Self-care Program in the Prevention of Admissions of Patients (AUTOCUID)
Recruitment status was Recruiting
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.
Pulmonary Disease, Chronic Obstructive
Behavioral: Multidisciplinary Intervention
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Effectiveness of an Self-care Program in the Prevention of Admissions of Patients With Hospitalizations Potentially Avoidable: Randomized Clinical Trial|
- Readmission rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]in the twelve months following the intervention, according to the electronic record of the hospital
- Number of admissions to emergency service or number of visits to general practitioner's office or number of visits to emergency service [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- time until the first admission to the hospital [ Time Frame: it wil be measured at 12 months ] [ Designated as safety issue: No ]
- time until first visit to general practitioner's office [ Time Frame: it will be measured at 12 months ] [ Designated as safety issue: No ]
- time until the first visit to emergency service [ Time Frame: it will be measured at 12 months ] [ Designated as safety issue: No ]
- Health related quality of life through several questionnaires [ Time Frame: At month, 3, 6 and 12 months after discharge ] [ Designated as safety issue: No ]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.
- HbA1c [ Time Frame: at month, 3, 6 and 12 months ] [ Designated as safety issue: No ]glycated hemoglobin
- Type B natriuretic peptide (BNP), blood pressure [ Time Frame: At month, 3, 6 and 12 months of discharge ] [ Designated as safety issue: No ]
- APACHE III INDEX, Functional Category of New York Heart Association (NYHA) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
No Intervention: Control group
Habitual Clinical Practice
Experimental: 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.
Behavioral: Multidisciplinary Intervention
Health education sessions consisting in controlling disease and stress asociated to it, and modifying eating habits
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726244
|Araba Universitary Hospital (Txagorritxu)||Recruiting|
|Vitoria-Gasteiz, Alava, Spain, 01009|
|Contact: Naiara Parraza, PhD 945007413 firstname.lastname@example.org|