Patient-centred Intervention With Virtual Support for Obesity and Kidney Transplant Access (PIVOT)
Obesity has a serious impact on people's health and quality of life. For those with advanced kidney disease (i.e. approaching the need for dialysis), obesity is especially problematic - obesity can not only lead to worsening kidney function and kidney failure, but it can also prevent patients from receiving a lifesaving kidney transplantation due to concerns about operation risks. Unfortunately, there is an urgent need but no rigorously proven treatments to help people with advanced kidney disease lose weight effectively and safely.
The investigative team is a large team of doctors, nurses, dieticians, exercise specialists, social scientists, and patients with a lived experience, have spent three years advancing research to help people with advanced kidney disease achieve a healthier body weight. They have created a special weight loss program that combines individualized coaching on diet and save activity with a medication proven to help people with healthier kidneys lose weight (i.e. Ozempic). This research program is called PIVOT: Patient-centred Intervention with Virtual support for Obesity and kidney Transplant access.
The investigators have started to test PIVOT in a small pilot study and early results show that there is potential to study the program on a much larger scale (i.e. across Canada). With funding from CIHR, the investigators aim to reach more Canadians with advanced kidney disease (including people of lower income, women, and people of different races) with an aim of helping them lose weight safely, feel better, obtain a kidney transplant, and staying healthier over the longer term.
研究概览
地位
地位
条件
条件
干预/治疗
干预/治疗
研究类型
研究类型
注册 (估计的)
注册
阶段
阶段
- 第四阶段
联系人和位置
学习联系方式
学习联系方式
- 姓名：Heather LaPier
- 电话号码：65373 519-646-6100
- 邮箱：heather.lapier@sjhc.london.on.ca
学习地点
-
-
Ontario
-
London、Ontario、加拿大
- London Health Sciences Centre
-
接触：
- Heather LaPier, MD
- 电话号码：65373 519-646-6100
- 邮箱：heather.lapier@sjhc.london.on.ca
-
London、Ontario、加拿大、N6A4V2
- St. Joseph's Health Care
-
接触：
- Heather LaPier
- 电话号码：65373 519-646-6100
- 邮箱：heather.lapier@sjhc.london.on.ca
-
-
参与标准
资格标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 18 years or older
- BMI >35 kg/m2
- eGFR <15ml/min/1.73m2 at baseline OR 2-year KFRE2 of 10% or greater
Exclusion Criteria:
- Known contraindication to a GLP-1RA (pancreatitis, personal or family history of medullary thyroid cancer, hypersensitivity, pregnancy, breastfeeding)
- Type 1 diabetes
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
手臂数量
武器和干预
参与者组/臂参与者组/臂 |
干预/治疗干预/治疗 |
|---|---|
|
实验性的：Virtual Weight Management Program
A maximum tolerated dose of semaglutide will be administered once weekly subcutaneously, up to a dose of 2.0 mg. Participants will also receive nutritional and movement advice, as well as virtual coaching once every 4 weeks for 6 months. |
Maximum tolerated dose of semaglutide subcutaneously once weekly. Maximum dose of 2.0 mg.
其他名称：
Virtual meeting with intervention coach once every 4 weeks for 6 months, where the coach will discuss the goals and progress with participant, nutritional advice, exercise advice, and motivational support.
