Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001396314
Ethics application status
Approved
Date submitted
28/09/2017
Date registered
3/10/2017
Date last updated
5/02/2019
Date data sharing statement initially provided
5/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Strength-Based, Peer Education Approach to helping Maori elders work through later-stage life transitions
Scientific title
Kaumatua managing life-transitions through tuakana-teina/peer-education: Impacts on health-related quality of life and mana motuhake
Secondary ID [1] 293005 0
None
Universal Trial Number (UTN)
Trial acronym
KMM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Life transitions in ageing 304910 0
Condition category
Condition code
Public Health 304240 304240 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We developed a “Tuakana-teina (older sibling/younger sibling)/peer education orientation programme” for life-transitions of kaumatua (elders). The orientation includes four 4-hour sessions over two-weeks for the peer educator (tuakana) comprised of the following material: (a) Maori values; (b) definitions of tuakana-teina/peer support; (c) four kinds of peer support; (d) forms of Maori communication; and (e) specific communication tools to support the peer educator (tuakana) working with their peers (teina). There will be at least one follow-up orientation session to tuakana progress. After the orientation programme, each tuakana will have a face-to-face semi-structured conversation with six teina at least three times over a four-month period to address relevant life-transitions of their teina. The tuakana will have a checklist to guide the conversations and assess the needs, and interests in learning about resources, around five life transitions (loss of independent living, loss of driver’s licence, loss of spouse, serious change in health condition, and retirement). The tuakana will provide various types of emotional and tangible support including linking to health and social services. Fidelity of the conversations will be assessed through coding of recorded conversations against the checklist.

The development of the orientation programme was a collaboration of academic and community researchers working in consultation with advisory boards of experts (medical, social services, ageing) and a board of trustees (i.e., as cultural advisors). The orientation programme is a written manual including instructions, activities, information, and questions for the people delivering the sessions. Including in the manual is a written handouts for participants in the training. Each session is to be delivered face-to-face by members of the academic research team who are experts in Maori communication, Maori worldviews and ageing. and have doctoral degrees supported by community researchers and doctoral students.. The sessions include some didactic information although mostly interactive discussions, reflections and chances to practice the peer education (i.e., role plays with feedback).
Intervention code [1] 299237 0
Treatment: Other
Intervention code [2] 299267 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 6.5 months after the initial group.
Control group
Active

Outcomes
Primary outcome [1] 303524 0
Health-related quality of life; SF-8
Timepoint [1] 303524 0
Pre-intervention assessment of outcomes; post first group-intervention assessment of outcomes==4 months follow-up (primary timepoint); post-second group intervention assessment of outcomes 8 months follow-up
Secondary outcome [1] 339198 0
Mana motuhake (identity, autonomy): items from Te Kupenga Maori Social Survey measuring perceived autonomy
Timepoint [1] 339198 0
Pre-intervention assessment of outcomes; post first group-intervention assessment of outcomes==4 months follow-up (primary timepoint); post-second group intervention assessment of outcomes 8 months follow-up
Secondary outcome [2] 339328 0
Mana motuhake: Cantril's ladder
Timepoint [2] 339328 0
Pre-intervention assessment of outcomes; post first group-intervention assessment of outcomes==4 months follow-up (primary timepoint); post-second group intervention assessment of outcomes 8 months follow-up

Eligibility
Key inclusion criteria
People aged 55 or above who are registered/receive services at Rauawaawa Kaumatua Charitable Trust
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

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 the evaluation of the orientation programme is a pre- and post-test, clustered staggered design with Tuatahi (first group) and Tuarua (second group/comparison) groups.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The sample size of tuakana and teina was determined by a balance of resources and statistical power to determine the optimal design. There are 6 participants for each tuakana. We conducted power and sample size estimates based on the research design and confirmed with the ‘od.exe’ software package. The following assumptions were made: (a) probability value = .05; and (b) rho (intra-class correlation) = .10. Six teina for each tuakana results in power of .80 with a medium effect size (d=.55).

Using the pre-test data, we will (re-)establish the psychometric properties of measures. Factorial and discriminant validity will be assessed with confirmatory factor analysis (CFA) and reliability established with Cronbach’s alpha.

The intervention analysis will compare the two groups and identify if there are intervening variables that explain differential patterns in the changes in the dependent variables. The primary dependent variables are mana motuhake and HRQOL. The independent variables are the time receiving the orientation programme (tuatahi/tuarua) and the three time periods (pre-test, 1st post-test, final post-test). Potential intervening variables that will be controlled for include characteristics about the conversations, characteristics of the tuakana/teina, and whether participants talked with each other during the intervention.
The quantitative data analysis will be a hiearchical, repeated measures analysis. to account for the characteristics about the conversations with the tuakana. Further, we will determine estimates of cost effectiveness using incremental cost effectiveness analysis (ICEA). We have some open-ended questions and will analyse these qualitative data using thematic analysis


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/09/2017
Date of last participant enrolment
Anticipated
30/04/2018
Actual
30/04/2018
Date of last data collection
Anticipated
31/12/2018
Actual
21/12/2018
Sample size
Target
210
Accrual to date
Final
209
Recruitment outside Australia
Country [1] 9247 0
New Zealand
State/province [1] 9247 0

Funding & Sponsors
Funding source category [1] 297624 0
Government body
Name [1] 297624 0
Ministry of Business Innovation and Employment --Ageing Well National Science Challenge
Country [1] 297624 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] 296651 0
None
Name [1] 296651 0
Address [1] 296651 0
Country [1] 296651 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298713 0
Te Manu Taiko: Human Research Ethics Committee Faculty of Maori & Indigenous Studies, University of Waikato
Ethics committee address [1] 298713 0
Ethics committee country [1] 298713 0
New Zealand
Date submitted for ethics approval [1] 298713 0
Approval date [1] 298713 0
11/08/2017
Ethics approval number [1] 298713 0

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

Contacts
Principal investigator
Name 77990 0
Prof Brendan Hokowhitu
Address 77990 0
Faculty of Maori and Indigenous Studies
University of Waikato
Private Bag 3105
Hamilton 3240
Country 77990 0
New Zealand
Phone 77990 0
+64 7 838 4075
Fax 77990 0
Email 77990 0
[email protected]
Contact person for public queries
Name 77991 0
Brendan Hokowhitu
Address 77991 0
Faculty of Maori and Indigenous Studies
University of Waikato
Private Bag 3105
Hamilton 3240
Country 77991 0
New Zealand
Phone 77991 0
+64 7 838 4075
Fax 77991 0
Email 77991 0
[email protected]
Contact person for scientific queries
Name 77992 0
John Oetzel
Address 77992 0
Faculty of Management
University of Waikato
Private Bag 3105
Hamilton 3240
Country 77992 0
New Zealand
Phone 77992 0
+64 7 838 4431
Fax 77992 0
Email 77992 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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
No additional documents have been identified.