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Clinical Studies


  • A Qualitative Analysis of Lung Transplant Recipients’ Perspective on Antifungal Prophylaxis Jacksonville, Fla., Rochester, Minn.

    The purpose of this study is to explore adherence, barriers, side effects, and preference for pharmacologic antifungal prophylaxis following lung transplant. 

  • Transplant Caregiver (CG) Research Registry Rochester, Minn. Currently transplant caregivers are viewed as healthy volunteers caring for patients following heart or lung transplant. However research has revealed that thoracic transplant caregivers have increased mood disorders, distress, and high caregiver burden, especially while caring for patients on the organ transplant waiting list. By monitoring caregiver traits and behaviors we will be better able to provide care and services for CG to improve both CG and patient outcomes.
  • Wellness Coaching for Caregivers of Thoracic Transplant Candidates Rochester, Minn.

    The purpose of this study is to examine the effects of a health coaching intervention on the stress and burden of caregivers of patients awaiting heart or lung transplant.

    Hypotheses:  Caregivers will have traits and behaviors pre-transplant that will predict caregiver readiness, quality of life, and transplant recipient outcomes. Specifically, thoracic pre-transplant caregivers report stress, symptoms of anxiety or depression, and perceive high caregiver burden. These factors may be amenable to pre-transplant intervention to improve overall patient and caregiver outcomes.

    Aims, purpose, or objectives:  We will conduct a pilot trial to test whether caregivers of heart and lung transplant candidates who receive wellness coaching will experience improvement in caregiver-related distress. We will also explore the relationship between caregiving and factors such as uncertainty, resilience, stress level, and affect.

Closed for Enrollment

  • A Prospective Assessment of Uncertainty and Its Relationship to Important Transplant Outcomes Rochester, Minn.

    The purpose of this study is to measure uncertainty using the Mishel Uncertainty in Illness (MUIS) questionnaire (every 12 months) until 3 months posttransplant to explore the relationship of uncertainty and uncertainty subcategories (ambiguity, unpredictability prognosis, unpredictability symptoms, complexity) to important posttransplant outcomes (well-being, length of stay, and mortality).

  • Does Pulmonary Rehabilitation Improve Frailty in Chronic Lung Disease? Rochester, Minn.

    Frailty is a state of health with predisposition to adverse events, morbidity and mortality. Frailty consists of weakness, slowness, low physical activity, exhaustion, and wasting. Frailty is associated with increased hospitalizations and death in lung disease. It is unknown if pulmonary rehabilitation will improve frailty markers.

  • Exercise as an Intervention to Treat Frailty and Decreased Physical Function in Kidney Transplant Candidates Rochester, Minn.

    Frailty is a condition characterized by slowness, weakness, low physical activity, wasting, and exhaustion. Frailty increases the risk for adverse outcomes following transplant such as increased length of stay in the hospital, mortality, or graft function. No interventions for frailty are known for patients with renal disease, but exercise programs like pulmonary rehabilitation have been effective in improving frailty in patients with other diseases, such as lung disease. The goal of this study is to test whether exercise will also improve frailty among patients who are waiting for a kidney transplant and who are considered frail or pre-frail.

  • Health Coaching to Improve Self-Management in Thoracic Transplant Candidates Rochester, Minn.

    Ability to adhere to complex medical regimens is critical to achieving successful transplant outcomes, as non-adherent patients suffer graft failure and death following transplantation. Since potential recipients greatly exceed organ availability, identification of candidates who will adhere to complex post-transplant regimens is critically important and emphasized by practice guidelines. When selecting candidates for transplant, physicians try to subjectively predict post-transplant adherence because, although tools exist to measure current adherence, tools that reliably predict future adherence are lacking. Despite rigorous medical and psychosocial screening pretransplant, non-adherence rates are high following transplant. Therefore, the current approach for predicting future non-adherence is suboptimal, subjective, and greatly needs strategies for improvement.

    Pre-transplant self-management abilities represent a marker of future adherence post-transplant. Assessing self-management as a means for predicting future adherence has been largely overlooked. Self-management is defined as "taking responsibility for one's own behavior and well-being" and consists of three management tasks: medical condition, emotions, and social roles. Self-management ability can be measured. However, self-management has not been systematically studied in heart and lung transplant patients. Fostering self-management abilities may improve post-transplant outcomes by optimizing not only adherence, but also proven pretransplant risk factors (e.g. frailty and obesity).Self-management abilities may be improved via behavioral interventions such as health coaching.Self-management represents a measurable criterion that could be utilized in pre-transplant screening and serve as a point of intervention for optimizing adherence and pre-transplant risk factors.The overall objective of the proposed research is to improve the knowledge gap regarding self-management (and thereby adherence) in transplant by qualitatively and quantitatively studying patient factors associated with self-management and testing an intervention that may improve self-management.

    The investigators hypothesize: Individualized health coaching including strategies to address poor resilience, coping with uncertainty, frailty, and/or negative affect will be an effective therapeutic strategy at improving self-management while in the pre-transplant state.

    Specific Aim: To test whether transplant candidates who receive pre transplant health coaching have greater improvement in self-management abilities.

    The investigators will conduct a randomized, controlled pilot trial testing the effectiveness of health coaching versus usual care in a heart and lung transplant cohort on self-management abilities (SMAS-30).

  • Qualitative Assessment of Pre-Transplant Patients’ Experiences with Uncertainty Jacksonville, Fla., Rochester, Minn.

    The primary research goal of this qualitative study is to explore how patients experience the time between transplant listing and transplantation especially with regards to uncertainty.

  • Qualitative Examination of the Pretransplant Experience of Lay Care Providers Rochester, Minn.

    The objective of this study is to explore the experiences of patients and their caregivers during Mayo Clinic’s pretransplant care program. The study will use semi-structured interviews to describe pretransplant experiences from the perspectives of the primary caregivers of patients waitlisted for transplant, including a focus on uncertainty. The sutdy will also aim to determine if the Mishel Uncertainty of Illness theory is an appropriate construct for pretransplant caregivers' experience with uncertainty or if this needs to be expanded to reflect the specific experience of caregivers caring for patients on the transplant waitlist.