Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000263291
Ethics application status
Approved
Date submitted
8/02/2018
Date registered
20/02/2018
Date last updated
22/02/2019
Date data sharing statement initially provided
22/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Development of a person-centred model of care for people living with dementia in rural residential aged care homes
Scientific title
Harmony in the Bush: Co-design of a personalised model of care for dementia in rural residential aged care and its effect on agitation level, sleep quality and overall wellbeing for residents living with dementia, and on caregivers' stress level and the workplace culture change.
Secondary ID [1] 293985 0
'Nil known'
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 306499 0
Condition category
Condition code
Neurological 305604 305604 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will implement innovative strategies of an individualised care model developed based on the seven principles of a well-established Progressively Lowered Stress Threshold (PLST) framework for non-pharmacological care of dementia. The PLST intervention entails the introduction of individualised care plans based on the following principles of PLST theory:
• Introduce consistent individualised routines to compensate for conative losses
• Organise small group activities to eliminate overwhelming stimuli
• Allow residents to set their own sleep/wake cycle to prevent fatigue.
• Plan activities based on past experiences and practices taking into account present
cognitive and functional abilities
• Eliminate misleading stimuli that trigger illusions
The PLST model recognises that behavioural and psychological symptoms of dementia, such as agitation, are experienced by people with dementia and increased stress is triggered by internal and external environmental factors. These factors will be identified during the assessment phase of this research intervention, and the investigators will work with the residential aged care staff to help them modify the daily routine and implement more flexible, personalised activities of daily living including sleep. Prue Mellor (our Chief Investigator) will provide two one-hour training workshops to all aged care staff, on the theory and delivery of the PLST model and the use of the measurement tools to assess behaviours for residents living with dementia. Registered Nurses will attend an extra one-hour session of training.
Prue Mellor (RN, MNg (Geront), MNg (NPrac), MACN) is a clinical nurse specialist (gerontic and neurocognitive disorders) who is very experienced in delivering training in personalised aged care. The PLST model underpins her practice as a nurse specialist in dementia care for residential aged care facilities including Indigenous organisations, multipurpose organisations, Dementia Support Groups, and her own company - Age Concern Pty Ltd. She assists organisations to implement person-centred care practices that improves outcomes and meets accreditation requirements. An equal amount of her time is spent in consultations with organisations, assisting them to develop planned, workable nursing strategies for residents with negative behaviours or responses to care.
In this study, Prue Mellor will prepare/develop a co-designed personalised care and care plan for each resident living with dementia participant. All staff will be involved by assisting with the development of PLST-based personalised care plans through informing the investigators about previously observed or known needs and demands for care of the individual residents, and by implementing innovative personalised care plans during the intervention. The prepared, co-designed personalised care plans will be the guidelines for daily care of the resident participants during the research intervention period (n = 8 weeks), and during the 1-and 3-months post-intervention follow up periods. The aged care facility is expected to carry on with the personalised care plans beyond the research intervention period; with constant monitoring and updating of the care plans as necessary.
Senior management of the aged care facility will appoint two staff (one registered nurse and one carer) to act as change champions during the course of the intervention. The champions will be trained in the process to ensure sustainability. All staff members on duty will be responsible for observing and recording the residents’ behaviour on each shift.
The study also aims to measure sleep patterns of participating residents with dementia over five continuous days, with the main goal to investigate the quality of their sleep. Sleep will be measured using Actigraphy ACTi watches at baseline (0 weeks), and at 4 and 8 weeks after the introduction of the PLST intervention. ACTi watches will be fitted on the wrists of participating residents living with dementia to record the sleep patterns. Data from the sleep study will be incorporated into individualised care plans for those residents, predictably resulting in an improved sleep quality or wellbeing.
This research will also expand the PLST-based personalised care model intervention, by incorporating individualised preferred music/arts and movement programs to co-design a PLST plus music/arts and movement personalised care intervention. The investigators hypothesise that these co-designed PLST-based (without and with integrated individualised preferred music/arts activities) personalised care interventions will result in a low stress organisational environment and a positive workplace culture; thus leading to improved residents with dementia outcomes such as reduced agitation level, better quality sleep and overall wellbeing, reduced carers’ stress, and a positive change in the workplace culture. The music and arts/movement activities to be applied will be personalised and dependent on the participants’ preferences, and their appropriateness to the participants’ capability, participation and response. They can take the forms of music that may involve (1) past preferred music that will be individualised for listening by the participants with dementia and (2) group music and movement/dance, disability arts and creative aging program/s, visual arts mediums, storytelling, basketry/weaving, painting, drawing, screen-printing, knitting, and etching. Music/Arts preferences will be determined with the assistance of family or caregivers.
