Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06367244
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-08
Brief Title:
Transplant Wellness Program
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Exercise and Wellness Behaviour Change for Solid Organ Transplant A Hybrid Effectiveness-Implementation Trial of the Transplant Wellness Program
Status:
RECRUITING
Status Verified Date:
2024-04
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:
TWP
Brief Summary:
Wellness is defined as the active pursuit of activities choices and lifestyles that lead to a state of overall health Prehabilitation or using rehabilitation in the period before surgery can improve the pre during and post operative experience for the patient Although exercise as prehabilitation has been well established in organ transplant the investigators believe a multiphase approach will help to better serve patients and support patient wellness in the long-term Supporting wellness behaviour change such as exercise stress reduction and sleep is associated with improved quality of life QoL mood and improvements in well-being Including behaviour change support in an exercise program can help support transplant patients in long-term positive lifestyle changes The Transplant Wellness Program TWP is an exercise behaviour change program that includes additional wellness components such as nutrition stress reduction and sleep programs to support overall health and QoL of transplant patients Specifically the TWP will implement physical activity and behaviour change support for patients pre- and post-transplant surgery addressing functional frailty indices of fitness physical activity levels and mental anxiety stress outcomes to improve overall QoL The TWP includes a 12-week exercise program that is delivered either pre-transplant or post-transplant depending on length of time from study enrollment to transplant surgery In addition to the exercise intervention the TWP includes maintenance resources access to group exercise classes wellness webinars group wellness coaching etc and wellness behaviour change support The goal of the TWP is to improve outcomes of participants throughout their transplant journey as well as reduce health services use Collected outcomes will include program reach effectiveness measures such as changes in physical fitness adoption by healthcare practitioners implementation of the program and maintenance In addition will also collect health care use measures as the investigators believe the TWP will result in the reduction of several health care use outcomes such as the number of hospital admissions including intensive care unit admissions length of hospital stays and emergency room utilization
Detailed Description:
Background and Rationale
Wellness is defined as the active pursuit of activities choices and lifestyles that lead to a state of holistic health Prehabilitation or using rehabilitation in the period before surgery can help to optimize the surgical candidate and can improve the pre peri and post operative experience for the patient Although exercise as prehabilitation has been well established in solid organ transplant the investigators believe a multiphasic approach will help to better serve patients and establish further health behavior change to support patient wellness in the long-term Supporting wellness behaviour change including using tenets from health coaching and patient-directed motivational counselling is associated with improved QOL mood and lowered perceived stress as well as improvements in functional well-being Incorporating behaviour change support in a multiphasic exercise prehabilitation program will support transplant patients in making positive lifestyle behaviour changes Wellness programs need to be personalized and include behaviour change support to maintain motivation provide feedback and modify the program content as needed
Research Question and Objectives The Transplant Wellness Program TWP will target lifestyle behaviour change to enhance wellness with a focus on improving exercise behaviour change Specifically the TWP will implement physical activity and behaviour change support for patients pre- and post-transplant surgery addressing functional frailty indices of fitness physical activity levels and mental anxiety stress outcomes to improve overall QOL The goal of the TWP is to improve outcomes of participants throughout their transplant journey as well as reduce health services utilization In addition the investigators believe the TWP will result in the reduction of several health care utilization outcomes including the number of hospital admissions including intensive care unit admissions length of hospital stays and emergency room utilization Finally the TWP will also work in conjunction with additional resources across wellness including nutrition services stress reduction and sleep programs to support an integration of lifestyle modifiable behaviours that support enhanced well-being and quality of life
Methods The transplant wellness program TWP is intended to enhance wellness across the transplant trajectory Introducing exercise and wellness behaviour change to support physical and psychosocial well-being before and after transplant surgery the TWP will work closely with participants to tailor programming to meet their needs The TWP specifically includes the Exercise Intervention EI which is a 12-week exercise program EI is delivered either pre-transplant EI-Pre-Transplant or after transplant EI-Post-Transplant if patients are unable to participate before transplant In addition to the exercise intervention the TWP includes maintenance resources access to group exercise classes wellness webinars group wellness coaching etc and wellness behaviour change support The exercise intervention will be multiphasic pre-transplant and post-transplant and include wellness behavior change support Implementation outcomes will be evaluated using the reach effectiveness adoption implementation and maintenance RE-AIM framework
To gain a better understanding of program implementation and to improve the quality of the program participants will be requested to share their feedback upon completion of the exercise intervention through participant experience surveys and semi-structured interviews Effectiveness outcomes include functional fitness outcomes frailty and musculoskeletal function measures and patient-reported outcomes PROs The PROs include QOL using generic and disease specific measures physical activity levels sleep habits nutrition and mental health anxiety and depression Health economic evaluations will be performed to determine the cost-utility of implementing transplant wellness into the care pathway Chart reviews will be done to collect information regarding outpatient and inpatient health care encounters medication use emergency visits hospital admissions length of hospital stays intensive care unit admissions length of stay and days intubated patient and graft survival
Procedures
