CONNECARE-Assuta-Case Study 2
Integrated Personalized Connected Care and Preventive Patient-centred Intervention for Complex Chronic Patients Undergoing Elective Major Surgical Procedures
The European Union's Horizon 2020 project issued a Call for Action [1] in December 2013 to design, develop, disseminate and evaluate new IT technologies for use in integrative treatment processes, with emphasis on complex adult patient. Assuta Hospital submitted a proposal for this call, as part of a broad consortium of 10 participants from various European countries.
The CONNECARE consortium has formulated a general model for integrative treatment, and is currently in the technological development stages, to create a smart (supportive decision) and adaptive system that supports integrative treatment processes both in the hospital and in the community for personalized treatment in complex chronic patients. The development includes a significant integrative component of self-care management by the patient and / or the primary caregiver.
Following the completion of the technological development, clinical trials will be held in four organizations throughout Europe - Assuta Hospital in Ashdod in cooperation with the Maccabi community in Ashdod, two centers in Catalonia and the Groningen region in the Netherlands. The purpose of the studies is to assess the impact of the implementation of the model, processes and digital tools that will be built during the project.
연구 개요
상세 설명
The intervention in this study consists of three parts:
- Empowering the patient to self-manage his or her health by using applications for smart devices.
- Intensive pre-habilitation plan with close monitoring during the month prior to surgery.
- Integrative treatment in the community, which includes a close followup with a coordinating nurse for three months after discharge from the hospital.
The study protocol:
- Recruitment of participants after scheduling a major elective surgery, explanation of the study and signing the consent form.
- Evaluation process for the patient, using valid questionnaires, in order to determine the baseline level at the entrance to the study.
- Distribution of research kit and related accessories and training.
- Close monitoring during pre habilitation plan for a month prior to surgery.
- Reassessment of the patient after the surgery and before discharge from the hospital.
- Close monitoring during three months in the community after discharge from the hospital and use of the research kit.
- Reassessment of the patient at the exit of the study.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- All Maccabi members who were scheduled for a major elective surgery
- Age over 65
- Living in a home and not in a nursing home
- Anesthesiologist ASA score evaluation of levels 2 or 3 only
- Diagnosis of at least one chronic disease of the following - COPD, cardiovascular disease, diabetes, hypertension, cancer or obesity.
- The patient and / or the main caregiver speak Hebrew, English or Russian
- The patient or primary caregiver has a password to the Maccabi Online website
- The patient and / or the primary caregiver have basic technological knowledge in the use of the applications
- The patient has wireless Internet access at home (via Wifi or through a cellular connection)
Exclusion Criteria:
- Patients with cognitive or dementia problems
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Intervention group
Implementing the Connecare system to support integrated care for complex patients who are plan to undergo a major elective surgery in Assuta Ashdod and are discharged back to the community with an emphasis on Connecare self managment system for the patient and close follow up and coordination of all of the medical, health and social care in the community for two periods of time: (1) Pre habilitation plan for a month prior to surgery (2) a period of 3 months post discharge.
|
The CONNECARE SMS will rely on a hybrid solution that, besides being autonomous (the patient may use the SMS to monitor and access to her/his data and information), has also a collaborative component (through the interaction with the SACM) to allow participation by clinicians and to provide feedback to them.
In so doing, the patient may control her/his activity, receiving recommendations to improve the treatment and to be encouraged in following it.
|
|
간섭 없음: No Intervention: Matched control group
The control group will be selected from Maccabi's database and will be patients who are matched 1:1 with the intervention sample and live in another community similar to Ashdod in socioeconomic characteristics who undergo the same elective major surgery in other hospitals
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Re-Hospitalizations and emergency room visits in the short term after discharge from the hospital
기간: One month
|
Number of hospitalizations and emergency room visits after discharge
|
One month
|
|
Re-Hospitalizations and emergency room visits in the long term after discharge from the hospital
기간: One year
|
Number of hospitalizations and emergency room visits after discharge
|
One year
|
|
Length of hospitalization
기간: Less then one month
|
In days
|
Less then one month
|
|
Length of hospitalization after surgery and complications during and after hospitalization
기간: Less then one month
|
Less then one month
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Compliance with the assignments in the discharge program guidelines
기간: One year
|
At the time of discharge from the hospital, the patient receives a list of tasks to be performed as part of the release letter.
We would like to know how many out of this tasks were carried out
|
One year
|
|
Community health services use
기간: One year
|
Number of appointments made by the patient during the follow up time for primary physician, professionals, laboratory tests and imaging, physiotherapy and nutritionist.
|
One year
|
|
Evaluation of usability of the technology systems developed
기간: One year
|
Using questionnaires for nurses and patients to express their opinion on the use of the technology systems in the project and how much these systems assisted them
|
One year
|
|
Cost-benefits evaluation for the intervention
기간: One year
|
Economic evaluation of tests and services saved as a result of active and orderly monitoring of the patient
|
One year
|
|
Assessment of satisfaction of patients from all the projects components (The follow up and the technology systems)
기간: One year
|
Using satisfaction questionnaires to be passed at the end of the study
|
One year
|
|
Assessment of satisfaction of medical staff from all the projects components (The follow up and the technology systems)
기간: One year
|
Using satisfaction questionnaires to be passed at the end of the study
|
One year
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Bella Azaria, Doctor, Assuta Medical Center
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 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. .