Clinical trial NCT02065427: Intervention to Improve Social and Family Support for Caregivers of Dependent Patients. (ICIAS)
Official title: Intervention to Improve Social and Family Support for Caregivers of Dependent Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dependency Burden
Keywords: Caregiver
Burden
Social support
Primary health Care
Home Care
Intervention
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Institut Catala de Salut
name: Catalan Society of Family Medicine
First posted: 2014-02-19
Enrollment: 282
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

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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

Primary outcomes:
measure: Score in Zarit's short version test for caregiver's burden
timeFrame: 6 months
Secondary outcomes:
measure: Score in caregivers social support (Medical Outcomes Study), (MOS)
timeFrame: 6 months
Other outcomes:
measure: Score in caregiver reported quality of life (SF-12)
timeFrame: 6 months
Locations:
city: Sabadell
country: Spain
facility: CAP Rambla
state: Barcelona
Study officials:
affiliation: Institut Català de la Salut
name: Magdalena I Rosell-Murphy, MD
role: STUDY_DIRECTOR
affiliation: Institut Català de la Salut
name: Josep Mª Bonet, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.