其他名称：
|
|
无干预：Usual Care
Usual care participants will continue to receive the typical standard of kidney and diabetes care. They will not receive any study medication or coaching. |
研究衡量的是什么？
主要结果指标
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Body Weight
大体时间：Baseline to 26 weeks +/- 14 days
|
Continuous measure of weight in kilograms assessed on calibrated clinic scales (dry weight for those receiving dialysis given fluid shifts) |
Baseline to 26 weeks +/- 14 days
|
次要结果测量
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Quality of Life - Kidney Disease Quality of Life 36-Item Short Form
大体时间：Baseline to 26 weeks +/- 14 days
|
Change in Kidney Disease Quality of Life (KDQOL-36) score across treatment arms. KDQOL-36 is scored on a 0-100 scale across five domains, with higher scores indicating better health-related quality of life. |
Baseline to 26 weeks +/- 14 days
|
|
Health-Related Quality of Life - European Quality of Life 5 Dimensions, 5 Level (EQ-5D-5L) Questionnaire
大体时间：Baseline to 26 weeks +/- 14 days
|
Change in health-related quality of life measured using the European Quality of Life 5-Dimension, 5-Level questionnaire across treatment arms. A score of 11111 = no problems in any dimension (best), and a score of 55555 = extreme problems in all dimensions (worst). |
Baseline to 26 weeks +/- 14 days
|
|
Change in Functional Status - Kidney Disease Quality of Life 36-Item Short form (KDQOL-36)
大体时间：Baseline to 26 weeks +/- 14 days
|
Change in functional status measured with KDQOL-36™ scores across treatment arms. KDQOL-36 is scored on a 0-100 scale across five domains, with higher scores indicating better health-related quality of life. |
Baseline to 26 weeks +/- 14 days
|
|
Change in Functional Status - European Quality of Life five-dimensional, five-level generic measure (EQ-5D-5L) scores across treatment arms.
大体时间：Baseline to 26 weeks +/- 14 days
|
Measured via EQ-5D-5L (European Quality of Life five-dimensional, five-level generic measure) scores across treatment arms. A score of 11111 = no problems in any dimension (best), and a score of 55555 = extreme problems in all dimensions (worst). |
Baseline to 26 weeks +/- 14 days
|
|
Weight Loss ≥5%
大体时间：Baseline to 26 weeks +/- 14 days
|
Percentage of participants achieving at least 5% reduction in body weight from baseline. |
Baseline to 26 weeks +/- 14 days
|
|
Weight Loss ≥10%
大体时间：Baseline to 26 weeks +/- 14 days
|
Percentage of participant achieving at least 10% reduction in body weight from baseline. |
Baseline to 26 weeks +/- 14 days
|
|
Weight Loss ≥15%
大体时间：26 weeks +/- 14 days
|
Percentage of participants achieving at least 15% reduction in body weight from baseline. |
26 weeks +/- 14 days
|
|
Weight Loss ≥20%
大体时间：Baseline to 26 weeks +/- 14 days
|
Percentage of participants achieving at least 20% reduction in body weight from baseline. |
Baseline to 26 weeks +/- 14 days
|
|
Body Mass Index (BMI)
大体时间：Baseline to 26 weeks +/- 14 days
|
Change in BMI across treatment arms. Measured in kg/m² |
Baseline to 26 weeks +/- 14 days
|
|
Body Surface Area (BSA)
大体时间：Baseline to 26 weeks +/- 14 days
|
Change in BSA across treatment arms. Measured in m². |
Baseline to 26 weeks +/- 14 days
|
|
Body Mass Index <35 kg/m²
大体时间：Week 26 +/- 14 days
|
Percentage of participants achieving a BMI below <35 kg/m², corresponding to the specified weight-based threshold for transplant listing. |
Week 26 +/- 14 days
|
|
Dalhousie Clinical Frailty Scale Rating
大体时间：Baseline to 26 weeks +/- 14 days
|
Change in Dalhousie Clinical Frailty Scale rating across treatment arms. The scale ranges from 1 (very fit) to 9 (terminally ill). |
