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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Living well with long term neurological conditions: The living well toolkit
Scientific title
The living well toolkit: a practical solution to facilitate two-way communication, self-management and continuum of care for people living with a long-term neurological condition, a pilot study.
Secondary ID [1] 284607 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
long term neurological conditions 291909 0
Condition category
Condition code
Neurological 292256 292256 0 0
Other neurological disorders

Study type
Description of intervention(s) / exposure
This trial is a pilot study where 6 to 9 consenting participants will be introduced to a toolkit, 2 weeks prior to their discharge home or transition into another service. The introduction will be through one of the participating health professionals involved in that person's care who will have attended an information and education session on the purpose of the toolkit and how to use the toolkit. It is then anticipated that the health professional will introduce this to one of their clients who fits the inclusion criteria. This toolkit can be in paper form or an electronic data file that will allow the participant (person living with a neurological condition) to record important information and exchange this with other service providers, that will give them the skills and resources to take charge of their condition and to live well with this condition, and that will assist with the continuum of care over a lifespan. The participant (person living with a neurological condition) will be able to choose which toolkit suits them best, either electronic or paper based. The content of the toolkit, electronic or paper, will be identical; only the media of delivery and format will be different. The toolkit is currently under construction.
The Participants (people living with neurological conditions) and consenting family members/carers or support staff, and health professional involved in the introduction of the toolkit will be asked to provide feedback on the usability and value of the toolkit approximately 1 week after implementation and at 3 months follow up. This will happen by means of a semi-structured focus group (for health professionals), face to face interviews (for people living with a neurological condition and their family) or a short phone interview (carers or support staff). An implementation coordinator will monitor the adherence to the intervention.
Intervention code [1] 289379 0
Intervention code [2] 289380 0
Comparator / control treatment
we will not use a control group. Non-participants will receive the standard discharge or transition processes used in that locality
Control group

Primary outcome [1] 292119 0
qualitative study - feedback on value and usability will be sought through semi-structured interviews.
The interviews are with participating health professionals by means of a one-off locality focus group or individual face to face interview (if more practical or preferred). We will also seek feedback from people living with a neurological condition and their family (together) by means of a face to face interview. And we will seek feedback on the usability of the toolkit from nominated and consenting carers / support workers via a one-off phone interview.
Timepoint [1] 292119 0
1 week post intervention
Secondary outcome [1] 308232 0
Face to face interviews with participating people living with a neurological condition and their family will be held to further evaluate the toolkit's value and use in the longer term
Timepoint [1] 308232 0
A 3 month follow- up

Key inclusion criteria
We have 3 participant groups:
1) people living with a long-term neurological condition
- at the point where they are close to discharge or transitioning into another service
- older than 18 years ( adults able to consent)
2)nominated family/ carers/ support staff, older than 18 years and able to consent, and being a significant other or support person involved in the care of the person living with a neurological condition
3) health care providers such as nurses, physio's, OT's, SLT', social workers, key workers etc. involved in the care of people living with a neurological condition.
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
not able to give consent
not 18 years of age
not having a long-term neurological condition (patient participants)
not having the cognitive capacity to express their thoughts on the experience of using the toolkit (patient participants)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
We will recruit 6 to 9 consenting health care providers from 3 to 6 of our primary recruiting localities including in-patient and community/primary care settings. They will be asked to nominate 6 to 9 consenting people living with a long term condition (their client), who are close to being discharged home or who are close to being transitioned into another service. Participating health care providers will be trained in the use of the toolkit and will be asked to introduce the toolkit to their participating client and family/carers and implement the toolkit as part of the discharge/transition process.
The participating client will be asked to nominate a family member involved in their care and one or two carers/ support workers also willing to participate in this study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This study uses a non-random approach. We will include suitable potential health provider participants in order of consent to participate, however we will seek to recruit from a variety of localities (inpatient, rehabilitation, community etc.). Potential client participants (people living with neurological conditions) will need to meet the inclusion criteria and where possible we will seek diversity in age, gender, ethnicity and diagnosis.
Family and carers will be nominated by participating clients.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Traditional content analysis will be used incorporating methods of constant comparison according to Charmaz (2006) to identify categories and themes of importance such as key strengths of the toolkit, issues or concerns and recommendations for future wider implementation. Rigour checks will include independent coding by two members of the research team, team analysis meetings, and knowledge user committee involvement in checking interpretation. key findings will be synthesised with existing knowledge from prior research to inform the development the final version(s) of the toolkit and implementation protocol.

Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 6053 0
New Zealand
State/province [1] 6053 0

Funding & Sponsors
Funding source category [1] 289236 0
Government body
Name [1] 289236 0
Health Research Council (HRC)
Address [1] 289236 0
Level 3 , 110 Stanley Street,
1010 ,Auckland
PO BOX 5541 (Wellesley Street, Auckland 1141)
Country [1] 289236 0
New Zealand
Primary sponsor type
AUT University
School of Rehabilitation and Occupation Studies
North Shore Campus
90 Akoranga Drive
Auckland, 1020
New Zealand
Secondary sponsor category [1] 287910 0
Name [1] 287910 0
Peter Larmer
Address [1] 287910 0
AUT University
90 Akoranga Drive
Auckland, 1020
Country [1] 287910 0
New Zealand

Ethics approval
Ethics application status
Ethics committee name [1] 291006 0
Health and Disability Ethics Committees (HDEC)
Ethics committee address [1] 291006 0
Ministry of Health
c/ MEDSAFE, Level 6, Deloitte House
10 Brandon Street
PO BOX 5013
Ethics committee country [1] 291006 0
New Zealand
Date submitted for ethics approval [1] 291006 0
Approval date [1] 291006 0
Ethics approval number [1] 291006 0

Brief summary
Long term neurological conditions result in great personal, whanau/family and societal burdens associated with long term neurological conditions; which evidence tells us, can be achieved by improving two-way communication, by equipping people living with a neurological condition (PLWNC) and their whanau/families with skills that allow them to do as much as possible for themselves, and by better coordinating the provision of care over a lifespan. This study aims to develop and implement a workable solution, the “living well toolkit", to meet these three health needs. This application relates to phase II of the study, where we intend to further develop and refine the toolkit based on the findings from Phase I, and existing knowledge gained from former research. In this phase, we will also pilot the toolkit with six to nine consenting participants, recruited from the primary recruitment localities or Non-Governmental Organisations (NGO's) identified in Phase I. We will purposefully select participants who are transitioning from in-patient hospital care to Primary Health Care or in-patient rehabilitation, or from rehabilitation to community services. Where discharge timeframes are predictable we will introduce the toolkit approximately two weeks before planned discharge. Information concerning the utility of the toolkit will be obtained through semi-structured interviews with the individual participants and their whanau/family, one week after they start using the toolkit and at 3 months follow-up. Data on the usability of the toolkit will also be obtained by asking participants to nominate 1 or 2 current health professionals/carers willing to participate in a 15 -20 minute phone interview at three months follow-up. Health providers who were involved with the introduction of the toolkit at discharge/transition, will also be invited to share their experience in a one-off locality based focus group.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 54 54 0 0

Principal investigator
Name 48430 0
Dr Suzie Mudge
Address 48430 0
Centre for Person Centred Research
AUT University
90 Akoranga Drive
Auckland, 1142
Private bag 92006
Country 48430 0
New Zealand
Phone 48430 0
+64 9 9219999 ext 7096
Fax 48430 0
Email 48430 0
Contact person for public queries
Name 48431 0
Mrs Ann Sezier
Address 48431 0
Centre for Person Centred Research
AUT University
90 Akoranga Drive
Auckland, 1142
Private bag 92006
Country 48431 0
New Zealand
Phone 48431 0
+64 9 9219999 ext 7029
Fax 48431 0
Email 48431 0
Contact person for scientific queries
Name 48432 0
Dr Suzie Mudge
Address 48432 0
Centre for Person Centred Research
AUT University
90 Akoranga Drive
Auckland, 1142
Private bag 92006
Country 48432 0
New Zealand
Phone 48432 0
+64 9 9219999 ext 7096
Fax 48432 0
Email 48432 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary