Reducing challenging behaviours in people with dementia through a nurse-led intervention
| ISRCTN | ISRCTN61397797 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61397797 |
| Secondary identifying numbers | 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
Scientific
Charité - Universitätsmedizin Berlin
Institut für Medizinische Soziologie
Thielallee 47
Berlin
14195
Germany
| Phone | +49 (0)30 8445 1800 |
|---|---|
| medsoz@charite.de |
Study information
| 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 |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 |
| Completion date | 30/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | n = 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
14195
Germany
Sponsor information
Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)
Hospital/treatment centre
Hospital/treatment centre
Institut für Medizinische Soziologie
Charitéplatz 1
Berlin
10117
Germany
| Phone | +49 (0)30 450 577 004 |
|---|---|
| Thomas.Fischer@charite.de | |
| Website | http://www.charite.de/medsoz |
"ROR" |
https://ror.org/001w7jn25 |
Funders
Funder type
Government
German Federal Ministry of Health (Bundesministerium fur Gesundheit [BMG]) (Germany) (ref: LT Demenz 44-083)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
11/06/2019: Publication reference added.
