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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
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dependence, Dementias

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    October 7, 2013
    Last Updated
    October 15, 2013
    Sponsor
    Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
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    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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