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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04166994
Other study ID # 19-413 IMPACT
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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