Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12620000979954
Ethics application status
Approved
Date submitted
27/07/2020
Date registered
30/09/2020
Date last updated
27/10/2021
Date data sharing statement initially provided
30/09/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot study of the Online Personalised Training in Memory Strategies for Everyday (OPTIMiSE) intervention program for older adults
Scientific title
Investigating the feasibility and efficacy of the Online Personalised Training in Memory Strategies for Everyday (OPTIMiSE) intervention program for older adults
Secondary ID [1] 301846 0
Nil known
Universal Trial Number (UTN)
Trial acronym
OPTIMiSE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Memory difficulties associated with ageing 318357 0
Condition category
Condition code
Mental Health 316366 316366 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 316762 316762 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This pilot is a single-arm pre-post study of 8 weeks duration plus a single maintenance session (booster) delivered 3 months post-intervention, to evaluate the feasibility and efficacy of OPTIMiSE. OPTIMiSE is a free online course focused on psychoeducation regarding memory models and reasons for forgetting, and teaching of strategies that are effective for everyday memory difficulties.

OPTIMiSE comprises 6 core modules plus one booster module. Each module comprises approximately 2 hours content. Modules will be released on a weekly basis, e.g. Module 1 will be released in Week 1, Module 2 in Week 2, etc. Module 6 will be split into two and delivered across two weeks (weeks 6 and 7). Week 8 is a "catch-up" period where no content is released. Once a module has been released, it can be completed at any time within the set 8 week study period, however participants will be encouraged to complete each module the same week that it is released. A single booster module will be delivered 3 months after completion of the 8-week intervention, to review and reflect upon the implementation and effectiveness of memory strategies in everyday life over the preceding 3 months. The booster module comprises approximately 2 hours content which can be accessed anytime within a set 2­ week period.

The proposed timeline of the pilot study intervention is as follows:

Week 1: Module 1
Week 2: Module 2
Week 3: Module 3
Week 4: Module 4
Week 5: Module 5
Week 6: Module 6.1
Week 7: Module 6.2
Week 8: Catch-up period (no content released)
Week 20: Booster module

Participants will begin OPTIMiSE by answering questions regarding the type of memory difficulties that they have been experiencing, how much each of these areas bothers them, and which memory difficulties they would most like to improve. This information will guide the content that each participant is directed to, providing a personalised experience. The booster module will not be personalised (content will be the same for all participants), although it will provide an avenue for personal reflection and interaction with other course participants, through the online discussion board.

All participants will be directed to complete core modules covering the following topics: Understanding memory and how it works; Learning new information; Understanding memory changes associated with normal ageing compared with mild cognitive impairment (MCI) and dementia; Memory strategies for everyday life; Connections between physical and mental well-being and memory; Sleep and memory; Prospective memory; and Forgetting items, words, and conversations. Some modules will cover a single topic, whereas others will cover multiple topics. Each of the 6 core modules will include personalised content relevant to each participant's individual goals, covering memory concerns such as: Remembering names; Losing items; Learning and recalling new information; Remembering to do something in the near future; Remembering passwords; Remembering the word you want, when you need it; Recalling what has been said to you; Remembering how to get somewhere.

OPTIMiSE will include information in a variety of formats, including written information, diagrams and photographs, videos of experts speaking about topics, and moderated text-based online discussion boards. Participants will be encouraged to work at their own pace, though it will be recommended that participants take breaks and not attempt to undertake an entire module in a single sitting. It will be recommended to complete each module within the same week that it becomes available.

OPTIMiSE will be interactive, including online practice of memory strategies, as well as exercises to practice in everyday life. For example, in the module on remembering names, participants would be introduced to various evidence ­based strategies, including association and spaced retrieval. This may first occur via written information for a single strategy (e.g. spaced retrieval), followed by viewing of a video demonstrating the use of spaced retrieval for remembering names in an everyday situation. Participants would then be directed to an online exercise mimicking an everyday situation and giving them an opportunity to use spaced retrieval. After completion of exercises such as this, participants will be prompted to provide any feedback or reflections that they might have, via a pop-up window whereby they are able to type notes. This feedback will saved for participants' future reference. Following this, they would be directed to a diagram of how spaced retrieval works, and then asked to choose a few people in their everyday life whose names they will try to learn using spaced retrieval over the next week. When they log into OPTIMiSE, at least one week later, they will be asked about how their practice in daily life went and asked to provide written feedback. Participants will also be encouraged to log into the moderated discussion boards to interact with other participants, in order to help create a sense of community.

