NCT01965392

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2009

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 18, 2013

Completed
Last Updated

October 18, 2013

Status Verified

October 1, 2013

Enrollment Period

9 months

First QC Date

October 7, 2013

Last Update Submit

October 15, 2013

Conditions

Dependence, Dementias

Outcome Measures

Primary Outcomes (1)

  • life quality

    Data were evaluated with an average one month after discharge, a maximum in September 2009

Secondary Outcomes (1)

  • Caregiver´s burden

    Data were evaluated with an average one month after discharge, a maximum in September 2009

Study Arms (1)

healtn education

EXPERIMENTAL

one group received an educational program

Other: Health education intervention

Interventions

Health education interventionOTHER

'Health education intervention'

healtn education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2013

First Posted

October 18, 2013

Study Start

March 1, 2009

Primary Completion

December 1, 2009

Study Completion

March 1, 2010

Last Updated

October 18, 2013

Record last verified: 2013-10