Clinical Trials Logo

Clinical Trial Summary

Kidney transplant recipients (KTR) are at greater risk of weight gain, diabetes and cardiovascular events post-transplant; but medications are limited in their effectiveness, and patients may face contraindications and unwanted side effects, given their complex post-transplant immunosuppression regimen. The investigators will pilot a randomized-controlled trial to test the feasibility and acceptability of a culturally-appropriate, multi-behavior (diet and exercise) lifestyle intervention for 20 American Indian, Hispanic/Latino(a), and White KTRs. Critical components of the pilot trial include: (a) an individually tailored exercise and diet plan with a physical therapist/exercise physiologist and a registered dietitian nutritionist, who will work closely with the post-transplant team to carefully monitor patient stability; and, (b) the use of the Twistle Patient Engagement Platform to follow-up with participants between their scheduled appointments and to collect all questionnaire data.


Clinical Trial Description

In Improving Healthcare Outcomes in American Indian and Hispanic Transplant Recipients Using Culturally-Tailored Novel Technology (IMPACT), the investigators will pilot the feasibility and acceptability of a culturally-tailored, multi-behavior lifestyle intervention using a novel technology for 14-20 AI, HL, and White KT recipients. Because of KT recipients' varied stability immediately post-transplant, and the need to individually monitor their post-transplant immunosuppression regimen, a critical component of IMPACT will be an individually-tailored exercise and diet plan with a physical therapist/exercise physiologist and a registered dietitian nutritionist, who will work closely with the post-transplant team to carefully monitor patient stability. IMPACT will combine a personalized assessment of the patient's food preferences and access to exercise resources within their environment (based on a standard list of factors developed by the nutrition and rehabilitation experts) along with clinical specifications from the transplant team. The study is innovative because it addresses previous limitations, while adapting the intervention to meet the needs of the culturally-diverse ESKD population. The final innovation of the IMPACT Pilot is the use of the Twistle Patient Engagement Platform to follow-up with participants between their scheduled appointments, ensure adherence to the intervention, collect all questionnaire data, and enhance participant retention. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04166994
Study type Interventional
Source University of New Mexico
Contact
Status Completed
Phase N/A
Start date November 1, 2020
Completion date January 13, 2023

See also
  Status Clinical Trial Phase
Completed NCT03965559 - The Efficacy of Plasmapheresis and Double Filtration Plasmapheresis (DFPP) in Kidney Transplant
Completed NCT03464149 - The Longitudinal PTH-Study
Not yet recruiting NCT06374095 - 1 vs 7 RATG Infusions in Renal Transplantation
Not yet recruiting NCT06374121 - Kidney Perfusion With or Without Absorption N/A
Recruiting NCT06129617 - Intermittent ADVOS vs. Hemodialysis in Non-intensive Care Patients With Liver Dysfunction N/A
Not yet recruiting NCT06182475 - Development and Test of a Communication Skills Training for Transplant Providers - Aims 2 & 3 N/A
Recruiting NCT06445205 - Utilising Volumetric Absorptive Microsampling (VAMS) Technology to Monitor Tacrolimus and Creatinine
Recruiting NCT05473143 - Proactive Prescription-based Fluid Management vs Usual Care in Critically Ill Patients on Kidney Replacement Therapy N/A