabilitation interventions delivered in their home municipality which were generally less structured with more individual sessions compared to the intervention group Based on a systematic identification through semi-structured interviews with representatives from all 19 municipalities in Central Denmark Region the rehabilitation provided for long COVID patients was described for each municipality using the TIDieR template Throughout the study period it will be explored if it is possible to divide the control groups into two subgroups depending on the rehabilitation provided in the municipalities
With a mean Mental Fatigue Scale score of 186 SD 56 a minimal clinical important difference of 2 points a power of 80 and a two-sided significance level of 005 a total study population of 375 125 patients in each group patients should be included To account for a 20 loss to follow-up the total number is 450 patients For long term sick leave a power calculation will be performed during the fall 2024 based on data from an ongoing study
Data are collected through questionnaires sent out electronically and through register data Sociodemographic characteristics sex age and self-reported living status education work status and occupation and self-reported information on main symptoms and time since infection is collected at inclusion Study data are collected and managed using REDCap electronic data capture tools
Descriptive statistics will be conducted to describe sociodemographic characteristics To evaluate the effectiveness of the intervention outcomes in the intervention group will be compared to outcomes in the control group using multiple linear regression analysis adjusting for possible confounders chosen prior to the analyses ie sociodemographic variables
In the economic evaluation study a cost-utility analysis and a cost-effectiveness analysis will be performed from a societal perspective alongside the effectiveness study The outcome in the cost-utility analysis will be quality-adjusted life years QALYs assessed by EQ-5D-5L measured at baseline and 12 months follow-up and valued by Danish preference weights The outcome in the cost-effectiveness analysis will be changes in Mental Fatigue Scale The costs of The Long COVID Rehabilitation Intervention will be estimated using micro-costing Cost of usual rehabilitation will be estimated using micro-costing when possible or based on survey information from the municipalities Visits to primary health care services will be extracted from the Danish National Health Service Register for Primary Care Secondary healthcare services will be extracted from the National Patient Register The valuation will be determined by the Diagnosis-Related-Grouping reimbursement rate and the outpatient-grouping-system Productivity loss will be extracted from Danish Register for Evaluation of Marginalisation The productivity costs per patient will be calculated using the Human Capital method
To evaluate the cost-effectiveness of the intervention the Incremental Cost-Effectiveness Ratio ICER will be calculated Bias-corrected and accelerated bootstrapping with 10000 replications will be performed to estimate 95 confidence intervals around cost differences and the uncertainty surrounding the ICERs Uncertainty will be shown in cost-effectiveness plane The cost-effectiveness acceptability curve will be drawn to show the probability that the intervention is cost-effective at different thresholds for willingness to pay for a gain in QALY or a clinical relevant improvement in Mental Fatigue Scale Sensitivity analyses will be performed to test the robustness of the study results
In the process evaluation study the investigators will explore the processes of The Long COVID Rehabilitation Intervention by evaluating implementation mechanism of impact and contextual factors The study design is a concurrent mixed method study with quantitative and qualitative data collected and analysed during a similar timeframe Implementation of the intervention will be investigated focusing on fidelity dose adaptations and reach using patient baseline characteristics routine monitored data from the patient journals and interviews with patients and health professionals To evaluate mechanism of impact and contextual factors the investigators will use a realist evaluation approach with pre-defined Context-Mechanism-Outcome configurations CMOs to explore under what circumstances for whom why and how the intervention works This will be done using routine monitoring data from patient journals individual interviews with patients n15 and focus group interviews with health professionals n5 An initial programme theory has been developed and graphically shown in a general logic model
Quantitative and qualitative data are obtained and analysed simultaneously and linked at multiple points Descriptive statistics will be used to analyse fidelity dose and reach and will be presented with mean and standard deviation or median and percentiles as appropriate Interview data will be transcribed verbatim and will be analysed following the standards for realist evaluations The qualitative and quantitative results and most important CMOs will be merged to support refinement of the programme theory
This study aims to evaluate the effectiveness of a structured and group-based rehabilitation intervention called The Long COVID Rehabilitation Intervention with the goal to optimise the rehabilitation of patients experiencing long-term symptoms after COVID-19 long COVID
The primary hypothesis A structured and personalised rehabilitation intervention for patients with long COVID is more effective evaluated on sick leave mental fatigue and disability compared to usual rehabilitation
To evaluate the aim the intervention group patients receiving The Long COVID Rehabilitation Intervention in Aarhus Municipality Central Denmark Region Denmark will be compared to a control group patients receiving rehabilitation in the 18 other municipalities in Central Denmark Region Denmark
