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

Abstract

Objectives: To evaluate the effectiveness of a tailored multidimensional intervention in reducing the care burden of family caregivers of stroke survivors. This intervention considered caregivers' perceived needs and incorporated three evidence-based dimensions (psychoeducation, skill-building and peer support).

Design: A prospective randomised control trial.

Setting: A community-based study conducted in Egypt.

Participants: A total of 110 caregivers aged ≥18 years who cared for a survivor within 6 months of stroke, with modified Rankin Scale scores of 3-5, and without other physical disabilities or terminal illnesses were recruited between December 2019 and May 2020. Participants were assigned to the intervention group (IG; n=55) and control group (CG; n=55) through open-label, parallel 1:1 randomisation.

Intervention: The IG was provided with tailored multidimensional interventions for 6 months until November 2020, including three home visits, six home-based telephone calls and one peer-support session. The CG received simple educational instructions at a single visit.

Outcome: The participants completed the Zarit Burden Interview (primary outcome) and the WHO Quality of Life-BREF (secondary outcome) before the intervention (T0), at 3 months (T1) and at 6 months (T2).

Results: No differences were observed between the characteristics of the groups at baseline (T0). The independent t-test showed no significant differences in the care burden and Quality of Life (QoL) at T1 and T2 between the groups. The intervention had no significant effect on the outcomes between or within groups over time, as shown by the repeated-measures analysis of variance. However, the group and time interaction had significant main effects on caregivers' QoL (psychological and social domains).

Conclusion: The main results showed that participants in the IG did not experience an improvement in the main outcomes. Nevertheless, the improvement in the psychological and social domains may have been attributed to our intervention.

Trial registration number: NCT04211662.

Keywords: mental health; public health; quality in health care; rehabilitation medicine; stroke medicine.

Figure 1

Conceptual framework.

Figure 2

Diagram according to Consolidated Standards of Reporting Trials (CONSORT).

Figure 3

Mean of Zarit Burden Interview with SE bars (95% CI and ±2 SE); T0, baseline; T1, 3 months; T2, 6 months.Intervention group (n=55);control group (n=55).

Figure 4

Means of four domains of WHO Quality of Life-BREF with SE bars (95% CI and ±2 SE). (A) Physical, (B) psychological, (C) social relationships, and (D) environment; T0, baseline; T1, 3 months; T2, 6 months.