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

NCT ID: NCT02065427

Last Updated: 2014-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 282 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2012-12-31

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.

Conditions

Dependency Burden

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Social support

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.

Group Type: EXPERIMENTAL

Social Support

Intervention Type: BEHAVIORAL

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.

Usual home health care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Social Support

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.

Intervention Type: BEHAVIORAL

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

• 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Catala de Salut

OTHER_GOV

Sponsor Role: collaborator

Catalan Society of Family Medicine

OTHER

Sponsor Role: collaborator

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Magdalena I Rosell-Murphy, MD

Role: STUDY_DIRECTOR

Institut Català de la Salut

Josep Mª Bonet, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Català de la Salut

Locations

CAP Rambla

Sabadell, Barcelona, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 24666438 (View on PubMed)

Other Identifiers

ICIAS

Identifier Type: -

Identifier Source: org_study_id