The data will be handled in accordance with the World Medical Association Coherence Declaration of Helsinki and with the General Data Protection Regulation The study is approved by the Danish Regional Data Protection Agency Jnr 1-16-02-655-20
The intervention group patients from Aarhus Municipality Central Denmark Region received The Long COVID Rehabilitation Intervention a rehabilitation programme with a duration of minimum 3 months comprising 4-12 individual sessions and 1-4 group-based courses with physiotherapists and occupational therapists The control group patients from the other 18 municipalities in Central Denmark region received the rehabilitation interventions delivered in their home municipality which were generally less structured with more individual sessions compared to the intervention group Based on a systematic identification through semi-structured interviews with representatives from all 19 municipalities in Central Denmark Region the rehabilitation provided for long COVID patients was described for each municipality using the TIDieR template Throughout the study period it will be explored if it is possible to divide the control groups into two subgroups depending on the rehabilitation provided in the municipalities
With a mean Mental Fatigue Scale score of 186 SD 56 a minimal clinical important difference of 2 points a power of 80 and a two-sided significance level of 005 a total study population of 375 125 patients in each group patients should be included To account for a 20 loss to follow-up the total number is 450 patients For long term sick leave a power calculation will be performed during the fall 2024 based on data from an ongoing study
Data are collected through questionnaires sent out electronically and through register data Sociodemographic characteristics sex age and self-reported living status education work status and occupation and self-reported information on main symptoms and time since infection is collected at inclusion Study data are collected and managed using REDCap electronic data capture tools
Descriptive statistics will be conducted to describe sociodemographic characteristics To evaluate the effectiveness of the intervention outcomes in the intervention group will be compared to outcomes in the control group using multiple linear regression analysis adjusting for possible confounders chosen prior to the analyses ie sociodemographic variables
In the economic evaluation study a cost-utility analysis and a cost-effectiveness analysis will be performed from a societal perspective alongside the effectiveness study The outcome in the cost-utility analysis will be quality-adjusted life years QALYs assessed by EQ-5D-5L measured at baseline and 12 months follow-up and valued by Danish preference weights The outcome in the cost-effectiveness analysis will be changes in Mental Fatigue Scale The costs of The Long COVID Rehabilitation Intervention will be estimated using micro-costing Cost of usual rehabilitation will be estimated using micro-costing when possible or based on survey information from the municipalities Visits to primary health care services will be extracted from the Danish National Health Service Register for Primary Care Secondary healthcare services will be extracted from the National Patient Register The valuation will be determined by the Diagnosis-Related-Grouping reimbursement rate and the outpatient-grouping-system Productivity loss will be extracted from Danish Register for Evaluation of Marginalisation The productivity costs per patient will be calculated using the Human Capital method
To evaluate the cost-effectiveness of the intervention the Incremental Cost-Effectiveness Ratio ICER will be calculated Bias-corrected and accelerated bootstrapping with 10000 replications will be performed to estimate 95 confidence intervals around cost differences and the uncertainty surrounding the ICERs Uncertainty will be shown in cost-effectiveness plane The cost-effectiveness acceptability curve will be drawn to show the probability that the intervention is cost-effective at different thresholds for willingness to pay for a gain in QALY or a clinical relevant improvement in Mental Fatigue Scale Sensitivity analyses will be performed to test the robustness of the study results
In the process evaluation study the investigators will explore the processes of The Long COVID Rehabilitation Intervention by evaluating implementation mechanism of impact and contextual factors The study design is a concurrent mixed method study with quantitative and qualitative data collected and analysed during a similar timeframe Implementation of the intervention will be investigated focusing on fidelity dose adaptations and reach using patient baseline characteristics routine monitored data from the patient journals and interviews with patients and health professionals To evaluate mechanism of impact and contextual factors the investigators will use a realist evaluation approach with pre-defined Context-Mechanism-Outcome configurations CMOs to explore under what circumstances for whom why and how the intervention works This will be done using routine monitoring data from patient journals individual interviews with patients n15 and focus group interviews with health professionals n5 An initial programme theory has been developed and graphically shown in a general logic model
Quantitative and qualitative data are obtained and analysed simultaneously and linked at multiple points Descriptive statistics will be used to analyse fidelity dose and reach and will be presented with mean and standard deviation or median and percentiles as appropriate Interview data will be transcribed verbatim and will be analysed following the standards for realist evaluations The qualitative and quantitative results and most important CMOs will be merged to support refinement of the programme theory
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None