Self-care Program in the Prevention of Admissions of Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Pulmonary Disease, Chronic Obstructive, Heart Failure

Intervention / Treatment
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* Behavioral: Multidisciplinary Intervention


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Habitual Clinical Practice | |
| Experimental: Intervention Group<br>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<br>* Health education sessions consisting in controlling disease and stress asociated to it, and modifying eating habits<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission rate | in the twelve months following the intervention, according to the electronic record of the hospital | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 |