Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001328965
Ethics application status
Approved
Date submitted
2/09/2020
Date registered
8/12/2020
Date last updated
8/12/2020
Date data sharing statement initially provided
8/12/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Experiences of the use of the English version of an iPad application Aid for decision-making in occupation choice ,(ADOC-E), for shared decision making around goal setting in rehabilitation: a qualitative descriptive study
Scientific title
Investigating patient and health professional experiences of the use of an iPad application (ADOC-E) for shared decision making around goal setting in rehabilitation: a qualitative descriptive study
Secondary ID [1] 302096 0
Nil Known
Universal Trial Number (UTN)
U1111-1257-2302
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical rehabilitation 318714 0
Condition category
Condition code
Physical Medicine / Rehabilitation 316728 316728 0 0
Occupational therapy
Physical Medicine / Rehabilitation 316729 316729 0 0
Other physical medicine / rehabilitation
Physical Medicine / Rehabilitation 316730 316730 0 0
Physiotherapy
Physical Medicine / Rehabilitation 316731 316731 0 0
Speech therapy
Injuries and Accidents 317212 317212 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study is to investigate preliminary experience of health professionals and patients regarding the use of the iPad application ADOC-E to facilitate shared decision making around goal setting in rehabilitation. We want to develop an understanding of: how ADOC-E can be usefully incorporated into clinical practice; what health professionals and patients like and do not like about the application; how ADOC-E aligns with other clinical processes and practices; how ADOC-E influences clinical decision-making in everyday rehabilitation setting; and what patient outcomes or process outcomes ADOC-E might most affect.
We will recruit allied health professionals and patients from public and private rehabilitation services in New Zealand. We will recruit a total of 6 - 12 health professionals and provide them with an iPad, with the ADOC-E app already installed and with a short training in the use of the application ADOC-E. The training will last approximately 60 to 120 minutes. The health professionals will be asked to use ADOC-E with patients in their service as part of their usual goal setting meeting. During the goal setting meeting, health professionals will ask their patients what they expect from the rehabilitation and which goals they would like to achieve or to work towards. Health professionals will not have any limit in terms on how to conduct the goal setting meeting and for how long. The only difference with their usual goal setting meeting is that health professional will have to set patient's goals using the app ADOC-E. ADOC-E should facilitate the goal setting meeting and help the health professional to set goals that are shared together with the patient. To be interviewed, health professionals will have had to use ADOC-E at least one time and signed the consent form. Once they have used the app ADOC-E, they will interviewed about their perception and experience using the app.
The 6-12 patients (in total), who have volunteered and given consent to participate to the study, will be interviewed to explore their experiences and perceptions of the use of ADOC-E app for goal setting in rehabilitation. We will conduct two interviews with health professionals, the first will be soon after using ADOC-E for the first time and the second will be after 4 weeks of using ADOC-E for the first time. We will interview patients only once and it will be before discharge or within 4 weeks from using ADOC-E for the first time.
Intervention code [1] 318510 0
Treatment: Other
Intervention code [2] 318717 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324997 0
The primary outcome is to investigate health professionals experience in using the app ADOC-E. We will investigate what health professionals like and do not like about the app. Health professionals acceptability and experience of the use of the ADOC-E to facilitate shared decision making around goal setting in rehabilitation will be determined by semi-structured audio-recorded one-on-one interviews.
Timepoint [1] 324997 0
We will conduct two interviews with health professionals, the first will be soon after using ADOC-E for the first time and the second will be after 4 weeks of using ADOC-E for the first time.
Primary outcome [2] 325280 0
The primary outcome is to investigate patients' experience in using the app ADOC-E. We will investigate what patients like and do not like about the app, Patient's acceptability and experience of the use of the ADOC-E, that facilitates shared decision making around goal setting in rehabilitation, will be determined by semi-structured audio-recorded one-on-one interviews.
Timepoint [2] 325280 0
We will interview patients only once and it will be before discharge or within 4 weeks from using ADOC-E for the first time
Secondary outcome [1] 387387 0
ADOC-E influenced or not health professionals clinical decision making into clinical practice. This outcome will be determinate by semi-structured audio-recorded one-on-one interviews.
Timepoint [1] 387387 0
First interview soon after using the app and second interview after 4 weeks of using the app.

