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Clinical Trials/NCT02065427
NCT02065427
Completed
N/A

Intervention to Improve Social and Family Support for Caregivers of Dependent Patients

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina1 site in 1 country282 target enrollmentMay 2010

Overview

Phase
N/A
Intervention
Not specified
Conditions
Dependency Burden
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Enrollment
282
Locations
1
Primary Endpoint
Score in Zarit's short version test for caregiver's burden
Status
Completed
Last Updated
12 years ago

Overview

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.

Detailed Description

Objective: To assess whether an intervention designed to improve the social support for caregivers effectively decreases caregivers burden and improves their quality of life. Methodology: Design: Controlled, multicentre, community intervention trial, with patients and their caregivers randomized to the intervention or control group according to their assigned Primary Health Care Team (PHCT). Study area: Primary Health Care network (9 PHCTs). Study participants: Primary informal caregivers of patients receiving home health care from participating PHCTs. Sample: Required sample size is 282 caregivers (141 from PHCTs randomized to the intervention group and 141 from PHCTs randomized to the control group. Intervention: 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. Control: Caregivers and dependent patients: usual home health care, consisting of bimonthly scheduled visits, follow-up as needed, and additional attention upon request. Data Analysis. Dependent variables: Caregiver burden (short-form Zarit test), caregivers social support (Medical Outcomes Study), and caregiver reported quality of life (SF-12) Independent variables: a) Caregiver: sociodemographic data, Goldberg Scale, Apgar family questionnaire, Holmes and Rahe Psychosocial Stress Scale, number of chronic diseases. b) Dependent patient: sociodemographic data, level of dependency (Barthel Index), cognitive impairment (Pfeiffer test) Discussion: If the intervention intended to improve social and family support is effective in reducing the burden on primary informal caregivers of dependent patients, this model can be readily applied throughout usual PHCT clinical practice.

Registry
clinicaltrials.gov
Start Date
May 2010
End Date
December 2012
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 6 months

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

Secondary Outcomes

  • Score in caregivers social support (Medical Outcomes Study), (MOS)(6 months)

Study Sites (1)

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