Study participants will complete functional fitness assessments across the TWP including i at pre-intervention or intake ii post-12-week exercise intervention EI and iii after surgery 12 weeks post Follow-up assessments will occur at 6 months and 1-year post-EI intake Participants will complete a wellness behaviour change support session before the12-week EI The EI can be done before or after the transplant surgery The functional fitness assessments and the wellness behaviour support session will take approximately 30 minutes each and can be done in-person or online based on logistics and participant preference The functional fitness assessment will include height and weight measurements aerobic fitness test muscular endurance test and the standing balance test The Patient Reported Outcome PRO questionnaires will be repeated at the same time points as functional fitness assessments and then annually for 5 years Questionnaires will be done online REDCap The investigators will review the participants medical chart and collect medical history at the same time pointsPRO questionnaires will take approximately 20 minutes to complete and be done online These will be completed to assess QOL physical activity levels diet sleep habits nutrition and mental health Participants will be requested to share their feedback upon completion of the EI through participant experience surveys and semi-structured interviews
Wellness is defined as the active pursuit of activities choices and lifestyles that lead to a state of holistic health Prehabilitation or using rehabilitation in the period before surgery can help to optimize the surgical candidate and can improve the pre peri and post operative experience for the patient Although exercise as prehabilitation has been well established in solid organ transplant the investigators believe a multiphasic approach will help to better serve patients and establish further health behavior change to support patient wellness in the long-term Supporting wellness behaviour change including using tenets from health coaching and patient-directed motivational counselling is associated with improved QOL mood and lowered perceived stress as well as improvements in functional well-being Incorporating behaviour change support in a multiphasic exercise prehabilitation program will support transplant patients in making positive lifestyle behaviour changes Wellness programs need to be personalized and include behaviour change support to maintain motivation provide feedback and modify the program content as needed
Research Question and Objectives The Transplant Wellness Program TWP will target lifestyle behaviour change to enhance wellness with a focus on improving exercise behaviour change Specifically the TWP will implement physical activity and behaviour change support for patients pre- and post-transplant surgery addressing functional frailty indices of fitness physical activity levels and mental anxiety stress outcomes to improve overall QOL The goal of the TWP is to improve outcomes of participants throughout their transplant journey as well as reduce health services utilization In addition the investigators believe the TWP will result in the reduction of several health care utilization outcomes including the number of hospital admissions including intensive care unit admissions length of hospital stays and emergency room utilization Finally the TWP will also work in conjunction with additional resources across wellness including nutrition services stress reduction and sleep programs to support an integration of lifestyle modifiable behaviours that support enhanced well-being and quality of life
Methods The transplant wellness program TWP is intended to enhance wellness across the transplant trajectory Introducing exercise and wellness behaviour change to support physical and psychosocial well-being before and after transplant surgery the TWP will work closely with participants to tailor programming to meet their needs The TWP specifically includes the Exercise Intervention EI which is a 12-week exercise program EI is delivered either pre-transplant EI-Pre-Transplant or after transplant EI-Post-Transplant if patients are unable to participate before transplant In addition to the exercise intervention the TWP includes maintenance resources access to group exercise classes wellness webinars group wellness coaching etc and wellness behaviour change support The exercise intervention will be multiphasic pre-transplant and post-transplant and include wellness behavior change support Implementation outcomes will be evaluated using the reach effectiveness adoption implementation and maintenance RE-AIM framework
To gain a better understanding of program implementation and to improve the quality of the program participants will be requested to share their feedback upon completion of the exercise intervention through participant experience surveys and semi-structured interviews Effectiveness outcomes include functional fitness outcomes frailty and musculoskeletal function measures and patient-reported outcomes PROs The PROs include QOL using generic and disease specific measures physical activity levels sleep habits nutrition and mental health anxiety and depression Health economic evaluations will be performed to determine the cost-utility of implementing transplant wellness into the care pathway Chart reviews will be done to collect information regarding outpatient and inpatient health care encounters medication use emergency visits hospital admissions length of hospital stays intensive care unit admissions length of stay and days intubated patient and graft survival
Procedures
Study participants will complete functional fitness assessments across the TWP including i at pre-intervention or intake ii post-12-week exercise intervention EI and iii after surgery 12 weeks post Follow-up assessments will occur at 6 months and 1-year post-EI intake Participants will complete a wellness behaviour change support session before the12-week EI The EI can be done before or after the transplant surgery The functional fitness assessments and the wellness behaviour support session will take approximately 30 minutes each and can be done in-person or online based on logistics and participant preference The functional fitness assessment will include height and weight measurements aerobic fitness test muscular endurance test and the standing balance test The Patient Reported Outcome PRO questionnaires will be repeated at the same time points as functional fitness assessments and then annually for 5 years Questionnaires will be done online REDCap The investigators will review the participants medical chart and collect medical history at the same time pointsPRO questionnaires will take approximately 20 minutes to complete and be done online These will be completed to assess QOL physical activity levels diet sleep habits nutrition and mental health Participants will be requested to share their feedback upon completion of the EI through participant experience surveys and semi-structured interviews
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