Eligibility
Key inclusion criteria
To be included in the study, the health professionals must be qualified and registered allied health professionals (physiotherapists, occupational therapists, speech therapists or nurses), and undertake goal setting with patients in their rehabilitation service as part of their usual role. Participants will not be remunerated economically to participate to the study, however, the department and health professional will receive the free and latest version of the software ADOC-E for use on their own devices after the study, to thank them for their important contribution. Patients will be eligible to participate in the study if they are adults over 18 years of age, are current recipients of hospital rehabilitation services, are able to make their own decision about joining this study, are able to sign the consent form, are able to have a basic conversation in English about their preferences, with at least simple phrases and words, are able to communicate their own experiences. Patients, also need to score a minimum of 3 on the Montreal Cognitive Assessment (MoCA) exam (that it has been shown to be equivalent of MMSE of 9) and a minimum of 21 in the Mini-ACE. Type of injury or illness and time since injury/illness onset are not reasons for exclusion from the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
22/07/2020
Date of last participant enrolment
Anticipated
15/02/2021
Actual
Date of last data collection
Anticipated
15/02/2021
Actual
Sample size
Target
18
Accrual to date
4
Final
Recruitment outside Australia
Country [1] 22914 0
New Zealand
State/province [1] 22914 0
Wellington
Country [2] 23090 0
New Zealand
State/province [2] 23090 0
Auckland

Funding & Sponsors
Funding source category [1] 306641 0
University
Name [1] 306641 0
University of Otago
Country [1] 306641 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Centre for Innovation, Level 1 (East Wing), 87 St David St, 9016, Dunedin
Country
New Zealand
Secondary sponsor category [1] 307044 0
None
Name [1] 307044 0
Address [1] 307044 0
Country [1] 307044 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306719 0
Northern B Health and Disability Ethics Committees
Ethics committee address [1] 306719 0
Ethics committee country [1] 306719 0
New Zealand
Date submitted for ethics approval [1] 306719 0
18/02/2020
Approval date [1] 306719 0
04/05/2020
Ethics approval number [1] 306719 0
20/NTB/40

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

Contacts
Principal investigator
Name 104782 0
Mrs Carla Strubbia
Address 104782 0
Department of Medicine.
University of Otago Wellington.
PO Box 7343, 23a Mein St,
Newtown,
6242
Country 104782 0
New Zealand
Phone 104782 0
+642041604900
Fax 104782 0
Email 104782 0
[email protected]
Contact person for public queries
Name 104783 0
Carla Strubbia
Address 104783 0
Department of Medicine.
University of Otago Wellington.
PO Box 7343, 23a Mein St,
Newtown,
6242
Country 104783 0
New Zealand
Phone 104783 0
+642041604900
Fax 104783 0
Email 104783 0
[email protected]
Contact person for scientific queries
Name 104784 0
Carla Strubbia
Address 104784 0
Department of Medicine.
University of Otago Wellington.
PO Box 7343, 23a Mein St,
Newtown,
6242
Country 104784 0
New Zealand
Phone 104784 0
+642041604900
Fax 104784 0
Email 104784 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
IPD will not be available


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9026Ethical approvalEthics ref: 20/NTB/40 Health and Disability Ethics Committees [email protected] 380431-(Uploaded-02-09-2020-14-49-48)-Study-related document.pdf
9675Study protocol https://ourarchive.otago.ac.nz/[email protected] OUR Archive 380431-(Uploaded-10-11-2020-08-17-59)-Study-related document.docx
9676Informed consent formOUR Archivehttps://ourarchive.otago.ac.nz/[email protected] 380431-(Uploaded-10-11-2020-08-17-59)-Study-related document.docx



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.