Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06517251
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-03
Brief Title:
Aha BOOST Arm-hand BOOST Therapy to Enhance Recovery After Stroke Clinical Health Economic and Process Evaluation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Aha BOOST Arm-hand BOOST Therapy to Enhance Recovery After Stroke Clinical Health Economic and Process Evaluation
Status:
RECRUITING
Status Verified Date:
2024-07
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:
AHA-BOOST
Brief Summary:
The overall aim of this study is to establish the clinical- and cost-effectiveness of the arm-hand BOOST therapy when delivered on top of the usual care program in the sub-acute phase post stroke and to perform a process evaluation
In this phase III RCT 80 patients with stroke will be recruited from two inpatient stroke rehabilitation wards in Belgium and randomized to the experimental group receiving arm-hand BOOST therapy or the control group receiving the L-BOOST intervention on top of their usual inpatient care program The arm-hand BOOST program 1 hourday 5xweek 4 weeks consists of group exercises based on four key aspects namely neurophysiology sequences of reaching and grasping de-weighting of the arm and orientation of the hand towards objects Additionally technology-supported upper limb therapy will be provided two times 30 minutes per week The L-BOOST intervention comprises a dose-matched program of lower limb exercises and general reconditioning At baseline after 4 weeks of training 3 months after the intervention and at 12 months post stroke outcome assessment will be performed The primary outcome measure is the action research arm test ARAT Secondary outcomes include measures in the domain of upper limb function and capacity independence participation and quality of life Multivariate ANOVA and sensitivity analyses will be used to compare change from baseline between groups Information on medical costs will be collected to allow a health economic evaluation Finally a process evaluation will be performed to assist in identifying why arm-hand BOOST succeeds or fails unexpectedly or has unanticipated consequences and how this can be optimized
At the start of this study the investigators hypothesize that I Aha BOOST will result in a significant greater improvement in arm-hand activity post-intervention at follow-up and 12 months post stroke compared to control therapy L-BOOST II Aha BOOST will result in a significant greater improvement in upper limb function performance independence and activity of daily living and participation post-intervention at follow up and 12 months post stroke III Investing in 24 hours of extra arm-hand therapy to subacute stroke patient in the inpatient rehabilitation setting can reduce the health-economic and societal cost 12 months post stroke
In this phase III RCT 80 patients with stroke will be recruited from two inpatient stroke rehabilitation wards in Belgium and randomized to the experimental group receiving arm-hand BOOST therapy or the control group receiving the L-BOOST intervention on top of their usual inpatient care program The arm-hand BOOST program 1 hourday 5xweek 4 weeks consists of group exercises based on four key aspects namely neurophysiology sequences of reaching and grasping de-weighting of the arm and orientation of the hand towards objects Additionally technology-supported upper limb therapy will be provided two times 30 minutes per week The L-BOOST intervention comprises a dose-matched program of lower limb exercises and general reconditioning At baseline after 4 weeks of training 3 months after the intervention and at 12 months post stroke outcome assessment will be performed The primary outcome measure is the action research arm test ARAT Secondary outcomes include measures in the domain of upper limb function and capacity independence participation and quality of life Multivariate ANOVA and sensitivity analyses will be used to compare change from baseline between groups Information on medical costs will be collected to allow a health economic evaluation Finally a process evaluation will be performed to assist in identifying why arm-hand BOOST succeeds or fails unexpectedly or has unanticipated consequences and how this can be optimized
At the start of this study the investigators hypothesize that I Aha BOOST will result in a significant greater improvement in arm-hand activity post-intervention at follow-up and 12 months post stroke compared to control therapy L-BOOST II Aha BOOST will result in a significant greater improvement in upper limb function performance independence and activity of daily living and participation post-intervention at follow up and 12 months post stroke III Investing in 24 hours of extra arm-hand therapy to subacute stroke patient in the inpatient rehabilitation setting can reduce the health-economic and societal cost 12 months post stroke
Detailed Description:
Data collection and transfer
Data will be collected by the clinical sites and by the external researchers from the KU Leuven VUB and Jessa Hospital Source documents will be used to collect the data these can be on paper or digital document
