Condition category
Mental and Behavioural Disorders
Date applied
10/04/2013
Date assigned
15/04/2013
Last edited
13/06/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The main objective of caring for people with dementia is to keep up and improve their quality of life (QoL). Many of the residents in nursing homes behave in a challenging (or demanding) manner that strongly affects their QoL. Person-centered care (PCC) aims to achieve the best possible QoL and to reduce this type of behaviour. Dementia Care Mapping (DCM) is a method of carrying out PCC that has been used in Germany for several years. We do not know how well DCM works and we want to find out about the effects of DCM for all concerned: patients and their caregivers.

Who can participate?
People with dementia and their caregivers in nine nursing homes in the St. John of Jerusalem Nursing Home Section West (Germany).

What does the study involve?
The nine nursing groups will be allocated to one of three groups:
Three groups will be set up. Dementia Care Mapping will be performed on group 1 . This group differs from group 2 , in that group 2 has already had experience in the use of DCM. Otherwise group 2 receives the same treatment as group 1. Group 3 will be assessed from time to time to check the Quality of Life. This will be done using a special method called QUALIDEM. In group 3, the QoL of all the people with dementia will be assessed at the start and will be done again if notable changes in the residents’ needs are noticed later. At least every 6 months, a new QoL assessment must be carried out. If necessary, the staff will discuss each individual case based on the results of the assessments in order to understand the particular needs of that resident/patient.

What are the possible benefits and risks of participating?
There are no risks of injury or harm if you take part in this study. The results of the QoL assessments will be standardized and these, when applied, will help to improve the person-centered care (PCC) of every person suffering from dementia. The participating caregivers will get additional or new information about person-centered care of people with dementia and will be able to compare it with the previous care offered.

Where is the study being run?
In nine nursing homes in the St. John of Jerusalem Nursing Home Section West.

When will the study start and how long is it expected to run for?
The study started in April 2011 and is expected to run until April 2013.

Who is funding the study?
The Public Welfare Foundation North Rhine-Westphalia (Stiftung Wohlfahrtspflege Nordrhein-Westfalen) and the Knights of St. John Regional Centre West provide the funding for this study.

Who is the main contact person for the study?
Dr Margareta Halek
Margareta.Halek@dzne.de

Trial website

Contact information

Type

Scientific

Primary contact

Dr Margareta Halek

ORCID ID

Contact details

Stockumer Str. 12
Witten
58453
Germany
Margareta.Halek@dzne.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Leben-QD II Strengthening Quality of life for people with dementia through dementia care-mapping: design of the quasi-experimental study

Acronym

Leben-QD II

Study hypothesis

The aims of this study are to evaluate the effects of Dementia Care Mapping (DCM) in dementia care in German nursing homes, to explore the implementation of Dementia Care Mapping and to perform a cost-effectiveness analysis.

Ethics approval

Ethics Committee of the German Society of Nursing Science approved on the 19 August 2010.

Study design

Quasi-experimental controlled trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Not specified

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

The study consists of three study arms.
To measure the effects of Dementia Care Mapping a quasi-experimental design is being used, with 3 measurement points. 9 nursing home units will be assigned to either the DCM intervention group or 1 of 2 comparison groups. The care provider will be responsible for the assignment of a unit to 1 of the 3 groups. The DCM method will be implemented in the 3 units assigned to the intervention group. The first comparison group will consist of 3 nursing units that have at least 3 years of experience in the use of the DCM method. The 3 units in the second comparison group will receive a control intervention based on the use of the dementia-specific Qol-measurement QUALIDEM. The groups will get the following interventions:

Intervention group: Dementia Care Mapping as interventions consists of 6 fixed components: 1) briefing and preparation of care staff and leadership, 2) DCM observation, 3) DCM data analysis and report-writing, 4) feedback of results to care staff and leadership, 5) action-planning by care staff based on the DCM results and 6) realization of the action plan.

Comparison group 1: This group receives the same intervention like the intervention group. The difference to the intervention group is that the 3 included nursing home units are experienced in the use of Dementia Care Mapping. The DCM process has been ongoing since 2009 in the comparison group units.

Comparison group 2: Based on the quality assurance criteria of the German medical advisory service of the statutory health insurance about the well-being of people with dementia and the integration of study results into the care process, it was not possible designate 1 group to care as usual. The dementia-specific measurement QUALIDEM was selected as a comparison intervention because it is known in Germany and, therefore, is a feasible option for assessing Qol in nursing homes. The assumption is that simply measuring Qol leads to a greater awareness of Qol by caregivers and supports the discussion on how to maintain or enhance it. For comparison group 2, the use of the QUALIDEM as a Qol assessment tool is nested in the following intervention components:
1. A short (1.5 hours) training program for staff on the 3 units, including some general information about Qol assessment for people with dementia and the usage of QUALIDEM in particular.
2. QUALIDEM usage as follows
a. An initial Qol-rating will be given to all residents with dementia within 3 months of the training (October – December 2012).
b. An additional Qol assessment will be conducted if notable changes in the residents’ needs are perceived. At least every 6 months, a new Qol assessment must be carried out. The Qol assessments will always be based on the proxy-rating agreements of 2 staff members (nurses or social workers) in relation to a retrospective observation period of 2 weeks.
c. If necessary, staff will initiate case conferences based on the results of the Qol ratings, to understand the individual needs of a particular resident. The care team will participate in these case conferences.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Quality of Life of people with Dementia measured with the Qol-AD proxy-measurement
2. Caregivers attitutes towards dementia meausred with the Attitudes to Dementia Questionnaire

Measured at baseline measure, a first follow up after 6 months and a second follow up after 20 months.

Secondary outcome measures

1. Quality of Life of people with Dementia measured with the QUALIDEM proxy-measurement
2. Challenging behavior of people with Dementia measured with the NPI-NH proxy-measurement
3. Caregivers job satisfaction (measured with the COPSOQ) and personal burnout (measured with the CBI)

Measured at baseline measure, a first follow up after 6 months and a second follow up after 20 months.

Overall trial start date

15/04/2011

Overall trial end date

30/04/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. People with dementia in 9 participating nursing homes units from the Knights of St. John of Jerusalem Nursing Home Section West.
2. People with dementia with a length of stay > 2 weeks on the respective nursing home unit
3. Caregivers from the 9 participating nursing homes units from the Knights of St. John of Jerusalem Nursing Home Section West.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

9 nursing home units (approximately 170 people with dementia and 120 caregivers).

Participant exclusion criteria

No informed consent for either patients or caregivers.

Recruitment start date

15/04/2011

Recruitment end date

30/04/2013

Locations

Countries of recruitment

Germany

Trial participating centre

Stockumer Str. 12
Witten
58453
Germany

Sponsor information

Organisation

St. John Regional Centre West (Johanniter Regionalzentrum West) (Germany)

Sponsor details

Siegburger Str. 197
Köln
50679
Germany
Stefan.Ortner@jose-johanniter.de

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

The funding for this study is provided by Public Welfare Foundation North Rhine-Westphalia (Stiftung Wohlfahrtspflege Nordrhein-Westfalen) and the Knights of St. John Regional Centre West - 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

2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23725292

Publication citations

  1. Results

    Halek M, Dichter MN, Quasdorf T, Riesner C, Bartholomeyczik S, The effects of dementia care mapping on nursing home residents' quality of life and staff attitudes: design of the quasi-experimental study Leben-QD II., BMC Geriatr, 2013, 13, 53, doi: 10.1186/1471-2318-13-53.

Additional files

Editorial Notes