NCT02295462

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,158

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 20, 2014

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

May 3, 2017

Status Verified

May 1, 2017

Enrollment Period

2.2 years

First QC Date

November 12, 2014

Last Update Submit

May 2, 2017

Conditions

Dementia

Keywords

nursing homesperson-centered careinappropriate prescriptionscluster-randomised controlled trialantipsychotic drugs

Outcome Measures

Primary Outcomes (1)

  • Proportion of residents receiving at least one antipsychotic medication after 12 months

    12 months

Secondary Outcomes (6)

  • Residents' quality of life

    12 months

  • Behavioural and psychological symptoms of dementia

    12 months

  • Costs within trial period

    12 months

  • Falls and fall-related medical attention

    12 months

  • Physical restraints within study period

    12 months

  • +1 more secondary outcomes

Other Outcomes (1)

  • Process evaluation

    12 months

Study Arms (2)

Person-centered Care

EXPERIMENTAL

Medication Review + Person-centered Care

Other: Person-centered CareOther: Optimised Treatment

Optimised Treatment

ACTIVE COMPARATOR

Medication Review

Other: Optimised Treatment

Interventions

Person-centered CareOTHER

Medication Review + Person-centered Care

Person-centered Care
Optimised TreatmentOTHER

Medication Review only

Optimised TreatmentPerson-centered Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • nursing homes with at least 50 residents

You may not qualify if:

  • other ongoing trial in the institution
  • On individual level
  • all residents within a cluster are eligible to participate in the study
  • diagnoses of schizophrenia, schizoaffective psychosis, or other forms of primary psychosis
  • respite care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Universität Witten/Herdecke

Witten Herdecke, North Rhine-Westphalia, 58448, Germany

Location

Martin-Luther-Universität Halle-Wittenberg

Halle, Saxony-Anhalt, 06110, Germany

Location

University of Luebeck

Lübeck, Schleswig-Holstein, 23562, Germany

Location

Related Publications (4)

  • 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.

    PMID: 35804407DERIVED

  • 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.

    PMID: 30806453DERIVED

  • 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.

    PMID: 29914389DERIVED

  • 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.

    PMID: 26037324DERIVED

MeSH Terms

Conditions

Dementia

Interventions

Patient-Centered Care

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Primary Health CareComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Gabriele Meyer, Prof. Dr.

    Martin-Luther-Universität Halle-Wittenberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

November 12, 2014

First Posted

November 20, 2014

Study Start

December 1, 2014

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

May 3, 2017

Record last verified: 2017-05

Locations

DE(3)