Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000783729
Ethics application status
Approved
Date submitted
11/04/2022
Date registered
2/06/2022
Date last updated
2/06/2022
Date data sharing statement initially provided
2/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Co-development and end-user testing of a Mobile App to support dementia carers.
Scientific title
Agile co-development and end-user testing of the usability, perceived helpfulness, and potential inter-system integration of a general well-being and coping App (Carers' CARE) for dementia carers .
Secondary ID [1] 306906 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dementia 326010 0
carer well-being 326121 0
Condition category
Condition code
Neurological 323315 323315 0 0
Dementias
Mental Health 323444 323444 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The App content was designed specifically for this study. It contains content areas that cover self-care, management of behaviours and symptoms of dementia (BPSD), financial and legal matters, respite care, community-based non-government organisations (NGOs) and government services, positive aspects of caregiving, and mobilizing social support and social connectedness.

There is also information on professional support in the community and the steps to seeking support from medical, psychological, and allied health professionals as well as dementia carers’ support groups and services. Links to services in dementia and carer support services provided through Australian government departments, NGOs and charitable organisations are embedded in the App.

The App uses written content, short video clips, still shots and interactive features (such as serious games) to provide general coping and wellbeing education and information for Australian carers or people with dementia (PWD) .

Carers' usage of the APP: To enhance end-user engagement and satisfaction, the App design gives carers agency (free choice/control), and flexibility to self-regulate the way they use the App and content they engage with. The Carers’CARE App is fully self-directed with no instructions or specifications to carers about the minimum amount of usage, no required dose, and no predetermined prescriptive pathways through the App modules. If carers wish they can use a navigation tool that enables them to know about modules in the App that might be most relevant to their self-identified needs. This is an optional feature they can choose to use to locate modules in the App to visit or explore that might be relevant to their circumstances.

Duration of participants access to the App: For the first agile cycle, carers' will have access to the App for the 3 months post-enrolment. Carers who elect to participate in both agile cycles will have access to the App across both agile cycles (i.e., for 3 months post -enrolment, and across the second 3 month cycle, which will occur 5 months post enrolment through to 8 months post enrolment)

Participants access the App directly from the Google Play Store and Apple App Store, either by searching for the App on those stores, or from direct links provided to participants during the onboarding process (i.e.., online eligibility screening and informed consent process) after registration is complete. The App will be identified as a Utas App with restricted access on the Google Play and Apple App store pages. To prevent unintended downloading of the App, it is clearly outlined in the description of the App, that it is intended only for use by those who have consented and registered to use the App. If someone discovers the App on the Google Play Store or Apple App Store without having first completed the registration and consent process, they will be unable to use the App as they will not have login details for the App.
The direct links provided during onboarding can be opened in a web browser on a computer or mobile device. To assist participants who initially sign up on their computers but wish to proceed on their mobile device, an option is provided to send these links via email to their mobile device. To use the App on a desktop computer, participants can simply use the link provided to them after registering from any computer.

Treatment adherence is not applicable and there is no prescribed dose or required therapy content. However, App analytics will provide information about participants’ patterns of App usage and usage patterns associations with primary and secondary outcomes.

Agile cycles of App testing: There are two 3-month iterative feedback cycles of App testing. Analysis, minor refinements (e.g., bug fixes), and testing will happen concurrently and iteratively within a cycle. The phase between the two cycles will take in total around 6-8 weeks. It will encompass an iterative process (taking approximately 3-4 weeks) of examining quantitative usage data and qualitative feedback from participants to collectively identify parts of the app that are frequently used, well received, and useful, as well as parts of the app that need improvement, have usability issues, or are under-used. Members of the study team will test the changes to the app prior to the second participant testing cycle and this process is expected to take 3-4 weeks.

Participants from the first agile cycle can elect to participate in the second cycle. The second agile cycle of testing will also involve a second round of recruitment to get feedback and usage data from a unique cohort of participants as well, who are not aware of the changes that have been made to the app.

There are three types of participant groups being recruited:
Group 1: carers of PWD (minimum 50 carers).
Group 2: staff representing collaborating NGO organisations (maximum 2-3 per organisations)
Group 3: subset of carers from group 1, randomly selected for interview (maximum 16)

Groups 2 & 3 also participate in interviews.

Selection of Group 2 NGO representatives: In agile methodology a co-development approach is taken. This involves direct participatory engagement with partner or stakeholder groups (in this case the dementia and carer NGOs) to co-develop the App. This helps shape that App’s alignment with NGOs’ respective services and enhance implementation planning for App dissemination and implementation through the NGOs in the future. Each NGO will nominate the staff who are best placed to provide the NGO’s feedback about refinements to enhance the APP’s utility, alignment, and complementarity with their services. NGO’s were involved in Alpha and preliminary beta testing of the App in prior research.

Group 3: subset of carers from group 1: In enrolment process carers can opt-in or opt-out of random selection for an interview at the end of an agile cycle . From the group 1 carer sample who gave consent we will stratify on the basis of relationship to care-recipients (spouse/adult offspring) and randomly select maximum of 8 participants from each of these subgroups.
Intervention code [1] 323352 0
Treatment: Other
Intervention code [2] 323353 0
Lifestyle
Intervention code [3] 323354 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331053 0
Qualitative feedback about App features. Collected in-App and from thematic analyses from semi-structure standardized interviews conducted with groups 2 & 3 participants. Composite measure
Timepoint [1] 331053 0
Cumulative qualitative In-App feedback data will be collected continuously over each agile cycle (3 months post-enrolment). Interviews are conducted once at the end of each cycle (3 months post enrolment). Participants in cycle 1 can elect to be involved in both cycles of testing, and thus interviews will occur 3 months post-enrolment and again at 8 months post enrolment (as there is an 8 week gap between cycles of testing). Participants whose enrolment occurs in cycle 2 will only be assessed pre and 3mths post their enrolment.
Primary outcome [2] 331055 0
Qualitative feedback about user-friendliness and acceptability. Collected in-App and from thematic analyses from semi-structure standardized interviews conducted with groups 2 & 3 participants. Composite measure The interviews involve semi-structured, one-on-one interviews with a member of the research team; conducted face-to-face or via phone/video conferences, dependent upon personal requirements/circumstances, general health recommendations during global pandemic and geographic location.
Timepoint [2] 331055 0
Cumulative qualitative In-App feedback data will be collected continuously over each agile cycle (3 months post-enrolment). Interviews are conducted once at the end of each cycle (3 months post enrolment) Participants in cycle one can elect to be involved in both cycles of testing, and thus interviews will occur 3 months post-enrolment and again at 8 months post enrolment (as there is an 8 week gap between cycles of testing). Participants whose enrolment occurs in cycle 2 will only be assessed pre and 3mths post their enrolment.
Primary outcome [3] 331054 0
Qualitative feedback about App Content. Collected in-App and from thematic analyses from semi-structure standardized interviews conducted with groups 2 & 3 participants. Composite measure
Timepoint [3] 331054 0
Cumulative qualitative In-App feedback data will be collected continuously over each agile cycle (3 months post-enrolment). Interviews are conducted once at the end of each cycle (3 months post enrolment). Participants in cycle one can elect to be involved in both cycles of testing, and thus interviews will occur 3 months post-enrolment and again at 8 months post enrolment (as there is an 8 week gap between cycles of testing) . Participants whose enrolment occurs in cycle 2 will only be assessed pre and 3mths post their enrolment.
Secondary outcome [1] 408597 0
Patient Health Questionnaire, PHQ-4 assesses anxiety and depression symptoms. (completed by groups 1 & 3 only)
Timepoint [1] 408597 0
Completed twice per feedback cycle; upon recruitment, and at the end of a feedback cycle
Secondary outcome [2] 408594 0
Qualitative feedback from standardized interviews with Group 2 participants (NGO representatives) about the App’s potential to align with and complement their respective organisation’s suite of support services and to identify future implementation considerations. Gathered via semi-structured, one-on-one interviews with a member of the research team; conducted face-to-face or via phone/video conferences, dependent upon general health requirements/circumstances during the global pandemic and geographic location. Composite measure
Timepoint [2] 408594 0
Interviews are conducted once at the end of each cycle (3 months post enrolment). Participants in cycle one can elect to be involved in both cycles of testing, and this interviews will occur 3 months post-enrolment and again at 8 months post enrolment (as there is an 8 week gap between cycles of testing). Participants whose enrolment occurs in cycle 2 will only be assessed pre and 3mths post their enrolment.
Secondary outcome [3] 409258 0
UCLA Loneliness Scale – 3 Item (completed by groups 1 & 3 only)
Timepoint [3] 409258 0
Completed twice per feedback cycle; upon recruitment, and at the end of a feedback cycle
Secondary outcome [4] 408596 0
User feedback on perceived helpfulness of each App module for coping confidence. experimenter derived, 9 items assessed on 0-100 scales (composite measure)
Timepoint [4] 408596 0
Assessed at the end of each 3-month agile cycle . For participants only involved in first cycle this will occur at 3 months post enrolment only, where as for participants from cycle 1 who elect to be involved in both cycles, this will occur 3 months post enrolment and again at 8 months post enrolment. Participants whose enrolment occurs in cycle 2 will only be assessed 3mths post their enrolment.
Secondary outcome [5] 408595 0
Usage patterns assessed by App analytics - composite measure of app usage patterns. includes: a. Frequency of page visits over time, data categorised based upon hour of day, day of week b. Frequency of page visits, data categorised based upon days since starting the app, days after notification reminders to “check in” c. Length of time spent per page, average time spent per page, pages with most time spent viewing d. Proportion of time spent in each of the App modules/components Proportion of “Saved/Favourite” pages in each of the App modules, i.e., most favoured sections of the App.
Timepoint [5] 408595 0
Cumulative data will be collected continuously over each 3-month agile cycle. Some participants from cycle one will elect to be involved in only one 3-month agile cycle, whilst others will be involved in both cycles (thus providing 6 months of continuous data) . Participants whose enrolment occurs in cycle 2 will only provide provide data usage across the 3month period of cycle 2.
Secondary outcome [6] 409259 0
Positive Aspects of Caregiving scale (completed by groups 1 & 3 only)
Timepoint [6] 409259 0
Completed twice per feedback cycle; upon recruitment, and at the end of a feedback cycle

Eligibility
Key inclusion criteria
A. 18 years of age or older.
B. living in Australia.
C. ‘Lay carers’ (i.e., provide regular unpaid care, except for carers’ allowance/benefits)
D. caring for a spouse/partner, parent, other family member, or a friend
E. own or have access to a mobile device that can use android or iOS Apps
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Care Workers (people who provide care in their capacity as a paid/professional health care worker to a client/patient with dementia).

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
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Usability or feasibility studies for carers that employ mixed methods approaches primarily involve sample sizes of around 50 end users for quantitative assessments and far fewer for interviews. The exact number of target consumers or potential end users to engage in usability testing is contentious in the App development literature. It is arbitrary and not predetermined. Rather it is governed by when saturation, i.e., diminished diversity, of usability problems and thematic feedback is found. Our sample size is informed by the extant peer-reviewed literature pertaining to App agile development usability testing.

We will develop histograms and infographics of usage patterns and carers’ qualitative and quantitative feedback to explore the relative uptake and perceived helpfulness. . Word clouds will also be created of entered text, sentiment analysis, to indicate positive, neutral, or negative sentiment.

Descriptive analyses will be used to examine carers’ overall App usage, pattern of usage of specific modules, all participants’ feedback and scores on psychological measures and helpfulness feedback. The results will be considered in the context of carers’ areas of unmet needs, demographic characteristics and care-giving circumstances, e.g., perceived stage of disease and duration care giving etc.

The results of the study aim to refine an App prototype and as such the study is not powered or designed to test efficacy. However, to garner a preliminary understanding of the potential helpfulness and usefulness of the App for carers’ coping and well-being, we will calculate Reliable Change Index scores to evaluate whether the magnitude of change over time in individuals’ scores on the PHQ-4 and ULS-3 is suggestive of statistically reliable and clinically meaningful change.

We will also examine Reliable Recovery rates in terms of the number of carers whose change scores improve sufficiently to move their scores below clinical cut-offs, i.e., ‘caseness’ thresholds on these measures.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/06/2022
Actual
Date of last participant enrolment
Anticipated
30/11/2022
Actual
Date of last data collection
Anticipated
28/02/2023
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 311215 0
Charities/Societies/Foundations
Name [1] 311215 0
Tasmanian Community Fund
Country [1] 311215 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
University of Tasmania, Private Bag 3, Hobart, Tasmania, 7001
Country
Australia
Secondary sponsor category [1] 312735 0
None
Name [1] 312735 0
Address [1] 312735 0
Country [1] 312735 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310743 0
University of Tasmania Human Research Ethics
Ethics committee address [1] 310743 0
Ethics committee country [1] 310743 0
Australia
Date submitted for ethics approval [1] 310743 0
01/12/2021
Approval date [1] 310743 0
11/04/2022
Ethics approval number [1] 310743 0
24583

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

Contacts
Principal investigator
Name 118714 0
A/Prof Kristy de Salas
Address 118714 0
School of ICT, University of Tasmania, Private Bag 87, Hobart, Tasmania. 7001
Country 118714 0
Australia
Phone 118714 0
+61 3 62266220
Fax 118714 0
Email 118714 0
[email protected]
Contact person for public queries
Name 118715 0
Jennifer Scott
Address 118715 0
School of Psychological Sciences Social Sciences Building, Sandy Bay Campus, Churchill Ave, Sandy Bay, 7005, Private Bag 30, HOBART Tasmania. 7001
Country 118715 0
Australia
Phone 118715 0
+61 3 62262237
Fax 118715 0
Email 118715 0
[email protected]
Contact person for scientific queries
Name 118716 0
Jennifer Scott
Address 118716 0
School of Psychological Sciences Social Sciences Building, Sandy Bay Campus, Churchill Ave, Sandy Bay, 7005, Private Bag 30, HOBART Tasmania 7001
Country 118716 0
Australia
Phone 118716 0
+61 3 62262237
Fax 118716 0
Email 118716 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Participants have not consented to sharing IPD
Usability data is only relevant to the unique App to which it applies




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.