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Trial registered on ANZCTR


Registration number
ACTRN12617000496314
Ethics application status
Approved
Date submitted
20/03/2017
Date registered
5/04/2017
Date last updated
5/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Behavioural and psychological symptoms of dementia in residential care: efficacy of an education and non-pharmacological intervention program
Scientific title
BPSDplus: a person centred approach to managing behavioural and psychological symptoms of dementia in residential care
Secondary ID [1] 291368 0
NHMRC APP1102028
Universal Trial Number (UTN)
Trial acronym
BPSDplus
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 302358 0
Behavioural and Psychological Symptoms of Dementia 302359 0
Condition category
Condition code
Neurological 301947 301947 0 0
Dementias
Mental Health 301950 301950 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This program evaluates the efficacy of a person-centred care approach to reduce behavioural and psychological symptoms of dementia (BPSD) and the use of pharmacological treatments to manage these behaviours in residential care.

The BPSDplus program is an evidence-based program developed by the research team. Principles are derived from a systematic review of person-centred care approaches (e.g. DICE approach) to provide structured care for people with BPSD and the use of non-pharmacological interventions (NonPI) to manage BPSD. The program is guided by the recent Clinical Practice Guidelines for Dementia in Australia 2016.

The BPSDplus program includes two intervention components: 1) education delivered to staff (nursing and personal care assistants); and 2) a structured person-centred program to identify BPSD and treat them using NonPI.

PART1: CARE STAFF EDUCATION
A two-day training course made up of six modules (1. Introduction; 2. Dementia; 3. BPSD; 4. Australian Guidelines of Best Practice; 5. NonPI for BPSD; 6. BPSDplus intervention implementation). Care staff will receive a comprehensive training manual that complements the course. Care staff will be trained by the project team.

PART 2: BPSDplus PROGRAM
The BPSDplus program provides care staff with a structured approach to identify BPSD amongst residents and implement person-centred care to manage these behaviours using NonPI. Care staff will completed the following steps as part of the program:

STEP 1: Identification of presence and severity of BPSD using the Neuropsychiatric Inventory Nursing Home (NPI-NH).

STEP 2: Determine potential causes of BPSD: identification of possible physical or medical causes of BPSD using the Abbey Pain Scale, Delirium Observation Screening Scale and a Checklist of Potential Unmet Needs).

STEP 3: Using person-centred care approach determine which NonPI to be used to manage the most severe BPSD using the BPSDplus Intervention Selection Flowchart. Selection of the intervention is specific to the BPSD identified as being most severe on the NPI-NH. Care staff select the most appropriate intervention for the presenting behaviour. Interventions included in this program were identified through an evidence-based review of the literature. Interventions to be included in this program are detailed below.

STEP 4: Implementation of resident-specific NonPI (3 times per week for 4 weeks). Care staff to be randomly allocated to residents for the administration of the intervention sessions.

STEP 5: Efficacy of the selected intervention is evaluated every four weeks using Steps 1 to 4. Evaluation will be done by care staff in accordance with a Sequential Multiple Assignment Randomized Trial (SMART) design. For interventions found to not be effective after 4 weeks, care staff will select the next NonPI identified in the BPSDplus Intervention Selection Flowchart. This intervention will then be implemented for 4 weeks and progress then reviewed.

INTERVENTION PROTOCOLS: Care staff to deliver all interventions. Intervention time slots will be 30 minutes (15 min active intervention; 15 min preparation and debrief). Care staff will be trained in the delivery of interventions as part of their two day training. 10% of each intervention type to be observed by the principle investigator or project team for inter-rater reliability and to monitor communication styles.

EXERCISE The intervention protocol involves talking the participating resident with dementia on a 15 minute walk. The walk will be on a predetermined route, either within the facility or outside the facility depending upon care needs. Communication to be limited to prescriptive informative and supportive language to minimise the potential of confounding results with social communication. Protocol fidelity: care staff leading the walk to complete a checklist of essential protocol items, including pre-walk checklist (asked to go for walk, wearing appropriate clothing, elimination needs attended to, offered a drink), time walk started, duration of walk, route taken, comments about deviations from protocol).

MASSAGE AND TOUCH The intervention protocol involves a hand and arm massage for 15 minutes. The massage will be administered by the care staff. Communication to be limited to prescriptive informative and supportive language to minimise the potential of confounding results with social communication. Protocol fidelity: care staff providing the massage to complete a checklist of essential protocol items, including pre-massage checklist (asked if resident wants a massage, wearing appropriate clothing, elimination needs attended to, offered a drink), time massage started, duration of massage, location where given massage, comments about deviations from protocol).

