Pilot of IMPACT Intervention at the University of New Mexico

Kidney Replacement Clinical Trial

— IMPACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04166994
• Other study ID #: 19-413 IMPACT
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: January 13, 2023

Study information

• Verified date: May 2023
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 13, 2023
• Est. primary completion date: January 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Replacement

Intervention

Behavioral:
• Exercise and diet
IMPACT Intervention

Other:
• No Intervention: Usual Care
No exercise or diet specialization.

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intervention Acceptability: Satisfaction	Client Satisfaction Questionnaire, rated 1-4, where higher satisfaction will indicate greater intervention acceptability	12 months
Primary	Intervention Acceptability: Usability	System Usability Scale, rated 1-5, where higher scores indicate ease of usability	12 months
Primary	Intervention feasibility: Retention	Retention rates	Through study completion, an average of 1 year
Primary	Intervention feasibility: Missing data	Estimates of the expected rates of missing data	Through study completion, an average of 1 year
Primary	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
Primary	Intervention feasibility: Participation	Time required for study participation during every intervention session	Through study completion, an average of 1 year
Secondary	Medical records outcomes: Weight	Percent weight change	Through study completion, an average of 1 year
Secondary	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
Secondary	Medical records outcomes: HbA1c	HbA1c	Through study completion, an average of 1 year
Secondary	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
Secondary	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
Secondary	Patient reported outcomes: Occupational	Occupational Functioning Subscale: CHART-SF rated 0-100, where higher scores indicate greater levels of participation	Baseline, 1 year