Effect of a tailored multidimensional intervention on the care burden among family caregivers of stroke survivors: A randomised controlled trial

Introduction: Caring for stroke survivors at home creates high levels of
care burden among family caregivers. As the nature of caregiving is
multidimensional, previous initiatives at alleviating the care burden
using a single approach have not been adequate. It was recommended that
future studies focus on tailored interventions that address the needs of
family caregivers and combine different approaches to relieve caregivers’
burden. However, there is a lack of literature regarding interventions
that incorporate these recommendations. The proposed study aims to
evaluate the effect of a tailored multidimensional intervention developed
by researchers to reduce the care burden among family caregivers of stroke
survivors. Based on the perceived needs of family caregivers of stroke
survivors, this intervention takes into account scientific recommendations
to combine three different approaches: skill-building, psycho-education,
and peer support. Methods and analysis: Using a prospective, randomized,
open-label, parallel-group design, 110 family caregivers were enrolled and
randomly assigned to either the intervention group or the control group.
The intervention was administered for 6 months and included three home
visits and six home-based telephone calls, as well as one peer support
session. Family caregivers of the control group received a simple
educational booklet during only one home visit. The primary outcome is the
care burden as measured using the Zarit Burden Interview. The secondary
outcome is the quality of life. Outcomes evaluation was conducted
at baseline (T0), Month 3 (T1), and Month 6 (T2). An Independent t-test
will be performed to compare the mean values of study variables between
the two groups at both T1 and T2. In addition, repeated-measures analysis
of variance was conducted to assess changes in effects over time.