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Completed

NCT Number: NCT02065427

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

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.

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Key information

Conditions

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CAP Rambla

Sabadell, Barcelona, 08202, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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

Treatment and study plan

Social Support

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.

Primary outcomes

  1. 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

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

    Time frame: 6 months

    Difference in score in MOS Test beefore and after intervention

Other outcomes

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

    Time frame: 6 months

    Diference in score in quality of life ( SF-12 test) before and after intervention

Sponsors and collaborators

Lead sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Other

Collaborators

  • Institut Catala de Salut
  • Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC)

Registry information

Official study title

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

Acronym: ICIAS

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Feb 19, 2014
Registry last updated
Feb 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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