Effectiveness of a Standardized Bereavement Intervention in Primary Care - Full Text View

Sponsor:	Carlos III Health Institute
Collaborator:	Health Department of the Basque Government
Information provided by:	Carlos III Health Institute
ClinicalTrials.gov Identifier:	NCT00133263

Purpose

The purpose of this study is to evaluate the efficacy of "Primary Bereavement Care" (PBC) -a standardized bereavement intervention- delivered by family physicians (FP), in widows.

Condition	Intervention	Phase
Bereavement Grief	Behavioral: Primary Bereavement Care Behavioral: the current bereavement care in primary care	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Effectiveness of "Primary Bereavement Care" (PBC) in Widows: A Cluster Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Bereavement

U.S. FDA Resources

Further study details as provided by Carlos III Health Institute:

Primary Outcome Measures:

Texas Revised Inventory of Grief (TRIG) [ Time Frame: at 3, 9, 15 and 21 months since death ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Grief Experience Inventory (GEI) [ Time Frame: at 3, 9, 15 and 21 months since death ] [ Designated as safety issue: Yes ]
General Health Questionnaire - 28 items (GHQ-28) [ Time Frame: at 3, 9, 15 and 21 months since death ] [ Designated as safety issue: Yes ]
SF-36 Health Profile (SF-36) [ Time Frame: at 3, 9, 15 and 21 months since death ] [ Designated as safety issue: Yes ]

Enrollment:	87
Study Start Date:	January 2001
Study Completion Date:	December 2006
Primary Completion Date:	April 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Behavioral: Primary Bereavement Care a standardized bereavement intervention in Primary Care
2: Active Comparator	Behavioral: the current bereavement care in primary care the non-standardized bereavement care that usually provided family physicians in primary care

Detailed Description:

Nowadays there is little evidence about what is the best bereavement intervention in primary care and each family physician (FP) assists bereaved people in a different way. The death of a loved one is the most stressful life event that can face a person; in fact, bereavement is associated with an increased risk of depression, generalized anxiety and panic disorder, alcohol abuse and use of medications, sudden cardiac events, suicide, and an increased demand for health resources. The FP is the only specialist who -through his position in the health system and in the community- can give emotional support to the bereaved and simultaneously deal with the health problems associated with the process. In response to this, our work group has designed a guide specifically for FP: Primary Bereavement Care (PBC), and is currently testing its efficacy in a randomized controlled study.

Comparison (s): Recently widows attended by FP trained in PBC through seven PBC sessions, compared to recently widows attended by FP not trained in PBC through seven "ordinary" sessions.

Eligibility

Ages Eligible for Study:	up to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Partner death during the last 3 months.

Exclusion Criteria:

Partner death through suicide or AIDS.
Son or daughter death during the last 3 years.
Parent or sibling death the year before.
Alcohol or drug abuse.
Psychotic disorder or dementia.
To be confined to bed
Illiteracy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00133263

Locations

Spain, Bizkaia
Primary Care Research Unit of Bizkaia, Basque Health Service/Osakidetza
Bilbao, Bizkaia, Spain, 48014

Sponsors and Collaborators

Carlos III Health Institute

Health Department of the Basque Government

Investigators

Principal Investigator:

Jesus A. Garcia, MD

Primary Care Research Unit of Bizkaia, Basque Health Service/Osakidetza.

More Information

Additional Information:

Landa V, García JA. Duelo. Guías Clínicas [Internet]. 2007 [cited 2008 Mar 13];7(26). Available from: http://www.fisterra.com/guias2/duelo.asp. This is a summary in Spanish of the intervention - Primary Bereavement Care - which is used in our project. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

In this presentation we explain the rationale of Primary Bereavement Care (PBC) and the PBC general techniques (REFINO), and summarize the project. This link exits the ClinicalTrials.gov site

Publications:

Garcia Garcia JA, Landa Petralanda V, Trigueros Manzano MC, Gaminde Inda I. [Texas revised inventory of grief: adaptation to Spanish, reliability and validity] Aten Primaria. 2005 Apr 30;35(7):353-8. Spanish.

Garcia-Garcia JA, Landa Petralanda V, Trigueros Manzano MC, Gaminde Inda I. [Inventory of experiences in grief (IEG): adaptation to Spanish, reliability and validity] Aten Primaria. 2001 Feb 15;27(2):86-93. Spanish.

Garcia-Garcia JA, Landa Petralanda V, Trigueros Manzano MC, Calvo Aedo P, Gaminde Inda I. [Grief for loss of a spouse: a study with discussion groups in primary care] Aten Primaria. 1996 Nov 30;18(9):475-9. Spanish.

Responsible Party:	Basque Health Service / Osakidetza ( Jesus Angel García García )
Study ID Numbers:	PI020827, 200011007
Study First Received:	August 22, 2005
Last Updated:	January 26, 2010
ClinicalTrials.gov Identifier:	NCT00133263 History of Changes
Health Authority:	Spain: Ministry of Health and Consumption

Keywords provided by Carlos III Health Institute:

Randomized controlled trial
Primary Care

ClinicalTrials.gov processed this record on February 08, 2010