Secondary Prevention of Dug-related Problems Through Digital Health
2021년 4월 8일 업데이트: Ana Juanes, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Secondary Prevention of Dug-related Problems Through Patient Empowerment Through Digital Health
The purpose of this study is to evaluate the clinical impact of a program for the secondary prevention of drug-realted problems (DRP) focused on the patient empowerment through Digital Health in patients who visit the Emergency Department (ED) of the Hospital de la Santa Creu i Sant Pau (HSCiSP) for a health problem related to medication in terms of readmissions, revisits and quality of life.
연구 개요
상세 설명
After being infomed about the estudy and potential risks, all patients who meet the eligibility requirements and giving written informed consent, will be randomized.
The project is structured in two consecutive phases.
- st Phase: 3-month randomized pilot study. Patients will be randomized with a 1:1 distribution to be included in the Drug Code Active Patient or DCAP (intervention group) or to receive usual care (control group). The pilot study will confirm whether the proposed methodology is feasible to implement it on a large scale, as well as providing the information necessary to calculate the sample of patients according to the main objective of the study.
- nd Phase: Randomized clinical trial lasting 18 months (6 of which will be recruitment and 12 months follow-up) following the methodology described for the pilot in a larger sample of patients until the calculated sample size is achieved.
연구 유형
중재적
등록 (예상)
200
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Ana Juanes Borrego, Doctor
- 전화번호: 7459 932 91 90 00
- 이메일: ajuanes@santpau.cat
연구 연락처 백업
- 이름: Jesús Ruiz Ramos, Doctor
- 전화번호: 7459 932 91 90 00
- 이메일: jruiz@santpau.cat
연구 장소
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Barcelona, 스페인
- Hospital De La Santa Creu I Sant Pau
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연락하다:
- Ana Juanes, Doctor
- 이메일: ajuanes@santpau.cat
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연락하다:
- Jesús Ruiz, Doctor
- 이메일: jruiz@santpau.cat
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수석 연구원:
- Laia López
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Age greater than or equal to 18 years.
- Visit ED for a DRP caused bu a drug of the ATC groups A, B, C or N.
- Be independent for activities of daily living (equivalent to Barthel 100).
- Have a Chalson Comorbidity Index 2 <= 3.
- Not present cognitive impairment.
- Be directly responsible for pharmacotherapy.
- Have a mobile device compatible with the MyPlan mobile application and access to Wi-Fi or mobile data, enabling the use of the technology platform from home.
Exclusion Criteria:
- Important language barrier.
- Impossibility of carrying out the necessary questionnaires or interviews defined in the methods of this study.
- Mental pathology that makes the autonomous use of technology impossible or that represents a safety problem for the patient according to clinical criteria.
- Patients not residing in the territory who cannot be followed-up later.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Drug Code Active Patient o DCAP
Inclusion in the active group involves the use of MyPlan digital health tool that aims to improve clinical-patient communication, enahnce patient empowerment, improve early detection of side effects and allows professionals to individualize interventions. Patients will receive follow-up by videoconference 48 hours after discharge and in the phase II, at 6 and 12 months after discharge. |
Inclusion in the active group involves the use of MyPlan digital health tool that aims to improve clinical-patient communication, enahnce patient empowerment, improve early detection of side effects and allows professionals to individualize interventions.
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위약 비교기: Standard care
Inclusion in the control group do not involves the use of MyPlan digital health tool. Patients will receive the standard of care. Patients will receive follow-up by videoconference 48 hours after discharge and in the phase II, at 6 and 12 months after discharge. |
Inclusion in the control group do not involves the use of MyPlan digital health tool.
Patients will receive the standard of care.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Clinical impact of a digitial health tool for secondary prevention of DRP focused on patient empowerment.
기간: Baseline, 48h after discharge, 30-day and 90-day after discharge (in phase I, Pilot Trial)
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Change in clinical impact during the follow-up time will be evaluated in terms of number of readmissions, number of revisits and quality of life (based on the result obtained in the EQ-5D-3L51 questionnaire)
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Baseline, 48h after discharge, 30-day and 90-day after discharge (in phase I, Pilot Trial)
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|
Clinical impact of a digitial health tool for secondary prevention of DRP focused on patient empowerment.
기간: Baseline, 48h after discharge, 6-month and 12-month after discharge (in phase II, Clinical Trial)
|
Change in clinical impact during the follow-up time will be evaluated in terms of number of readmissions, number of revisits and quality of life (based on the result obtained in the EQ-5D-3L51 questionnaire)
|
Baseline, 48h after discharge, 6-month and 12-month after discharge (in phase II, Clinical Trial)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Identify, classify, and quantify DRP that cause urgent care in a tertiary hospital in this patient population.
