Condition category
Mental and Behavioural Disorders
Date applied
29/07/2008
Date assigned
19/08/2008
Last edited
19/08/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Adelheid Kuhlmey

ORCID ID

Contact details

Charité - Universitätsmedizin Berlin
Institut für Medizinische Soziologie
Thielallee 47
Berlin
14195
Germany
+49 (0)30 8445 1800
medsoz@charite.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

LT-Demenz 44-083

Study information

Scientific title

Effectiveness of the German version of the Serial Trial Intervention for the reduction of challenging behaviours in people with Dementia

Acronym

STI-D

Study hypothesis

Application of the Serial Trial Intervention for Dementia (STI-D) reduces challenging behaviours in nursing home patients with dementia to a significantly greater extent than standard care.

Ethics approval

Ethics approval received from the Ethikkommission der Charite - Universitatsmedizin Berlin on the 12th June 2008 (ref: EA1/094/08)

Study design

Multicentre cluster-randomised single-blinded placebo-controlled study

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

German version of the Serial Trial Intervention (STI-D). The Serial Trial Intervention constitutes a structured framework for the process of assessment and intervention when challenging behaviours occur. It is carried out by skilled nurses in the nursing home setting. A detailed manual exists.

Nurses from nursing homes assigned to the intervention group are trained to implement the STI-D in their daily clinical care. This is included in a seminar on challenging behaviours in persons with dementia and appropriate care approaches in general.

Nurses from nursing homes assigned to the control group receive a seminar about challenging behaviours in persons with dementia and appropriate care approaches in general that does not include a STI-D training.

Both seminars include two days of classroom session for the registered nurses as well as clinical visits from instructors. Duration of treatment as well as follow-up will both last for six months after nurses have completed training. This applies for both study arms.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Challenging behaviours, measured using the Neuropsychiatric Inventory Nursing Home Version (NPI-NH).

Time points:
Before staff trainings are initiated, four weeks after training is completed, six months after training is completed.

Secondary outcome measures

1. Quality of life, measured using the Qualidem questionnaire
2. Pain, measured either using a Verbal Descriptor Scale oder BISAD (Beobachtungsinstrument für das Schmerzassessment bei alten Menschen mit Demenz), a tool for behavioural pain measurement, depending on the cognitive capacity of the patient
3. Analgesics and psychotropics prescribed, taken from patient records and converted to Defined Daily Doses

Time points:
Before staff trainings are initiated, four weeks after training is completed, six months after training is completed.

Overall trial start date

01/09/2008

Overall trial end date

30/09/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Nursing home resident
2. Dementia
3. Mini-Mental State Examination (MMSE) less than 24
4. Aged 65 years and older, male and female

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

n = 465

Participant exclusion criteria

1. Psychotic disorders
2. Residency in nursing home less than four weeks

Recruitment start date

01/09/2008

Recruitment end date

30/09/2009

Locations

Countries of recruitment

Germany

Trial participating centre

Charité - Universitätsmedizin Berlin
Berlin
14195
Germany

Sponsor information

Organisation

Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)

Sponsor details

Institut für Medizinische Soziologie
Charitéplatz 1
Berlin
10117
Germany
+49 (0)30 450 577 004
Thomas.Fischer@charite.de

Sponsor type

Hospital/treatment centre

Website

http://www.charite.de/medsoz

Funders

Funder type

Government

Funder name

German Federal Ministry of Health (Bundesministerium fur Gesundheit [BMG]) (Germany) (ref: LT Demenz 44-083)

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

Publication citations

Additional files

Editorial Notes