- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01965392
Efficiency of an Educational Program for Informal Caregivers of Hospitalized, Dependent Patients: Cluster Randomised Trial
October 15, 2013 updated by: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
The aim was to assess whether nursing interventions based on Health Educational Programs for primary informal caregivers of dependent patients may improve their quality of life, decreasing emotional burden and increasing caregiving knowledge, in order to better meet patients' basic needs.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
151
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Primary informal caregivers of dependent patients, admitted in 30 hospital units, with expected hospital stays of at least one week. A dependent patient is understood to require the aid of someone else in order to carry out basic daily activities.
Exclusion Criteria:
- caregivers with cognitive deficits that could be an obstacle for adequate verbal understanding, illiteracy, persons taking part in other clinical trials or who had taken part in similar workshops in the previous two years, as well as health professionals.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: healtn education
one group received an educational program
|
'Health education intervention'
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
life quality
Time Frame: Data were evaluated with an average one month after discharge, a maximum in September 2009
|
Data were evaluated with an average one month after discharge, a maximum in September 2009
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Caregiver´s burden
Time Frame: Data were evaluated with an average one month after discharge, a maximum in September 2009
|
Data were evaluated with an average one month after discharge, a maximum in September 2009
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
October 7, 2013
First Submitted That Met QC Criteria
October 15, 2013
First Posted (Estimate)
October 18, 2013
Study Record Updates
Last Update Posted (Estimate)
October 18, 2013
Last Update Submitted That Met QC Criteria
October 15, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ESCPD-2010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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