The MAKS-s study: multicomponent non-pharmacological intervention for people with severe dementia in inpatient care – study protocol of a randomised controlled trial

Abstract

Background Nursing homes accommodate a large number of people with severe dementia. More than 80% of residents with dementia suffer from behavioural and psychological symptoms, that can have consequences on the perceived burden of the formal caregivers. Internationally, the number of studies on non-pharmacological interventions for people with severe dementia is very small. One way to reduce these symptoms is to meet the needs of people with severe dementia. The non-pharmacological group intervention MAKS-s, which we will investigate in this study, is intended to reduce the behavioural and psychological symptoms and to improve the quality of life of such people. Additionally, we will investigate the effects on the burden carried by formal caregivers. Methods With the present study, we will investigate the effectiveness of a multicomponent non-pharmacological intervention for people with severe dementia living in nursing homes (primary target group). A power analysis indicated that 144 dementia participants should initially be included. In addition, a secondary target group (nursing home staff) will be examined with respect to their dementia-related stress experiences. The study will be conducted as a cluster randomised controlled trail in Germany with a 6-month intervention phase. The nursing homes in the waitlist control group will provide “care as usual.” The primary endpoints of the study will be the behavioural and psychological symptoms of dementia and the quality of life of people with severe dementia. The total duration of the study will be 18 months. Data will be collected by using observer rating scales. Discussion The project has some outstanding quality features. The external validity is high, because it is situated in a naturalistic setting in nursing homes and is being carried out with available nursing employees. Due to this fact, a permanent implementation also seems to be possible. Since the participating nursing homes are disseminated across several German federal states and rural and urban regions, the results should be transferable to the entire population. Trial registration ISRCTN15722923 (Registration date: 07 August 2019).

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

“…The study was registered prospectively on 07 August 2019 at ISRCTN registry (Trial identification number: ISRCTN15722923). For more information about the study design, please see our study protocol by Diehl et al [ 23 ].…”

“…at least 24 nursing homes) should be recruited in order to analyse at least 114 PWSDs in the final intention-to-treat sample after an estimated dropout rate of 20% over a 6-month period. Sample size estimation was based on a ranomised-controlled pilot study with two assessments (t0 and t6) in a single nursing home [ 24 ] with an alpha error of 5%, a statistical power of 80%, and an effect size of Cohen’s d = 0.52 for the outcome BPSDs (for further details regarding the sample size estimation, please see the study protocol [ 23 ]). In each participating nursing home, on-site study coordinators were trained in the study protocol, the instruments, and the procedures they needed to follow to conduct the screening and to act as a contact person between the study headquarters and the nursing home.…”

“…The final component involves training in basic ADLs, such as buttering bread, washing hands, or screwing a nut on a thread (approximately 20 minutes). For further details, please see the study protocol [ 23 ].…”

“…The IG was trained before the intervention period, whereas the CG was trained subsequent to the intervention period and after the t6 data collection. Both groups received a therapy manual as well as standardised materials and structured weekly plans to carry out the intervention (for details, see the study protocol [ 23 ]). During the intervention period, MAKS-s should be administered to the IG three times a week for 1 hour in groups of six PWSDs and two of the four trained therapists.…”

Unter welchen Bedingungen können Menschen mit schwerer Demenz im Pflegeheim von einer psychosozialen Mehrkomponenten-Intervention profitieren?

“…The MAKS-s baseline study [11,12] was a two-arm, cluster-randomised, controlled intervention study with a waitlist control group design. The study was conducted in 26 nursing homes (13 intervention, 13 control groups) in different federal states of Germany.…”