Self-care Program in the Prevention of Admissions of Patients

NCT ID: NCT01726244

Last Updated: 2013-03-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2014-03-31

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.

Conditions

Pulmonary Disease, Chronic Obstructive; Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control group

Habitual Clinical Practice

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Multidisciplinary Intervention

Intervention Type: BEHAVIORAL

Health education sessions consisting in controlling disease and stress asociated to it, and modifying eating habits

Interventions

Multidisciplinary Intervention

Health education sessions consisting in controlling disease and stress asociated to it, and modifying eating habits

Intervention Type: BEHAVIORAL

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Basque Health Service

OTHER_GOV

Sponsor Role: lead

Responsible Party

Naiara Parraza Diez

main researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Araba Universitary Hospital (Txagorritxu)

Vitoria-Gasteiz, Alava, Spain

Site Status: RECRUITING

Countries

Spain

Facility Contacts

Naiara Parraza, PhD

Role: primary

naiara.parrazadiez@osakidetza.net

945007413

Other Identifiers

AC-01

Identifier Type: -

Identifier Source: org_study_id