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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 4단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Heather LaPier
- 전화번호: 65373 519-646-6100
- 이메일: heather.lapier@sjhc.london.on.ca
연구 장소
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Ontario
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London, Ontario, 캐나다
- London Health Sciences Centre
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연락하다:
- Heather LaPier, MD
- 전화번호: 65373 519-646-6100
- 이메일: heather.lapier@sjhc.london.on.ca
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London, Ontario, 캐나다, N6A4V2
- St. Joseph's Health Care
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연락하다:
- Heather LaPier
- 전화번호: 65373 519-646-6100
- 이메일: heather.lapier@sjhc.london.on.ca
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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실험적: 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.
다른 이름들:
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.
다른 이름들:
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간섭 없음: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Body Weight
기간: Baseline to 26 weeks +/- 14 days
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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
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Quality of Life - Kidney Disease Quality of Life 36-Item Short Form
기간: Baseline to 26 weeks +/- 14 days
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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
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Health-Related Quality of Life - European Quality of Life 5 Dimensions, 5 Level (EQ-5D-5L) Questionnaire
기간: Baseline to 26 weeks +/- 14 days
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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
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Change in Functional Status - Kidney Disease Quality of Life 36-Item Short form (KDQOL-36)
기간: Baseline to 26 weeks +/- 14 days
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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
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Change in Functional Status - European Quality of Life five-dimensional, five-level generic measure (EQ-5D-5L) scores across treatment arms.
기간: Baseline to 26 weeks +/- 14 days
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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
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Weight Loss ≥5%
기간: Baseline to 26 weeks +/- 14 days
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Percentage of participants achieving at least 5% reduction in body weight from baseline. |
Baseline to 26 weeks +/- 14 days
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Weight Loss ≥10%
기간: 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
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Weight Loss ≥15%
기간: 26 weeks +/- 14 days
|
Percentage of participants achieving at least 15% reduction in body weight from baseline. |
26 weeks +/- 14 days
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Weight Loss ≥20%
기간: Baseline to 26 weeks +/- 14 days
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Percentage of participants achieving at least 20% reduction in body weight from baseline. |
Baseline to 26 weeks +/- 14 days
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Body Mass Index (BMI)
기간: Baseline to 26 weeks +/- 14 days
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Change in BMI across treatment arms. Measured in kg/m² |
Baseline to 26 weeks +/- 14 days
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Body Surface Area (BSA)
기간: Baseline to 26 weeks +/- 14 days
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Change in BSA across treatment arms. Measured in m². |
Baseline to 26 weeks +/- 14 days
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Body Mass Index <35 kg/m²
기간: Week 26 +/- 14 days
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Percentage of participants achieving a BMI below <35 kg/m², corresponding to the specified weight-based threshold for transplant listing. |
Week 26 +/- 14 days
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Dalhousie Clinical Frailty Scale Rating
기간: Baseline to 26 weeks +/- 14 days
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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
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SARC-F Score
기간: Baseline to 26 weeks +/- 14 days
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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
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FRAIL Scale
기간: Baseline to 26 weeks +/- 14 days
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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
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Acute Kidney Injury (AKI)
기간: Baseline to 26 weeks +/- 14 days
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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
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Hypoglycemia
기간: Baseline to week 26 +/- 14 days
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Incidence of hypoglycemia (blood glucose <4 mmol/L or time below target using continuous glucose monitoring) |
Baseline to week 26 +/- 14 days
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Gastrointestinal Symptoms
기간: Baseline to 26 weeks +/- 14 days
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Incidence of gastrointestinal symptoms, including nausea, vomiting, constipation |
Baseline to 26 weeks +/- 14 days
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Acute Biliary Disease
기간: Baseline to 26 weeks +/- 14 days
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Incidence of acute biliary disease. |
Baseline to 26 weeks +/- 14 days
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Acute Pancreatitis
기간: Baseline to 26 weeks +/- 14 days
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Incidence of acute pancreatitis. |
Baseline to 26 weeks +/- 14 days
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Diabetic Retinopathy Interventions
기간: Baseline to 26 weeks +/- 14 days
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Incidence of interventions for diabetic retinopathy |
Baseline to 26 weeks +/- 14 days
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Injection-site reactions
기간: Baseline to 26 weeks +/- 14 days