Baseline to 26 weeks +/- 14 days
|
|
SARC-F Score
大体时间：Baseline to 26 weeks +/- 14 days
|
Change in sarcopenia measured by SARC-F score across treatment arms. This questionnaire is scored out of 10, with a score of 4 or higher indicating probable sarcopenia. |
Baseline to 26 weeks +/- 14 days
|
|
FRAIL Scale
大体时间：Baseline to 26 weeks +/- 14 days
|
Change in frailty measured by the FRAIL Scale across treatment arms. The scale scores five components - fatigue, resistance, ambulation, illnesses, and loss of weight - on a 0-5 scale, with 0 indicating robust, 1-2 pre-frail, and 3 or more indicating frailty. |
Baseline to 26 weeks +/- 14 days
|
|
Acute Kidney Injury (AKI)
大体时间：Baseline to 26 weeks +/- 14 days
|
Incidence of AKI. AKI defined by KDIGO as creatinine ≥ 1.5x baseline within 7 days in non-dialysis participants |
Baseline to 26 weeks +/- 14 days
|
|
Hypoglycemia
大体时间：Baseline to week 26 +/- 14 days
|
Incidence of hypoglycemia (blood glucose <4 mmol/L or time below target using continuous glucose monitoring) |
Baseline to week 26 +/- 14 days
|
|
Gastrointestinal Symptoms
大体时间：Baseline to 26 weeks +/- 14 days
|
Incidence of gastrointestinal symptoms, including nausea, vomiting, constipation |
Baseline to 26 weeks +/- 14 days
|
|
Acute Biliary Disease
大体时间：Baseline to 26 weeks +/- 14 days
|
Incidence of acute biliary disease. |
Baseline to 26 weeks +/- 14 days
|
|
Acute Pancreatitis
大体时间：Baseline to 26 weeks +/- 14 days
|
Incidence of acute pancreatitis. |
Baseline to 26 weeks +/- 14 days
|
|
Diabetic Retinopathy Interventions
大体时间：Baseline to 26 weeks +/- 14 days
|
Incidence of interventions for diabetic retinopathy |
Baseline to 26 weeks +/- 14 days
|
|
Injection-site reactions
大体时间：Baseline to 26 weeks +/- 14 days
|
Incidence of injection-site reactions in the intervention arm. |
Baseline to 26 weeks +/- 14 days
|
|
Malignant Neoplasms
大体时间：Baseline to 26 weeks +/- 14 days
|
Incidence of malignant neoplasms. |
Baseline to 26 weeks +/- 14 days
|
|
Coaching Visit Adherence
大体时间：Baseline to 26 weeks +/- 14 days
|
Percentage of participants completing ≥4 of 6 coaching visits. |
Baseline to 26 weeks +/- 14 days
|
|
Semaglutide Discontinuation
大体时间：Baseline to 26 weeks +/- 14 days
|
Percentage of participants discontinuing semaglutide in the intervention arm. |
Baseline to 26 weeks +/- 14 days
|
|
Achievement of semaglutide dose ≥1.0 mg/week
大体时间：Week 26 +/- 14 days
|
Percentage of participants in the intervention group achieving a semaglutide dose of ≥1.0 mg/week. |
Week 26 +/- 14 days
|
|
Achievement of Semaglutide Dose ≥2.0 mg/week
大体时间：26 weeks +/- 14 days
|
Percentage of participants achieving a semaglutide dose of ≥2.0 mg/week |
26 weeks +/- 14 days
|
|
Semaglutide Initiation in Usual Care
大体时间：Baseline to 26 weeks +/- 14 days
|
Percentage of usual care arm participants initiating semaglutide during the study period. |
Baseline to 26 weeks +/- 14 days
|
|
Use of Semaglutide in Usual Care Participants
大体时间：Baseline to 26 weeks +/- 14 days
|
Percentage of participants using semaglutide in the usual care arm. |
Baseline to 26 weeks +/- 14 days
|
|
Semaglutide Dose ≥1.0 mg/Week in Usual care Arm
大体时间：26 weeks +/- 14 days
|
Percentage of usual care participants achieving semaglutide dose ≥1.0 mg/week |
26 weeks +/- 14 days
|
|
Semaglutide Dose ≥2.0 mg/Week in Usual Care Arm
大体时间：26 Weeks +/- 14 days
|
Percentage of usual care participants achieving semaglutide dose ≥2.0 mg/week |
26 Weeks +/- 14 days
|
|
Body Fat Percentage Measured with Smart Scale
大体时间：Baseline to 26 weeks +/- 14 days
|
Change in body fat percentage among the subsample of intervention participants using the study smart scale. |
