Kidney Replacement Clinical Trial
— IMPACTOfficial title:
Improving Healthcare Outcomes in American Indian and Hispanic Transplant Recipients Using Culturally-Tailored Novel Technology (IMPACT)
Verified date | May 2023 |
Source | University of New Mexico |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of New Mexico | Albuquerque | New Mexico |
Lead Sponsor | Collaborator |
---|---|
University of New Mexico |
United States,
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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