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

• Register: ISRCTN
• Last refreshed on: 1 July 2019
• Main ID: ISRCTN61397797
• Date of registration: 19/08/2008
• Prospective Registration: Yes
• Primary sponsor: Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)
• Public title: Reducing challenging behaviours in people with dementia through a nurse-led intervention
• Scientific title: Effectiveness of the German version of the Serial Trial Intervention for the reduction of challenging behaviours in people with Dementia
• Date of first enrolment: 01/09/2008
• Target sample size: 465
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN61397797
• Study type: Interventional
• Study design: Multicentre cluster-randomised single-blinded placebo-controlled study (Quality of life)
• Phase: Not Specified

Countries of recruitment

Germany

Contacts

• Name: Adelheid Kuhlmey

Key inclusion & exclusion criteria

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

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Dementia
Mental and Behavioural Disorders
Unspecified dementia

Intervention(s)

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.

Primary Outcome(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.

Secondary Outcome(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.

Secondary ID(s)

LT-Demenz 44-083

Source(s) of Monetary Support

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

Ethics review

Status:
Approval date:
Contact:

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

Results

• Results available: Yes
• Date Completed: 30/09/2009