Contact information
Type
Scientific
Contact name
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/CTIS number
IRAS 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(s)
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
Study setting(s)
Other
Study 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
Primary outcome measure
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 study start date
01/09/2008
Overall study end date
30/09/2009
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Senior
Sex
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
Study 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
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/09/2008 | 11/06/2019 | Yes | No |