Efficiency of an Educational Program for Informal Caregivers of Hospitalized, Dependent Patients: Cluster Randomised Trial
Primary Purpose
Dependence, Dementias
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Health education intervention
Sponsored by

About this trial
This is an interventional treatment trial for Dependence, Dementias
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
healtn education
Arm Description
one group received an educational program
Outcomes
Primary Outcome Measures
life quality
Secondary Outcome Measures
Caregiver´s burden
Full Information
NCT ID
NCT01965392
First Posted
October 7, 2013
Last Updated
October 15, 2013
Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
1. Study Identification
Unique Protocol Identification Number
NCT01965392
Brief Title
Efficiency of an Educational Program for Informal Caregivers of Hospitalized, Dependent Patients: Cluster Randomised Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dependence, Dementias
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
151 (Actual)
8. Arms, Groups, and Interventions
Arm Title
healtn education
Arm Type
Experimental
Arm Description
one group received an educational program
Intervention Type
Other
Intervention Name(s)
Health education intervention
Intervention Description
'Health education intervention'
Primary Outcome Measure Information:
Title
life quality
Time Frame
Data were evaluated with an average one month after discharge, a maximum in September 2009
Secondary Outcome Measure Information:
Title
Caregiver´s burden
Time Frame
Data were evaluated with an average one month after discharge, a maximum in September 2009
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
Efficiency of an Educational Program for Informal Caregivers of Hospitalized, Dependent Patients: Cluster Randomised Trial
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