NCT02065427

Brief Summary

The purpose of this study is to determine wether a multi-factor intervention involving the primary caregiver of a dependent patient, with the goal of improving his or her social and family support and carried out by the professionals of the patient's regular PHCT, will decrease the burden and increase quality of life for the primary caregiver.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
282

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 19, 2014

Completed
Last Updated

February 19, 2014

Status Verified

February 1, 2014

Enrollment Period

8 months

First QC Date

February 16, 2014

Last Update Submit

February 16, 2014

Conditions

Dependency Burden

Keywords

CaregiverBurdenSocial supportPrimary health CareHome CareIntervention

Outcome Measures

Primary Outcomes (1)

  • Score in Zarit's short version test for caregiver's burden

    Difference in Zarit's score in the primary caregiver for a dependent patient before and after iintervention

    6 months

Secondary Outcomes (1)

  • Score in caregivers social support (Medical Outcomes Study), (MOS)

    6 months

Other Outcomes (1)

  • Score in caregiver reported quality of life (SF-12)

    6 months

Study Arms (2)

Social support

EXPERIMENTAL

Social support intervention Intervention is performed by the health professionals working at the primary health care team responsible for the patient, and consisits of the following components: a) PHCT professionals: standardized training to implement caregivers intervention. b) Caregivers: 1 individualized counselling session, 1 family session, and 4 educational group sessions conducted by participating PHCT professionals; in addition to usual home health care visits, periodic telephone follow-up contact and unlimited telephone support.

Behavioral: Social Support

Usual home health care

NO INTERVENTION

Caregivers and dependent patients: usual home health care, consisting of bimonthly scheduled visits, follow-up as needed, and additional attention upon request

Interventions

Social SupportBEHAVIORAL

a) PHCT professionals: standardized training to implement caregivers intervention. b) Caregivers: 1 individualized counselling session, 1 family session, and 4 educational group sessions conducted by participating PHCT professionals; in addition to usual home health care visits, periodic telephone follow-up contact and unlimited telephone support.

Social support

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (older than 18 years) identified in the eCAP database as the primary caregiver for a dependent patient, and who act as caregivers without remuneration.
  • Both the caregivers and the dependent patients have an active clinical record in a participating primary care centre.

You may not qualify if:

  • \- 1. Caregivers for intermittent periods, independently of the length of care provided.
  • \. Caregivers who have provided less than one year of ongoing care. 3. Caregivers with any communication problem (psychiatric disorders, etc.) that makes them difficult to interview

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CAP Rambla

Sabadell, Barcelona, 08202, Spain

Location

Related Publications (1)

  • Rosell-Murphy M, Bonet-Simo JM, Baena E, Prieto G, Bellerino E, Sole F, Rubio M, Krier I, Torres P, Mimoso S; ICIAS research group. Intervention to improve social and family support for caregivers of dependent patients: ICIAS study protocol. BMC Fam Pract. 2014 Mar 25;15:53. doi: 10.1186/1471-2296-15-53.

    PMID: 24666438DERIVED

Study Officials

  • Magdalena I Rosell-Murphy, MD

    Institut Català de la Salut

    STUDY DIRECTOR

  • Josep Mª Bonet, MD

    Institut Català de la Salut

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2014

First Posted

February 19, 2014

Study Start

May 1, 2010

Primary Completion

January 1, 2011

Study Completion

December 1, 2012

Last Updated

February 19, 2014

Record last verified: 2014-02

Locations

ES(1)