Wellness Program for Transplant Patients

(TWP Trial)

Overseen By Stefan Mustata, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Must not be taking: Non-selective beta blockers

Disqualifiers: Refractory encephalopathy, unsafe environment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

420 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with your doctor or the trial coordinators.

What data supports the effectiveness of the Transplant Wellness Program (TWP) treatment?

The effectiveness of the Transplant Wellness Program (TWP) may be supported by similar programs that focus on enhanced recovery and pharmaceutical care, which have shown improvements in patient satisfaction, compliance with medication, and overall care quality for transplant patients. ^{1 2 3 4 5}

Is the Wellness Program for Transplant Patients safe for humans?

The research articles do not provide specific safety data for the Wellness Program for Transplant Patients or similar programs like TWP. They focus on medication management and adherence, which are important for transplant patients, but do not directly address the safety of the wellness program itself. ^{1 6 7 8 9}

How is the Transplant Wellness Program (TWP) treatment different from other treatments for transplant patients?

The Transplant Wellness Program (TWP) is unique because it focuses on patient education and self-care to promote wellness and graft survival, rather than just medication management. It provides a comprehensive approach that includes home visits and personalized education to ensure patients and their families understand and comply with post-transplant responsibilities, which is not typically emphasized in standard medication-focused treatments. ^{4 7 10 11 12}

What is the purpose of this trial?

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.

Research Team

Stefan Mustata, MD

Principal Investigator

University of Calgary

Eligibility Criteria

The Transplant Wellness Program is for patients awaiting or having recently undergone kidney or liver transplant surgery. It aims to support their overall health and quality of life through a multiphase approach including exercise, nutrition, stress reduction, and sleep programs.

Inclusion Criteria

Able to provide written informed consent and understand study information in English

Have access to an internet connected device

I am on the waiting list for a kidney or liver transplant.

Exclusion Criteria

Not cleared for participation in the TWP by attending physician

I am unable to understand and give consent for treatment.

Unsafe environment for virtual participation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants engage in prehabilitation activities including exercise and wellness behavior change support before transplant surgery

12 weeks

Multiple visits (in-person or virtual)

Post-Transplant Rehabilitation

Participants continue with exercise and wellness behavior change support after transplant surgery

12 weeks

Multiple visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including functional fitness assessments and patient-reported outcomes

5 years

Annual assessments (in-person or virtual)

Treatment Details

Interventions

• Transplant Wellness Program

Trial Overview This trial tests the TWP's effectiveness in improving physical fitness, reducing healthcare use, and enhancing mental well-being pre- and post-transplant. The program includes a 12-week exercise regimen complemented by wellness webinars, group coaching, and behavior change support.

Participant Groups

Group I: Liver transplant arm Experimental Treatment 1 Intervention

Liver transplant patients will be assigned to the liver transplant arm and receive the standard 12-week exercise intervention in the TWP. Specific to the liver arm will be certain PROs and functional fitness measures. The Chronic Liver Disease Questionnaire (CLQD) measures health-related QOL in patients with advanced liver disease and has been previously used in patients awaiting transplant. Liver arm participants will also complete the Liver frailty index, which requires a timed 5 sit-to-stands in addition to the other measures collected for the Fried Frailty Index. Participants in this arm will receive liver-specific exercise and wellness materials to support their behaviour change.

Group II: Kidney transplant arm Experimental Treatment 1 Intervention

Kidney transplant patients will be assigned to the kidney transplant arm and receive the standard 12-week exercise intervention in the TWP. Specific to the kidney arm will be certain patient reported outcomes (PROs). The Kidney Disease Quality of Life-36 (KDQOL-36) is a short form survey widely used to measure patient-reported QOL in patients on dialysis and is a validated tool in kidney transplant patients. Participants in the kidney arm will also receive disease-specific exercise and wellness materials to support their behaviour change.

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Findings from Research

A transplantation specialty pharmacy (TSP) program significantly increased patient satisfaction, with 84% of patients expressing satisfaction and 98% willing to recommend the program, while 96% of healthcare providers noted improved continuity of care.

The TSP program also demonstrated higher medication adherence among patients compared to historical controls, contributing to a positive financial margin of over $2 million in its first year, despite no significant differences in hospital readmissions or length of stay.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a transplantation specialty pharmacy program. Hlubocky, JM., Stuckey, LJ., Schuman, AD., et al.[2019]

The enhanced recovery program for renal transplant patients significantly reduced postoperative morphine requirements (median of 9.5 mg vs 47 mg in traditional recovery), indicating better pain management and potentially improved patient comfort.

Patients in the enhanced recovery group had a shorter hospital stay (median of 5 days for living donors and 5 days for deceased donors) compared to traditional recovery (7 days and 8.5 days, respectively), leading to substantial cost savings and high patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Better Journey for Patients, a Better Deal for the NHS: The Successful Implementation of an Enhanced Recovery Program After Renal Transplant Surgery. Halawa, A., Rowe, S., Roberts, F., et al.[2018]

Pharmacists play a crucial role in the care of solid organ transplant recipients, with their interventions leading to significant improvements in medication adherence, morbidity, and reduction of medication errors, based on a review of 12 studies involving 1837 patients.

Key pharmacist activities included medication counseling, reconciliation, and optimizing drug therapy, highlighting the importance of integrating clinical pharmacy services into transplant programs to enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Roles and Impacts of the Transplant Pharmacist: A Systematic Review. Sam, S., Guérin, A., Rieutord, A., et al.[2022]

A pharmaceutical care program for liver transplant patients significantly improved compliance with immunosuppressive therapy, with an average dosing compliance of 90% in the intervention group compared to 81% in the control group, based on a study using medication event monitoring systems.