Adherence to the intervention will be assessed through analysing usage statistics such as completion rate of all modules; proportion of each module completed; time spent on each page; number of elements (such as notes, web-links, pop-ups, etc.) interacted with; number of discussion board posts made; number of replies made to other discussion board posts; time spent on the discussion boards; etc.
Intervention code [1] 318154 0
Behaviour
Intervention code [2] 318418 0
Treatment: Other
Comparator / control treatment
No control group (pre-post design)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324529 0
Intervention feasibility will be assessed on a priori determined criteria recommended for use in feasibility studies: recruitment, acceptability, attrition, and data collection. Questionnaires assessing acceptability were designed specifically for this study. Two questionnaires were developed; one to be administered upon completion of each of module, and a more comprehensive questionnaire to be administered upon completion of the course as a whole. The individual module questionnaires assess if the module’s objectives were well defined and whether the information and tasks in the module enabled participants to achieve the module’s objectives. Also assessed are whether the content was easy to follow, and appropriate in amount and complexity, and if the practical exercises were beneficial in applying knowledge into practice, Participants can also provide open-ended feedback about aspects of each module they particularly liked or didn't like. The end-of-course questionnaire is more comprehensive and contains items assessing factors related to the mode of delivery (online, weekly modules, etc.), the participant's learning experience, group learning aspects (online discussion board), and application of learning to real life. Feasibility will also be measured by recruitment rates (ratio of actual enrolments to eligible potential participants, number of enrolled participants per recruitment source, time taken to reach recruitment target), acceptability (mean score regarding recommendation of OPTIMiSE to others; suggestions for improvements; proportion of modules completed; number of discussion board posts made), attrition (percentage of recruited participants completing OPTIMiSE) and data collection (amount and nature of missing data).
Timepoint [1] 324529 0
Acceptability: brief evaluation questionnaires at the completion of each module (weeks 1-5) and an overall evaluation questionnaire upon completion of module 6 (8 week time-point). Attrition will be assessed at the following time-points: (i) Baseline - prior to commencement of OPTIMiSE; (ii) 8-weeks - upon course completion; (iii) 20 weeks - at the booster session.
Primary outcome [2] 324889 0
Intervention efficacy is a composite primary outcome which will be assessed using the following outcome measures: Memory Strategy Knowledge; the Multifactorial Memory Questionnaire (MMQ); Knowledge of Memory Ageing Questionnaire.
Timepoint [2] 324889 0
These measures will be administered at three time-points: (i) Baseline - prior to commencement of OPTIMiSE; (ii) 8-weeks - upon course completion; (iii) 20-weeks - at the booster session.
Secondary outcome [1] 384886 0
Sense of community: the ability of OPTIMiSE to create a sense of community among participants, and whether the sense of community engendered through OPTIMiSE is sufficient to normalise participants’ memory concerns. Assessed using a modified version of the Brief Sense of Community Scale.
Timepoint [1] 384886 0
(i) 8-weeks - upon course completion; (ii) 20-weeks - at the booster session.
Secondary outcome [2] 386107 0
Self efficacy is a composite secondary outcome which will asses if the program is able to foster and enhance feelings of coping and self-efficacy with respect to memory ability. Assessed using the Memory Controllability Inventory (MCI) and a Memory Self-efficacy Questionnaire.
Timepoint [2] 386107 0
(i) Baseline - prior to commencement of OPTIMiSE; (ii) 8-weeks - upon course completion; (iii) 20-weeks - at the booster session.