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Incidence of injection-site reactions in the intervention arm. |
Baseline to 26 weeks +/- 14 days
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Malignant Neoplasms
기간: Baseline to 26 weeks +/- 14 days
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Incidence of malignant neoplasms. |
Baseline to 26 weeks +/- 14 days
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Coaching Visit Adherence
기간: Baseline to 26 weeks +/- 14 days
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Percentage of participants completing ≥4 of 6 coaching visits. |
Baseline to 26 weeks +/- 14 days
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Semaglutide Discontinuation
기간: Baseline to 26 weeks +/- 14 days
|
Percentage of participants discontinuing semaglutide in the intervention arm. |
Baseline to 26 weeks +/- 14 days
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Achievement of semaglutide dose ≥1.0 mg/week
기간: Week 26 +/- 14 days
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Percentage of participants in the intervention group achieving a semaglutide dose of ≥1.0 mg/week. |
Week 26 +/- 14 days
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Achievement of Semaglutide Dose ≥2.0 mg/week
기간: 26 weeks +/- 14 days
|
Percentage of participants achieving a semaglutide dose of ≥2.0 mg/week |
26 weeks +/- 14 days
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Semaglutide Initiation in Usual Care
기간: Baseline to 26 weeks +/- 14 days
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Percentage of usual care arm participants initiating semaglutide during the study period. |
Baseline to 26 weeks +/- 14 days
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Use of Semaglutide in Usual Care Participants
기간: Baseline to 26 weeks +/- 14 days
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Percentage of participants using semaglutide in the usual care arm. |
Baseline to 26 weeks +/- 14 days
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Semaglutide Dose ≥1.0 mg/Week in Usual care Arm
기간: 26 weeks +/- 14 days
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Percentage of usual care participants achieving semaglutide dose ≥1.0 mg/week |
26 weeks +/- 14 days
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Semaglutide Dose ≥2.0 mg/Week in Usual Care Arm
기간: 26 Weeks +/- 14 days
|
Percentage of usual care participants achieving semaglutide dose ≥2.0 mg/week |
26 Weeks +/- 14 days
|
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Body Fat Percentage Measured with Smart Scale
기간: Baseline to 26 weeks +/- 14 days
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Change in body fat percentage among the subsample of intervention participants using the study smart scale. |
Baseline to 26 weeks +/- 14 days
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Muscle Mass Measured with Smart Scale
기간: Baseline to 26 weeks +/- 14 days
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Measured in kilograms. Change in muscle mass among the subsample of intervention participants using the study smart scale. |
Baseline to 26 weeks +/- 14 days
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Intervention Costs
기간: Baseline to 26 weeks
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The total cost of the intervention incurred by participants during the 26-week follow-up period, in Canadian dollars (CAD) |
Baseline to 26 weeks
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Out-of-pocket costs
기간: Baseline to 26 weeks
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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
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Lost Productivity Costs
기간: Baseline to 26 weeks
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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
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Health care utilization costs
기간: Baseline to 26 weeks
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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
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기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in HbA1c
기간: Baseline to 24 Months
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Change in glycated hemoglobin among participants with diabetes across treatment arms. |
Baseline to 24 Months
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Hospitalization for Hyperglycemia
기간: Baseline to 24 Months
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Incidence of hospitalization for hyperglycemia in participants with diabetes across treatment arms |
Baseline to 24 Months
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Hospitalization for hypoglycemia
기간: Baseline to 24 Months
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Incidence of hospitalization for hypoglycemia in participants with diabetes across treatment arms. |
Baseline to 24 Months
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Initiation of Dialysis
기간: Baseline to 24 Months
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Percentage of non-dialysis participants initiating dialysis across treatment arms |
Baseline to 24 Months
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Cardiovascular Composite
기간: Baseline to 24 Months
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Composite of hospitalization for acute myocardial infarction, stroke, amputation, or heart failure across treatment arms. |
Baseline to 24 Months
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Kidney Transplantation
기간: Baseline to 24 months
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Percentage of participants receiving kidney transplantation across treatment arms. |
Baseline to 24 months
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Healthcare utilization
기간: 24 months
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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
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Health care costs
기간: 24 months
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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
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공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Kristin Clemens, MD, St. Joseph's Health Care London, Western University
- 수석 연구원: Louise Moist, MD, London Health Sciences Centre
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- PIVOT
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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