Reducing challenging behaviours in people with dementia through a nurse-led intervention

ISRCTN	ISRCTN61397797
DOI	https://doi.org/10.1186/ISRCTN61397797
Protocol serial number	LT-Demenz 44-083
Sponsor	Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)
Funder	German Federal Ministry of Health (Bundesministerium fur Gesundheit [BMG]) (Germany) (ref: LT Demenz 44-083)

Submission date: 29/07/2008
Registration date: 19/08/2008
Last edited: 11/06/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Adelheid Kuhlmey
Scientific

Charité - Universitätsmedizin Berlin
Institut für Medizinische Soziologie
Thielallee 47
Berlin
14195
Germany

Phone	+49 (0)30 8445 1800
Email	medsoz@charite.de

Study information

Primary study design	Interventional
Study design	Multicentre cluster-randomised single-blinded placebo-controlled study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Effectiveness of the German version of the Serial Trial Intervention for the reduction of challenging behaviours in people with Dementia
Study acronym	STI-D
Study objectives	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(s)	Ethics approval received from the Ethikkommission der Charite - Universitatsmedizin Berlin on the 12th June 2008 (ref: EA1/094/08)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	30/09/2009

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	465
Key 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
Key exclusion criteria	1. Psychotic disorders 2. Residency in nursing home less than four weeks
Date of first enrolment	01/09/2008
Date of final enrolment	30/09/2009

Locations

Countries of recruitment

Germany

Study participating centre

Charité - Universitätsmedizin Berlin

Berlin
14195
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	01/09/2008	11/06/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

11/06/2019: Publication reference added.