Effectiveness of a Standardized Bereavement Intervention in Primary Care

NCT ID: NCT00133263

Last Updated: 2014-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2006-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bereavement Grief

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Primary Bereavement Care

Intervention Type BEHAVIORAL

a standardized bereavement intervention in Primary Care

2

Group Type ACTIVE_COMPARATOR

the current bereavement care in primary care

Intervention Type BEHAVIORAL

the non-standardized bereavement care that usually provided family physicians in primary care

Interventions

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Primary Bereavement Care

a standardized bereavement intervention in Primary Care

Intervention Type BEHAVIORAL

the current bereavement care in primary care

the non-standardized bereavement care that usually provided family physicians in primary care

Intervention Type BEHAVIORAL

Other Intervention Names

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Bereavement Primary Care Bereavement Intervention in Primary Care Grief Intervention in Primary Care The current grief care in primary care

Eligibility Criteria

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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.
Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Health Department of the Basque Government

UNKNOWN

Sponsor Role collaborator

Carlos III Health Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Basque Health Service / Osakidetza

Principal Investigators

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Jesus A. Garcia, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Bilbao, Bizkaia, Spain

Site Status

Countries

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Spain

References

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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. doi: 10.1157/13074293. Spanish.

Reference Type BACKGROUND
PMID: 15871796 (View on PubMed)

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. doi: 10.1016/s0212-6567(01)78779-3. Spanish.

Reference Type BACKGROUND
PMID: 11256097 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9280441 (View on PubMed)

Related Links

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https://www.fisterra.com/guias-clinicas/cuidados-primarios-duelo/

Landa V, García JA. Duelo. Guías Clínicas. Cuidados Primarios de Duelo. 2011. This is a summary in Spanish of the intervention - Primary Bereavement Care - which is used in our project.

Other Identifiers

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200011007

Identifier Type: -

Identifier Source: secondary_id

PI020827

Identifier Type: -

Identifier Source: org_study_id

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