Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001253695
Ethics application status
Approved
Date submitted
20/10/2023
Date registered
4/12/2023
Date last updated
23/02/2024
Date data sharing statement initially provided
4/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Paearahi (health navigator) supported health and wellbeing assessment for koeke (older Maori)
Scientific title
Paearahi (health navigator) supported interRAI Check Up Self Report (CU-SR) Assessment Delivery Project for older Maori in the Lakes area: assessing the impact on wellbeing.
Secondary ID [1] 310826 0
Nil
Universal Trial Number (UTN)
U1111-1299-2839
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Older adult health 331821 0
Condition category
Condition code
Public Health 328566 328566 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Completion of a Check-Up Self-Report (CU-SR) interRAI assessment: The interRAI Check-Up Self Report (CU-SR) is one of the tools in the suite of interRAI assessments and is used to gain a person’s perspective on their own health and wellbeing. The CU-SR differs from other interRAI tools as it does not require a health professional to complete the assessment. Participants are required to respond to 78 different multi-choice questions across 9 domains including demographic information; thinking and communication; Well-being; daily activities; health conditions; disease diagnoses; nutrition; procedures and treatments; finances and stressors.
interRAI CU-SR Assessment - a physical copy of the assessment will be available in the general practice waiting room for self-completion or be provided by the paearahi for participant to complete themselves {after having either received a referral from a staff member at Korowai Aroha or via if participants get in touch after advertisements in the waiting room/general practice social media page). There is no allocation but numbers of participants who entered via each recruitment pathway will be recorded. If participants are unable to complete it independently, paearahi will administer the assessment (i.e ask the questions) and record the responses. Responses will then be entered by the paearahi into the interRAI software (Momentum (TM)). Due to interRAI requirements, all questions need to be asked using the exact words on the assessment tool.
The assessment takes approximately 30minutes to complete.

The paearahi have received 4 hours of training from an interRAI educator regarding how to undertake an assessment and how to enter the information into the interRAI database. They will also receive 2 hours training from the Principal Investigator to familarise themselves with the study protocol. This training will all occur prior to first enrolment. Principal investigator and interRAI educator will be available throughout the study to support paearahi if needed.

The paearahi will record if they have had to support the participants to complete the assessment or if the participant was able to complete it themselves. Paearahi will record all questions that participants are reluctant to answer or which are perceived to cause discomfort or confusion. All questions need to be completed for the assessment to be able to entered into the Momentum software.
Intervention code [1] 327238 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336371 0
Wellbeing
Timepoint [1] 336371 0
Baseline and 12-weeks post-assessment
Secondary outcome [1] 428066 0
Any change in holistic wellbeing
Timepoint [1] 428066 0
12 weeks post-assessment
Secondary outcome [2] 428067 0
Number of assessments completed
Timepoint [2] 428067 0
At the conclusion of the study, after assessment has finished with all participants.
Secondary outcome [3] 428069 0
Number of Needs Assessment Coordinator (NASC) assessments
Timepoint [3] 428069 0
12 weeks post-assessment
Secondary outcome [4] 428070 0
Number of referrals to health/social providers and activities. This is composite endpoint. Examples of activities could include group exercise programmes or social groups.
Timepoint [4] 428070 0
12 weeks post-assessment
Secondary outcome [5] 428071 0
Primary care utilisation
Timepoint [5] 428071 0
6 months pre-assessment and 6 months post assessment
Secondary outcome [6] 428073 0
Ambulatory sensitive hospitalisations
Timepoint [6] 428073 0
6 months pre and post assessment
Secondary outcome [7] 428074 0
Participant and family experiences of intervention
Timepoint [7] 428074 0
12 weeks post-assessment
Secondary outcome [8] 428075 0
Increase in capacity and capability to undertake assessments
Timepoint [8] 428075 0
At the conclusion of the study, after assessment has finished with all participants
Secondary outcome [9] 428076 0
Number of paearahi visits
Timepoint [9] 428076 0
12 weeks post-assessment
Secondary outcome [10] 428077 0
Record questions that cause confusion or discomfort
Timepoint [10] 428077 0
During assessment delivery within 1 month after enrollment.
Secondary outcome [11] 428078 0
Time to complete assessment
Timepoint [11] 428078 0
Throughout assessment delivery within 1 month after enrollment
Secondary outcome [12] 428079 0
Extra resources required to deliver intervention by health practice
Timepoint [12] 428079 0
During assessment delivery within 1 month after enrollment.

Eligibility
Key inclusion criteria
Maori (or Maori whanau)
55-years plus
Enrolled in Korowai Aroha General Practice
Community-dwelling
Ability to understand written and/or spoken English
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Previous Needs Assessment Service Coordination (NASC) assessment
On waitlist for NASC assessment
Currently receiving publicly funded home supports
Resides in aged residential care
Unable to provide informed consent

Study design
Purpose of the study
Diagnosis
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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/12/2023
Actual
15/01/2024
Date of last participant enrolment
Anticipated
29/02/2024
Actual
Date of last data collection
Anticipated
30/06/2024
Actual
Sample size
Target
50
Accrual to date
15
Final
Recruitment outside Australia
Country [1] 25911 0
New Zealand
State/province [1] 25911 0

Funding & Sponsors
Funding source category [1] 315073 0
Government body
Name [1] 315073 0
Te Whatu Ora - interRAI
Country [1] 315073 0
New Zealand
Funding source category [2] 315074 0
Hospital
Name [2] 315074 0
Te Whatu ora - Lakes
Country [2] 315074 0
New Zealand
Primary sponsor type
Government body
Name
Te Whatu Ora - interRAI
Address
69 Tory St Wellington 6011
Country
New Zealand
Secondary sponsor category [1] 317091 0
Hospital
Name [1] 317091 0
Te Whatu ora - Lakes
Address [1] 317091 0
Corner Arawa St, Rotorua 3010
Country [1] 317091 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314020 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 314020 0
Ethics committee country [1] 314020 0
New Zealand
Date submitted for ethics approval [1] 314020 0
16/10/2023
Approval date [1] 314020 0
13/12/2023
Ethics approval number [1] 314020 0

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

Contacts
Principal investigator
Name 130146 0
Dr Joanna Hikaka
Address 130146 0
University of Auckland, 93 Grafton Rd, Auckland, 1010
Country 130146 0
New Zealand
Phone 130146 0
+64211304917
Fax 130146 0
Email 130146 0
j.hikaka@auckland.ac.nz
Contact person for public queries
Name 130147 0
Joanna Hikaka
Address 130147 0
University of Auckland, 93 Grafton Rd, Auckland, 1010
Country 130147 0
New Zealand
Phone 130147 0
+64 21 130 4917
Fax 130147 0
Email 130147 0
j.hikaka@auckland.ac.nz
Contact person for scientific queries
Name 130148 0
Joanna Hikaka
Address 130148 0
University of Auckland, 93 Grafton Rd, Auckland, 1010
Country 130148 0
New Zealand
Phone 130148 0
+64 211304917
Fax 130148 0
Email 130148 0
j.hikaka@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We have not included this in our ethics application.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20697Study protocol  j.hikaka@auckland.ac.nz



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.