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Trial registered on ANZCTR


Registration number
ACTRN12618001505291
Ethics application status
Approved
Date submitted
3/09/2018
Date registered
6/09/2018
Date last updated
14/01/2020
Date data sharing statement initially provided
14/01/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
iPads for people with dementia in residential care: A feasibility pilot randomized controlled trial
Scientific title
iPads as an adjunctive intervention for people with dementia in residential care: A feasibility pilot randomized controlled trial
Secondary ID [1] 295977 0
Nil known
Universal Trial Number (UTN)
U1111-1219-8767
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementias 309491 0
Condition category
Condition code
Neurological 308322 308322 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
iPads with a personalised selections of apps. Participants will be randomised into two groups - the intervention group will receive a personalised iPad immediately while the control group will receive a personalised iPad at the conclusion of the six month trial. Prior to the intervention commencing with residents, a general training session will be offered to staff and interested family members. This session will provide information about what iPads are, how to use them and general guidelines on safe use of the internet and social media. It will also provide an opportunity for staff and families to ask questions and try out an iPad.
The intervention with consumers will commence with an individual session with the Research Occupational Therapist. The Research Occupational Therapist will use the Aid for Decision Making in Occupational Choice (ADOC) to guide an interview with the resident about personally meaningful activities. The ADOC will generate a list of personally meaningful activities which align with their individual preferences and interests which will be used to select appropriate apps (e.g. the app of their favourite football club, a petcare simulator if they owned pets) and personalise the iPad. Apps will be selected based on individual preference, interests and functional abilities (including hearing, vision, physical and mental capacity). Once each device has been personalized, both staff and the resident will be offered training by the Research Occupational Therapist around using these specific apps. The resident is then free to use the iPad as they wish for the next six months and beyond. Patterns of app and device usage will be monitored using an analytical app which tracks which apps have been opened and how long users have engaged with them. The resident and Research Occupational Therapist may add additional apps over the trial, should relevant apps become available or the resident express an emerging interest or preference.
Residents will be guided to use the device for no more than one hour at a time, but for at least two hours per week. Residential care staff, volunteers, and family members will be encouraged to regularly facilitate device use, and the devices will be left in the resident’s room for easy access. Examples of strategies for facilitation will include prompting the resident to use the device, providing support to select and open apps of interest, adjusting device settings (i.e. volume), sending data and resources (i.e. photos, emails) to access on the device and problem solving any issues which may arise. The Research Occupational Therapist will also visit on a regular basis (fortnightly) to support ongoing participation and usage, and volunteers will also be sought to support resident participation on these devices. Wireless internet access will be made available via sim cards within each iPad, and each resident will have an iPad for their exclusive use while they remain a resident at the care home. The progress of the intervention will be monitored by the Research Occupational Therapist, associate investigators (AI) and the chief investigator (CI), who will have regular contact with the residential care homes and each other throughout the six-month trial. At the conclusion of the intervention phase, and following collection of final outcome measures, the control group will receive the same training and support to set up their own personalised iPad.
Intervention code [1] 312304 0
Treatment: Other
Intervention code [2] 312305 0
Lifestyle
Comparator / control treatment
Treatment as usual will continue for the control group, with all of these residents on a waiting list for a personalised iPad at the end of the six month trial. These residents may access any services deemed appropriate to their treatment while on the waiting list. Treatment as usual is provided according to the current practices employed in these residential facilities, which is generally guided by evidence and practice guidelines. However, each residents treatment will be tailored to their individual needs.
Control group
Active

Outcomes
Primary outcome [1] 307298 0
Speed of dementia progression as measured by the Clinical Dementia Rating
Timepoint [1] 307298 0
Baseline (primary time point), 3 months, 6 months (primary end point)
Secondary outcome [1] 351422 0
Functional performance, as measured by the Assessment of Motor and Process Skills)
Timepoint [1] 351422 0
Baseline, 3 months, 6 months
Secondary outcome [2] 351423 0
Neuropsychiatric Symptoms, as measured by the Neuropsychiatric Inventory (Nursing Home version)
Timepoint [2] 351423 0
Baseline, 3 months, 6 months
Secondary outcome [3] 351424 0
Quality of Life, as measured by the Dementia Quality of Life Measure (DEMQOL) - patient and proxy versions
Timepoint [3] 351424 0
Baseline, 3 months, 6 months
Secondary outcome [4] 351425 0
Experience of intervention, as measured by a bespoke qualitative interview (residents) and/or focus group (staff members)
Timepoint [4] 351425 0
6 months only

