Condition category
Respiratory
Date applied
21/08/2009
Date assigned
18/09/2009
Last edited
16/10/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
We are carrying out an educational program before hospital discharge in patients hospitalised with community-acquired pneumonia. Our goal is decrease additional healthcare visits and rehospitalisation within 30 days of hospital discharge. We also want to look at the time to return to activities of daily living, degree of satisfaction and achievement of the objectives of the educational program.

Who can participate?
Adult patients aged 18 years and over, diagnosed with community-acquired pneumonia and requiring hospitalisation.

What does the study involve?
Participants will be randomly allocated to receive either conventional health information or the new educational program before hospital discharge. Patient and family or caregiver receive the educational program in two sessions each about 30-45 minutes long and receive an information leaflet about self-management. Prior to hospital discharge and 30 and 90 days after hospitalisation we will invite participants to answer a survey about their use of healthcare services and the educational program or conventional health information.

What are the possible benefits and risks of participating?
Patients in the conventional health information group receive health information according to standard clinical practice. Patients in the educational program group will have an opportunity to receive individual discharge planning to improve knowledge, skills and attitudes about self-management of community-acquired pneumonia. Information obtained from this study may help improve health education in patients hospitalized with community-acquired pneumonia. By taking part in this study there are no risks of physical injury or harm.

Where is the study run from?
Institute of Biomedical Investigations of Bellvitge (Institut d'Investigació Biomèdica de Bellvitge) (IDIBELL) (Spain).

When is the study starting and how long is it expected to run for?
The study started in November 2011 and will run until October 2014.

Who is funding the study?
Institute of Biomedical Investigations of Bellvitge (Institut d'Investigació Biomèdica de Bellvitge) (IDIBELL) (Spain).

Who is the main contact?
Mr Jordi Adamuz Tomás
Jordi.Adamuz@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Mr Jordi Adamuz Tomás

ORCID ID

Contact details

Servei de Malalties Infeccioses (Pl.12)
C/Feixa Llarga s/n
Barcelona
08907
Spain
+34 (0) 610 32 92 37
Jordi.Adamuz@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EDU001NEUM

Study information

Scientific title

Impact of an EDUcational program in the management of Community-Acquired Pneumonia: a prospective randomised controlled trial

Acronym

EDUCAP

Study hypothesis

1. Patients admitted with diagnosis of community-acquired pneumonia who receive the health education program will have a significantly decreased healthcare resource utilisation during the month after discharge: readmissions and consultations to primary care and emergency department
2. The satisfaction degree with the information to discharge in the intervention group will be higher than the control group
3. Patients who receive the educational program will have a decreased time to return to normal activities than the control group
4. Patients receiving the education program will achieve the objectives of the program

On 05/09/2014 the following changes were made to the trial record:
1. The acronym was changed from IEPMCAP to EDUCAP
2. The study design was changed from 'Prospective randomised controlled trial' to 'Prospective randomised multicenter controlled trial'
3. The anticipated start date was changed from 05/10/2009 to 01/01/2011
4. The anticipated end date was changed from 29/07/2011 to 31/10/2014
5. The target number of participants was changed from '182 participants in each group (total = 364)' to '102 participants in each group (total = 204)'

Ethics approval

Clinical Research Ethics Committee of Hospital Universitari de Bellvitge, 08/10/2009, ref: AC064/09

Study design

Prospective randomised multicenter controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Community-acquired pneumonia

Intervention

Patients will be randomly assigned to receive the educational program during hospitalisation to improve their own understanding of the disease and self-care management at home. The control group will receive the conventional health education.

The educative program is based in the planning model of health educational program (PRECEDE). The nurse will carry out the educational program to the intervention group. The patient and family or caregiver will receive the educational program. The duration is approximately 30 - 45 minutes and the patient will receive the information leaflet. The objectives of the educational program are: improve the hydration of the patient, maintain a good disease control and improve the treatment adherence, balanced diet, progressive physical activity and smoking and alcohol gradual decline.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Epidemiological, clinical and evolutive characteristics during the admission
2. Healthcare resources utilisation (readmissions and consultations to primary care and emergency department) within 30 days subsequent to discharge

We will conduct a complete medical history to obtain epidemiological, clinical and evolutionary variables during the hospitalisation. To achieve the variables related to the healthcare resource utilisation, all patients will be followed up a month after discharge. All variables will be collected in a Statistical Package for the Social Sciences (SPSS) database.

Secondary outcome measures

1. Patient satisfaction
2. Time to return to normal activities
3. Intermediate objectives of the educational program

To achieve the variables all patients will be followed up a month after discharge. At 3 months, we also will assess the educational program through a telephone call. All variables will be collected in a Statistical Package for the Social Sciences (SPSS) database.

Overall trial start date

01/11/2011

Overall trial end date

31/10/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult patients (aged 18 years and over), either sex
2. Diagnosed with community-acquired pneumonia
3. Requiring hospitalisation in the Infectious Diseases and Respiratory Departments of Hospital Universitari de Bellvitge

Updated 05/09/2014:
3. Requiring hospitalisation in the Infectious Disease or Respiratory Disease Departments of Hospital Universitari de Bellvitge, Respiratory Disease Department or Home-care Service of Hospital Clínic de Barcelona and Respiratory Disease or Internal Medicine Departments of Hospital Universitari Arnau de Vilanova de Lleida

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

102 participants in each group (total = 204)

Participant exclusion criteria

1. Derived from a nursing home or extended care facility
2. Cognitive deficit
3. Do not understand Spanish or Catalan languages
4. No signed informed consent

Added 05/09/2014:
5. Immunocompromised patients

Recruitment start date

01/11/2011

Recruitment end date

31/10/2014

Locations

Countries of recruitment

Spain

Trial participating centre

Servei de Malalties Infeccioses (Pl.12)
Barcelona
08907
Spain

Sponsor information

Organisation

Institute of Biomedical Investigations of Bellvitge (Institut d'Investigació Biomèdica de Bellvitge) (IDIBELL) (Spain)

Sponsor details

c/o Jordi Adamuz Tomás
Servei de Malalties Infeccioses (Pl.12)
C/Feixa Llarga s/n
Barcelona
08907
Spain
+34 (0) 610 32 92 37
jadamuz@bellvitgehospital.cat

Sponsor type

Hospital/treatment centre

Website

http://www.bellvitgehospital.cat/

Funders

Funder type

Hospital/treatment centre

Funder name

Institute of Biomedical Investigations of Bellvitge (Institut d'Investigació Biomèdica de Bellvitge) (IDIBELL) (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26460907

Publication citations

Additional files

Editorial Notes

16/10/2015: Added publication reference.