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Self-care Program in the Prevention of Admissions of Patients (AUTOCUID)

4. marts 2013 opdateret af: Naiara Parraza Diez, Basque Health Service

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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

144

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Spanien
    • Alava
      • Vitoria-Gasteiz, Alava, Spanien, 01009

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Control group
Habitual Clinical Practice
Eksperimentel: 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.
Adfærdsmæssigt: Multidisciplinary Intervention
Health education sessions consisting in controlling disease and stress asociated to it, and modifying eating habits

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Readmission rate
Tidsramme: 12 months
in the twelve months following the intervention, according to the electronic record of the hospital
12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of admissions to emergency service or number of visits to general practitioner's office or number of visits to emergency service
Tidsramme: 12 months
12 months
time until the first admission to the hospital
Tidsramme: it wil be measured at 12 months
it wil be measured at 12 months
time until first visit to general practitioner's office
Tidsramme: it will be measured at 12 months
it will be measured at 12 months
time until the first visit to emergency service
Tidsramme: it will be measured at 12 months
it will be measured at 12 months
Health related quality of life through several questionnaires
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
HbA1c
Tidsramme: at month, 3, 6 and 12 months
glycated hemoglobin
at month, 3, 6 and 12 months
Type B natriuretic peptide (BNP), blood pressure
Tidsramme: 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)
Tidsramme: 1 day
1 day

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Basque Health Service

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2012

Primær færdiggørelse (Forventet)

1. marts 2014

Studieafslutning (Forventet)

1. marts 2014

Datoer for studieregistrering

Først indsendt

9. november 2012

Først indsendt, der opfyldte QC-kriterier

13. november 2012

Først opslået (Skøn)

14. november 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

5. marts 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. marts 2013

Sidst verificeret

1. november 2012

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AC-01

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Hjertefejl

Kliniske forsøg med Multidisciplinary Intervention

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Sponsorer og samarbejdspartnere

Medicinske tilstande

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CROs in Uganda

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner