An interventional study of Person-centered Care and Optimised Treatment in Dementia, sponsored by Martin-Luther-Universität Halle-Wittenberg. Completed at 3 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-03.
Sponsored by Martin-Luther-Universität Halle-Wittenberg · Not applicable, Interventional, and Supportive care
Background: Up to 90% of nursing home residents with dementia experience behavioural and psychological symptoms like apathy, agitation, and anxiety. According to analyses of prescription prevalence in Germany, antipsychotic drugs seem to be prescribed as first line treatment of neuropsychiatric symptoms in persons with dementia. A huge number is prescribed for inappropriate reasons and too long without regular review. The use of antipsychotics is associated with adverse events like increased risk of falling, stroke, and mortality. This study aims to investigate whether a person-centered care approach developed in the United Kingdom can be adapted and implemented in German nursing homes. The aim of the investigators trial is to achieve a clinically relevant reduction of the proportion of residents with alt least one antipsychotic drug prescription.
Methods/Design: Cluster-randomised controlled trial comparing an intervention group (two-day initial skill training on person-centred care and on-going training and support programme) with a control group receiving optimised usual care. Both study groups will receive a medication review by an experienced psychiatrist with feedback to the prescribing physician. Overall, 36 nursing homes from East, North and West Germany will be included and randomised. The primary outcome is defined as the proportion of residents receiving at least one antipsychotic medication at 12 months. Secondary outcomes are residents' quality of life, behavioural and psychological symptoms of dementia as well as safety parameters like falls and fall-related medical attention. Cost parameters will be collected and process evaluation will be performed alongside the trial.
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's enrollment of 1,158 is above the median of 83 across 1,629 interventional studies indexed under Dementia.
Browse Dementia studies →Martin-Luther-Universität Halle-Wittenberg is the lead sponsor of 62 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
On cluster level
Inclusion Criteria:
Exclusion Criteria:
On individual level
Inclusion Criteria:
Exclusion Criteria:
Medication Review + Person-centered Care
Other: Person-centered Care · Other: Optimised Treatment
Medication Review
Other: Optimised Treatment
Medication Review + Person-centered Care
Medication Review only
Proportion of residents receiving at least one antipsychotic medication after 12 months
Time frame: 12 months
Residents' quality of life
Will be measured with the QoL-AD
Time frame: 12 months
Behavioural and psychological symptoms of dementia
Will be measured with the CMAI
Time frame: 12 months
Costs within trial period
Cost parameters will be collected alongside the trial on intervention-related components as well as outcome-related components. Costs which are explicitly trial-associated will not be taken into account for cost analysis.
Time frame: 12 months
Falls and fall-related medical attention
Time frame: 12 months
Physical restraints within study period
Physical restraints will be assessed retrospectively by data extraction from residents' records- The following devices will be assessed: bilateral bedrails, belts, fixed tables, and other measures limiting free body movement.
Time frame: 12 months
Median daily dose of antipsychotics in chlorpromazine equivalents within study period
Each resident's daily dose of antipsychotic drugs will be translated into chlorpromazine daily equivalents.
Time frame: 12 months
Process evaluation
Different methods will be used for data collection: investigators documentation, questionnaires on staff knowledge and self-efficacy, structured interviews and in depth-interviews with staff.
Time frame: 12 months
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Martin-Luther-Universität Halle-Wittenberg