ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619001002178

Ethics application status

Approved

Date submitted

25/06/2019

Date registered

15/07/2019

Date last updated

28/09/2023

Date data sharing statement initially provided

15/07/2019

Date results information initially provided

17/03/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

Peer support after brain injury

Scientific title

Evaluating a sustainable model of peer mentoring in traumatic brain injury: Randomised pragmatic waitlist trial with process evaluation

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1224-0476

Trial acronym

Linked study record

U111-1142-71 This UTN and citation references the feasibility study that preceded this definitive trial.
Kersten, P., Cummins, C., Kayes, N., Babbage, D., Elder, H., Foster, A.,Weatherall, M. Siegert, R. Smith, G. McPherson, K. (2018). Making sense of recovery after traumatic brain injury through a peer mentoring intervention: a qualitative exploration. BMJ Open, 8(10). doi:10.1136/bmjopen-2017-020672

Health condition

Health condition(s) or problem(s) studied:

traumatic brain injury

Condition category

Condition code

Injuries and Accidents

Other injuries and accidents

Neurological

Other neurological disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The peer mentoring intervention: eight face to face mentoring sessions spread over five months. The session duration would be approximately one hour. Core components: getting to know the mentor; exploring hopes for meaningful participation; exploring barriers and facilitators; mentor supported activities; reflection on supported activities; planning for the future. The mentoring sessions may take place in a rehabilitation facility, at the mentee's home or at another mutually agreed location. How and when these activities are enacted will be tailored to the mentees unique psychosocial context, and mentoring relationship. Our feasibility study findings would suggest the strength of this approach is in the mentor bringing their shared experience to support and enable the mentee to re-engage with life after TBI. Mentors training: mentors will attend a two day interactive workshop held over two separate weeks which will draw on their own recovery experiences and develop their strengths and skills. Workshop topics will include the role of the mentor, the core components of the intervention, the mentoring relationship, managing difficult and /or crisis situations and safety protocols. Mentors will be supported by the local service coordinator, who has experience in neurorehabilitation. They will keep in contact with the mentors through out the intervention, following-up via phone call after each mentor session and through the quarterly group debriefing sessions.

Intervention code [1]

Rehabilitation

Comparator / control treatment

Waitlist control. During the wait period the control group receives usual care. For the purposes of this study, usual care is defined as any and all rehabilitation received outside of the study intervention. Waitlist participants allocated to this group will receive the study intervention after the completion of the nine month data collection time point.

Control group

Active

Outcomes

Primary outcome [1]

The primary outcome will be mentee participation, measured by the 'Autonomy Outdoors' subscale of the Impact on Participation and Autonomy (IPA) as measured at 26 weeks immediately post intervention.

Timepoint [1]

22 weeks (immediately post-intervention)

Secondary outcome [1]

Mentee mood and well being captured using a collection of standardised self report measures including: a) The Short Warwick-Edinburgh Mental Well-Being Scale; b) The Satisfaction with Life Scale; c) Herth Hope index; and d) General self efficacy scale. This is a composite secondary outcome.

Timepoint [1]

Assessments will be carried out at baseline, 11, 22 (immediately post-intervention) and 35 (five-month post-intervention completion) weeks

Secondary outcome [2]

Health-related quality of life captured using the EQ-5D

Timepoint [2]

Assessments will be carried out at baseline, 11, 22 (immediately post-intervention) and 35 (five-month post-intervention completion) weeks

Secondary outcome [3]

Mentee productivity status, including satisfaction with current productivity status captured by self-report questions specifically designed for this study

Timepoint [3]

Assessments will be carried out at baseline, 11, 22 (immediately post-intervention) and 35 (five-month post-intervention completion) weeks

Secondary outcome [4]

Mentee health service resource use will be measured by self report of health social service utilisatiion, medication homecare and out of pocket expenses. Questions designed specifically for this study.

Timepoint [4]

Assessments will be carried out at baseline, 11, 22 (immediately post-intervention) and 35 (five-month post-intervention completion) weeks

Secondary outcome [5]

Mentor mood and well being as a composite secondary outcome will be captured using standardised self report measures including: a) The Short Warwick-Edinburgh Mental Well-Being Scale; b) Hospital Anxiety and Depression Scale;

Timepoint [5]

At the time of mentor recruitment and on completion of intervention delivery phase of the project.

Secondary outcome [6]

Process Evaluation data to determine key process variables relating to context and implementation relevant for future service delivery for optimal effectiveness and uptake will be collected using qualitative semi structured questionnaires and in-depth interviews with mentees and mentors.This data will be collected through questionnaires specifically designed for this study.

Timepoint [6]

At 22 weeks (immediately post intervention) (mentees) and on completion of intervention delivery phase (mentors).

