Self-care Program in the Prevention of Admissions of Patients (AUTOCUID)
Primary Purpose
Pulmonary Disease, Chronic Obstructive, Heart Failure
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Multidisciplinary Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Pulmonary Disease, Chronic Obstructive
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.
Sites / Locations
- Araba Universitary Hospital (Txagorritxu)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Intervention Group
Arm Description
Habitual Clinical Practice
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.
Outcomes
Primary Outcome Measures
Readmission rate
in the twelve months following the intervention, according to the electronic record of the hospital
Secondary Outcome Measures
Number of admissions to emergency service or number of visits to general practitioner's office or number of visits to emergency service
time until the first admission to the hospital
time until first visit to general practitioner's office
time until the first visit to emergency service
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01726244
Brief Title
Self-care Program in the Prevention of Admissions of Patients
Acronym
AUTOCUID
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
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
March 2014 (Anticipated)
Study Completion Date
March 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Basque Health Service
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive, Heart Failure
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Habitual Clinical Practice
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Multidisciplinary Intervention
Intervention Description
Health education sessions consisting in controlling disease and stress asociated to it, and modifying eating habits
Primary Outcome Measure Information:
Title
Readmission rate
Description
in the twelve months following the intervention, according to the electronic record of the hospital
Time Frame
12 months
Secondary Outcome Measure Information:
Title
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
Title
time until the first admission to the hospital
Time Frame
it wil be measured at 12 months
Title
time until first visit to general practitioner's office
Time Frame
it will be measured at 12 months
Title
time until the first visit to emergency service
Time Frame
it will be measured at 12 months
Title
Health related quality of life through several questionnaires
Description
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.
Time Frame
At month, 3, 6 and 12 months after discharge
Other Pre-specified Outcome Measures:
Title
HbA1c
Description
glycated hemoglobin
Time Frame
at month, 3, 6 and 12 months
Title
Type B natriuretic peptide (BNP), blood pressure
Time Frame
At month, 3, 6 and 12 months of discharge
Title
APACHE III INDEX, Functional Category of New York Heart Association (NYHA)
Time Frame
1 day
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Araba Universitary Hospital (Txagorritxu)
City
Vitoria-Gasteiz
State/Province
Alava
ZIP/Postal Code
01009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naiara Parraza, PhD
Phone
945007413
Email
naiara.parrazadiez@osakidetza.net
12. IPD Sharing Statement
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Self-care Program in the Prevention of Admissions of Patients
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