Improving Healthcare Outcomes in American Indian and Hispanic Transplant Recipients Using Culturally-Tailored Novel Technology (IMPACT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Intervention Acceptability: Usability
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Received kidney transplant at UNMH
- •Greater than 18 years of age
- •Mentally competent
排除标准
- •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
结局指标
主要结局
Intervention Acceptability: Usability
时间窗: 12 months
System Usability Scale, rated 1-5, where higher scores indicate ease of usability
Intervention feasibility: Participation
时间窗: Through study completion, an average of 1 year
Time required for study participation during every intervention session
Intervention feasibility: Missing data
时间窗: Through study completion, an average of 1 year
Estimates of the expected rates of missing data
Intervention Acceptability: Satisfaction
时间窗: 12 months
Client Satisfaction Questionnaire, rated 1-4, where higher satisfaction will indicate greater intervention acceptability
Intervention feasibility: Retention
时间窗: Through study completion, an average of 1 year
Retention rates
Intervention feasibility: Attrition
时间窗: Through study completion, an average of 1 year
Participant attrition will be measured by counting participants who do not continue with the study
次要结局
- Medical records outcomes: HbA1c(Through study completion, an average of 1 year)
- Medical records outcomes: Lipids(Through study completion, an average of 1 year)
- Patient reported outcomes: Sleep(Baseline, 1 year)
- Patient reported outcomes: Occupational(Baseline, 1 year)
- Medical records outcomes: Weight(Through study completion, an average of 1 year)
- Patient reported outcomes: QOL(Baseline, 1 year)
研究者
Larissa Myaskovsky, PhD
Associate Professor, Director: CHEK-D
University of New Mexico