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. 2023 Apr 22:33:101146.
doi: 10.1016/j.conctc.2023.101146. eCollection 2023 Jun.

Impact of pharmaceutical care integrated at a psychosocial intervention to reduce caregiver's burden in Alzheimer's disease or related dementias: Negative results at 18 months and difficulties to conduct PHARMAID RCT

Teddy Novais  1   2   3 , Soraya Qassemi  4 , Philippe Cestac  5   6 , Cécile McCambridge  5 , Hélène Villars  6   7 , Audrey Zueras  7 , Bertrand Decaudin  8   9 , Mathilde Dambrine  9 , Dominique Huvent-Grelle  10 , Jean Roche  11 , Sylvie Schoenenburg  10 , Denis Federico  2   12 , Anne-Cécile Nier  2 , Pierre Krolak-Salmon  2   12   13   14 , Christelle Mouchoux  1   2   13   14
Affiliations

Impact of pharmaceutical care integrated at a psychosocial intervention to reduce caregiver's burden in Alzheimer's disease or related dementias: Negative results at 18 months and difficulties to conduct PHARMAID RCT

Teddy Novais et al. Contemp Clin Trials Commun. .

Abstract

Background: Psychosocial interventions for caregivers of patients with Alzheimer disease and relative dementias (ADRD) reported a caregiver burden improvement. Multicomponent intervention integrating pharmaceutical care has not yet been evaluated while ADRD patients and their caregivers are exposed to high risk of drug-related problems. The PHARMAID study aimed to assess the impact of personalized pharmaceutical care integrated to a psychosocial program on the burden of ADRD caregivers at 18 months.

Methods: The PHARMAID RCT was conducted between September 2016 and June 2020 [ClinicalTrials.gov: NCT02802371]. PHARMAID study planned to enroll 240 dyads, i.e. ADRD patients and caregivers, whose inclusion criteria were: outpatient with mild or major neurocognitive disorders due to ADRD, living at home, receiving support from a family caregiver. Three parallel groups compared a control group with two interventional groups: psychosocial intervention and integrated pharmaceutical care at a psychosocial intervention. The main outcome was the caregiver burden assessed by the Zarit Burden Index (ZBI, score range 0-88) at 18 months.

Results: Overall, 77 dyads were included (32% of the expected sample size). At 18 months, the mean ZBI scores were 36.7 ± 16.8 in the control group, 30.3 ± 16.3 for the group with psychosocial intervention, and 28.8 ± 14.1 in group with integrated pharmaceutical care at psychosocial intervention. No significant difference was demonstrated between the three groups (p = 0.326).

Conclusions: The findings suggest that PHARMAID program had no significant impact on caregiver burden at 18 months. Several limitations have been highlighted and discussed by the authors in order to formulate recommendations for further research.

Keywords: Alzheimer's disease and related dementias; Burden; Caregivers; Negative results; Pharmaceutical care; Psychosocial intervention.

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Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
Study design and flow chart of PHARMAID study.
See this image and copyright information in PMC

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