- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03490188
Design of a Standardized Patient: Mentoring Program for Kidney Transplant Patients
An Innovative Patient-mentoring Program for Kidney Transplant Patients to Reduce Anxiety and Readmission Rates: a Randomized Controlled Trial Leveraging Patients
연구 개요
상세 설명
In this research, the investigators will seek to examine the efficacy of using former patients as mentors to newly transplanted patients and its relationship with patient anxiety following discharge as well as the prevention of 30-day readmissions for kidney transplant recipients. The primary hypothesis is that the treatment group of patients who undergo a targeted mentorship program will be better compliant with the discharge instructions and will perform better when compared to the control group who undergoes current routine post-transplantation care. Evidence from this experiment can help advance our understanding of patient-engagement in the continuity of care delivery, decrease patient readmission rates, and improve overall cost utilization.
Methods:
The investigators will conduct a single institution randomized control trial assigning patients getting discharged after a kidney transplant to a treatment group that involves a 30-day mentoring initiative by former transplant patients, and comparing the efficacy with a similar control group. The overall study period will be divided into the following sections, summarized in Figure 1.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Ohio
-
Columbus, Ohio, 미국, 43210
- 모병
- Comprehensive Transplant Center
-
연락하다:
- Kristen Hill, RN
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- any patient who received a kidney transplantation, deceased or living donor, during the study period.
Exclusion Criteria:
- anyone younger than 18 years old or older than 70 years old.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Treatment Arm
Patients assigned to treatment arm will receive standard post-transplantation discharge care that includes weekly follow-up visits and 24-hour access to transplant triage call center.
In addition, they will be matched with a mentor who will conduct 5 meetings with the patients (which includes one video chat meeting, 4 30-minute phone calls) and discuss the following topics related to post-discharge: Medications, Lab Work, Fluid Intake and Adherence to doctor's appointment
|
Phone Conversations on the importance of complying to discharge instructions delivered before discharge
|
|
간섭 없음: Control Arm
Control arm recipient will receive standard post-transplantation discharge care that includes weekly follow-up visits and 24-hour access to transplant triage call center
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
30-day readmissions
기간: 30-days
|
30-days
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Post Transplant Anxiety
기간: 1 Day of Discharge and 30-days after discharge
|
State-Trait Anxiety Inventory (STAI) for Adults
|
1 Day of Discharge and 30-days after discharge
|
|
Preventable Re-admissions
기간: 30-days after day of discharge
|
Re admissions due to missed labs or medications as measured by time of readmission for any readmission that was deemed preventable by physiologic laboratory data, reason for readmission, and primary complaint determined by trained kidney transplantation nurses
|
30-days after day of discharge
|
공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2017H0190
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
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .