Study population
Outcome measures
All primary outcome measures were assessed by facility staff blind to treatment assignment. A cognitive assessment was undertaken at baseline and at the end of the six week intervention, using the Mini Mental State Examination (MMSE) [25]. The MMSE is the most widely used instrument to measure cognitive functioning and has been shown to have an excellent test/retest reliability of .89, and internal consistency of .83 [26]. The maximum score is 30 points. An MMSE score from 19 to 24 points indicates mild cognitive function impairment, a score from 10 to 18 indicates moderate cognitive impairment; and a score less than 10 indicates severe cognitive impairment [27].
Participants’ aggressive/non aggressive and agitated behaviours were measured using the Cohen-Mansfield Agitation Inventory-Short Form [8]. The CMAI-SF was administered five times in the study: 1. within the month prior to the intervention; 2. at the end of the second week of intervention; 3. at the end of the fourth week of intervention; 4. at the completion of the intervention, at the end of the sixth week; and 5. six weeks after the completion of the intervention, in week 12.
The Cohen-Mansfield Agitation Inventory (CMAI-SF) is an internationally validated instrument that measures behavioural disturbance in people with dementia in the previous two weeks. The items are scored on a five point frequency scale, from 1 “Never”, to 5 “A few times an hour or continuing for half an hour or more”. The CMAI-SF is completed by caregivers and takes approximately 10 minutes to complete. In the current study, to accommodate staff leave, a trained research assistant (rater) asked small groups of staff who were regular carers of the individual to rate the individual’s behaviour over the previous fortnight. The group discussed the rating to ensure there was consensus in the rating. At anyone rating session there were always a minimum of two carers who had previously rated the individual. Retrospective reviews of each participant’s functional needs were assessed from patient record data. This data recorded assessment data, including type and amount of assistance required for daily living.
We invited the facility care managers to identify residents who appeared to meet the selection criteria from a population of 284. They then sent information and informed consent forms to next of kin of the 165 residents identified. Randomisation assignments were given to participants following baseline testing; these were generated using a random number table and a person not involved in the study randomised participants into three groups in each residential care facility. Participant demographics were obtained from the facility manager who copied information required for the study from resident records.