Effectiveness of a Standardized Bereavement Intervention in Primary Care

This study has been completed.
Sponsor:
Collaborator:
Health Department of the Basque Government
Information provided by:
Carlos III Health Institute
ClinicalTrials.gov Identifier:
NCT00133263
First received: August 22, 2005
Last updated: January 26, 2010
Last verified: March 2008
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of "Primary Bereavement Care" (PBC) in Widows: A Cluster Randomized Controlled Trial

Resource links provided by NLM:


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
Experimental: 1 Behavioral: Primary Bereavement Care
a standardized bereavement intervention in Primary Care
Other Names:
  • Bereavement Primary Care
  • Bereavement Intervention in Primary Care
  • Grief Intervention in Primary Care
Active Comparator: 2 Behavioral: the current bereavement care in primary care
the non-standardized bereavement care that usually provided family physicians in primary care
Other Name: The current grief care 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
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:
Publications:
Responsible Party: Jesus Angel García García, Basque Health Service / Osakidetza
ClinicalTrials.gov Identifier: NCT00133263     History of Changes
Other Study ID Numbers: PI020827, 200011007
Study First Received: August 22, 2005
Last Updated: January 26, 2010
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 April 23, 2014