Secondary outcome [7]

Mentor productivity status will be captured using a specifically designed self-report questionnaire

Timepoint [7]

Baseline and end of intervention delivery period

Eligibility

Key inclusion criteria

Mentees: People will be eligible to take part if they have moderate or severe TBI (Initial Glasgow Coma Scale score less than 13 and/or post-traumatic amnesia duration of more than one hour)
or people with mild TBI experiencing persistent difficulties (>6 months post injury) impacting on their participation in ways that are important to them and are:
• up to 3 years post-injury;
• at least 16 years old;
• able to communicate with the mentor and researcher (with or without assistance)
• capable of giving informed consent (or assent if under 18 years of age)
• living within one of the three study regions (Auckland, Gisborne, and Northland)

Mentors: People will be eligible to apply for the role of mentor if they are:
• 18 years of age or older
• up to six years post TBI
• at least one-year post discharge from inpatient rehabilitation
• satisfied with their current level of participation, health and well-being
• able to communicate and engage in intervention delivery
• living within one of the three study regions (Auckland, Gisborne, and Northland)
• available during the peer mentoring intervention period

Minimum age

16 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Mentees will be excluded if 1) their medical situation is considered unstable and could severely limit participation in mentoring activities or 2) they are enrolled in other intervention trials
Mentors will be excluded if they 1) experience persistent drug or alcohol difficulties, 2) have a recent history of violence, 3) criminal record checks indicate significant potential ongoing risk, and/or 4) they are experiencing severe mental illness that would impact their ability to fulfil mentor roles and responsibilities.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

The mentors, study manager, principal investigator and local service coordinators will necessarily know the allocation after randomisation. The data manager and study statistician will be aware of group allocation after randomisation but will not be aware of which group equates to intervention versus control. Randomisation will be carried out centrally by the the data manager who will communicate this to the local service coordinator online. The research manager will hold randomisation allocation in sealed opaque envelopes. The researcher collecting outcomes data will not be told group allocation and will remind participants not to disclose.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computerised randomisation by a statistician using a fixed block size of four, stratifying by intervention site (Auckland, Northland, Gisborne) and ethnicity (Maori, Non-Maori).

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Other

Other design features

Waitlist control will receive the intervention after the 9 month data collection

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

The primary analysis of the continuous variables will be ANCOVA with baseline measurement as a co-variate and randomised treatment as the main explanatory predictor variable after 22 weeks. Secondary analyses will be to model mentors as a random effect in a mixed linear model to determine if there is a strong element of correlated data within mentors and if so to estimate the relevant ICC. Content analysis will be applied to Qualitative data.

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

6/07/2020

Actual

6/07/2020

Date of last participant enrolment

Anticipated

31/03/2022

Actual

31/03/2022

Date of last data collection

Anticipated

2/10/2023

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland, Northland, Gisborne

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Health Research Council of New Zealand

Address [1]

Level 3 110 Stanley St Auckland 1010

Country [1]

New Zealand

Primary sponsor type

University

Name

AUT University

Address

Centre for Person Centred Research
School of Clinical Sciences
North Campus
Private Bag 92006
Auckland 1142

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

New Zealand Health and Disability Ethics Committee

Ethics committee address [1]

Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

23/05/2019

Approval date [1]

24/06/2019

Ethics approval number [1]

19/NTB/82

Summary

Brief summary

This study aims to test effectiveness of peer mentoring for improving participation, health and well-being outcomes following TBI compared to usual care, and determine key process variables relating to context and implementation to underpin an evidence-based framework for ongoing service provision. Peer mentors are those who have successfully faced a particular experience and can provide good counsel and empathic understanding to help others faced with a similar experience. Mentoring relationships are distinct from ‘professional’ support and offer credibility, mutuality of experience, acceptance, and normalisation. Peer mentoring interventions have demonstrated positive effects on health and social outcomes for both the mentee and mentor across a diversity of populations. Our feasibility study found peer mentoring after TBI is highly acceptable to both mentors and mentees and has the potential to impact health and wellbeing outcomes for both mentees and mentors.

Trial website

https://cpcr.aut.ac.nz/our-research/peer-support-after-brain-injury

Trial related presentations / publications

Public notes

Kersten, P., Cummins, C., Kayes, NM., Babbage, D., Elder, H., Foster, A., Weatherall, M., Siegert, R., Smith, G., McPherson, KM. (2018). Making sense of recovery after traumatic brain injury through a peer mentoring intervention: a qualitative exploration. BMJ Open. 8 (10). doi: 10.1136/bmjopen-2017-020672

Contacts

Principal investigator

Name

Prof Nicola Kayes

Address

Centre for Person Centred Research
School of Clinical Sciences
AUT University
North Campus
Private Bag 92006
Auckland 1142

Country

New Zealand

Phone

+64 9 921 9999 x7309

Fax

[email protected]

Contact person for public queries

Name

Prof Nicola Kayes

Address

Centre for Person Centred Research
School of Clinical Sciences
AUT University
North Campus
Private Bag 92006
Auckland 1142

Country

New Zealand

Phone

+64 9 921 9999 x7309

Fax

[email protected]

Contact person for scientific queries

Name

Prof Nicola Kayes

Address

Centre for Person Centred Research
School of Clinical Sciences
AUT University
North Campus
Private Bag 92006
Auckland 1142

Country

New Zealand

Phone

+64 9 921 9999 x7309

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

New Zealand and specifically the regions have a small population and protecting the anonymity of participants can be difficult. We would not like to risk identification and cause any undue harm to participants.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
18609	Study protocol	Kayes N, Cummins C, Weatherall M, et al Randomised pragmatic waitlist trial with process evaluation investigating the effectiveness of peer support after brain injury: protocol BMJ Open 2023;13:e069167. doi: 10.1136/bmjopen-2022-069167
20520	Statistical analysis plan					376386-(Uploaded-18-09-2023-10-12-58)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Randomised pragmatic waitlist trial with process evaluation investigating the effectiveness of peer support after brain injury: Protocol.	2023	https://dx.doi.org/10.1136/bmjopen-2022-069167

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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