Remote Therapy to Improve Outcomes in Lung Transplant Recipients: Design of the INSPIRE-III Randomized Clinical Trial

BACKGROUND. Impaired functional capacity and emotional distress are associated with lower quality of life (QoL) and worse clinical outcomes in post lung transplant patients. Strategies to increase physical activity and reduce distress are needed. METHODS. The Investigational Study of Psychological Interventions in Recipients of Lung Transplant-III study is a single site, parallel group randomized clinical trial in which 150 lung transplant recipients will be randomly assigned to 3 months of telephone-delivered coping skills training combined with aerobic exercise (CSTEX) or to a Standard of Care plus Education control group. The primary endpoints are a global measure of distress and distance walked on the 6-Minute Walk Test. Secondary outcomes include measures of transplant-specific QoL, frailty, health behaviors, and chronic lung allograft dysfunction–free survival. RESULTS. Participants will be evaluated at baseline, at the conclusion of 3 months of weekly treatment, at 1-year follow-up, and followed annually thereafter for clinical events for up to 4 years (median = 2 y). We also will determine whether functional capacity, distress, and health behaviors (eg, physical activity, medication adherence, and volume of air forcefully exhaled in 1 second (FEV1), mediate the effects of the CSTEX intervention on clinical outcomes. CONCLUSIONS. Should the CSTEX intervention result in better outcomes compared with the standard of care plus post-transplant education, the remotely delivered CSTEX intervention can be made available to all lung transplant recipients as a way of enhancing their QoL and improving clinical outcomes.