Clinical trial NCT01726244: Self-care Program in the Prevention of Admissions of Patients
Official title: Effectiveness of an Self-care Program in the Prevention of Admissions of Patients With Hospitalizations Potentially Avoidable: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Heart Failure
Lead sponsor: Basque Health Service
Sponsor class: OTHER_GOV
First posted: 2012-11-14
Enrollment: 144
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Readmission rate
timeFrame: 12 months
Secondary outcomes:
measure: Number of admissions to emergency service or number of visits to general practitioner's office or number of visits to emergency service
timeFrame: 12 months
measure: time until the first admission to the hospital
timeFrame: it wil be measured at 12 months
measure: time until first visit to general practitioner's office
timeFrame: it will be measured at 12 months
measure: time until the first visit to emergency service
timeFrame: it will be measured at 12 months
measure: Health related quality of life through several questionnaires
timeFrame: At month, 3, 6 and 12 months after discharge
Other outcomes:
measure: HbA1c
timeFrame: at month, 3, 6 and 12 months
measure: Type B natriuretic peptide (BNP), blood pressure
timeFrame: At month, 3, 6 and 12 months of discharge
measure: APACHE III INDEX, Functional Category of New York Heart Association (NYHA)
timeFrame: 1 day
Locations:
city: Vitoria-Gasteiz
country: Spain
facility: Araba Universitary Hospital (Txagorritxu)
state: Alava
Study officials:
References: