Pilot of IMPACT Intervention at the University of New Mexico (IMPACT)

Improving Healthcare Outcomes in American Indian and Hispanic Transplant Recipients Using Culturally-Tailored Novel Technology (IMPACT)

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.

Study Overview

• Status: Completed
• Conditions: Kidney Replacement
• Intervention / Treatment: Behavioral: Exercise and diet; Other: No Intervention: Usual Care

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IMPACT Intervention; Incorporate a rehabilitation approach to slowly increasing KT recipients' physical activity in addition to individualized dietary intervention at every post-transplant appointment through six months post-transplant, with follow-up at 12 months post-transplant.	Behavioral: Exercise and diet; IMPACT Intervention
Other: Usual Care; No exercise or diet specialization.	Other: No Intervention: Usual Care; No exercise or diet specialization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Acceptability: Satisfaction	Client Satisfaction Questionnaire, rated 1-4, where higher satisfaction will indicate greater intervention acceptability	12 months
Intervention Acceptability: Usability	System Usability Scale, rated 1-5, where higher scores indicate ease of usability	12 months
Intervention feasibility: Retention	Retention rates	Through study completion, an average of 1 year
Intervention feasibility: Missing data	Estimates of the expected rates of missing data	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	Through study completion, an average of 1 year
Intervention feasibility: Participation	Time required for study participation during every intervention session	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medical records outcomes: Weight	Percent weight change	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	Through study completion, an average of 1 year
Medical records outcomes: HbA1c	HbA1c	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	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.	Baseline, 1 year
Patient reported outcomes: Occupational	Occupational Functioning Subscale: CHART-SF rated 0-100, where higher scores indicate greater levels of participation	Baseline, 1 year

Collaborators and Investigators

• Sponsor: University of New Mexico
• Investigators: Principal Investigator: Larissa Myaskovsky, PhD, University of New Mexico

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): January 13, 2023
• Study Completion (Actual): January 13, 2023

Study Registration Dates

• First Submitted: October 30, 2019
• First Submitted That Met QC Criteria: November 15, 2019
• First Posted (Actual): November 18, 2019

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Exercise; Diet
• Other Study ID Numbers: 19-413 IMPACT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No