REMINISCENCE THERAPY The intervention protocol involves discussion of past activities, events and life experiences. This intervention will be administered one-on-one by the care staff. The discussion is aided by the use of prompts such as question cards, photographs, or recordings if available. Care staff will be provided with set questions and instructions to facilitate discussion. This intervention itself will last for 15 minutes. Protocol fidelity: care staff facilitating the reminiscence therapy will complete a checklist of protocol items which include questions asked, number of responses and session duration.

MUSIC THERAPY The intervention protocol involves listening to a selection of preferred music as selected by the resident or their next-of-kin prior to the intervention. The music will be downloaded onto a portable device (e.g. iPod/iPad) and listened to using headphones or speaker based on preference. The resident will listen to the selected music for 15 minutes. The intervention will be delivered by the care staff who will remain with the resident for the duration of the intervention to observe reactions to the music. Protocol fidelity: care staff will complete a checklist of essential protocol items, including pre-music therapy checklist (asked if resident wants to listen to music, wearing appropriate clothing, elimination needs attended to, offered a drink), time music listening started, duration of music listening, location where music listening occurred, mood of resident before and after listening to music, mode through which resident listened to music (headphone/speaker), comments about deviations from protocol).

MEANINGFUL AND PLEASANT ACTIVITIES (MaPA) intervention protocol involves identifying activities are meaningful to the resident with dementia by creating feelings of pleasure and enjoyment; a sense of connection and belonging; and promoting a sense of autonomy and personal identity. A list of MaPA will be identified by each the resident, their next-of-kin and care staff prior to the intervention. This will include the top 10 preferred and disliked activities. The top 5 preferred activities as identified by all will form the meaningful and pleasant activities list for each resident. Care staff will select the top activity to implement, rotating through the activities over time and sessions. Care staff will engage the resident in accordance with the activity instructions provided for 15 minutes. Protocol fidelity: care staff will complete a checklist of essential protocol items, including pre-activity checklist (which activity implemented, asked if resident wants to engage in the activity, wearing appropriate clothing, elimination needs attended to, offered a drink), time activity started, duration of activity, location where activity occurred, materials used in activity, comments about deviations from protocol).

PARTICIPATION DURATION:

CARE STAFF will participate in the program for a duration of 24 months. During this time they will complete the care staff training and implement the BPSDplus program with residents. Care staff will be allocated to specific residents throughout the 24 month program and will completed the following assessments: a) Care staff questionnaire: to be completed at 5 monthly intervals (total of 5 assessment points); b) Resident Questionnaire: to be completed at monthly intervals (total of 12 assessment points) for each allocated resident. c) Resident Intervention sessions: care staff to be randomly allocated to timeslots to administer NonPI with residents (intervention timetable to be provided to care staff). Each intervention timeslot to last for a duration of 30 minutes. Care staff will be randomly allocated to intervention timeslots to avoid administrator effects/bias and not confound assessments. Random allocation of staff to intervention timeslots (monthly roster) will help reduce treatment bias and reduce staff burden.

RESIDENTS will participate in the program for a duration of 12 months. Residents will completed the following tasks where possible: a) Resident Questionnaire: administered by the research team on a monthly basis (total of 12 assessment points) to assess changes in cognitive function and quality of life as rated by the resident. b) NonPI sessions: residents will partake in 30-min intervention sessions (15 min active intervention, 3 times per week, for 4 weeks) when BPSD are present. The intervention type may be changed every four weeks in accordance with the SMART design of the study. For residents who do not present with clinically significant BPSD, no intervention sessions will be implemented.

NEXT-OF-KIN with enduring power of attorney (EPOA) will only complete pre- and post-intervention telephone interviews with the research team.

INTERVENTION ADHERENCE AND FIDELITY:

Intervention adherence and fidelity checks will be implemented in accordance with the NIH’s Behavioural Change Consortium treatment fidelity framework. For example, to ensure adherence to the intervention protocols, a small number of intervention sessions will be videotaped (with consent) to enable fidelity assessments. The video recordings will only focus on the care staff and will not include the resident. Care staff training sessions will also be videotaped (with consent) to enable fidelity assessments of the training. The video recording will only focus on the research team.
Intervention code [1] 297403 0
Behaviour
Intervention code [2] 297404 0
Early detection / Screening
Intervention code [3] 297569 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301410 0
RESIDENT: BPSD as measured by the NPI-NH which assessed the presence and severity of 12 BPSD.
Timepoint [1] 301410 0
Pre-intervention baseline assessment; monthly assessment for a total of 12 month during particpation in the intervention program; post-intervention.
Primary outcome [2] 301411 0
RESIDENT: Change in the administration of antipsychotic medication (frequency and dose) used to treat BPSD and recorded in the medical records held by the care facility.
Timepoint [2] 301411 0
Pre-intervention baseline assessment; monthly assessment for a total of 12 month during particpation in the intervention program; post-intervention.
Primary outcome [3] 301412 0
RESIDENT: Quality of life as measured by the Quality of Life in Alzheimer's Disease (QoL-AD).
Timepoint [3] 301412 0
Pre-intervention baseline assessment; monthly assessment for a total of 12 month during particpation in the intervention program; post-intervention.
Secondary outcome [1] 332559 0
CARE STAFF: Self-reported stress associated with the provision of care to residents with BPSD as assessed by the Strain in Dementia Care Scale (SDCS).
Timepoint [1] 332559 0
Pre-training baseline assessment; post-training every five months during the 24 month implementation of the intervention program; post-completion of the BPSDplus intervention program. Total of 6 assessments.
Secondary outcome [2] 332560 0
CARE STAFF: Self-report of skills and competence in working with residents with dementia as measured by the Sense of Competence in Dementia Care Staff (SCIDS).
Timepoint [2] 332560 0
Pre-training baseline assessment; post-training every five months during the 24 month implementation of the intervention program; post-completion of the BPSDplus intervention program. Total of 6 assessments.
Secondary outcome [3] 332561 0
CARE STAFF: Knowledge of dementia as assessed by the Dementia Knowledge Assessment Scale (DKAS).
Timepoint [3] 332561 0
Pre-training baseline assessment; post-training every five months during the 24 month implementation of the intervention program; post-completion of the BPSDplus intervention program. Total of 6 assessments.
Secondary outcome [4] 332962 0
CARE STAFF: Extent to which care within the facility is experienced by staff as being person-centred as assessed by the Person-Centred Care Assessment Tool.
Timepoint [4] 332962 0
Pre-training baseline assessment; post-training every five months during the 24 month implementation of the intervention program; post-completion of the BPSDplus intervention program. Total of 6 assessments.
Secondary outcome [5] 332963 0
CARE STAFF: Care staff burden associated with the provision of formal care as assessed by the Professional Care Team Burden Scale.
Timepoint [5] 332963 0
Pre-training baseline assessment; post-training every five months during the 24 month implementation of the intervention program; post-completion of the BPSDplus intervention program. Total of 6 assessments.
Secondary outcome [6] 332964 0
Attitudes towards people with dementia as assessed by the Approaches to Dementia Questionnaire.
Timepoint [6] 332964 0
Pre-training baseline assessment; post-training every five months during the 24 month implementation of the intervention program; post-completion of the BPSDplus intervention program. Total of 6 assessments.
Secondary outcome [7] 332965 0
Work engagement as assessed by the Work and Wellbeing Survey.
Timepoint [7] 332965 0
Pre-training baseline assessment; post-training every five months during the 24 month implementation of the intervention program; post-completion of the BPSDplus intervention program. Total of 6 assessments.
Secondary outcome [8] 332966 0
Staff experiences, satisfaction, and relationships with both other staff and relatives of residents with dementia as assessed by the Staff Experience with Residents with Dementia Questionnaire (composite).
Timepoint [8] 332966 0
Pre-training baseline assessment; post-training every five months during the 24 month implementation of the intervention program; post-completion of the BPSDplus intervention program. Total of 6 assessments.
Secondary outcome [9] 332967 0
NEXT OF KIN: Knowledge of dementia as assessed by the Dementia Knowledge Assessment Scale (DKAS).
Timepoint [9] 332967 0
Pre-intervention baseline assessment and post-intervention.
Secondary outcome [10] 332968 0
NEXT OF KIN: Next of kin report of percieved skills and competence of care staff working with residents with dementia as measured by the Sense of Competence in Dementia Care Staff (SCIDS) - adapted.
Timepoint [10] 332968 0
Pre-intervention baseline assessment and post-intervention.
Secondary outcome [11] 332969 0
NEXT OF KIN: Extent to which care within the facility is experienced by next of kin as being person-centred as assessed by the Person-Centred Care Assessment Tool - adapted.
Timepoint [11] 332969 0
Pre-intervention baseline assessment and post-intervention.
Secondary outcome [12] 332970 0
RESIDENT: Independence in activities of daily living as assessed by the Katz Index of Independence in Activities of Daily Living.
Timepoint [12] 332970 0
Pre-intervention baseline assessment; monthly assessment for a total of 12 month during particpation in the intervention program; post-intervention.
Secondary outcome [13] 332971 0
RESIDENT: Measurement of pain in people living with dementia as assessed by the Abbey Pain Scale.
Timepoint [13] 332971 0
Pre-intervention baseline assessment; monthly assessment for a total of 12 month during particpation in the intervention program; post-intervention.
Secondary outcome [14] 332972 0
RESIDENT: Assessment of delirium as assessed by the Delirium Observation Screening Scale.
Timepoint [14] 332972 0
Pre-intervention baseline assessment; monthly assessment for a total of 12 month during particpation in the intervention program; post-intervention.
Secondary outcome [15] 332973 0
RESIDENT: Potential unmet needs as assessed by the Needs Assessment.
Timepoint [15] 332973 0
Pre-intervention baseline assessment; monthly assessment for a total of 12 month during particpation in the intervention program; post-intervention.
Secondary outcome [16] 332974 0
RESIDENT: Level of cognitive functioning as assessed by the Montreal Cognitive Assessment.
Timepoint [16] 332974 0
Pre-intervention baseline assessment; monthly assessment for a total of 12 month during particpation in the intervention program; post-intervention.
Secondary outcome [17] 332975 0
RESEARCH TEAM: Assessment of the care environment using the Environmental Audit Tool..
Timepoint [17] 332975 0
Pre-intervention baseline assessment.

Eligibility
Key inclusion criteria
RESIDENT: permanent resident of a residential aged care facility, diagnosis of dementia (any type), mild cognitive impairment, or cognitive impairement as indicated by MMSE < 27. Resident (if able to) give consent, next-of-kin/informant with EPOA to consent to trial if unable to consent.

CARE STAFF: Nursing or personal care staff employed at participating residential aged care facility, and involved in daily care of residents.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
RESIDENTS:
- No consent from EPOA/Guardian and/or verbal assent.
- Schizophrenia, bipolar disorder, psychotic depression or other current psychotic condition under active treatment.
- Medical illness or condition that would make data collection impossible.
- Respite residential status.
- Resident at residential aged care for less than one month (to be waitlisted for later participation in intervention).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2017
Actual
Date of last participant enrolment
Anticipated
1/05/2019
Actual
Date of last data collection
Anticipated
31/12/2019
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment postcode(s) [1] 15554 0
2602 - Ainslie
Recruitment postcode(s) [2] 15555 0
2904 - Monash
Recruitment postcode(s) [3] 15556 0
2607 - Farrer

Funding & Sponsors
Funding source category [1] 295840 0
Government body
Name [1] 295840 0
NHMRC-ARC Dementia Fellowship
Country [1] 295840 0
Australia
Primary sponsor type
University
Name
Australian National University
Address
Centre for Research on Ageing, Health & Wellbeing
The Australian National University
Florey, Building 54, Mills Road, Acton
ACT 2601 Australia
Country
Australia
Secondary sponsor category [1] 294736 0
None
Name [1] 294736 0
Address [1] 294736 0
Country [1] 294736 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297122 0
Australian National University Human Research Ethics Committee
Ethics committee address [1] 297122 0
Ethics committee country [1] 297122 0
Australia
Date submitted for ethics approval [1] 297122 0
11/01/2017
Approval date [1] 297122 0
24/03/2017
Ethics approval number [1] 297122 0
2015/740

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73050 0
Dr Moyra Mortby
Address 73050 0
Centre for Research on Ageing Health an Wellbeing,
CMBE Research School of Population Health
Florey, Building 54, Mills Road,
The Australian National University
Acton ACT 2601
Country 73050 0
Australia
Phone 73050 0
+61 2 6125 8413
Fax 73050 0
Email 73050 0
[email protected]
Contact person for public queries
Name 73051 0
Moyra Mortby
Address 73051 0
Centre for Research on Ageing Health an Wellbeing,
CMBE Research School of Population Health
Florey, Building 54, Mills Road,
The Australian National University
Acton ACT 2601
Country 73051 0
Australia
Phone 73051 0
+61 2 6125 8413
Fax 73051 0
Email 73051 0
[email protected]
Contact person for scientific queries
Name 73052 0
Moyra Mortby
Address 73052 0
Centre for Research on Ageing Health an Wellbeing,
CMBE Research School of Population Health
Florey, Building 54, Mills Road,
The Australian National University
Acton ACT 2601
Country 73052 0
Australia
Phone 73052 0
+61 2 6125 8413
Fax 73052 0
Email 73052 0
[email protected]

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No Supporting Document Provided



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