Baseline to 26 weeks +/- 14 days
|
|
Muscle Mass Measured with Smart Scale
大体时间：Baseline to 26 weeks +/- 14 days
|
Measured in kilograms. Change in muscle mass among the subsample of intervention participants using the study smart scale. |
Baseline to 26 weeks +/- 14 days
|
|
Intervention Costs
大体时间：Baseline to 26 weeks
|
The total cost of the intervention incurred by participants during the 26-week follow-up period, in Canadian dollars (CAD) |
Baseline to 26 weeks
|
|
Out-of-pocket costs
大体时间：Baseline to 26 weeks
|
Total out-of-pocket costs incurred by participants during the 26-week study period-including costs directly related to the intervention. Measured in Canadian dollars (CAD) |
Baseline to 26 weeks
|
|
Lost Productivity Costs
大体时间：Baseline to 26 weeks
|
Costs associated with productivity losses during the 26-week follow-up period, including costs directly related to the participant's health care and intervention. Measured in Canadian dollars (CAD) |
Baseline to 26 weeks
|
|
Health care utilization costs
大体时间：Baseline to 26 weeks
|
Total costs associated with health care utilization during the study period, including physician visits, hospitalizations, emergency department visits, medications, allied health services. Measured in Canadian dollars (CAD) using provincial administrative health data. |
Baseline to 26 weeks
|
其他结果措施
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in HbA1c
大体时间：Baseline to 24 Months
|
Change in glycated hemoglobin among participants with diabetes across treatment arms. |
Baseline to 24 Months
|
|
Hospitalization for Hyperglycemia
大体时间：Baseline to 24 Months
|
Incidence of hospitalization for hyperglycemia in participants with diabetes across treatment arms |
Baseline to 24 Months
|
|
Hospitalization for hypoglycemia
大体时间：Baseline to 24 Months
|
Incidence of hospitalization for hypoglycemia in participants with diabetes across treatment arms. |
Baseline to 24 Months
|
|
Initiation of Dialysis
大体时间：Baseline to 24 Months
|
Percentage of non-dialysis participants initiating dialysis across treatment arms |
Baseline to 24 Months
|
|
Cardiovascular Composite
大体时间：Baseline to 24 Months
|
Composite of hospitalization for acute myocardial infarction, stroke, amputation, or heart failure across treatment arms. |
Baseline to 24 Months
|
|
Kidney Transplantation
大体时间：Baseline to 24 months
|
Percentage of participants receiving kidney transplantation across treatment arms. |
Baseline to 24 months
|
|
Healthcare utilization
大体时间：24 months
|
Health care utilization over 24 months including number of hospital admissions, emergency department, outpatient and primary care visits, specialist visits, rehabilitation, allied health care visits. Measured using provincial administrative health data. |
24 months
|
|
Health care costs
大体时间：24 months
|
Health care costs over 24 months, including total health care costs, hospitalization-related costs, emergency department costs, outpatient and physician costs, medication costs. Measured in Canadian dollars (CAD) using provincial administrative health data. |
24 months
|
合作者和调查者
调查人员
调查人员
- 首席研究员：Kristin Clemens, MD、St. Joseph's Health Care London, Western University
- 首席研究员：Louise Moist, MD、London Health Sciences Centre
研究记录日期
研究主要日期
学习开始 (估计的)
学习开始
初级完成 (估计的)
初级完成
研究完成 (估计的)
研究完成
研究注册日期
首次提交
首次提交
首先提交符合 QC 标准的
首先提交符合 QC 标准的
首次发布 (实际的)
首次发布
研究记录更新
最后更新发布 (实际的)
最后更新发布
上次提交的符合 QC 标准的更新
上次提交的符合 QC 标准的更新
最后验证
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
其他研究编号
- PIVOT
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
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研究美国 FDA 监管的设备产品
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