Eligibility
Key inclusion criteria
Residents must be aged over 55 years, and may be of either gender. All participants will have a confirmed diagnosis of dementia (inclusive of all forms), and will be permanent residents of one of the three residential care facilities. Their physical and mental health must be stable (with no acute physiological or psychiatric illnesses requiring acute admission at the time of recruitment). As co-morbidity is so prevalent amongst this population, participants who meet all other inclusion criteria but have other diagnoses will be included. Each participant’s medical history will be recorded as part of the demographic data collection. For their data to be included, participants must use their iPad for at least 2 hours per week. If this has not occurred for three consecutive weeks, they will be automatically withdrawn from the study, but will be allowed to keep the device for ongoing use while a resident at the facility. Staff members working in each of the facilities (including clinicians and relevant non-clinical staff e.g. leisure and lifestyle coordinators) will be invited to participate in the study, by completing outcome measures for residents they know well.
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any consumers who do not meet the above criteria, and staff with insufficient knowledge of a participating resident’s presentation to complete outcome measures, will be excluded from this study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The unit of randomization will be the individual residents, with the total sample size bounded pragmatically by the residents who choose to participate in the study. The person deciding whether the resident is eligible for recruitment to this study will be unaware of which group they will be allocated to, as allocation will occur after recruitment is finalised. Contamination may be an issue, given that residents from the same facility may be in the treatment or control group, however a condition of participation in the study is that the personalised iPad is only used by the resident to whom it is assigned. Objective outcome measurement will be undertaken by appropriately trained IAs, who are blinded as to which group the resident has been allocated to and will have no no other role in the trial. Staff in each residential home will be aware of who has been in the treatment group, which may result in possible expectancy bias. Instructions provided to staff will emphasise that all ratings should be based solely on clinical observations and corroborating evidence of the persons current function and health. All other participant measures are self-report, and therefore blinding will not be possible.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random number generator will be used to allocate residents to the intervention or control conditions.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analyses will be performed using the SPSS package, and a biostatistician will be consulted to ensure the rigour of all statistical analysis. The statistical analysis will depend on the distribution of the data, and the size of the final sample. Data from all outcome measures (both continuous and ordinal) will be treated as continuous for the purposes of this study.
Paired t-tests will be used to analyse data related to the primary outcome - maintaining dementia severity - if the sample is normally distributed, and Wilcoxon signed rank test will be used if it is not. Based on this choice of statistical test, an a priori power analysis indicates that 15 participants are required in each group (treatment and control) to have 70% power for detecting an effect size of 0.8 when employing the traditional .05 criterion of statistical significance.
The first goal of the analysis will be to ensure the treatment and control groups do not significantly differ demographically. Descriptive statistics will be calculated first; for interval variables, these statistics will be means, standard deviations, and ranges; for categorical variables, the statistics will be frequencies and proportions. Given the similarities in resident profiles across the residential care homes, the cohorts are not expected to differ significantly demographically.
Differences between the treatment and control groups will then be assessed using the appropriate parametric or non-parametric test. The second goal of the analyses will be to assess the baseline scores and differences at 3 and 6 months for all variables of interest. After the outcome measures have been statistically analysed, the impact of the demographic characteristics and the confounding variable of app usage time and choices on the outcome measures will be analysed using scatter plots and Spearman’s r correlations to investigate whether demographics factors and/or app use influenced the baseline scores and changes over time.
The third goal of data analysis will be to report on consumer and staff experiences of using iPads. This data will be collected using qualitative interviews or focus groups, and will be subjected to thematic analysis (Vaismoradi, Turunen, & Bondas, 2013). Themes will be derived directly from the comments provided by participants. Using this method, the data will be coded, grouped into similar responses and categorised under a theme. Several trustworthiness measures will be employed to ensure the quality of the analysis. Two members of the research team, who will then meet to discuss the level of agreement between the codes, will initially code each transcript. Any areas of disagreement will be discussed and resolved. A comprehensive audit trail will also be kept for this project.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/09/2018
Date of last participant enrolment
Anticipated
31/12/2018
Actual
31/12/2018
Date of last data collection
Anticipated
30/06/2019
Actual
30/06/2019
Sample size
Target
36
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 300574 0
Charities/Societies/Foundations
Name [1] 300574 0
The Yulgibar Foundation - Post Doctoral Excellence Award
Country [1] 300574 0
Australia
Primary sponsor type
Hospital
Name
Melbourne Health
Address
c/o Psychosocial Research Centre
130 Bell Street
Coburg Victoria 3058
Country
Australia
Secondary sponsor category [1] 300065 0
None
Name [1] 300065 0
Address [1] 300065 0
Country [1] 300065 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301363 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 301363 0
Ethics committee country [1] 301363 0
Australia
Date submitted for ethics approval [1] 301363 0
Approval date [1] 301363 0
22/08/2017
Ethics approval number [1] 301363 0
HREC/17/MH/138

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

Contacts
Principal investigator
Name 86754 0
Dr Danielle Hitch
Address 86754 0
c/o Psychosocial Research Centre
130 Bell Street
Coburg Victoria 3058
Country 86754 0
Australia
Phone 86754 0
+61 406 932 734
Fax 86754 0
Email 86754 0
Danielle.Hitch@mh.org.au
Contact person for public queries
Name 86755 0
Danielle Hitch
Address 86755 0
c/o Psychosocial Research Centre
130 Bell Street
Coburg Victoria 3058
Country 86755 0
Australia
Phone 86755 0
+61 406 932 734
Fax 86755 0
Email 86755 0
Danielle.Hitch@mh.org.au
Contact person for scientific queries
Name 86756 0
Danielle Hitch
Address 86756 0
c/o Psychosocial Research Centre
130 Bell Street
Coburg Victoria 3058
Country 86756 0
Australia
Phone 86756 0
+61 406 932 734
Fax 86756 0
Email 86756 0
Danielle.Hitch@mh.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6414Study protocol  Danielle.Hitch@mh.org.au
6415Informed consent form  Danielle.Hitch@mh.org.au



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.