Non-pharmacological, psychosocial MAKS-s intervention for people with severe dementia in nursing homes: results of a cluster-randomised trial

Abstract Background Severe dementia is one of the most challenging conditions when caring for people in nursing homes. A manualised non-pharmacological, psychosocial group intervention especially adapted to the needs of people with severe dementia (PWSDs) is currently still lacking. To close this ga...

Full description

Bibliographic Details
Main Authors: André Kratzer, Kristina Diehl, Olaf Gefeller, Sebastian Meyer, Elmar Graessel
Format: Article
Language:English
Published: BMC 2022-12-01
Series:BMC Geriatrics
Subjects:
Online Access:https://doi.org/10.1186/s12877-022-03695-z
_version_ 1797973490917179392
author André Kratzer
Kristina Diehl
Olaf Gefeller
Sebastian Meyer
Elmar Graessel
author_facet André Kratzer
Kristina Diehl
Olaf Gefeller
Sebastian Meyer
Elmar Graessel
author_sort André Kratzer
collection DOAJ
description Abstract Background Severe dementia is one of the most challenging conditions when caring for people in nursing homes. A manualised non-pharmacological, psychosocial group intervention especially adapted to the needs of people with severe dementia (PWSDs) is currently still lacking. To close this gap, we adapted the evidence-based multicomponent non-pharmacological MAKS intervention (Motor stimulation, ADL stimulation, Cognitive [german: Kognitive] stimulation, and Social functioning in a group setting) to the special needs of PWSDs called the MAKS-s intervention, where the s stands for severe dementia. Methods In a prospective, multicentre, cluster-randomised trial with a waitlist control group design, 26 nursing homes comprising 152 PWSDs were randomly assigned to either the MAKS-s intervention group (IG) or control group (CG) – 121 PWSDs were still alive after the 6-month intervention period (t6) and included in the intention-to-treat (ITT) sample. The two primary outcomes, behavioural and psychological symptoms (BPSDs, measured with NPI-NH) and quality of life (QoL, measured with QUALIDEM), and the secondary outcome, activities of daily living (ADLs, measured with ADCS-ADL-sev), were assessed at baseline (t0) and at t6. Mixed ANOVAs were computed to investigate possible effects of the MAKS-s intervention on the outcomes. Results In the ITT sample, BPSDs and QoL did not change significantly over time, and group assignment did not affect them, although the IG participants had significantly better overall QoL than the CG participants. ADLs decreased significantly over time, but group assignment did not affect them. Analyses in the per protocol (PP) sample showed comparable results, with the exception that the IG participants showed a significantly greater increase in BPSDs than the CG participants did. Discussion Under the situational conditions of the Covid-19 pandemic, no beneficial effects of the MAKS-s intervention on BPSDs, QoL, or ADLs were observed. This finding also means that under ‘normal circumstances’ (i.e., if there had been no pandemic), we could not make any statements about the effect or non-effect of MAKS-s. In order to be able to address the hypotheses formulated here, the study will have to be repeated incorporating helpful experiences of the present study. Trial registration https://doi.org/10.1186/ISRCTN15722923 (Registered prospectively, 07. August 2019).
first_indexed 2024-04-11T04:05:41Z
format Article
id doaj.art-d5fcd82240ca4272bc5f1cd17bcead61
institution Directory Open Access Journal
issn 1471-2318
language English
last_indexed 2024-04-11T04:05:41Z
publishDate 2022-12-01
publisher BMC
record_format Article
series BMC Geriatrics
spelling doaj.art-d5fcd82240ca4272bc5f1cd17bcead612023-01-01T12:27:09ZengBMCBMC Geriatrics1471-23182022-12-0122111410.1186/s12877-022-03695-zNon-pharmacological, psychosocial MAKS-s intervention for people with severe dementia in nursing homes: results of a cluster-randomised trialAndré Kratzer0Kristina Diehl1Olaf Gefeller2Sebastian Meyer3Elmar Graessel4Centre for Health Services Research in Medicine, Department of Psychiatry and Psychotherapy, Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU)Centre for Health Services Research in Medicine, Department of Psychiatry and Psychotherapy, Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU)Institute of Medical Informatics, Biometry, and Epidemiology (IMBE), Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU)Institute of Medical Informatics, Biometry, and Epidemiology (IMBE), Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU)Centre for Health Services Research in Medicine, Department of Psychiatry and Psychotherapy, Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU)Abstract Background