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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Alava
-
Vitoria-Gasteiz, Alava, Espagne, 01009
- Recrutement
- Araba Universitary Hospital (Txagorritxu)
-
Contact:
- Naiara Parraza, PhD
- Numéro de téléphone: 945007413
- E-mail: naiara.parrazadiez@osakidetza.net
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Aucune intervention: Control group
Habitual Clinical Practice
|
|
|
Expérimental: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Readmission rate
Délai: 12 months
|
in the twelve months following the intervention, according to the electronic record of the hospital
|
12 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of admissions to emergency service or number of visits to general practitioner's office or number of visits to emergency service
Délai: 12 months
|
12 months
|
|
|
time until the first admission to the hospital
Délai: it wil be measured at 12 months
|
it wil be measured at 12 months
|
|
|
time until first visit to general practitioner's office
Délai: it will be measured at 12 months
|
it will be measured at 12 months
|
|
|
time until the first visit to emergency service
Délai: it will be measured at 12 months
|
it will be measured at 12 months
|
|
|
Health related quality of life through several questionnaires
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
HbA1c
Délai: at month, 3, 6 and 12 months
|
glycated hemoglobin
|
at month, 3, 6 and 12 months
|
|
Type B natriuretic peptide (BNP), blood pressure
Délai: 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)
Délai: 1 day
|
1 day
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- AC-01
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .