Self-care Program in the Prevention of Admissions of Patients

NCT01726244 | Unknown

• 1 other identifier: AC-01
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Readmission rate

  in the twelve months following the intervention, according to the electronic record of the hospital

  12 months

Secondary Outcomes (5)

• Number of admissions to emergency service or number of visits to general practitioner's office or number of visits to emergency service

  12 months

• time until the first admission to the hospital

  it wil be measured at 12 months

• time until first visit to general practitioner's office

  it will be measured at 12 months

• time until the first visit to emergency service

  it will be measured at 12 months

• Health related quality of life through several questionnaires

  At month, 3, 6 and 12 months after discharge

Other Outcomes (3)

• HbA1c

  at month, 3, 6 and 12 months

• Type B natriuretic peptide (BNP), blood pressure

  At month, 3, 6 and 12 months of discharge

• APACHE III INDEX, Functional Category of New York Heart Association (NYHA)

  1 day

Study Arms (2)

Control group

NO INTERVENTION

Habitual Clinical Practice

Intervention Group

EXPERIMENTAL

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

Interventions

Multidisciplinary Intervention BEHAVIORAL

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

Intervention Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Basque Health Service: lead

Study Sites (1)

Araba Universitary Hospital (Txagorritxu)

Vitoria-Gasteiz, Alava, 01009, Spain

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Heart Failure

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: main researcher

Study Record Dates

• First Submitted: November 9, 2012
• First Posted: November 14, 2012
• Study Start: December 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 5, 2013

Record last verified: 2012-11

Locations

ES (1)