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Effectiveness of a Standardized Bereavement Intervention in Primary Care. - Article


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Bereavement

 




Clinical Trial: Effectiveness of a Standardized Bereavement Intervention in Primary Care.

This study is no longer recruiting patients.

Sponsors and Collaborators: Carlos III Health Institute
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
 Behavior: Primary Bereavement Care
Phase III

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Official Title: Effectiveness of "Primary Bereavement Care" (PBC) in Widows: A Cluster Randomized Controlled Trial.

Further Study Details: 
Primary Outcomes: Texas Revised Inventory of Grief (TRIG); Grief Experience Inventory (GEI); General Health Questionnaire - 28 items (GHQ-28); SF-36 Health Profile (SF-36); all the primary outcomes are assessed at 3, 9, 15 and 21 months since death.
Secondary Outcomes: Criteria of Complicated Grief at 13 months since death; Inventory of Complicated Grief - Revised (ICG-R) at 21 months since death.
Expected Total Enrollment:  98

Study start: January 2001;  Study completion: December 2006
Last follow-up: February 2006;  Data entry closure: May 2006

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
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.

Location Information


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

Study chairs or principal investigators

Jesus A. Garcia, MD,  Principal Investigator,  Primary Care Research Unit of Bizkaia, Basque Health Service/Osakidetza.   

More Information

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.

Study ID Numbers:  PI020827; 200011007
Last Updated:  August 22, 2005
Record first received:  August 22, 2005
ClinicalTrials.gov Identifier:  NCT00133263
Health Authority: Spain: Ministry of Health and Consumption
ClinicalTrials.gov processed this record on 2005-09-13

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Page Updated: September 6, 2005
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