기간: Baseline
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Type of DRP that promotes ED visits characterized according to the three dimensions of the Third Consensus of Granada (Need, Effectiveness and Safety)
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Baseline
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Identify risk factors for ED visits related to DRP
기간: Baseline
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Age, sex, social and familiar environment, blood presure (mmHg), heart frequency (bpm), Hb1Ac (%), pain (visual analog scale), weight (kg) and height (cm), chronic kidney disease, number of drugs at admission and at discharge, number of chronic health problems.
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Baseline
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Identify which groups of drugs are more frequently associated to DRP
기간: Baseline
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Using ATC group classification
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Baseline
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Change in the patient therapeutic adherence
기간: Baseline, 48h after discharge, 30-day and 90-day after discharge (in phase I, Pilot Trial)
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Active days on the MyPlan platform, functionalities used, number of queries made through platform messaging
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Baseline, 48h after discharge, 30-day and 90-day after discharge (in phase I, Pilot Trial)
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Change in the patient therapeutic adherence
기간: Baseline, 48h after discharge, 6-month and 12-month after discharge (in phase II, Clinical Trial)
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Active days on the MyPlan platform, functionalities used, number of queries made through platform messaging
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Baseline, 48h after discharge, 6-month and 12-month after discharge (in phase II, Clinical Trial)
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Mesure therapeutic complexity
기간: Baseline
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Using patient Medication Regimen Complexity Index (pMRCI-S) questionnaire
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Baseline
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Identify predictive factors of a greater capacity for digital empowerment.
기간: Baseline
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Using the CAMBADOS questionnaire
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Baseline
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Measure the usability and satisfaction of patients, caregivers and professionals of the MyPlan digital health tool
기간: 90-day after discharge (in phase I, Pilot Trial)
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Using the TrilemaSalud questionnaire
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90-day after discharge (in phase I, Pilot Trial)
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Measure the usability and satisfaction of patients, caregivers and professionals of the MyPlan digital health tool
기간: 12-month after discharge (in phase II, Clinical Trial)
|
Using the TrilemaSalud questionnaire
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12-month after discharge (in phase II, Clinical Trial)
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Change in the quality of life of patients in the active group
기간: Baseline, 30-day and 90-day after discharge (in phase I, Pilot Trial)
|
Using the EQ-5D-3L51 questionnaire
|
Baseline, 30-day and 90-day after discharge (in phase I, Pilot Trial)
|
|
Change in the quality of life of patients in the active group
기간: Baseline, 6-month and 12-month after discharge (in phase II, Clinical Trial)
|
Using the EQ-5D-3L51 questionnaire
|
Baseline, 6-month and 12-month after discharge (in phase II, Clinical Trial)
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Laia López Vinardell, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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- Baena MI, Fajardo PC, Pintor-Marmol A, Faus MJ, Marin R, Zarzuelo A, Martinez-Olmos J, Martinez-Martinez F. Negative clinical outcomes of medication resulting in emergency department visits. Eur J Clin Pharmacol. 2014 Jan;70(1):79-87. doi: 10.1007/s00228-013-1562-0. Epub 2013 Oct 3.
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- Banerjee J, Conroy S, Cooke MW. Quality care for older people with urgent and emergency care needs in UK emergency departments. Emerg Med J. 2013 Sep;30(9):699-700. doi: 10.1136/emermed-2012-202080. Epub 2012 Dec 18. No abstract available.
- Leendertse AJ, Egberts AC, Stoker LJ, van den Bemt PM; HARM Study Group. Frequency of and risk factors for preventable medication-related hospital admissions in the Netherlands. Arch Intern Med. 2008 Sep 22;168(17):1890-6. doi: 10.1001/archinternmed.2008.3.
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (예상)
2021년 4월 1일
기본 완료 (예상)
2021년 10월 1일
연구 완료 (예상)
2023년 4월 1일
연구 등록 날짜
최초 제출
2021년 3월 18일
QC 기준을 충족하는 최초 제출
2021년 4월 8일
처음 게시됨 (실제)
2021년 4월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 4월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 4월 8일
마지막으로 확인됨
2021년 4월 1일
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Monitor clinical trial will have access to all study data
IPD 공유 기간
Data will be avaliable for monitor during the whole study period
IPD 공유 액세스 기준
All data may be analysed and revised during the whole study period by the monitor and investigators
IPD 공유 지원 정보 유형
- 연구 프로토콜
- 통계 분석 계획(SAP)
- 정보에 입각한 동의서(ICF)
- 임상 연구 보고서(CSR)
- 분석 코드
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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. .
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