Clinical trial NCT04166994: Pilot of IMPACT Intervention at the University of New Mexico
Official title: Improving Healthcare Outcomes in American Indian and Hispanic Transplant Recipients Using Culturally-Tailored Novel Technology (IMPACT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Replacement
Keywords: Diet
Exercise
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2019-11-18
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Received kidney transplant at UNMH
2. Greater than 18 years of age
3. Mentally competent

Exclusion Criteria:

1. Children under the age of 18
2. Incarcerated patients
3. Pregnant women
4. Active systemic infection
5. Non-skin malignancy or melanoma in the past 2 years
6. Known cognitive impairment

Primary outcomes:
measure: Intervention Acceptability: Satisfaction
timeFrame: 12 months
measure: Intervention Acceptability: Usability
timeFrame: 12 months
measure: Intervention feasibility: Retention
timeFrame: Through study completion, an average of 1 year
measure: Intervention feasibility: Missing data
timeFrame: Through study completion, an average of 1 year
measure: Intervention feasibility: Attrition
timeFrame: Through study completion, an average of 1 year
measure: Intervention feasibility: Participation
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Medical records outcomes: Weight
timeFrame: Through study completion, an average of 1 year
measure: Medical records outcomes: Lipids
timeFrame: Through study completion, an average of 1 year
measure: Medical records outcomes: HbA1c
timeFrame: Through study completion, an average of 1 year
measure: Patient reported outcomes: Sleep
timeFrame: Baseline, 1 year
measure: Patient reported outcomes: QOL
timeFrame: Baseline, 1 year
measure: Patient reported outcomes: Occupational
timeFrame: Baseline, 1 year
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Larissa Myaskovsky, PhD
role: PRINCIPAL_INVESTIGATOR
References: