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Completed

NCT Number: NCT04166994

Pilot of IMPACT Intervention at the University of New Mexico

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.

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Key information

Conditions

Kidney Replacement Behavior Motor Activity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Received kidney transplant at UNMH
  • Greater than 18 years of age
  • Mentally competent

Exclusion criteria

  • Children under the age of 18
  • Incarcerated patients
  • Pregnant women
  • Active systemic infection
  • Non-skin malignancy or melanoma in the past 2 years
  • Known cognitive impairment

Treatment and study plan

exercise and diet

Behavioral

IMPACT Intervention

No Intervention: usual care

Other

No exercise or diet specialization.

Primary outcomes

  1. Intervention Acceptability: Satisfaction

    Time frame: 12 months

    Client Satisfaction Questionnaire, rated 1-4, where higher satisfaction will indicate greater intervention acceptability

  2. Intervention Acceptability: Usability

    Time frame: 12 months

    System Usability Scale, rated 1-5, where higher scores indicate ease of usability

  3. Intervention feasibility: Retention

    Time frame: Through study completion, an average of 1 year

    Retention rates

  4. Intervention feasibility: Missing data

    Time frame: Through study completion, an average of 1 year

    Estimates of the expected rates of missing data

  5. Intervention feasibility: Attrition

    Time frame: Through study completion, an average of 1 year

    Participant attrition will be measured by counting participants who do not continue with the study

  6. Intervention feasibility: Participation

    Time frame: Through study completion, an average of 1 year

    Time required for study participation during every intervention session

Secondary outcomes

  1. Medical records outcomes: Weight

    Time frame: Through study completion, an average of 1 year

    Percent weight change

  2. Medical records outcomes: Lipids

    Time frame: 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

  3. Medical records outcomes: HbA1c

    Time frame: Through study completion, an average of 1 year

    HbA1c

  4. Patient reported outcomes: Sleep

    Time frame: 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

  5. Patient reported outcomes: QOL

    Time frame: 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.

  6. Patient reported outcomes: Occupational

    Time frame: Baseline, 1 year

    Occupational Functioning Subscale: CHART-SF rated 0-100, where higher scores indicate greater levels of participation

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Registry information

Official study title

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

Acronym: IMPACT

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 18, 2019
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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