For all the five aged care facilities, individualised music will form the basis for the music/art and movement intervention. A key aspect to the success of individualised music is identifying specific music preferences including exact song titles and performers. Thus, we will use The Assessment of Personal Music Preference Protocol in the Evidence-Based Guideline of Individualised Music for persons with Dementia© (5th edition; Gerdner L.A., 2013) to assist in the process of music selection for each of the participating residents with dementia. The individualised music will be chosen after discussion with the resident, the resident’s family member or next of kin/legal guardian, and the nursing staff, and produced onto a device for listening at an appropriate time by the resident/s. The guideline presents a detailed description of the intervention.
The music/arts and movement activities will be delivered by different musicians/artists whose skills and knowledge best matched the most appropriate and preferred group or individualised music/arts and movement activities by the participants with dementia. Additional criteria for selecting and enlisting the musicians/artists include that they must be living and working locally within the area in which the relevant Aged Care facility to participate in is located. This is to ensure the project benefits the local community, and the intervention will be sustainable after the research project completion. The musicians/artists must also have acquired/will acquire the Criminal Clearance Check for working with the vulnerable people by relevant national or state authorities in Australia. During four weeks in each facility over the course of 2018, the artists will spend 1-hour session for two days each week alongside residents of the aged care facility. Each day will offer a whole group or individual activity, during which all participants will be encouraged to have a hands on experience sharing and playing with their favourite tracks, mixing, dubbing and exploring possibilities supported by the artists. The artists will facilitate each music/art and movement session guiding the conversations and musical explorations, posing questions to stimulate group and individual discussion. Aged care workers will work together with artists to ensure individuals are able to engage as fully as possible. The Music in Dementia Assessment Scales (MIDAS) will be used to assess changes in the wellbeing of a person with dementia participating in music or arts intervention.
Prior to the beginning of the study, Participants' Consent Forms, Information sheets and stamped return envelops will be posted to legal guardians of residents living with dementia by aged care administrators. Also, the Participants’ Consent Forms, Information sheets and stamped return envelops will be provided to the aged care senior staff/managers, caregivers and nurses, and the artists. Only those who freely and willingly volunteered to consent to the research participation will participate.
The research interventions will sequentially be implemented at five residential aged care facilities in rural South Australia (n = 2) and Queensland (n = 3) over 15 months period. On completion of the assessments and baseline data collection, aged care staff will be trained on the theory and delivery of PLST model and PLST + personalised music/arts activities interventions, and the use of the assessment tools. In addition, an individualised care plan for each resident participant will be co-designed or developed. The resident participants will then be introduced to four (4) weeks of developed personalised care plans involving only PLST-based intervention, follow by additional four (4) weeks of developed PLST + music/arts programs personalised care intervention. The nvestigators will gauge the desired activity and stimulation levels for each participant by using disturbed and dysfunctional behaviour as a measure, and adjust care as necessary. Data analysis will compare pre and post-intervention measures with 1 and 3 months follow up, to evaluate the effectiveness of the new model of care with and without music/arts integrated activities by analysing the impact of the interventions on the residents’ behavioural outcomes and sleep patterns. The analysis will also compare the baseline and post-interventions staff stress inventory data to measure the changes in levels of staff stress before and after the interventions. At least three videoconferencing sessions, of approximately 40 minutes each, of stakeholders (aged care staff and investigators) focus group discussions will be conducted after the PLST + music/arts interventions in each aged care facility. Also, consenting senior aged care staff, and randomly selected nursing/care staff and residents’ families (that freely and voluntarily consent) will participate in a 30-minutes one off one-to-one interview with the investigator. These qualitative data will offer interesting insights into the management and understanding of dementia care, and workplace culture.
Intervention code [1] 300262 0
Behaviour
Intervention code [2] 300263 0
Lifestyle
Intervention code [3] 300264 0
Treatment: Other
Comparator / control treatment
"No control group"
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304725 0
Change in agitation level of participants living with dementia as measured by the Cohen-Mansfield Agitation Inventory (CMAI)
Timepoint [1] 304725 0
Baseline, weeks 4 and 8 (Primary endpoint), 1 month after intervention commencement, and 3 months after intervention commencement.
Primary outcome [2] 304726 0
Change in caregivers stress levels as assessed by the Caregiver Stress Inventory (CSI)
Timepoint [2] 304726 0
Baseline, weeks 4 and 8 (Primary endpoint)
Primary outcome [3] 304727 0
Changes in sleep patterns of participants living with dementia as measured using Actigraphy ACTi watches fitted on the wrists of participating residents living with dementia over five continuous days
Timepoint [3] 304727 0
Baseline, weeks 4 and 8 (Primary endpoint)
Secondary outcome [1] 342940 0
Changes in the Apathy level of participants living with dementia assessed by the Apathy Evaluation Scale-clinician version (AES-C)
Timepoint [1] 342940 0
Baseline, week 8
Secondary outcome [2] 342941 0
Changes in levels of interest in engaging in music or arts activities by participants living with dementia as measured by Music in Dementia Assessment Scale (MiDAS):
Timepoint [2] 342941 0
Baseline, week 8
Secondary outcome [3] 342942 0
Changes in the depression signs or symptoms in participants living with dementia as assessed by Cornell Scale for Depression in Dementia (CSDD)
Timepoint [3] 342942 0
Baseline, weeks 4 and 8

