The effects of a blended care intervention in partners of patients with acquired brain injury - results of the CARE4Carer randomized controlled trial

OBJECTIVE: To assess effects of the CARE4Carer blended care intervention on caregiver mastery and psychosocial functioning compared to usual care in partners of patients with acquired brain injury (ABI). DESIGN: Multicenter randomized controlled trial. SETTING: Nine sites for rehabilitation medicine. PARTICIPANTS: 120 partners of outpatients with ABI were randomly allocated to blended care (N=59) or usual care (N=61). INTERVENTION: The blended care intervention (20 weeks) was aimed at improving caregiving skills and consisted of nine online sessions, combined with two face-to-face consultations with a social worker. MAIN OUTCOME MEASURES: Mastery was assessed with the caregiver mastery scale (CMS), secondary outcome measures were caregiver strain (Caregiver Strain Index), family functioning (Family Assessment Device), anxiety and depression (Hospital Anxiety and Depression Scale), burden (self-rated) and quality of life (CarerQol). Assessments were performed at baseline, 24 and 40 weeks. RESULTS: The adjusted mean difference in caregiver mastery between intervention and control group at week 24 was 1.31 (SD3.48, 95%CI -0.12-2.74, p=0.072) and at week 40 was 1.31 (SD3.69, 95%CI -0.26-2.88, p=0.100). In the per protocol analysis, the adjusted mean difference in caregiver mastery at week 24 was 1.53 (SD3.38, 95%CI 0.10-2.96, p=0.036) and at week 40 was 1.57 (SD3.63, 95%CI 0.01-3.14, p=0.049). Regarding secondary outcomes, caregiver strain was lower in the intervention group in the per protocol analysis at week 40. Family functioning was higher in the intervention group in week 24, whereas anxiety was lower at both timepoints. CONCLUSIONS: In the subset of participants who were able to complete the intervention, caregiver mastery and psychosocial functioning improved. Future work should focus on improving adherence as this will optimize beneficial effects of blended care