Self-care Program in the Prevention of Admissions of Patients

Heart Failure Clinical Trial

— AUTOCUID  

Official title:

Effectiveness of an Self-care Program in the Prevention of Admissions of Patients With Hospitalizations Potentially Avoidable: Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01726244
• Other study ID #: AC-01
• Status: Recruiting
• Phase: N/A
• First received: November 9, 2012
• Last updated: March 4, 2013
• Start date: December 2012
• Est. completion date: March 2014

Study information

• Verified date: November 2012
• Source: Basque Health Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Disease
• Heart Failure
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Multidisciplinary Intervention
Health education sessions consisting in controlling disease and stress asociated to it, and modifying eating habits

Locations

Country	Name	City	State
Spain	Araba Universitary Hospital (Txagorritxu)	Vitoria-Gasteiz	Alava

Sponsors (1)

Lead Sponsor	Collaborator
Basque Health Service

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	HbA1c	glycated hemoglobin	at month, 3, 6 and 12 months	No
Other	Type B natriuretic peptide (BNP), blood pressure		At month, 3, 6 and 12 months of discharge	No
Other	APACHE III INDEX, Functional Category of New York Heart Association (NYHA)		1 day	No
Primary	Readmission rate	in the twelve months following the intervention, according to the electronic record of the hospital	12 months	No
Secondary	Number of admissions to emergency service or number of visits to general practitioner's office or number of visits to emergency service		12 months	No
Secondary	time until the first admission to the hospital		it wil be measured at 12 months	No
Secondary	time until first visit to general practitioner's office		it will be measured at 12 months	No
Secondary	time until the first visit to emergency service		it will be measured at 12 months	No
Secondary	Health related quality of life through several questionnaires	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	No