Different kinds of data will be collected on paper for example results of the clinical tests questionnaires and diaries A standardized case report form CRF will be completed during data collection containing researchers notes remarks concerning data quality contextual information deviations from the protocol etc These CRFs will be kept on paper in the same folder as the research data that are collected on paper and will become part of the participants source documentation These forms will be digitalized by the researchers in the e-CRFs via REDCap After digitalizing the data these paper forms will be stored in a locked cabinet in the Department of Rehabilitation Sciences Building The Nayer of the KU Leuven During data collection temporary storage is possible at building K on the health campus in Jette of the VUB Only authorized personnel will have access to this locked storage rooms as they will need to be granted access by the PI
The data collected by the clinical sites will consists of a combination of paper forms and digital documents A ManGO platform hosted by KU Leuven IT department will be used for collecting these different pseudonymized data forms The different paper forms and data received via ManGO will be processed to REDCap by the external researchers After digitalizing the data the paper forms will be stored in a locked cabinet in the Department of Rehabilitation Sciences Building The Nayer of the KU Leuven During data collection temporary storage is possible at building K on the health campus in Jette of the VUB Only authorized personnel will have access to this locked storage rooms as they will need to be granted access by the PI The recorded videos will be transferred via ZIVVER after which they will processed by the external researchers and deleted both on the computer of the external researcher and in the clinical sites
Any participant records or datasets that are transferred to the Sponsor or any partners of the Sponsor will contain the study-specific participant identifier only participant names or any information which would make the participant identifiable will not be transferred All pseudonymized data relating to the Investigation must be transmitted in a secure manner to the Sponsor or any partners of the Sponsor via the ManGO platform or Zivver Interim reports and a final report at the group level without individual patient data will be provided to the funder FWO
Power calculation
A power calculation was done based on the primary research question evaluating the short-term clinical effect of Aha BOOST intervention versus the control intervention on arm-hand capacity This give the following results In the proof of concept RCT an average difference of 78 points in ARAT between both groups in change from pre- to post intervention was found Furthermore the standard deviation of change from pre- to post intervention was estimated to be 117 points for the ARAT scale With 74 patients the comparison between experimental and control group for change from pre- to post intervention will have 80 power to detect an average difference of at least 78 points at the 5 two-sided level of significance assuming a standard deviation of at most 117 points
To account for an expected dropout of at most 8 80 patients will be recruited
Statistical analysis
1 Clinical data Changes in ARAT-scores from baseline between patients in the experimental and control group will be compared Change from baseline will be estimated in both groups based on a multivariate ANOVA model for the original ARAT scores with time and treatment as main effects and with time by treatment interaction As a further sensitivity analysis the analysis will be repeated correcting for patient characteristics such as age time post stroke and cognitive impairments
Secondary outcome measures Multivariate ANOVA and sensitivity analyses as described above
Subgroup analyses pre-specified subgroup analyses will be undertaken to explore the effects of the interventions in different types of stroke survivors such as experiencing cognitive impairments using appropriate caution about multiplicity in the interpretation of these results If there appear to be different effects in different subgroups this will be investigated using interaction or trend tests rather than the statistical significance of the result for the individual subgroup
2 Health economic data The economic evaluation will incorporate costs and health gains during the trial and follow-up period adopting healthcare and societal perspectives On the cost side the evaluation will focus on the direct medical and non-medical costs and on indirect costs depending on the perspective The direct medical costs encompass all costs for treatment and follow-up from the healthcare perspective and all out-of-pocket contributions by the participant Direct non-medical costs include transport costs and home care help whereas indirect costs include productivity loss eg the number of days away from work Productivity losses due to informal care will be documented and valued using the human capital approach The effects are expressed in utilities derived from the national values of the EQ-5D-5L