Eligibility
Key inclusion criteria
• reporting subjective memory decline (respond “yes” to the question: is your memory worse than it was 10 years ago?)
• sufficiently fluent in reading and typing English to be able to access the course material and participate in the online forums and discussion board
• able to complete OPTIMiSE during the set 8­-week period
• able to complete the online evaluation questionnaires independently, including having access to and being comfortable in using the internet
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• diagnosis of dementia
• diagnosis of current psychiatric disorder likely to impact cognition (e.g. psychotic illness or severe depression)
• history of neurological condition likely to impact significantly on cognition and study participation (e.g., stroke)

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 is 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
Power analysis suggests that 107 older adults will need to complete pre and post testing, given an expected effect size from meta­-analysis of memory training in older adults of Hedge’s g = 0.242, with power = 0.80, and alpha = 0.05. Allowing for 70% retention of those who begin OPTIMiSE (based on the Wicking Dementia Research and Education Centre’s Preventing Dementia MOOC), 153 older adults will be recruited to the pilot study.

Feasibility will be measured by recruitment rates, acceptability (mean score regarding recommendation of OPTIMiSE to others; suggestions for improvements), attrition (percentage of recruited participants completing OPTIMiSE), and data collection (amount of missing data).

Efficacy will be determined by a series of repeated measures t-tests, with alpha adjusted according to the Holm method, on pre­ and post­ performance on the outcome measures.

Effect maintenance will be determined by repeated measures t­-tests (again, using the Holm method for multiple comparisons) comparing outcome measures at the booster module versus immediately after the course.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
11/09/2020
Date of last participant enrolment
Anticipated
5/10/2020
Actual
3/12/2020
Date of last data collection
Anticipated
Actual
30/03/2021
Sample size
Target
153
Accrual to date
Final
312
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 306271 0
University
Name [1] 306271 0
La Trobe University
Country [1] 306271 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Department of Psychology & Counselling
Cnr Plenty Road And Kingsbury Drive
BUNDOORA VIC 3086
Country
Australia
Secondary sponsor category [1] 306760 0
None
Name [1] 306760 0
Address [1] 306760 0
Country [1] 306760 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306478 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 306478 0
Ethics committee country [1] 306478 0
Australia
Date submitted for ethics approval [1] 306478 0
20/01/2020
Approval date [1] 306478 0
03/03/2020
Ethics approval number [1] 306478 0
HEC20025

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

Contacts
Principal investigator
Name 104030 0
Dr Kerryn Pike
Address 104030 0
Department of Psychology & Counselling School of Psychology & Public Health Cnr Plenty Road And Kingsbury Drive La Trobe University Bundoora VIC 3086
Country 104030 0
Australia
Phone 104030 0
+61 03 9479 1381
Fax 104030 0
Email 104030 0
[email protected]
Contact person for public queries
Name 104031 0
Carl Moller
Address 104031 0
Department of Psychology & Counselling School of Psychology & Public Health Cnr Plenty Road And Kingsbury Drive La Trobe University Bundoora VIC 3086
Country 104031 0
Australia
Phone 104031 0
+61 03 9479 1467
Fax 104031 0
Email 104031 0
[email protected]
Contact person for scientific queries
Name 104032 0
Kerryn Pike
Address 104032 0
Department of Psychology & Counselling School of Psychology & Public Health Cnr Plenty Road And Kingsbury Drive La Trobe University Bundoora VIC 3086
Country 104032 0
Australia
Phone 104032 0
+61 03 9479 1381
Fax 104032 0
Email 104032 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocolPike, K. E., Moller, C. I., Bryant, C., Farrow, M., Dao, D. P., & Ellis, K. A. (2021). Online Personalised Training in Memory Strategies for Everyday (OPTIMiSE) Program for Older Adults with Cognitive Concerns: Pilot Study Protocol. Journal of Alzheimer's Disease Reports, 5(1), 143-152, 1-10.https://content.iospress.com/articles/journal-of-alzheimers-disease-reports/adr200251[email protected]


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseOnline Personalised Training in Memory Strategies for Everyday (OPTIMiSE) Program for Older Adults with Cognitive Concerns: Pilot Study Protocol.2021https://dx.doi.org/10.3233/ADR-200251
EmbaseExamination of the Feasibility, Acceptability, and Efficacy of the Online Personalised Training in Memory Strategies for Everyday Program for Older Adults: Single-Arm Pre-Post Trial.2023https://dx.doi.org/10.2196/41712
N.B. These documents automatically identified may not have been verified by the study sponsor.