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DementiaEPCentCareNCT02295462

Effect of Person-Centred-Care on Antipsychotic Drug Use in Nursing Homes: a Cluster-randomised Trial

A study testing Person-centered Care and Optimised Treatment in people with Dementia, run by Martin-Luther-Universität Halle-Wittenberg at 3 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dementia
What is being tested?
Person-centered Care and Optimised Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,158 participants
Where
3 sitesGermany
Study dates
Dec 2014to Feb 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • nursing homes with at least 50 residents
  • all residents within a cluster are eligible to participate in the study

Who cannot join

  • other ongoing trial in the institution
  • On individual level
  • diagnoses of schizophrenia, schizoaffective psychosis, or other forms of primary psychosis
  • respite care

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

  • Martin-Luther-Universität Halle-Wittenberg

    Halle, Saxony-Anhalt, 06110

  • University of Luebeck

    Lübeck, Schleswig-Holstein, 23562

  • Universität Witten/Herdecke

    Witten Herdecke, North Rhine-Westphalia, 58448

Other trials in Germany

About this study

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.

Conditions
Dementia
Being tested
Person-centered Care, Optimised Treatment
Keywords
nursing homes, person-centered care, inappropriate prescriptions, cluster-randomised controlled trial, antipsychotic drugs
Medical subject headings
Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Person-centered CareOther

    Medication Review + Person-centered Care

  • Optimised TreatmentOther

    Medication Review only

Study groups in NCT02295462
Study groupRoleWhat they receive
Person-centered CareExperimentalMedication Review + Person-centered Care
Receives: Other: Person-centered Care; Other: Optimised Treatment
Optimised TreatmentActive comparatorMedication Review
Receives: Other: Optimised Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 12 months

Secondary outcomes (6)

  1. Residents' quality of life

    Will be measured with the QoL-AD

    Measured: 12 months

  2. Behavioural and psychological symptoms of dementia

    Will be measured with the CMAI

    Measured: 12 months

  3. 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.

    Measured: 12 months

  4. Falls and fall-related medical attention

    Measured: 12 months

  5. 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.

    Measured: 12 months

  6. 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2014 (estimated)
  2. Study startDec 2014
  3. Primary completionFeb 2017
  4. Study completionFeb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,158 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02295462
Sponsor's protocol ID
EPCentCare
Other IDs
01GY1335A, 01GY1335B, 01GY1335C
Acronym
EPCentCare
Status last verified
May 2017
First submitted
12 Nov 2014
Last updated
3 May 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 35804407

  • 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.

    PubMed 30806453

  • 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.

    PubMed 29914389

  • 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.

    PubMed 26037324

Questions about this trial

What is this clinical trial studying?

A study testing Person-centered Care and Optimised Treatment in people with Dementia, run by Martin-Luther-Universität Halle-Wittenberg at 3 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of residents receiving at least one antipsychotic medication after 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02295462, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2017.

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