Severe dementia is one of the most challenging conditions when caring for people in nursing homes. A manualised non-pharmacological, psychosocial group intervention especially adapted to the needs of people with severe dementia (PWSDs) is currently still lacking. To close this gap, we adapted the evidence-based multicomponent non-pharmacological MAKS intervention (Motor stimulation, ADL stimulation, Cognitive [german: Kognitive] stimulation, and Social functioning in a group setting) to the special needs of PWSDs called the MAKS-s intervention, where the s stands for severe dementia. Methods In a prospective, multicentre, cluster-randomised trial with a waitlist control group design, 26 nursing homes comprising 152 PWSDs were randomly assigned to either the MAKS-s intervention group (IG) or control group (CG) – 121 PWSDs were still alive after the 6-month intervention period (t6) and included in the intention-to-treat (ITT) sample. The two primary outcomes, behavioural and psychological symptoms (BPSDs, measured with NPI-NH) and quality of life (QoL, measured with QUALIDEM), and the secondary outcome, activities of daily living (ADLs, measured with ADCS-ADL-sev), were assessed at baseline (t0) and at t6. Mixed ANOVAs were computed to investigate possible effects of the MAKS-s intervention on the outcomes. Results In the ITT sample, BPSDs and QoL did not change significantly over time, and group assignment did not affect them, although the IG participants had significantly better overall QoL than the CG participants. ADLs decreased significantly over time, but group assignment did not affect them. Analyses in the per protocol (PP) sample showed comparable results, with the exception that the IG participants showed a significantly greater increase in BPSDs than the CG participants did. Discussion Under the situational conditions of the Covid-19 pandemic, no beneficial effects of the MAKS-s intervention on BPSDs, QoL, or ADLs were observed. This finding also means that under ‘normal circumstances’ (i.e., if there had been no pandemic), we could not make any statements about the effect or non-effect of MAKS-s. In order to be able to address the hypotheses formulated here, the study will have to be repeated incorporating helpful experiences of the present study. Trial registration https://doi.org/10.1186/ISRCTN15722923 (Registered prospectively, 07. August 2019).https://doi.org/10.1186/s12877-022-03695-zSevere dementiaPsychosocial interventionBehavioural and psychological symptoms of dementiaQuality of lifeNursing homeRCT
spellingShingle André Kratzer
Kristina Diehl
Olaf Gefeller
Sebastian Meyer
Elmar Graessel
Non-pharmacological, psychosocial MAKS-s intervention for people with severe dementia in nursing homes: results of a cluster-randomised trial
BMC Geriatrics
Severe dementia
Psychosocial intervention
Behavioural and psychological symptoms of dementia
Quality of life
Nursing home
RCT
title Non-pharmacological, psychosocial MAKS-s intervention for people with severe dementia in nursing homes: results of a cluster-randomised trial
title_full Non-pharmacological, psychosocial MAKS-s intervention for people with severe dementia in nursing homes: results of a cluster-randomised trial
title_fullStr Non-pharmacological, psychosocial MAKS-s intervention for people with severe dementia in nursing homes: results of a cluster-randomised trial
title_full_unstemmed Non-pharmacological, psychosocial MAKS-s intervention for people with severe dementia in nursing homes: results of a cluster-randomised trial
title_short Non-pharmacological, psychosocial MAKS-s intervention for people with severe dementia in nursing homes: results of a cluster-randomised trial
title_sort non pharmacological psychosocial maks s intervention for people with severe dementia in nursing homes results of a cluster randomised trial
topic Severe dementia
Psychosocial intervention
Behavioural and psychological symptoms of dementia
Quality of life
Nursing home
RCT
url https://doi.org/10.1186/s12877-022-03695-z
work_keys_str_mv AT andrekratzer nonpharmacologicalpsychosocialmakssinterventionforpeoplewithseveredementiainnursinghomesresultsofaclusterrandomisedtrial
AT kristinadiehl nonpharmacologicalpsychosocialmakssinterventionforpeoplewithseveredementiainnursinghomesresultsofaclusterrandomisedtrial
AT olafgefeller nonpharmacologicalpsychosocialmakssinterventionforpeoplewithseveredementiainnursinghomesresultsofaclusterrandomisedtrial
AT sebastianmeyer nonpharmacologicalpsychosocialmakssinterventionforpeoplewithseveredementiainnursinghomesresultsofaclusterrandomisedtrial
AT elmargraessel nonpharmacologicalpsychosocialmakssinterventionforpeoplewithseveredementiainnursinghomesresultsofaclusterrandomisedtrial