Effectiveness of a Standardized Bereavement Intervention in Primary Care

NCT00133263 | Completed Phase 3

• 2 other identifiers: PI020827200011007
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bereavement; Grief

Keywords

Randomized controlled trial; Primary Care

Outcome Measures

Primary Outcomes (1)

• Texas Revised Inventory of Grief (TRIG)

  at 3, 9, 15 and 21 months since death

Secondary Outcomes (3)

• Grief Experience Inventory (GEI)

  at 3, 9, 15 and 21 months since death

• General Health Questionnaire - 28 items (GHQ-28)

  at 3, 9, 15 and 21 months since death

• SF-36 Health Profile (SF-36)

  at 3, 9, 15 and 21 months since death

Study Arms (2)

1

EXPERIMENTAL

Behavioral: Primary Bereavement Care

2

ACTIVE COMPARATOR

Behavioral: the current bereavement care in primary care

Interventions

Primary Bereavement Care BEHAVIORAL

a standardized bereavement intervention in Primary Care

Also known as: Bereavement Primary Care, Bereavement Intervention in Primary Care, Grief Intervention in Primary Care

1

the current bereavement care in primary care BEHAVIORAL

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

Also known as: The current grief care in primary care

2

Eligibility Criteria

• Age: Up to 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Partner death during the last 3 months.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carlos III Health Institute: lead
• Health Department of the Basque Government: collaborator

Study Sites (1)

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

Bilbao, Bizkaia, 48014, Spain

Location

Related Publications (3)

• 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.

  PMID: 15871796 BACKGROUND

• 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.

  PMID: 11256097 BACKGROUND

• 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.

  PMID: 9280441 BACKGROUND

Related Links

• 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.

MeSH Terms

Interventions

Primary Health Care

Intervention Hierarchy (Ancestors)

Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Jesus A. Garcia, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: August 22, 2005
• First Posted: August 23, 2005
• Study Start: January 1, 2001
• Primary Completion: April 1, 2005
• Study Completion: December 1, 2006
• Last Updated: July 10, 2014

Record last verified: 2008-03

Locations

ES (1)