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

This study is currently recruiting participants.
Verified November 2012 by Basque Health Service
Sponsor:
Information provided by (Responsible Party):
Naiara Parraza Diez, Basque Health Service
ClinicalTrials.gov Identifier:
NCT01726244
First received: November 9, 2012
Last updated: March 4, 2013
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Pulmonary Disease, Chronic Obstructive
Heart Failure
 Behavioral: Multidisciplinary Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effectiveness of an Self-care Program in the Prevention of Admissions of Patients With Hospitalizations Potentially Avoidable: Randomized Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Basque Health Service:

Primary Outcome Measures:
  • Readmission rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    in the twelve months following the intervention, according to the electronic record of the hospital


Secondary Outcome Measures:
  • Number of admissions to emergency service or number of visits to general practitioner's office or number of visits to emergency service [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • time until the first admission to the hospital [ Time Frame: it wil be measured at 12 months ] [ Designated as safety issue: No ]
  • time until first visit to general practitioner's office [ Time Frame: it will be measured at 12 months ] [ Designated as safety issue: No ]
  • time until the first visit to emergency service [ Time Frame: it will be measured at 12 months ] [ Designated as safety issue: No ]
  • Health related quality of life through several questionnaires [ Time Frame: At month, 3, 6 and 12 months after discharge ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • HbA1c [ Time Frame: at month, 3, 6 and 12 months ] [ Designated as safety issue: No ]
    glycated hemoglobin

  • Type B natriuretic peptide (BNP), blood pressure [ Time Frame: At month, 3, 6 and 12 months of discharge ] [ Designated as safety issue: No ]
  • APACHE III INDEX, Functional Category of New York Heart Association (NYHA) [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 144
Study Start Date: December 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group
Habitual Clinical Practice
Experimental: 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.
 Behavioral: Multidisciplinary Intervention
Health education sessions consisting in controlling disease and stress asociated to it, and modifying eating habits

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726244

Locations
Spain
Araba Universitary Hospital (Txagorritxu) Recruiting
Vitoria-Gasteiz, Alava, Spain, 01009
Contact: Naiara Parraza, PhD     945007413     naiara.parrazadiez@osakidetza.net    
Sponsors and Collaborators
Basque Health Service
  More Information

No publications provided

Responsible Party: Naiara Parraza Diez, main researcher, Basque Health Service
ClinicalTrials.gov Identifier: NCT01726244     History of Changes
Other Study ID Numbers: AC-01
Study First Received: November 9, 2012
Last Updated: March 4, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Additional relevant MeSH terms:
Chronic Disease
Heart Failure
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Disease Attributes
 Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive

ClinicalTrials.gov processed this record on June 18, 2013