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| ID | Type | Description | Link |
|---|---|---|---|
| 01GY1335A | Other Grant/Funding Number | German Federal Ministry of Education and Research | |
| 01GY1335B | Other Grant/Funding Number | German Federal Ministry of Education and Research | |
| 01GY1335C | Other Grant/Funding Number | German Federal Ministry of Education and Research |
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| Name | Class |
|---|---|
| University of Luebeck | OTHER |
| University of Witten/Herdecke | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Person-centered Care | Experimental | Medication Review + Person-centered Care |
|
| Optimised Treatment | Active Comparator | Medication Review |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Person-centered Care | Other | Medication Review + Person-centered Care |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of residents receiving at least one antipsychotic medication after 12 months | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Residents' quality of life | Will be measured with the QoL-AD | 12 months |
| Behavioural and psychological symptoms of dementia | Will be measured with the CMAI |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
On cluster level
Inclusion Criteria:
Exclusion Criteria:
On individual level
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gabriele Meyer, Prof. Dr. | Martin-Luther-Universität Halle-Wittenberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universität Witten/Herdecke | Witten Herdecke | North Rhine-Westphalia | 58448 | Germany | ||
| Martin-Luther-Universität Halle-Wittenberg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35804407 | Derived | Richter C, Fleischer S, Langner H, Meyer G, Balzer K, Kopke S, Sonnichsen A, Loscher S, Berg A. Factors influencing the implementation of person-centred care in nursing homes by practice development champions: a qualitative process evaluation of a cluster-randomised controlled trial (EPCentCare) using Normalization Process Theory. BMC Nurs. 2022 Jul 8;21(1):182. doi: 10.1186/s12912-022-00963-6. | |
| 30806453 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 5, 2019 | |
| Reset | Aug 28, 2019 | |
| Release | May 20, 2021 | |
| Reset | Jun 15, 2021 | |
| Release | Apr 27, 2026 | |
| Reset | May 19, 2026 | |
| Release | May 19, 2026 | |
| Reset | Jun 15, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 5, 2019 | Aug 28, 2019 | |||
| May 20, 2021 |
| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| ID | Term |
|---|---|
| D018802 | Patient-Centered Care |
| ID | Term |
|---|---|
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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| Optimised Treatment |
| Other |
Medication Review only |
|
| 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. | 12 months |
| Falls and fall-related medical attention | 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. | 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. | 12 months |
| Halle |
| Saxony-Anhalt |
| 06110 |
| Germany |
| University of Luebeck | Lübeck | Schleswig-Holstein | 23562 | Germany |
| Derived |
| Richter C, Berg A, Langner H, Meyer G, Kopke S, Balzer K, Wolschon EM, Silies K, Sonnichsen A, Loscher S, Haastert B, Icks A, Wolf U, Fleischer S. Effect of person-centred care on antipsychotic drug use in nursing homes (EPCentCare): a cluster-randomised controlled trial. Age Ageing. 2019 May 1;48(3):419-425. doi: 10.1093/ageing/afz016. |
| 29914389 | Derived | Dichter MN, Wolschon EM, Schwab CGG, Meyer G, Kopke S. Item distribution and inter-rater reliability of the German version of the quality of life in Alzheimer's disease scale (QoL-AD) proxy for people with dementia living in nursing homes. BMC Geriatr. 2018 Jun 19;18(1):145. doi: 10.1186/s12877-018-0834-z. |
| 26037324 | Derived | Richter C, Berg A, Fleischer S, Kopke S, Balzer K, Fick EM, Sonnichsen A, Loscher S, Vollmar HC, Haastert B, Icks A, Dintsios CM, Mann E, Wolf U, Meyer G. Effect of person-centred care on antipsychotic drug use in nursing homes (EPCentCare): study protocol for a cluster-randomised controlled trial. Implement Sci. 2015 Jun 4;10:82. doi: 10.1186/s13012-015-0268-3. |
| Jun 15, 2021 |
| Apr 27, 2026 | May 19, 2026 |
| May 19, 2026 | Jun 15, 2026 |
| D001523 | Mental Disorders |