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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Alava
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Vitoria-Gasteiz, Alava, Spanien, 01009
- Rekrytering
- Araba Universitary Hospital (Txagorritxu)
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Kontakt:
- Naiara Parraza, PhD
- Telefonnummer: 945007413
- E-post: naiara.parrazadiez@osakidetza.net
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Inget ingripande: Control group
Habitual Clinical Practice
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Experimentell: 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.
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Health education sessions consisting in controlling disease and stress asociated to it, and modifying eating habits
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Readmission rate
Tidsram: 12 months
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in the twelve months following the intervention, according to the electronic record of the hospital
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12 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Number of admissions to emergency service or number of visits to general practitioner's office or number of visits to emergency service
Tidsram: 12 months
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12 months
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time until the first admission to the hospital
Tidsram: it wil be measured at 12 months
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it wil be measured at 12 months
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time until first visit to general practitioner's office
Tidsram: it will be measured at 12 months
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it will be measured at 12 months
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time until the first visit to emergency service
Tidsram: it will be measured at 12 months
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it will be measured at 12 months
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Health related quality of life through several questionnaires
Tidsram: At month, 3, 6 and 12 months after discharge
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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.
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At month, 3, 6 and 12 months after discharge
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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HbA1c
Tidsram: at month, 3, 6 and 12 months
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glycated hemoglobin
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at month, 3, 6 and 12 months
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Type B natriuretic peptide (BNP), blood pressure
Tidsram: At month, 3, 6 and 12 months of discharge
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At month, 3, 6 and 12 months of discharge
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APACHE III INDEX, Functional Category of New York Heart Association (NYHA)
Tidsram: 1 day
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1 day
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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- AC-01
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