Intervention to Improve Social and Family Support for Caregivers of Dependent Patients. (ICIAS)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dependency Burden

Intervention / Treatment
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* Behavioral: Social Support


Participation Criteria
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Eligibility Criteria
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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: - 1. Caregivers for intermittent periods, independently of the length of care provided. 2. 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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Social support<br>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<br>* 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.<br>|
| No Intervention: Usual home health care<br>Caregivers and dependent patients: usual home health care, consisting of bimonthly scheduled visits, follow-up as needed, and additional attention upon request | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score in caregivers social support (Medical Outcomes Study), (MOS) | Difference in score in MOS Test beefore and after intervention | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caregiver, Burden, Social support, Primary health Care, Home Care, Intervention