Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000541808
Ethics application status
Approved
Date submitted
11/03/2021
Date registered
7/05/2021
Date last updated
7/05/2021
Date data sharing statement initially provided
7/05/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
He Huarahi Tautoko: An intervention to enhance intergenerational relationships, cultural exchange & identity, and physical wellbeing
Scientific title
Kaumatua Mana Motuhake Poi: He Huarahi Tautoko to enhance intergenerational relationships, cultural exchange & identity, and physical wellbeing of Maori elders
Secondary ID [1] 303623 0
Nill
Universal Trial Number (UTN)
Trial acronym
Linked study record


Health condition
Health condition(s) or problem(s) studied:
Overall wellbeing 321005 0
Condition category
Condition code
Public Health 318811 318811 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
He Huarahi Tautoko’(HHT) is a holistic, cultural and strength-based model of support that helps facilitate cultural continuity through enhancing kaumatua hauora (health) and mana motuhake (self-actualisation). HHT was co-designed by Maori health service providers, kaumatua (elders) and Te Kahui Rangahau (researcher group) this innovative model of support. HHT incorporates matapono or principles and values such as; kotahitanga (solidarity), manaakitanga (respect, caring, sharing) whanaungatanga (forging connections), wairuatanga (spirituality), tautokotanga (assistance, support), rangatiratanga (control/autonomy), hauoratanga (healthiness, vigorous), maramatanga (enlightenment), mana motuhaketanga (self-governing) to enhance the well-being and hauora of kaumatua.

Each programme has four wananga lasting approximately 4-6 hours spaced approximately 2 months apart with activities in between each wananga. Participants will be encouraged to engaged in the activities at least weekly. The wananga will be attended by approximately 40 people (30 participants and other interest parties). Wananga will be supervised by community researchers and Maori health service providers. University researchers are available if requested by the providers. Attendance list will be used for participation at the wananga; a journal will be used to track participation in actvities.

The general topics relate to sharing cultural knowledge, learning/sharing tikanga and te reo Maori and physical activities. The topics of wananga for each provider are adapted to fit their own tikanga (protocols), kaumatua experiences (e.g., some areas are strong in te reo and want to focus on physical activity; others want to learn more about tikanga and te reo), and physical communities. The key pou or pillars for the wananga include: a) walks to culturally significant places; b) cultural activities (e.g., weaving, singing, kapa haka (traditional chant/dance); c) cultural knowledge exchange (sharing traditional stories of wakapapa or ancestry); and d) relevant physical activity (e.g., planting a community garden, gathering food, exercising together).

The intervention provides lessons that a kaumatua and a member of his/her extended family participate in together. The four pillars provide the functional structure, while each provider adapts the form or specific content to be locally relevant.
Intervention code [1] 319919 0
Lifestyle
Comparator / control treatment
The programme is a pre- and post-test, clustered randomised staggered design with Tuatahi (three providers) and Tuarua (three providers) groups; providers are randomly assigned to Tuatahi and Tuarua. Tuatahi participate in the wananga programme initially, while Tuarua participate in subsequent programme 2-3 months later. Thus, the control group eventually receives the intervention on a delayed basis. Tuatahi and Tuarua groups will start at approximately the same time with slight delays possible due to scheduling/organising issues. (up to 1 month)
Control group
Active

Outcomes
Primary outcome [1] 326759 0
Health-related quality of life using a single item of self-rated health (Dulin PL, Stephens C, Alpass F, Hill RD, Stevenson B. The impact of socio-contextual, physical and lifestyle variables on measures of physical and psychological wellbeing among Maori and non-Maori: the New Zealand Health, Work and Retirement Study. Ageing Soc. 2011; 31:1406-24.) and 7 self-report items from 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] 326759 0
All participants will complete the evaluation measures at three time periods: (1) baseline—all participants (April 2021); (2) 2nd baseline for Tuarua group approximately 8 weeks post initial baseline (May/June 2021) OR post-Tuatahi wananga programme after 8 months initial wananga (December 2021); and (3) post-Tuarua wananga programme after 8 months initial wananga (Feb 2022)
Primary outcome [2] 326763 0
Physical functioning using three brief assessments from Guralnik J, Simonsick E, Ferrucci L, Glynn R, Berkman L, Blazer D, Scherr P, RB W: A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol 1994, 49:M85-94.
Timepoint [2] 326763 0
All participants will complete the evaluation measures at three time periods: (1) baseline—all participants (April 2021); (2) 2nd baseline for Tuarua group approximately 8 weeks post initial baseline (May/June 2021) OR post-Tuatahi wananga programme after 8 months initial wananga (December 2021); and (3) post-Tuarua wananga programme after 8 months initial wananga (Feb 2022)
Secondary outcome [1] 392609 0
Cultural knowledge measured by 10 self-report items created for this study
Timepoint [1] 392609 0
All participants will complete the evaluation measures at three time periods: (1) baseline—all participants (April 2021); (2) 2nd baseline for Tuarua group approximately 8 weeks post initial baseline (May/June 2021) OR post-Tuatahi wananga programme after 8 months initial wananga (December 2021); and (3) post-Tuarua wananga programme after 8 months initial wananga (Feb 2022)
Secondary outcome [2] 392610 0
Cultural identity measured with six self-report items from 2 sources: a) 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 and b) Statistics New Zealand: Te Kupenga 2013: A survey of Maori well-being.
Timepoint [2] 392610 0
All participants will complete the evaluation measures at three time periods: (1) baseline—all participants (April 2021); (2) 2nd baseline for Tuarua group approximately 8 weeks post initial baseline (May/June 2021) OR post-Tuatahi wananga programme after 8 months initial wananga (December 2021); and (3) post-Tuarua wananga programme after 8 months initial wananga (Feb 2022)
Secondary outcome [3] 392611 0
Intergenerational relationships measured with three self-report items from William S. Aquilino. Two Views of One Relationship: Comparing Parents' and Young Adult Children's Reports of the Quality of Intergenerational Relations: Journal of Marriage and Family , Nov., 1999, Vol. 61, No. 4 (Nov., 1999), pp. 858-870
Timepoint [3] 392611 0
All participants will complete the evaluation measures at three time periods: (1) baseline—all participants (April 2021); (2) 2nd baseline for Tuarua group approximately 8 weeks post initial baseline (May/June 2021) OR post-Tuatahi wananga programme after 8 months initial wananga (December 2021); and (3) post-Tuarua wananga programme after 8 months initial wananga (Feb 2022)
Secondary outcome [4] 392753 0
Social Support and Loneliness measured with 7 self-report items from 2 sources: a) 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 and b) 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 [4] 392753 0
All participants will complete the evaluation measures at three time periods: (1) baseline—all participants (April 2021); (2) 2nd baseline for Tuarua group approximately 8 weeks post initial baseline (May/June 2021) OR post-Tuatahi wananga programme after 8 months initial wananga (December 2021); and (3) post-Tuarua wananga programme after 8 months initial wananga (Feb 2022)

Eligibility
Key inclusion criteria
Participants will be kaumatua (55 or older) from the communities served by the six providers participating in this study and one whanau (extended family) member for each kaumatua (kaumatua choice).


Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Dementia and related cognitive impairment; any other health condition that a health professional suggests they shouldn't participate (eg., heart condition)

Study design
Purpose of the study
Prevention
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 the programme is a clustered randomised staggered design with Tuatahi (three providers) and Tuarua (three providers) groups; providers are randomly assigned to Tuatahi (1st group) and Tuarua (2nd group). Tuatahi participate in the wananga programme initially, while Tuarua participate in subsequent programme two to three months after the Tuatahi group. The research design enables a comparison of the programme whilst ensuring that all participants receive the programme. Providers were randomly assigned to Tuatahi and Tuarua; participants are randomly selected for inclusion from a list of eligible participants; one provider is using a census for selection as its numbers are similar to recruitment.
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. We will also establish the psychometric properties of specific scales within the projects that have not been validated with Maori populations, particularly those we haven’t used previously. Factorial validity will be assessed with confirmatory factor analysis and reliability established with Cronbach’s alpha. Analysis will be completed with AMOS 26.

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. Analysis will be completed with SPSS 26 using mixed models analysis. The comparison of Tuatahi and Tuarua groups is included in the analysis as a comparison group to strengthen conclusion of findings. We will share the statistical findings with participants and providers to check that interpretations are accurate and revise accordingly. We will invite community researchers to participant in some of the analysis (particularly descriptive information).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
5/04/2021
Date of last participant enrolment
Anticipated
31/05/2021
Actual
Date of last data collection
Anticipated
29/04/2022
Actual
Sample size
Target
180
Accrual to date
30
Final
Recruitment outside Australia
Country [1] 23518 0
New Zealand
State/province [1] 23518 0

Funding & Sponsors
Funding source category [1] 308045 0
Government body
Name [1] 308045 0
Ministry of Business Innovation and Employment --Ageing Well National Science Challenge
Country [1] 308045 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] 308777 0
None
Name [1] 308777 0
Address [1] 308777 0
Country [1] 308777 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308037 0
Human Research Ethics Committee, University of Waikato
Ethics committee address [1] 308037 0
Humans Resource Ethics Committee
Postal Address: The Secretary, Human Research Ethics Committee
Private Bag 3105
Hamilton 3240
Ethics committee country [1] 308037 0
New Zealand
Date submitted for ethics approval [1] 308037 0
30/10/2020
Approval date [1] 308037 0
28/01/2021
Ethics approval number [1] 308037 0
HREC(Health)2020#93

Summary
Brief summary
The Aotearoa New Zealand population is ageing and numerous studies demonstrate that with this phenomenon comes health and social challenges including chronic conditions, cancer, end-of-life issues and social isolation. More importantly, significant inequities exist between Maori and non-Maori around poor ageing and health. These inequities are due to structural discrimination such as unjust and unequal distribution of social determinants (e.g., income, education, housing) and a colonial history that resulted in cultural dissonance from loss of language and land, as well as other losses. The broader thesis to be tested is that Indigenous cultural revitalisation and physical activity increase the wellbeing of kaumatua (elders). This programme proposes a strengths-based approach that highlights the potential of kaumatua mana motuhake by focusing on and valuing Maori epistemologies surrounding ageing. Specifically, the project will use a co-designed intervention programme where kaumatua and a whanau member participate in activities to enhance cultural exchange (including te reo Maori--language) and physical activity. Please note that the term intervention is one that is seen by our partnership as a weakness-based approach and we prefer the term programme as it is more neutral. Our expectation is that participation in the programme will lead to significant increases in the primary and secondary outcomes including health-related quality of life, cultural identity, cultural knowledge, physical functioning, intergenerational relationships, and social support.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109298 0
Prof Brendan Hokowhitu
Address 109298 0
Faculty of Maori and Indigenous Studies
University of Waikato
Private Bag 3105
Hamilton 3240
Country 109298 0
New Zealand
Phone 109298 0
+64 7 8384977
Fax 109298 0
N/A
Email 109298 0
[email protected]
Contact person for public queries
Name 109299 0
A/Prof Sophie Nock
Address 109299 0
Faculty of Maori and Indigenous Studies
University of Waikato
Private Bag 3105
Hamilton 3240
Country 109299 0
New Zealand
Phone 109299 0
+64 7 838 4075
Fax 109299 0
N/A
Email 109299 0
[email protected]
Contact person for scientific queries
Name 109300 0
Prof John Oetzel
Address 109300 0
Faculty of Management
University of Waikato
Private Bag 3105
Hamilton 3240
Country 109300 0
New Zealand
Phone 109300 0
+64 7 838 4431
Fax 109300 0
Email 109300 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
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
10930Informed consent form  [email protected] Document attached 381560-(Uploaded-09-04-2021-07-21-57)-Study-related document.docx
10931Other  [email protected] Questionnaire
10932Ethical approval  [email protected] Letter attached 381560-(Uploaded-09-04-2021-07-21-57)-Study-related document.pdf
10984Study 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  



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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