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Trial registered on ANZCTR


Registration number
ACTRN12623000434695
Ethics application status
Approved
Date submitted
14/04/2023
Date registered
28/04/2023
Date last updated
4/08/2024
Date data sharing statement initially provided
28/04/2023
Date results provided
4/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Bringing Namaste Care to people with dementia at end of life in residential aged care services
Scientific title
Evaluating the Namaste Care Program on quality of life for people living with advanced dementia in residential aged care services
Secondary ID [1] 309455 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 329709 0
Quality of life 329787 0
Condition category
Condition code
Neurological 326608 326608 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Our project will address the need for a specialised program of care for people with dementia at EOL, by implementing the Namaste Care Program, a structured, non-pharmacological, person-centred group program that provides tailored, multi-sensory activities aimed at improving quality of life. Namaste Care has been specially developed for residents in the advanced stage of dementia, who may become agitated when there is too much stimulation. Namaste Care specifically stimulates a person’s senses to promote comfort and pleasure. Key activities of Namaste Care include options such as gentle face washing and face moisturising, shaving the “old-fashioned way”, hair combing/styling and application of makeup, if desired. Other key activities recommended within the program include hand and foot massage, range of motion exercises, reminiscence activities, interaction with seasonal scents, and other activities tailored to individual recipient preferences when these are known. The program is undertaken in a group setting, and includes family carers, staff and volunteers. The Namaste Care intervention will run for 2 hours, twice per day (am/pm sessions), 7 days a week for the duration of the project (6 months). Namaste Care champions from each service will be responsible for setting up the space and running the daily program. The space is prepared in advance and attention is given to creating a calm, relaxing and welcoming atmosphere. Natural light or low light is provided. Natural aromas are preferred including seasonal scents or an aromatherapy diffuser can be used. Gentle and relaxing sounds or music are used to create an atmosphere rather than providing entertainment. Relaxing visual images e.g. nature images, can be displayed on a screen or the presence of flowers or plants. Residents with advanced dementia are welcomed individually and made comfortable in a recliner chair. A soft blanket is wrapped around them. Pain assessments are undertaken with individual participants at the start of the session and levels of comfort are monitored throughout.
A range of multisensory activities (initiated by staff, family or volunteers) are then provided throughout the session:
• Expressive touch is used to communicate and connect with the residents, such as gentle face washing and hand massage.
• Snacks and beverages are offered to the residents throughout the session so that residents can receive favourite food and drinks, and experience different tastes, textures and sensations.
• Significant engagement items or items tailored for individual residents may be incorporated into the session e.g. personalised music, realistic dolls or animals or robotic simulations
Towards the end of the session, residents are aroused through a change of music, lighting and aromas.
• The Namaste Care Program will be implemented consistent with the implementation protocol for the individual site (developed in Stage 2).
• Data will be collected on resident participants receiving the Namaste Care intervention by Namaste Carers running the program. Two documents will be completed by the Namaste carers, these are: the Namaste Care Record Summary and Namaste Care Session record summary. These documents capture the types of activities that the person enjoys (or not), and the observed behaviours of the person receiving care as well as a progress notes on the Namaste Care session. This data will be collected at T2 (week 2), T3 (week 4) and T4 (week 12).

Intervention code [1] 325878 0
Treatment: Other
Intervention code [2] 325937 0
Lifestyle
Intervention code [3] 325938 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334465 0
Participant quality of life assessed using the Quality of Life in Late-Stage Dementia (QUALID) scale.
Timepoint [1] 334465 0
Baseline, 2, 4 (primary timepoint) and 12 weeks post intervention.
Primary outcome [2] 334466 0
Participant agitated behaviours assessed using the Cohen-Mansfield Agitation Inventory (CMAI).
Timepoint [2] 334466 0
Baseline, 2, 4 (primary timepoint) and 12 weeks post intervention
Secondary outcome [1] 420793 0
types of activities that the person enjoys (or not) - data collected using a Namaste Care Record Summary and Namaste Care Session record summary
Timepoint [1] 420793 0
week 2, 4 and 12 post intervention.
Secondary outcome [2] 420794 0
observed behaviours of the person receiving the Namaste Care Program using the Namaste Care Record Summary and Namaste Care Session record summary
Timepoint [2] 420794 0
week 2, 4 and 12 post intervention

