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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01786083
Other study ID # 070489
Secondary ID
Status Completed
Phase N/A
First received February 1, 2013
Last updated February 7, 2013
Start date September 2007
Est. completion date July 2011

Study information

Verified date February 2013
Source Jordi Gol i Gurina Foundation
Contact n/a
Is FDA regulated No
Health authority Spain: Departament de Salut de la Generalitat de Catalunya
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of the Problem Solving Technique (PST) in reducing symptoms of anxiety and depression among primary caregivers of chronically ill patients.

And also to describe and evaluate the process carried out by nurses when implementing the PST as a useful tool for care for family caregivers.


Description:

Background: In Spain, home care for the chronically ill and their family caregivers should be a priority in health and social policies due to the aging of the population and the progressive increase in dependent individuals. In our case, 88% of healthcare within dependency care is provided by the family and only 12% by health professionals. The family requires comprehensive and multidisciplinary ongoing care, in which the primary healthcare nurse plays a leading role. One of the areas involved is home-based nursing and counselling for family caregivers, in order to improve the quality of the care provided and to prevent issues arising that may adversely affect the caregiver's life.

Method: This is a research-action study with a mixed analysis methodology. Quantitative analysis was used to evaluate the effectiveness of the Problem Solving Technique in reducing symptoms of anxiety and depression among family caregivers. The clinical trial involved a control and experimental group and pre-post intervention measurements, using the Goldberg scale of anxiety and depression. The sample consisted of 122 caregivers who presented one of these positive subscales. The technique's application process was evaluated for the qualitative analysis, with a content analysis of the records of 10 nurses performing the experimental intervention.


Recruitment information / eligibility

Status Completed
Enrollment 122
Est. completion date July 2011
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

Caregivers of chronically ill patients included in the ATDOM programme, who at the time of the intervention had a positive score on the Goldberg scale for anxiety and/or depression.

Exclusion Criteria:

Professional caregivers

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Application of Problem Solving Technique


Locations

Country Name City State
Spain Primary Health Centers, Tarragona Province Tarragona

Sponsors (2)

Lead Sponsor Collaborator
Jordi Gol i Gurina Foundation Preventive Services and Health Promotion Research Network

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Anxiety Goldberg Scale Two years No
Primary Depression Goldberg scale Two years No
Primary perceived wellbeing levels Primary caregiver's Emotional health(NOC 2506) two years No
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