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Trial registered on ANZCTR


Registration number
ACTRN12621000032853
Ethics application status
Approved
Date submitted
1/10/2020
Date registered
15/01/2021
Date last updated
15/01/2021
Date data sharing statement initially provided
15/01/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Understanding Maori People's Experience with iPad App ADOC-M/P for Goal Setting in Rehabilitation
Scientific title
Field Testing a Maori/Pacific Version of a Japanese iPad App to Support Culturally Responsive Goal Setting in Clinical Rehabilitation: A Qualitative Study
Secondary ID [1] 302431 0
Nil Known
Universal Trial Number (UTN)
U1111-1259-0297
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Disability 319275 0
Physical rehabilitation 319950 0
Stroke 319951 0
Fractures 319952 0
Traumatic brain injury 319953 0
Condition category
Condition code
Physical Medicine / Rehabilitation 317241 317241 0 0
Occupational therapy
Physical Medicine / Rehabilitation 317242 317242 0 0
Physiotherapy
Stroke 317884 317884 0 0
Ischaemic
Stroke 317887 317887 0 0
Haemorrhagic
Injuries and Accidents 317888 317888 0 0
Fractures
Neurological 317889 317889 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention in this study is the use of our iPad app 'ADOC-M/P' which stands for Aid for Decision-making in Occupational Choice - Maori and Pacific version. This app is an adaption of the Japanese app ADOC. The app presents a catalogue of illustrations depicting various activities which the clinician uses to facilitate the collaborative goal-setting process with the patient. The app works by allowing the patient and therapist to individually choose up to 20 goals that they would like to work towards during rehabilitation. Then the app presents the selections together so the patient and therapist can choose 5 goals to create a rehabilitation plan. There is later a section where details regarding each specific goal may be typed up (time frame, therapist in charge, specific definition of the activity.) The app then creates a pdf with the 5 selected goals which can then be printed off an signed by the therapist and the patient.

The intervention may be delivered by any person who is employed by Whanganui district health board to work with rehabilitation patients. (Such as a physiotherapist, nurse, occupational therapist, or speech/language therapist.) Goal setting with our iPad app will be conducted by the therapist as they judge clinically appropriate. The goal setting process is face-to-face between the clinician and the patient, the iPad will be passed between the therapist and patient as necessary. The duration of goal setting with the app can be as short as 15 minutes but could be as long as 2 hours depending on how the app is used. The therapist does not need to be present when the patient is selecting their goals and the patient does not need to be present when the therapist is selecting their goals either. We will ask the clinician if they have used the app with patients/a specific patient to measure adherence. We are not employing any other strategies to measure adherence.

The participating patients with or without whanau (friends/family) will attend at least one goal setting session to be eligible for the trial. Participating patients must be able to provide informed consent.

The data collection will take place in an inpatient setting after the patient has had their goal setting session. The data collection will occur immediately after the goal setting session to up to 3 weeks after goal setting.
Intervention code [1] 318740 0
Rehabilitation
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325300 0
A patient's new subjective experience with novel iPad app ADOC-M/P to be explored in a semi-structured interview with the primary investigator and analysed by thematic analysis in NVivo.
Timepoint [1] 325300 0
Immediately after completion of goal setting with the intervention.
Secondary outcome [1] 387443 0
Change in patient's perception of patient-clinician relationship to be enquired about in a semi-structured interview with the primary investigator and analysed by thematic analysis in NVivo.
Timepoint [1] 387443 0
Immediately after to up to 3 weeks after completion of goal setting with the intervention.
Secondary outcome [2] 387444 0
Change in the goals set during goal setting for rehabilitation to be enquired about in a semi-structured interview with the primary investigator and analysed by thematic analysis in NVivo
Timepoint [2] 387444 0
Immediately after to up to 3 weeks after completion of goal setting with the intervention.
Secondary outcome [3] 389471 0
Health professionals' experiences with using the app to be enquired about in a semi-structured interview with the primary investigator and analysed by thematic analysis in NVivo
Timepoint [3] 389471 0
1 to 3 months after receiving the app to use.

Eligibility
Key inclusion criteria
A health professional is eligible to participate in the study if they are employed with Whanganui DHB as a health professional and if their work involves goal setting with patients.

Patients may participate if they:
• Are an adult over 16 years of age
• Identify as Maori
• Are a rehabilitation patient receiving care at Whanganui DHB (e.g. after a stroke, head injury, fractures, or other health problems.)
• Can provide informed consent
• Can communicate in English
• Can see with or without corrective lenses
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they:
• Score less than 8 on the MMSE (Mini Mental State Exam)
• Are discharged from the hospital before data collection and are unable to return to the hospital for an interview

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)
Allocation was not concealed.
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
30 to 90 minute interviews with participants to be transcribed and analysed in NVivo via thematic analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
29/10/2020
Date of last participant enrolment
Anticipated
29/01/2021
Actual
Date of last data collection
Anticipated
29/01/2021
Actual
Sample size
Target
12
Accrual to date
2
Final
Recruitment outside Australia
Country [1] 23035 0
New Zealand
State/province [1] 23035 0
Whanganui/Manuwatu

Funding & Sponsors
Funding source category [1] 306849 0
University
Name [1] 306849 0
University of Otago, Wellington
Country [1] 306849 0
New Zealand
Funding source category [2] 306877 0
Charities/Societies/Foundations
Name [2] 306877 0
Royal Society Te Aparangi
Country [2] 306877 0
New Zealand
Primary sponsor type
University
Name
University of Otago, Wellington
Address
23 Mein Street
Newtown
Wellington
6242
Country
New Zealand
Secondary sponsor category [1] 307431 0
None
Name [1] 307431 0
Address [1] 307431 0
Country [1] 307431 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307011 0
Southern Health and Disability Ethics Committees
Ethics committee address [1] 307011 0
Ethics committee country [1] 307011 0
New Zealand
Date submitted for ethics approval [1] 307011 0
30/06/2020
Approval date [1] 307011 0
28/09/2020
Ethics approval number [1] 307011 0

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

Contacts
Principal investigator
Name 105734 0
Miss Kato Robina McDonald
Address 105734 0
University of Otago, Wellington
23 Mein Street
Newtown
Wellington
6242
Country 105734 0
New Zealand
Phone 105734 0
+64 0272840605
Fax 105734 0
Email 105734 0
mcdka034@student.otago.ac.nz
Contact person for public queries
Name 105735 0
Kato Robina McDonald
Address 105735 0
University of Otago, Wellington
23 Mein Street
Newtown
Wellington
6242
Country 105735 0
New Zealand
Phone 105735 0
+64 0272840605
Fax 105735 0
Email 105735 0
mcdka034@student.otago.ac.nz
Contact person for scientific queries
Name 105736 0
Kato Robina McDonald
Address 105736 0
University of Otago, Wellington
23 Mein Street
Newtown
Wellington
6242
Country 105736 0
New Zealand
Phone 105736 0
+64 0272840605
Fax 105736 0
Email 105736 0
mcdka034@student.otago.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
To protect patient confidentiality we will not release the raw transcript data to the public even after it has been de-identified. As there may still be events described in the transcripts that may identify individuals.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9349Study protocol  mcdka034@student.otago.ac.nz 380669-(Uploaded-01-10-2020-09-17-02)-Study-related document.docx
9350Informed consent form  mcdka034@student.otago.ac.nz 380669-(Uploaded-01-10-2020-09-14-34)-Study-related document.docx
9351Ethical approval  mcdka034@student.otago.ac.nz 380669-(Uploaded-01-10-2020-09-14-34)-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
No additional documents have been identified.