Pilot of IMPACT Intervention at the University of New Mexico

Not Applicable

Completed

• Conditions: Kidney Replacement
• Interventions: Behavioral: Exercise and diet

• Registration Number: NCT04166994
• Lead Sponsor: University of New Mexico

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.

Study Timeline

• Study First Submitted: 2019-10-30
• Study First Submitted QC: 2019-11-15
• Study First Posted: 2019-11-18
• Study Start: 2020-11-01
• Primary Completion: 2023-01-13
• Study Completion: 2023-01-13
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IMPACT Intervention	Exercise and diet	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.

Primary Outcome Measures

Name	Time	Method
Intervention Acceptability: Usability	12 months	System Usability Scale, rated 1-5, where higher scores indicate ease of usability
Intervention feasibility: Participation	Through study completion, an average of 1 year	Time required for study participation during every intervention session
Intervention feasibility: Missing data	Through study completion, an average of 1 year	Estimates of the expected rates of missing data
Intervention Acceptability: Satisfaction	12 months	Client Satisfaction Questionnaire, rated 1-4, where higher satisfaction will indicate greater intervention acceptability
Intervention feasibility: Retention	Through study completion, an average of 1 year	Retention rates
Intervention feasibility: Attrition	Through study completion, an average of 1 year	Participant attrition will be measured by counting participants who do not continue with the study

Secondary Outcome Measures

Name	Time	Method
Medical records outcomes: HbA1c	Through study completion, an average of 1 year	HbA1c
Medical records outcomes: Lipids	Through study completion, an average of 1 year	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
Patient reported outcomes: Sleep	Baseline, 1 year	Pittsburgh Sleep Quality Index will measure different aspects of sleep and becomes one composite score, where lower scores denote a healthier sleep quality
Patient reported outcomes: Occupational	Baseline, 1 year	Occupational Functioning Subscale: CHART-SF rated 0-100, where higher scores indicate greater levels of participation
Medical records outcomes: Weight	Through study completion, an average of 1 year	Percent weight change
Patient reported outcomes: QOL	Baseline, 1 year	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.

Trial Locations

Locations (1)

University of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States