Condition category
Mental and Behavioural Disorders
Date applied
25/06/2013
Date assigned
10/07/2013
Last edited
13/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Case conference is an useful tool for staff to understand the behavior (like aggression) in people with dementia. Understanding their behavior is the basis for staff to begin with targeted interventions to improve quality of care of the people with dementia. Furthermore it may lead to a reduction of the dementia specific burden on the nursing staff.
All together there are two possible ways to conduct a case conference.
A) With help of an assessment instrument which guides the staff to understand the behavior of the resident.
B) In a free narrative way in which the staff has to find the reasons for the behavior of the resident in an unstructured way.
The aim of this study protocol is to study the effectiveness of two dementia-specific case conferences within German nursing homes.

Who can participate?
People with dementia and their caregivers in 12 nursing homes in North-Rhine-Westfalia (NRW), Germany.

What does the study involve?
12 nursing homes take part in the trial. The intervention is rolled-out sequentially every 3 months to two nursing homes over 19 months. Every nursing home will receive the intervention however the order in which the different nursing homes will receive the intervention and the kind of the intervention (Innovative Dementia Orientated Assessment Tool (IdA) or Narrative model of case conference) is determined at random.

What are the possible benefits and risks of participating?
It can be expected that both concepts of case conferences help the nursing staff to understand the residents challenging behavior and thus offers staff the opportunity to initiate interventions that lead to a reduction of resident’s challenging behavior, the use of psychotropic drugs and increase the quality of life of the residents. Overall they will help to improve the quality of care for the people with dementia living in nursing homes .
Furthermore the expected reduction of the challenging behavior of the residents also leads to a reduction of the dementia specific burden or burnout of the nursing staff.
There are no risks of injury or harm if you take part in this study.

Where is the study run from?
12 Nursing Homes in North-Rhine-Westfalia (NRW), Germany

When is the study starting and how long is it expected to run for?
The study started in May 2013 and will run till October 2015.

Who is funding the study?
The Public Welfare Foundation North Rhine-Westphalia, Germany

Who is the main contact?
Dr. rer. medic. Margareta Halek, MScN
Margareta.Halek@dzne.de

Trial website

http://www.dzne.de/standorte/witten/projekte/falldem.html

Contact information

Type

Scientific

Primary contact

Dr Margareta Halek

ORCID ID

Contact details

Stockumer Str. 12
Witten
58453
Germany
+49 23 02 926 108
Margareta.Halek@dzne.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

6227-Z

Study information

Scientific title

Evaluation of the effects of two dementia-specific case conferences within German nursing homes using a stepped-wedged randomized controlled trial

Acronym

FallDem (Fallbesprechung bei Demenz)

Study hypothesis

The study is based on the hypothesis that the engagement with challenging behavior within case conferences leads to a greater understanding of residents’ challenging behavior according to the Need driven dementia compromised behaviour (NDB) Model and thus offers nursing staff the opportunity to initiate purposive interventions that lead to a reduction in the prevalence of residents’ challenging behavior, the use of psychotropic drugs and increase residents’ quality of life (QoL).

Ethics approval

Ethics Committee of the German Society of Nursing Science approved on August 2011

Study design

Stepped-wedged randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Dementia

Intervention

Training phase (before the start of the intervention): Here all participating nursing staff will receive a one day training in the field of the diagnosis of dementia and challenging behavior and a half day training in handling one of the two models of case conference. Additionally each nursing home have to select two senior nursing staff members who get a two days training to moderate a case conference. The intervention itself starts after the education phase.
In this study two different kinds of interventions will be tested about their effectiveness. Both concepts of the studies are based on a fixed process and role structure but differ in the content structure. The nursing staff of each ward has to select the people with dementia being discussed in case conferences.

The two different concepts (A/B) of case conferences

A) The model of case conferences with the Innovative Dementia Orientated Assessment Tool (IdA): The staff are guided through the process of understanding the situation with the help of central question in six main topics. The first step is a detailed description and quantification of the challenging behavior. The second step is the search for potential causes of the behavior. For this IdA is divided into five dimensions (state of health, communication, personality, mood emotions and environment influences) with specific guiding questions.

