The objective of this randomized controlled study is to assess the neurocognitive outcomes between individuals using immediate-release (IR) tacrolimus (Prograf®) and those who were converted to extended-release tacrolimus (Envarsus XR) among older kidney transplant recipients (KTRs).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
92
Conversion from immediate-release tacrolimus (Prograf) to extended-release tacrolimus (Envarsus XR) as a part of the maintenance immunosuppressive treatment
Continuing immediate-release tacrolimus (Prograf) as a part of the maintenance immunosuppressive treatment
MGH Kidney Transplant Clinic
Boston, Massachusetts, United States
RECRUITINGThe difference in changes of neurocognitive function in intermediate-term (Total cognition composite, standard score)
Neurocognitive functions will be assessed across multiple cognitive domains using the NIH toolbox-Cognitive battery (NIHTB-CB) version 3. The NIHTB-CB version 3 encompasses seven tests to assess attention, executive function, language, memory, and processing speed. The total cognition composite will be derived by averaging normalized scores. The results will be reported in Standard Scores \[SS; mean of 100, standard deviation (SD) of 15\] adjusting the age of the subject. The investigators will compare the changes in standard score from baseline between the two intervention groups.
Time frame: 12 month
The difference in changes of neurocognitive function in intermediate-term (Fluid composite, standard score)
The fluid composite score will be obtained using the NIH toolbox-Cognitive battery (NIHTB-CB) version 3, similarly as described above. The fluid cognition composite will be derived by averaging normalized scores. The results will be reported in Standard Scores \[SS; mean of 100, standard deviation (SD) of 15\] adjusting the age of the subject. The investigators will compare the changes in standard score from baseline between the two intervention groups.
Time frame: 12 month
The difference in changes of neurocognitive function in intermediate-term (Crystallized composite, standard score)
The crystallized composite score will be obtained using the NIH toolbox-Cognitive battery (NIHTB-CB) version 3, similarly as described above. The crystallized cognition composite will be derived by averaging normalized scores. The results will be reported in Standard Scores \[SS; mean of 100, standard deviation (SD) of 15\] adjusting the age of the subject. The investigators will compare the changes in standard score from baseline between the two intervention groups.
Time frame: 12 month
The difference in changes of neurocognitive function in intermediate-term (Total cognition composite, T score)
The total composite score will be obtained using the NIH toolbox-Cognitive battery (NIHTB-CB) version 3, similarly as described above. The total cognition composite will be derived by averaging normalized scores. The results will be reported in T scores (mean of 50 and SD of 10) with adjustments for age, gender, education, and race/ethnicity. The investigators will compare the changes in T score from baseline between the two intervention groups.
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Time frame: 12 month
The difference in changes of neurocognitive function in intermediate-term (Fluid composite, T score)
The fluid composite score will be obtained using the NIH toolbox-Cognitive battery (NIHTB-CB) version 3, similarly as described above. The fluid cognition composite will be derived by averaging normalized scores. The results will be reported in T scores (mean of 50 and SD of 10) with adjustments for age, gender, education, and race/ethnicity. The investigators will compare the changes in T score from baseline between the two intervention groups.
Time frame: 12 month
The difference in changes of neurocognitive function in intermediate-term (Crystallized composite, T score)
The crystallized composite score will be obtained using the NIH toolbox-Cognitive battery (NIHTB-CB) version 3, similarly as described above. The crystallized cognition composite will be derived by averaging normalized scores. The results will be reported in T scores (mean of 50 and SD of 10) with adjustments for age, gender, education, and race/ethnicity. The investigators will compare the changes in T score from baseline between the two intervention groups.
Time frame: 12 month
The difference in changes of neurocognitive function in short-term (Total cognition composite, standard score)
Same as described above
Time frame: 3 month
The difference in changes of neurocognitive function in short-term (Fluid composite, standard score)
Same as described above
Time frame: 3 month
The difference in changes of neurocognitive function in short-term (Crystallized composite, standard score)
Same as described above
Time frame: 3 month
The difference in changes of neurocognitive function in short-term (Total cognition composite, T score)
Same as described above
Time frame: 3 month
The difference in changes of neurocognitive function in short-term (Fluid composite, T score)
Same as described above
Time frame: 3 month
The difference in changes of neurocognitive function in short-term (Crystallized composite, T score)
Same as described above
Time frame: 3 month
The changes in quality of life, measured by SONG-LP questionnaire
The Standardized Outcome in Nephrology-Life Participation (SONG-LP) questionnaire will evaluate each participant's engagement in significant life domains in correlation with the intervention. This questionnaire assesses life participation in the areas of leisure, family, work, and social activities through four simple questions. The score ranges from 4 to 20, with a higher score indicating greater engagement in life activities. The difference in changes of total score from baseline between the two intervention groups will be obtained.
Time frame: 3 month and 12 month
The changes in tremor, measured by QUEST questionnaire
Quality of Life in Essential Tremor (QUEST) questionnaire will be used to assess tremors subjectively. This questionnaire comprises 30 items contributing to the five dimensions: physical/activities of daily living, psychosocial, communication, hobbies/leisure, and work/finances. The investigators will also obtain self-rated tremor severity in various body parts. The score ranges from 0 to 120, with a higher score indicating a greater impact on their QOL from tremor. The investigators will compare the changes in total score and the score on each scale from baseline between the two intervention groups.
Time frame: 3 month and 12 month
The changes in sleep quantity, measured by a wearable device
The investigators will assess each participant's sleep quantity using wearable devices. The participants will be instructed to wear the device continuously for 14 days at pre-specified time points during the study period. Sleep quantity will be represented by the total amount of time spent asleep. The difference in changes in sleep quantity from baseline will be compared between the two intervention groups.
Time frame: 3 month and 12 month
The changes in sleep quality, measured by a wearable device
The investigators will objectively assess each participant's sleep quality using wearable devices. The participants will be instructed to wear the device continuously for 14 days at pre-specified time points during the study period. Sleep quality will be measured as a percentage of time spent in deep sleep and REM sleep to the total sleep time. A higher percentage indicates a better sleep quality. The changes in sleep quality from baseline will be compared between the two intervention groups.
Time frame: 3 month and 12 month