The cost-effectiveness of the intervention will be expressed in incremental cost per QALY quality-adjusted life years using a decision-analytic model based on the trial data with a time horizon of one year and on a lifetime horizon The incremental cost per QALY will be calculated as a ratio of Cost Experimental-Cost Control Outcome Experimental-Outcome Control The robustness of the results will be analyzed by probabilistic sensitivity analyses on the cost as well as on the outcome
Tornadodiagrams will be used to measure impact of individual components in healthcare utilization Probabilistic sensitivity analyses by bootstrapping with replacement will be employed to test the robustness of the results utilizing MS Excel using a minimum of 1000 iterations to obtain 25 and 975 percentiles of the incremental cost-effectiveness ratio ICER distribution In a second phase the health economic model will be further extended from a one-year time horizon to a life-time horizon based on literature A Markov-model is developed defining the health states in chronic stroke Estimations on resource use and utilities for each health state are derived from international peer-reviewed literature Special attention is paid to the transferability of the data to the Flemish healthcare context This will done by validation checks within the research consortium and advisory board Similar to the one-year model probabilistic sensitivity analyses will be used to account for uncertainty around the input parameters
3 Process evaluation data Qualitative data will be analyzed using content analysis a deductive analysis based on the defined indicators and thematic analysis an inductive analysis where themes will be generated from the data by the researchers using a generic qualitative approach The aim is to interview - 16 interviewees to achieve meaning saturation per respondent group patients expert therapists and treating physicians Approximately 48 interviews will be conducted although the final numbers will be determined by saturation Interviews will be audio recorded transcribed at verbatim and analyzed in NVIVO Different types of data-triangulation by using different methods or data-sources to gain a more in depth understanding will be applied 1 methodological triangulation eg using a combination of interviews and observations 2 data triangulation eg patients Aha BOOST therapists and treating physicians 3 theoretical triangulation eg involving researchers of different disciplines to look to the data from different perspectives 4 investigator triangulation eg involving different researchers in data analysis
Data will be collected by the clinical sites and by the external researchers from the KU Leuven VUB and Jessa Hospital Source documents will be used to collect the data these can be on paper or digital document
Different kinds of data will be collected on paper for example results of the clinical tests questionnaires and diaries A standardized case report form CRF will be completed during data collection containing researchers notes remarks concerning data quality contextual information deviations from the protocol etc These CRFs will be kept on paper in the same folder as the research data that are collected on paper and will become part of the participants source documentation These forms will be digitalized by the researchers in the e-CRFs via REDCap After digitalizing the data these paper forms will be stored in a locked cabinet in the Department of Rehabilitation Sciences Building The Nayer of the KU Leuven During data collection temporary storage is possible at building K on the health campus in Jette of the VUB Only authorized personnel will have access to this locked storage rooms as they will need to be granted access by the PI
The data collected by the clinical sites will consists of a combination of paper forms and digital documents A ManGO platform hosted by KU Leuven IT department will be used for collecting these different pseudonymized data forms The different paper forms and data received via ManGO will be processed to REDCap by the external researchers After digitalizing the data the paper forms will be stored in a locked cabinet in the Department of Rehabilitation Sciences Building The Nayer of the KU Leuven During data collection temporary storage is possible at building K on the health campus in Jette of the VUB Only authorized personnel will have access to this locked storage rooms as they will need to be granted access by the PI The recorded videos will be transferred via ZIVVER after which they will processed by the external researchers and deleted both on the computer of the external researcher and in the clinical sites
Any participant records or datasets that are transferred to the Sponsor or any partners of the Sponsor will contain the study-specific participant identifier only participant names or any information which would make the participant identifiable will not be transferred All pseudonymized data relating to the Investigation must be transmitted in a secure manner to the Sponsor or any partners of the Sponsor via the ManGO platform or Zivver Interim reports and a final report at the group level without individual patient data will be provided to the funder FWO
Power calculation