Eligibility
Key inclusion criteria
Inclusion criteria for residents
# Inability to actively participate in dementia activity/memory programs as assessed by a senior clinical nurse at the service
# FAST 6 or 7 or GDS 6 or 7 or PAS Cognitive Impairment Scale 16-21 – senior clinical nurse will confirm the resident’s score and eligibility from the resident documentation
# Difficulty verbally communicating
# Need for assistance with personal care
# Non-ambulatory
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Residents who are still able to participate in usual memory support activities;
residents who are likely to be disruptive and/or will wander away, or
who are too unwell to attend the Namaste Care Program 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)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Participants can join the program as consent is obtained.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We are aiming for 30 participants over a 6-month timeframe across three services.
Paired t-tests (one-tailed test) will be used to measure differences from baseline to week 4 timepoint.. Magnitude of effect desired is an increase on QUALID between 4 and 10 points to achieve a SD of 6, similar to a previous study with similar sample size.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/09/2023
Actual
12/09/2023
Date of last participant enrolment
Anticipated
8/12/2023
Actual
6/12/2023
Date of last data collection
Anticipated
27/02/2024
Actual
8/03/2024
Sample size
Target
30
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment postcode(s) [1] 40112 0
7004 - Battery Point
Recruitment postcode(s) [2] 40113 0
7249 - Youngtown
Recruitment postcode(s) [3] 40114 0
7015 - Lindisfarne

Funding & Sponsors
Funding source category [1] 313651 0
Commercial sector/Industry
Name [1] 313651 0
Aged Care Research & Industry Innovation Australia (ARIIA)
Country [1] 313651 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
Churchill Avenue
Sandy Bay Tasmania 7005 Australia
Country
Australia
Secondary sponsor category [1] 315443 0
None
Name [1] 315443 0
None
Address [1] 315443 0
None
Country [1] 315443 0
Other collaborator category [1] 282629 0
Commercial sector/Industry
Name [1] 282629 0
Southern Cross Care (Tas) Inc.
Address [1] 282629 0
85 Creek Road New Town Tasmania 7009 Australia
Country [1] 282629 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312819 0
University of Tasmania HREC
Ethics committee address [1] 312819 0
Ethics committee country [1] 312819 0
Australia
Date submitted for ethics approval [1] 312819 0
21/03/2023
Approval date [1] 312819 0
20/06/2023
Ethics approval number [1] 312819 0

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

Contacts
Principal investigator
Name 126030 0
Dr Sara Karacsony
Address 126030 0
School of Nursing, College of Health and Medicine University of Tasmania Cnr Church and Glover Street Lilyfield NSW 2040
Country 126030 0
Australia
Phone 126030 0
+61 2 8572 7993
Fax 126030 0
Email 126030 0
[email protected]
Contact person for public queries
Name 126031 0
Sara Karacsony
Address 126031 0
School of Nursing, College of Health and Medicine University of Tasmania Cnr Church and Glover Street Lilyfield NSW 2040
Country 126031 0
Australia
Phone 126031 0
+61 2 8572 7993
Fax 126031 0
Email 126031 0
[email protected]
Contact person for scientific queries
Name 126032 0
Sara Karacsony
Address 126032 0
School of Nursing, College of Health and Medicine, University of Tasmania Cnr Church and Glover Street Lilyfield NSW 2040
Country 126032 0
Australia
Phone 126032 0
+61 2 8572 7993
Fax 126032 0
Email 126032 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers who provided a sound reason for request

Conditions for requesting access:
• -

What individual participant data might be shared?
• De-identified group data

What types of analyses could be done with individual participant data?
• Meta -analysis

When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication

To:
no end date determined

Where can requests to access individual participant data be made, or data be obtained directly?
• contact principal researcher by email [email protected]


Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18873Study protocol  [email protected]
18874Ethical approval  [email protected]



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.