Patients receiving the pharmaceutical care were also more likely to achieve target blood levels of their medication, indicating that this intervention is effective and should be integrated into posttransplant care practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a pharmaceutical care program on liver transplant patients' compliance with immunosuppressive medication: a prospective, randomized, controlled trial using electronic monitoring. Klein, A., Otto, G., Krämer, I.[2022]

Nutrition is crucial for the recovery and long-term health of transplant recipients, with different nutrient needs during the acute recovery phase focused on healing and the chronic maintenance phase aimed at preventing complications.

Individualized nutrition therapy is essential, as it should be tailored to address specific health issues like obesity, diabetes, and hypertension that may arise after transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet therapy for organ transplantation. A problem-based approach. Hasse, JM.[2008]

In a study of 291 liver transplant recipients, those who received outpatient medication consultations from a clinical pharmacist had significantly fewer medication-related problems (MRPs) compared to those who did not, indicating the effectiveness of pharmacist involvement in post-transplant care.

Patients who received medication consultations used fewer unnecessary drugs (39.4% vs. 72.1%) and had lower rates of suboptimal therapy and underdosing, highlighting the importance of clinical pharmacists in improving medication management and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of medication-related problems in liver transplant recipients with and without an outpatient medication consultation by a clinical pharmacist: a cohort study. Mulder, MB., Doga, B., Borgsteede, SD., et al.[2022]

Implementing educational and support services can significantly reduce noncompliance in transplant recipients, leading to better health outcomes.

Choosing immunosuppression protocols with fewer side effects and medications enhances patient satisfaction and compliance, which is crucial for maintaining graft function and improving long-term quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effects of transplantation on quality of life. Galbraith, CA., Hathaway, D.[2019]

The Transplant-TAVIE intervention, a web-based program designed to improve medication adherence among kidney transplant patients, was found to be feasible and acceptable, with 54% of participants completing the sessions and high satisfaction rates reported.

Despite the intervention's positive reception, there were no significant differences in medication adherence or self-efficacy between the Transplant-TAVIE group and the control group using existing websites, indicating that while the program is promising, its impact on adherence may need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-Based Tailored Intervention to Support Optimal Medication Adherence Among Kidney Transplant Recipients: Pilot Parallel-Group Randomized Controlled Trial. Côté, J., Fortin, MC., Auger, P., et al.[2020]

Aetna has implemented a Disease Management (DM) program aimed at improving medication adherence among transplant patients, addressing the common issue of organ rejection due to non-compliance.

Early results suggest that this program is positively impacting patient outcomes by providing additional support for managing complex medication regimens and their side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New program applies principles of DM to transplant patients. [2004]

Pharmaceutical manufacturers offer medication assistance programs that can provide essential medications at little or no cost to indigent patients, which can improve medication compliance and reduce financial burdens.

This article serves as a valuable resource for healthcare professionals, summarizing the available assistance programs for commonly prescribed medications in transplant patients, thereby increasing awareness and access to these vital resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assistance programs available for medications commonly used in transplant patients. Chisholm, MA., Tackett, KL., Kendrick, BD., et al.[2019]

A new patient education tool was developed to support solid organ transplant recipients after early hospital discharge, addressing the challenges of ensuring patient and family understanding of post-transplant care.

This tool aims to enhance self-care practices, promote wellness, and improve graft survival by providing essential information that can be easily reviewed during home care visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-care guidelines: finding a common ground. Randolph, S., Scholz, K.[2019]

A medication assistance program with medication therapy management (MTM) significantly improved clinical outcomes for renal transplant recipients, including better control of hypertension, diabetes, and dyslipidemia, as well as a decrease in graft rejections over one year.

Participants in the program also experienced a notable increase in health-related quality of life (HQOL) after one year, indicating that the program not only enhanced medication access but also positively impacted patients' overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a medication assistance program with medication therapy management on the health of renal transplant recipients. Chisholm, MA., Spivey, CA., Mulloy, LL.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Evaluation of a transplantation specialty pharmacy program. [2019]

2. Turkey pubmed.ncbi.nlm.nih.gov

A Better Journey for Patients, a Better Deal for the NHS: The Successful Implementation of an Enhanced Recovery Program After Renal Transplant Surgery. [2018]

3. Canada pubmed.ncbi.nlm.nih.gov

Roles and Impacts of the Transplant Pharmacist: A Systematic Review. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Impact of a pharmaceutical care program on liver transplant patients' compliance with immunosuppressive medication: a prospective, randomized, controlled trial using electronic monitoring. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Diet therapy for organ transplantation. A problem-based approach. [2008]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of medication-related problems in liver transplant recipients with and without an outpatient medication consultation by a clinical pharmacist: a cohort study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Long-term effects of transplantation on quality of life. [2019]

8. Canada pubmed.ncbi.nlm.nih.gov

Web-Based Tailored Intervention to Support Optimal Medication Adherence Among Kidney Transplant Recipients: Pilot Parallel-Group Randomized Controlled Trial. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

New program applies principles of DM to transplant patients. [2004]

10. Denmark pubmed.ncbi.nlm.nih.gov

Assistance programs available for medications commonly used in transplant patients. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Self-care guidelines: finding a common ground. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Effects of a medication assistance program with medication therapy management on the health of renal transplant recipients. [2022]