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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01726244
Recruitment Status : Unknown
Verified November 2012 by Naiara Parraza Diez, Basque Health Service.
Recruitment status was:  Recruiting
First Posted : November 14, 2012
Last Update Posted : March 5, 2013
Information provided by (Responsible Party):
Naiara Parraza Diez, Basque Health Service

Brief Summary:

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 or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Heart Failure Behavioral: Multidisciplinary Intervention Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2012
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : March 2014

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Readmission rate [ Time Frame: 12 months ]
    in the twelve months following the intervention, according to the electronic record of the hospital

Secondary Outcome Measures :
  1. 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 ]
  2. time until the first admission to the hospital [ Time Frame: it wil be measured at 12 months ]
  3. time until first visit to general practitioner's office [ Time Frame: it will be measured at 12 months ]
  4. time until the first visit to emergency service [ Time Frame: it will be measured at 12 months ]
  5. Health related quality of life through several questionnaires [ Time Frame: 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.

Other Outcome Measures:
  1. HbA1c [ Time Frame: at month, 3, 6 and 12 months ]
    glycated hemoglobin

  2. Type B natriuretic peptide (BNP), blood pressure [ Time Frame: At month, 3, 6 and 12 months of discharge ]
  3. APACHE III INDEX, Functional Category of New York Heart Association (NYHA) [ Time Frame: 1 day ]

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01726244

Araba Universitary Hospital (Txagorritxu) Recruiting
Vitoria-Gasteiz, Alava, Spain, 01009
Contact: Naiara Parraza, PhD    945007413   
Sponsors and Collaborators
Basque Health Service

Responsible Party: Naiara Parraza Diez, main researcher, Basque Health Service Identifier: NCT01726244     History of Changes
Other Study ID Numbers: AC-01
First Posted: November 14, 2012    Key Record Dates
Last Update Posted: March 5, 2013
Last Verified: November 2012

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