- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01726244
Self-care Program in the Prevention of Admissions of Patients (AUTOCUID)
Effectiveness of an Self-care Program in the Prevention of Admissions of Patients With Hospitalizations Potentially Avoidable: Randomized Clinical Trial
One of the most cost effective intervention is to avoid unnecessary hospitalizations in the national health system. These unnecessary admissions are increasing for several years, reaching rates of over 30% in patients with chronic obstructive pulmonary disease (COPD) or heart failure at two months of hospital discharge. There is scientific evidence suggesting that a multidisciplinary intervention consisting in controling disease and stress associated with disease, and modifying eating habits could reduce the number of hospitalizations due to disease decompensation.
The main objective of the study is to assess the rate of readmissions at year of multidisciplinary intervention in patients with COPD and / or heart failure.
We will select 144 patients who will be randomized to two groups (control and intervention group) and they will be followed for 12 months through 4 visits (1 month, 3 months, 6 months and 12 months of hospital discharge).
Patients assigned to the intervention group will be receive three educational sessions (one of them will be imparted by nursing, another by the nutritionist and the last one by the psychologist). In addition, patients with a BMI <20 and / or> 30 will receive a closer monitoring by the nutritionist).
Patients assigned to the control group will receive usual care in clinical practice.
연구 개요
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Alava
-
Vitoria-Gasteiz, Alava, 스페인, 01009
- 모병
- Araba Universitary Hospital (Txagorritxu)
-
연락하다:
- Naiara Parraza, PhD
- 전화번호: 945007413
- 이메일: naiara.parrazadiez@osakidetza.net
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- COPD
- Heart failure: heart failure in clinically stable with ≥ II degree of NYHA . 1 or more emergency admissions for the same diagnosis in the prior year
Exclusion Criteria:
- Mental states that make difficult the self-care: Class 295, 296, 297, 298, 300, 301, 304 and 316 (schizophrenic disorders, episodic mood, delusional other nonorganic psychosis, anxiety, dissociative and somatoform, personality, alcohol and drug dependencies)
- Congenital respiratory diseases or presence of other obstructive pulmonary diseases
- Patients participating in other research studies.
- Other diseases that can affect patients' medium-term survival
- Moderate to severe cognitive impairment.
공부 계획
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 |
|---|---|
|
간섭 없음: Control group
Habitual Clinical Practice
|
|
|
실험적: Intervention Group
Multidisciplinary intervention consisting in controlling disease and stress associated to it, and modifying eating habits.
A Nurse, nutritionist and a psychologist will be the responsible of these educational sessions.
it will be three educational sessions.
Patients with a BMI lower than 20 or bigger than 30 will be receive a closer follow up by nutritionist.
In addition, patients with a score of 9 or more in the Patients Health Questionnaire-9 questionnaire will be also a closer follow up with the psychologist.
|
Health education sessions consisting in controlling disease and stress asociated to it, and modifying eating habits
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Readmission rate
기간: 12 months
|
in the twelve months following the intervention, according to the electronic record of the hospital
|
12 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of admissions to emergency service or number of visits to general practitioner's office or number of visits to emergency service
기간: 12 months
|
12 months
|
|
|
time until the first admission to the hospital
기간: it wil be measured at 12 months
|
it wil be measured at 12 months
|
|
|
time until first visit to general practitioner's office
기간: it will be measured at 12 months
|
it will be measured at 12 months
|
|
|
time until the first visit to emergency service
기간: it will be measured at 12 months
|
it will be measured at 12 months
|
|
|
Health related quality of life through several questionnaires
기간: At month, 3, 6 and 12 months after discharge
|
COPD Assessment Test (CAT), self efficacy scale in COPD patients, SORT Form-36, Patient Health Questionnaire-9, Minnesota Living with Heart Failure Questionnaire (MLHFQ), Physical Activity Questionnaire (IPAQ), Barthel Index, European heart failure self-care behaviour scale.
|
At month, 3, 6 and 12 months after discharge
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
HbA1c
기간: at month, 3, 6 and 12 months
|
glycated hemoglobin
|
at month, 3, 6 and 12 months
|
|
Type B natriuretic peptide (BNP), blood pressure
기간: At month, 3, 6 and 12 months of discharge
|
At month, 3, 6 and 12 months of discharge
|
|
|
APACHE III INDEX, Functional Category of New York Heart Association (NYHA)
기간: 1 day
|
1 day
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- AC-01
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. .