Eligibility
Key inclusion criteria
Participants must:
1. have a dementia diagnosis within the Diagnostic and Statistical Manual of Mental Health Disorders 5 (American Psychiatric Association, 2013),
2. have a Standardized Mini Mental Status Examination (SMMSE) (Molloy et al, 1991) score of less than 24,
3. be ambulant, and
4. display dysfunctional behaviour
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participants have a medical condition that affects normative behavioural patterns

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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The total number of residents living with dementia across the five participating aged care facilities in this this study is a approximately 170-180. Allowing for 10% attrition, the investigators have estimate that 70-80 residents from this cohort can ensure a statistical power of 0.90. This estimation was based on a recent meta-analysis on effect of music therapy on agitation, which reports an overall effect size (Cohen’s d) of 0.61 calculated from 12 studies (Pedersen et al. 2017), and by adopting an alpha level of 0.05 and employing the algorithm detailed in Senn (1993, p.218). There is, however, shortage of studies with adequate sample size – only 2 of the 12 studies in the meta-analysis had a sample size required of at least 70 participants.

A quasi-experimental study design which compares pre- and post-intervention measures with one and three-month follow-up will be used. Quantitative data will be analysed using the statistical package SPSS. Descriptive data will be checked for outliers and assumptions for parametric analyses. Paired-t test and repeated measures ANOVA will be used to understand difference in baseline and follow-up assessments. Multivariate analyses will investigate the effect of PLST intervention with music/arts component as against PLST intervention without the music component measured using the waiting-list approach. The model will be adjusted for potential confounders. Qualitative data will be thematically analysed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
26/03/2018
Actual
3/03/2018
Date of last participant enrolment
Anticipated
23/02/2019
Actual
Date of last data collection
Anticipated
30/06/2019
Actual
Sample size
Target
70
Accrual to date
64
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA

Funding & Sponsors
Funding source category [1] 298615 0
Government body
Name [1] 298615 0
Australian Government Department of Health
Country [1] 298615 0
Australia
Primary sponsor type
University
Name
The Flinders University of South Australia
Address
PO Box 852, Renmark, SA 5341

Lot 1, Ral Ral Avenue, Renmark, SA 5351
Country
Australia
Secondary sponsor category [1] 297777 0
None
Name [1] 297777 0
Address [1] 297777 0
Country [1] 297777 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299575 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 299575 0
Ethics committee country [1] 299575 0
Australia
Date submitted for ethics approval [1] 299575 0
16/01/2018
Approval date [1] 299575 0
14/02/2018
Ethics approval number [1] 299575 0

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

Contacts
Principal investigator
Name 80890 0
Prof Jennnene Greenhill
Address 80890 0
Flinders University Rural Health South Australia
PO Box 852, Renmark, SA 5341
Lot 1, Ral Ral Avenue, Renmark, SA 5351
Country 80890 0
Australia
Phone 80890 0
+61 8 85861023
Fax 80890 0
+61 8 8586 3668
Email 80890 0
[email protected]
Contact person for public queries
Name 80891 0
Abraham Kuot
Address 80891 0
Flinders University Rural Health South Australia
PO Box 852, Renmark, SA 5341
Lot 1, Ral Ral Avenue, Renmark, SA 5351
Country 80891 0
Australia
Phone 80891 0
+61 8 8586 1035
Fax 80891 0
+61 8 8586 3668
Email 80891 0
[email protected]
Contact person for scientific queries
Name 80892 0
Jennene Greenhill
Address 80892 0
Flinders University Rural Health South Australia
PO Box 852, Renmark, SA 5341
Lot 1, Ral Ral Avenue, Renmark, SA 5351
Country 80892 0
Australia
Phone 80892 0
+61 8 85861023
Fax 80892 0
+61 8 8586 3668
Email 80892 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePerson-centered, non-pharmacological intervention in reducing psychotropic medications use among residents with dementia in Australian rural aged care homes.2021https://dx.doi.org/10.1186/s12888-020-03033-w
EmbaseThe outcomes of a person-centered, non-pharmacological intervention in reducing agitation in residents with dementia in Australian rural nursing homes.2021https://dx.doi.org/10.1186/s12877-021-02151-8
N.B. These documents automatically identified may not have been verified by the study sponsor.