Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12620000316909
Ethics application status
Approved
Date submitted
26/02/2020
Date registered
6/03/2020
Date last updated
20/06/2023
Date data sharing statement initially provided
6/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A Strength-Based and Peer Education Approach to helping Maori elders work through greatest needs
Scientific title
Enhancing kaumatua wellbeing through tuakana-teina/peer-education: Impacts on health and mana motuhake (self-actualisation)
Secondary ID [1] 300592 0
Nill
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Health-related quality of life 316324 0
Condition category
Condition code
Public Health 314593 314593 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project uses a tuakana-teina (older sibling/younger sibling)/peer education orientation programme for service utilisation for health and wellbeing needs.

Through a co-design process we worked with five service providers to identify the key health and social issues particular to their community. Once these were defined, a resource kit and orientation programme was created to guide four kaumatua to be tuakana (peer educators) with each service provider. The tuakana then serve as tuakana for six teina for a period of six months. Teina are the recipients of the peer education.

The resource kit include a variety of health and social services to refer the teina. The Tuakana Orientation Programme is a training programme consisting of four, three-hour sessions over a two-week period (i.e., 2 sessions per week) guiding the tuakana on peer education skills from a Maori perspective (e.g., effective listening, eliciting information, sharing stories and providing advice/referrals).

After completing the orientation programme, tuakana will talk with teina once a month for six months to understand their needs and empower them to gain access to needed health and social services. Each conversation will last between 30 and 60 minutes and be face-to-face. They will share the resource kit with the teina and link them to advocates withing their respective health providers.

The aim is to select teina participants randomly from a list of elders within each provider. They are assigned an intervention time based on location and assigned a tuakana based on matching characteristics (i.e., age and gender).
Intervention code [1] 316899 0
Lifestyle
Comparator / control treatment
The comparison group is a similar group of older people who will not receive the intervention during the initial phase of the project. They will receive the intervention approximately 4 months after the initial group.
Control group
Active

Outcomes
Primary outcome [1] 322929 0
Health-related quality of life; 7 items self-report adapted from Medical Outcomes Study; Wu A, Revicki D, Jacobsen D, Malitz F. Evidence for reliability, validity and usefulness of the Medical Outcomes Study HIV health survey (MOS-HIV). Qual Life Res. 1997; 6:481-93.
Timepoint [1] 322929 0
Pre-intervention assessment of outcomes; post first group-intervention assessment of outcomes==6 months follow-up (primary timepoint for first group); post-second group intervention assessment of outcomes 12 months follow-up`(primary timepoint for second group)
Primary outcome [2] 322970 0
Received social support; 4 items self-report from Unger JB, McAvay G, Bruce ML, et al. Variation in the impact of social network characteristics on physical functioning in elderly persons: MacArthur Studies of Successful Aging. Journals of Gerontology Series B-Psychological Sciences & Social Sciences 1999;54(5):S245-51
Timepoint [2] 322970 0
Pre-intervention assessment of outcomes; post first group-intervention assessment of outcomes==6 months follow-up (primary timepoint for first group); post-second group intervention assessment of outcomes 12 months follow-up`(primary timepoint for second group)
Primary outcome [3] 323015 0
Service utilisation and satisfaction with use; 3 items self-report created for this study
Timepoint [3] 323015 0
Pre-intervention assessment of outcomes; post first group-intervention assessment of outcomes==6 months follow-up (primary timepoint for first group); post-second group intervention assessment of outcomes 12 months follow-up`(primary timepoint for second group)
Secondary outcome [1] 380263 0
Mana motuhake (identity, autonomy): 1 item self-report from Te Kupenga Maori Social Survey measuring perceived autonomy--http://www.stats.govt.nz/survey-participants/a-z-of-our-surveys/te-kupenga-2013-questionnaire.aspx
Timepoint [1] 380263 0
Pre-intervention assessment of outcomes; post first group-intervention assessment of outcomes==6 months follow-up; post-second group intervention assessment of outcomes 12 months follow-up
Secondary outcome [2] 380264 0
Mana motuhake: 1 item self-report from Cantril's ladder for life satisfaction; Cantril, H. (1965). The pattern of human concerns. New Brunswick, NJ: Rutgers University Press
Timepoint [2] 380264 0
Pre-intervention assessment of outcomes; post first group-intervention assessment of outcomes==6 months follow-up; post-second group intervention assessment of outcomes 12 months follow-up
Secondary outcome [3] 380393 0
Loneliness; Maori loneliness scale; .Waldegrave, C., Cunningham, C., Love, C. and Nguyen, G. (2019) Developing a Maori Loneliness Scale: Work in progress, in Older Maori Co-creating Research on Loneliness and Social Isolation: Challenging Western Perspectives. A presentation to the Ageing Well Together: Science, Policy and Translation Conference at Te Wharewaka, Wellington. Friday 15 November 2019. Wellington: Family Centre Social Policy Research Unit
Timepoint [3] 380393 0
Pre-intervention assessment of outcomes; post first group-intervention assessment of outcomes==6 months follow-up; post-second group intervention assessment of outcomes 12 months follow-up
Secondary outcome [4] 380395 0
Elder abuse; adapted from Vulnerability to Abuse Screening Scale, coercion subscale; Schofield MJ, Reynolds R, Mishra GD, Powers JR, Dobson AJ. Screening for vulnerability to abuse among older women: Women’s Health Australia Study. J Appl Gerontol. 2002;21(1):23-4.
Timepoint [4] 380395 0
Pre-intervention assessment of outcomes; post first group-intervention assessment of outcomes==6 months follow-up; post-second group intervention assessment of outcomes 12 months follow-up
Secondary outcome [5] 380396 0
Cultural connection; 3 items from LiLAC NZ study; Dyall, L., Kepa, M., Teh, R., Mules, R., Moyes, S., Wham, C., et al. (2014). Cultural and social factors and quality of life of Maori in advanced age. Te puawaitanga o nga tapuwae kia ora tonu—Life and living in advanced age: a cohort study in New Zealand (LiLACS NZ). NZ Medical Journal, 127, 62-79
Timepoint [5] 380396 0
Pre-intervention assessment of outcomes; post first group-intervention assessment of outcomes==6 months follow-up; post-second group intervention assessment of outcomes 12 months follow-up
Secondary outcome [6] 380533 0
Sense of purpose; 3 item self-report scale: Windsor, T., Curtis, R., & Luszcz, M.A. (2015). Sense of purpose as a psychological resource for aging well. Developmental Psychology, 51, 975-986.
Timepoint [6] 380533 0
Pre-intervention assessment of outcomes; post first group-intervention assessment of outcomes==6 months follow-up; post-second group intervention assessment of outcomes 12 months follow-up
Secondary outcome [7] 380584 0
Housing and financial issues; self-report with 4 items adapted from Te Kupenga (2 items) and created for this study (2 items)
Timepoint [7] 380584 0
Pre-intervention assessment of outcomes; post first group-intervention assessment of outcomes==6 months follow-up; post-second group intervention assessment of outcomes 12 months follow-up

Eligibility
Key inclusion criteria
Maori aged 55 or above who are registered/receive services at one of the following five service providers in New Zealand:

Tui Ora, Inc
Te Roopu Tautoko ki te Tonga Inc
Te Korowai Hauora o Hauraki
Poutini Trust Maori Development Organisation
Ngaruahine Health
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Severe forms of dementia and related cognitive impairment; any other health condition that a health professional suggests they shouldn't participate

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
Other
Other design features
The research design for this project is a mixed-methods, pre-test and two post-test, staggered design with 3 providers receiving the intervention first and then 2 receiving it on a delayed basis (providers were randomly assigned to delivery time). We will complete a pre-test (baseline) of all participants.
The intervention will then be implemented with the first group of providers. The second group will delay the intervention by three months and have a second data collection prior to the start of the intervention. They will then begin the intervention.. The first group will complete the intervention and have a follow-up data collection.. The second group of providers will completed their intervention and then all participants in both groups will complete a final data collection.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Prior to conducting the primary data analysis, we will re-affirm the psychometric properties of the scales to ensure there aren’t regional differences. Factorial validity will be assessed with confirmatory factor analysis and reliability established with Cronbach’s alpha. Analysis will be completed with AMOS 25.
Quantitative data analysis will include several steps. First, statistical assumptions including patterns of missing data will be assessed. Second, descriptive statistics including means, standard deviations, and confidence intervals for continuous data and frequencies for categorical data will be provided. Finally, the data will be analysed through longitudinal/panel analysis to explore changes in the variables over time. We will also consider a group (1st set vs. 2nd set of providers) by time comparison to account for the delayed implementation.
The sample size was determined by a balance of resources and power to determine the optimal design and confirmed with the od.exe software. We will recruit 20 tuakana and 120 teina among the five providers; with all tuakana retained/replaced and 67% of teina retention from our previous Tranche 1 research, we expect to retain at least 20 tuakana and 80 teina.
With the assumption of p=.05 and intra-class correlation=.01 (from our previous study), we will have sufficient power (=.80) to identify a medium effect (d=.5) in change over time and a group X time interaction. A medium effect size was chosen given prior research on the impact of elder peer educators on self-rated health and related.
Analysis will be completed with SPSS 26 using mixed models analysis. The models will isolated intervention, time, and several covariate effects including the quality and quantity of conversations. Finally, we will determine estimates of cost effectiveness using incremental cost effectiveness analysis (ICEA).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/03/2020
Actual
22/06/2020
Date of last participant enrolment
Anticipated
8/05/2020
Actual
31/03/2021
Date of last data collection
Anticipated
30/11/2021
Actual
31/03/2022
Sample size
Target
144
Accrual to date
Final
129
Recruitment outside Australia
Country [1] 22364 0
New Zealand
State/province [1] 22364 0

Funding & Sponsors
Funding source category [1] 305008 0
Government body
Name [1] 305008 0
Ministry of Business Innovation and Employment --Ageing Well National Science Challenge
Country [1] 305008 0
New Zealand
Primary sponsor type
University
Name
University of Waikato
Address
Private Bag 3105
Hamilton 3240
New Zealand
Country
New Zealand
Secondary sponsor category [1] 305365 0
None
Name [1] 305365 0
Address [1] 305365 0
Country [1] 305365 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305405 0
Human Research Ethics Committee, University of Waikato
Ethics committee address [1] 305405 0
Ethics committee country [1] 305405 0
New Zealand
Date submitted for ethics approval [1] 305405 0
27/11/2019
Approval date [1] 305405 0
18/12/2019
Ethics approval number [1] 305405 0
HREC 2019 #81; partial/conditional approval

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

Contacts
Principal investigator
Name 100266 0
Prof Brendan Hokowhitu
Address 100266 0
Faculty of Maori and Indigenous Studies
University of Waikato
Private Bag 3105
Hamilton 3240
Country 100266 0
New Zealand
Phone 100266 0
+64 7 838 4075
Fax 100266 0
Email 100266 0
brendan.hokowhitu@waikato.ac.nz
Contact person for public queries
Name 100267 0
Brendan Hokowhitu
Address 100267 0
Faculty of Maori and Indigenous Studies
University of Waikato
Private Bag 3105
Hamilton 3240
Country 100267 0
New Zealand
Phone 100267 0
+64 7 838 4075
Fax 100267 0
Email 100267 0
brendan.hokowhitu@waikato.ac.nz
Contact person for scientific queries
Name 100268 0
John Oetzel
Address 100268 0
Faculty of Management
University of Waikato
Private Bag 3105
Hamilton 3240
Country 100268 0
New Zealand
Phone 100268 0
+64 7 838 4431
Fax 100268 0
Email 100268 0
john.oetzel@waikato.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
Kaumatua and kaumatua service providers have suspicion of sharing their data because of historical misuses of their data. Reasonable request for data will be considered and permission sought from the service providers.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7014Study protocolHokowhitu, B, Oetzel, J.G., Simpson, M., Nock, S., Reddy, R., Meha, P., Johnston, K., Jackson, A-M., Erueti, B., Rewi, P., Warbrick, I., Cameron, M.P.,, Zhang, Y., & Ruru, S. (2020). Kaumatua Mana Motuhake Poi:A study protocol for enhancing wellbeing, social connectedness and cultural identify for Maori elders. BMC Geriatrics, 20, 377. DOI: 10.1186/s12877-020-01740-3.  john.oetzel@waikato.ac.nz
7016Informed consent form  john.oetzel@waikato.ac.nz
7017Ethical approval  john.oetzel@waikato.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.