A power calculation was done based on the primary research question evaluating the short-term clinical effect of Aha BOOST intervention versus the control intervention on arm-hand capacity This give the following results In the proof of concept RCT an average difference of 78 points in ARAT between both groups in change from pre- to post intervention was found Furthermore the standard deviation of change from pre- to post intervention was estimated to be 117 points for the ARAT scale With 74 patients the comparison between experimental and control group for change from pre- to post intervention will have 80 power to detect an average difference of at least 78 points at the 5 two-sided level of significance assuming a standard deviation of at most 117 points
To account for an expected dropout of at most 8 80 patients will be recruited
Statistical analysis
1 Clinical data Changes in ARAT-scores from baseline between patients in the experimental and control group will be compared Change from baseline will be estimated in both groups based on a multivariate ANOVA model for the original ARAT scores with time and treatment as main effects and with time by treatment interaction As a further sensitivity analysis the analysis will be repeated correcting for patient characteristics such as age time post stroke and cognitive impairments
Secondary outcome measures Multivariate ANOVA and sensitivity analyses as described above
Subgroup analyses pre-specified subgroup analyses will be undertaken to explore the effects of the interventions in different types of stroke survivors such as experiencing cognitive impairments using appropriate caution about multiplicity in the interpretation of these results If there appear to be different effects in different subgroups this will be investigated using interaction or trend tests rather than the statistical significance of the result for the individual subgroup
2 Health economic data The economic evaluation will incorporate costs and health gains during the trial and follow-up period adopting healthcare and societal perspectives On the cost side the evaluation will focus on the direct medical and non-medical costs and on indirect costs depending on the perspective The direct medical costs encompass all costs for treatment and follow-up from the healthcare perspective and all out-of-pocket contributions by the participant Direct non-medical costs include transport costs and home care help whereas indirect costs include productivity loss eg the number of days away from work Productivity losses due to informal care will be documented and valued using the human capital approach The effects are expressed in utilities derived from the national values of the EQ-5D-5L
The cost-effectiveness of the intervention will be expressed in incremental cost per QALY quality-adjusted life years using a decision-analytic model based on the trial data with a time horizon of one year and on a lifetime horizon The incremental cost per QALY will be calculated as a ratio of Cost Experimental-Cost Control Outcome Experimental-Outcome Control The robustness of the results will be analyzed by probabilistic sensitivity analyses on the cost as well as on the outcome
Tornadodiagrams will be used to measure impact of individual components in healthcare utilization Probabilistic sensitivity analyses by bootstrapping with replacement will be employed to test the robustness of the results utilizing MS Excel using a minimum of 1000 iterations to obtain 25 and 975 percentiles of the incremental cost-effectiveness ratio ICER distribution In a second phase the health economic model will be further extended from a one-year time horizon to a life-time horizon based on literature A Markov-model is developed defining the health states in chronic stroke Estimations on resource use and utilities for each health state are derived from international peer-reviewed literature Special attention is paid to the transferability of the data to the Flemish healthcare context This will done by validation checks within the research consortium and advisory board Similar to the one-year model probabilistic sensitivity analyses will be used to account for uncertainty around the input parameters
3 Process evaluation data Qualitative data will be analyzed using content analysis a deductive analysis based on the defined indicators and thematic analysis an inductive analysis where themes will be generated from the data by the researchers using a generic qualitative approach The aim is to interview - 16 interviewees to achieve meaning saturation per respondent group patients expert therapists and treating physicians Approximately 48 interviews will be conducted although the final numbers will be determined by saturation Interviews will be audio recorded transcribed at verbatim and analyzed in NVIVO Different types of data-triangulation by using different methods or data-sources to gain a more in depth understanding will be applied 1 methodological triangulation eg using a combination of interviews and observations 2 data triangulation eg patients Aha BOOST therapists and treating physicians 3 theoretical triangulation eg involving researchers of different disciplines to look to the data from different perspectives 4 investigator triangulation eg involving different researchers in data analysis
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