B) Narrative model of case conference: The main topics of understanding the situation takes place in an unstructured way. This means that the nursing staff have to approach the description and understanding of the situation in a free narrative way.

Every cluster will receive the intervention after a control phase. The intervention is rolled-out sequentially every 3 months to two nursing homes over 19 months. The order in which the different nursing homes will receive the intervention and the kind of the intervention (six nursing Homes receive the Case Conferences with IdA and six Narrative case conference) is determined at random.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Challenging behavior of residents with dementia measured with the NPI-NH proxy-measurement. Measured at baseline (T0) and after that every 3 months (T1-T6) over a period of 19 months.

Secondary outcome measures

Patients:
1. Quality of Life of people with Dementia measured with the QUALIDEM proxy- measurement
2. The Defined Daily Dose (DDD) of Psychotropic Drugs

Staff:
1. Burnout of the nursing staff with will be measured with the Copenhagen Burnout Inventory (CBI)
2. The dementia-specific burden on nursing staff will be assessed with the German BelaDem Questionnaire.
3. The vocational action competence of the nursing staff will be measured with the German questionnaire “Kompetenz – Reflektions – Inventar (KRI)

All above outcomes measured at baseline (T0) and after that every 3 months (T1-T6) over a period of 19 months.

Overall trial start date

01/05/2013

Overall trial end date

31/10/2015

Reason abandoned

Eligibility

Participant inclusion criteria

The following inclusion criteria were set for institution and patient level of the trial.

Institution Level
1. At least two wards of one nursing home must take part in the study that provide together at least 30 residents with dementia
2. The care of the residents have to take place most of the day in their ward

Patient level
1. Informed consent
2. Diagnosis of dementia
3. Living not less than 14 days in the ward

According to the Federal Statistical Office we expect that most of the patients are > 65 years and around 70% of the patients in our study sample will be women and 30% men.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

12 nursing homes (with 24 wards) and approximately 360 people with dementia and approximately 200 nursing staff)

Participant exclusion criteria

The following exclusion criteria were set for institution and patient level of the trial

Institution level
1. Nursing homes size < 30
2. Some kind of day care is integrated in the institution for people with dementia
3. Reconstruction work on the participated unit and participation in any other research project at the same time that bond personal resources

Patient level
1. Schizophrenia or any other kind of psychiatric diseases (found in the medical documentation)

Recruitment start date

01/05/2013

Recruitment end date

31/10/2015

Locations

Countries of recruitment

Germany

Trial participating centre

Stockumer Str. 12
Witten
58453
Germany

Sponsor information

Organisation

Public Welfare Foundation Northrine-Westphalia (Stiftung Wohlfahrtspflege (NRW) (Germany)

Sponsor details

Horionplatz 1
Düsseldorf
40213
Germany

Sponsor type

Government

Website

http://www.sw-nrw.de/home/

Funders

Funder type

Government

Funder name

Public Welfare Foundation North Rhine-Westphalia (Stiftung Wohlfahrtspflege Nordrhein-Westfalen) (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25118091
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25496425

Publication citations

  1. Protocol

    Reuther S, Holle D, Buscher I, Dortmann O, Müller R, Bartholomeyczik S, Halek M, Effect evaluation of two types of dementia-specific case conferences in German nursing homes (FallDem) using a stepped-wedge design: study protocol for a randomized controlled trial., Trials, 2014, 15, 319, doi: 10.1186/1745-6215-15-319.

  2. Protocol

    Holle D, Roes M, Buscher I, Reuther S, Müller R, Halek M, Process evaluation of the implementation of dementia-specific case conferences in nursing homes (FallDem): study protocol for a randomized controlled trial, Trials, 2014 , doi: 10.1186/1745-6215-15-485.

Additional files

Editorial Notes