Dependency Burden Clinical Trial
Official title:
Intervention to Improve Social and Family Support for Caregivers of Dependent Patients
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Supportive Care
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02667782 -
Feasibility Study on the Use of Mindfulness-based Intervention for Family Carers of People With Dementia
|
N/A |