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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
23
IMPACT Intervention
No exercise or diet specialization.
University of New Mexico
Albuquerque, New Mexico, United States
Intervention Acceptability: Satisfaction
Client Satisfaction Questionnaire, rated 1-4, where higher satisfaction will indicate greater intervention acceptability
Time frame: 12 months
Intervention Acceptability: Usability
System Usability Scale, rated 1-5, where higher scores indicate ease of usability
Time frame: 12 months
Intervention feasibility: Retention
Retention rates
Time frame: Through study completion, an average of 1 year
Intervention feasibility: Missing data
Estimates of the expected rates of missing data
Time frame: Through study completion, an average of 1 year
Intervention feasibility: Attrition
Participant attrition will be measured by counting participants who do not continue with the study
Time frame: Through study completion, an average of 1 year
Intervention feasibility: Participation
Time required for study participation during every intervention session
Time frame: Through study completion, an average of 1 year
Medical records outcomes: Weight
Percent weight change
Time frame: Through study completion, an average of 1 year
Medical records outcomes: Lipids
Total cholesterol: Less than 200 mg/dL, LDL: Less than 100 mg/dL, HDL: 60 mg/dL or higher, Triglycerides: less than 150 mg/dL
Time frame: Through study completion, an average of 1 year
Medical records outcomes: HbA1c
HbA1c
Time frame: Through study completion, an average of 1 year
Patient reported outcomes: Sleep
Pittsburgh Sleep Quality Index will measure different aspects of sleep and becomes one composite score, where lower scores denote a healthier sleep quality
Time frame: Baseline, 1 year
Patient reported outcomes: QOL
We will use the PROMIS Scale v1.2 Global Health measure to assess quality of life (QOL), which includes items relevant to patients with kidney disease, including overall health, physical limitations, work, pain, energy, and emotional problems.
Time frame: Baseline, 1 year
Patient reported outcomes: Occupational
Occupational Functioning Subscale: CHART-SF rated 0-100, where higher scores indicate greater levels of participation
Time frame: Baseline, 1 year
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