Abstract
BACKGROUND: Day-care and telephone counseling have been discussed as effective support measures for caregivers of people with cognitive impairment. METHODS: In a two-arm cluster-randomized trial involving multicomponent therapy for cognitively impaired persons in day-care centers and telephone counseling for their caregivers versus treatment as usual (TAU), we investigated long-term effects on caregivers' burden and depressiveness. Person-caregiver dyads involving home-dwelling persons with MCI, mild dementia, or moderate dementia were eligible. Day-care centers were randomized into an intervention group (IG) or a control group (CG). Outcome assessors were blinded. Out of 359 caregivers who had completed a 6-month intervention phase (n(IG) = 205, n(CG) = 154), a total of 304 of them were available at the 12-month follow-up (n(IG) = 173, n(CG) = 131). Instruments for assessing were the Burden Scale for Family Caregivers - short version (BSFC-s) (caregiver burden) and the Well-Being Index Score (WHO-5) (depressiveness). Mixed ANOVAs were used for the main analyses; descriptive statistics and subgroup analyses were additionally performed; secondary analyses involved multiple linear regressions for the main outcomes that were significant in the unadjusted main analysis. RESULTS: At follow-up, crude mean differences showed a nonsignificant advantage for the IG in caregiver burden [IG: -.20 (SD = 5.39) vs. CG: .76 (SD = 5.49), p = .126, d = .177] and depressiveness (reverse scored) [IG: -.05 (SD = 5.17) vs. CG: -.98 (SD = 5.65), p = .136, d = .173]. For caregiver burden, a mixed ANOVA resulted in significant main effects of group (F (1, 302) = 4.40; p = .037) and time (F (1.88, 568.96) = 3.56; p = .032) but not a significant interaction. The largest effects were found for the "mild dementia" subgroup (d = .443 for caregiver burden and d = .520 for depressiveness). DISCUSSION: Positive long-term effects of a combined intervention involving telephone counseling for caregivers and multicomponent activation for patients were observed especially for mild dementia. However, the treatment effects washed out after the intervention ended. TRIAL REGISTRATION: ISRCTN16412551 (date: 30 July 2014, retrospectively).