Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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
ACTRN12618000513213
Ethics application status
Approved
Date submitted
30/03/2018
Date registered
9/04/2018
Date last updated
12/03/2019
Date data sharing statement initially provided
12/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The assessment of Time to Improve Your Memory (TtIYM): a brief memory training program for community dwelling older adults.
Scientific title
The impact of a brief memory training program (Time to Improve Your Memory {TtIYM]) on community dwelling older adult's everyday use of memory and other areas of cognition.
Secondary ID [1] 294479 0
Nil known
Universal Trial Number (UTN)
U1111-1211-6024
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Memory 307242 0
Condition category
Condition code
Mental Health 306360 306360 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants attend two 3.5-hour memory training sessions, spaced a week apart.. The sessions involve learning more about memory and older adults in conjunction, practicing self-testing and spaced retrieval on word tasks, small tests of the information covered, and brainstorming activities of how the participants will apply what they have learned to everyday tasks. In the gap between the sessions participants are challenged to practice and tell someone (family or friend) what they have learned. There is no set criteria as it is just a small activity to encourage them to remember what they have learned After the second training session, participants are sent regular texts reminding participants to use the memory strategies throughout their day. They will receive these tests every day for the first week, every second day for the second week, every third day for the third week, and then back to everyday for the fourth week. The text which will be sent is the following : “Please reply back with the number of times you used a strategy (including self-testing and spaced-retrieval) or attempted to use throughout the day. Please guess if unsure”

They participants will also be sent encouragers via texts to reinforce their use of memory strategies. The first will be sent 3 days into the four-week period, the second will be sent 13 days into the four week period, the third will be sent 21 days into the four week period, and the fourth will be sent on the final day of the four week period.
Participants are given a participant manual containing information about memory and answer sheets for tasks they complete in the sessions. This participant manual has been designed specifically for this study..
Facilitators have a manual containing the same information about memory as the participant manual as well as instructions on how to run the sessions. They will have group training with the principle investigator. This training will be completed in two two-hour sessions, .
Two PowerPoint presentations will be used (one per session). The information on the two PowerPoints line up with the information given to facilitators and participants. It also follows the activities of the sessions.
Cards containing individual words and word-pairs are used in the training to help participants practice the memory strategies.
Challenge cards are given to the participants to help participants remember what they learned from session one during the week gap between the two session periods.
Participant information sheet given to participants before beginning pre-testing
Participant consent form which must be signed before beginning pre-testing

The intervention will be facilitated by individuals who are in their Honour's year of their Psychology degree or have completed a four-year psychology degree or are a psychology post-graduate student. The intervention requires facilitators who have at least some general knowledge of psychology and some flexibility to when they can work.
The intervention will be completed face-to-face in small groups as well as through texts. It will be run at the University of Queensland and community organizations.
There are currently no other strategies to monitor strategy use other then the texts sent back each day by participants regarding how many times they have used strategies during that day.
Intervention code [1] 300773 0
Prevention
Intervention code [2] 300774 0
Behaviour
Intervention code [3] 300775 0
Lifestyle
Comparator / control treatment
The study involves a wait-list control group who completes the training after the completion of the follow-up testing time point. The training will normally begin the weekend after the follow up testing unless it occurs to close to a holiday period (such as Easter) where it might be pushed back to after the holiday period.
Control group
Active

Outcomes
Primary outcome [1] 305371 0
The number of name-face pairs remembered - The name-face task will be used to measure the participants learning on a task that they are exposed to before the training but are not trained on. The task requires participants to learn a list of 20 name-face pairs in 20 minutes.
Timepoint [1] 305371 0
One week pre-intervention, 24-hours after the second training sessions, and four-weeks following the second training session.
Primary outcome [2] 305372 0
Then number of ideas remembered in a story - The participants will be presented with a short story involving a set amount of major ideas they must learn in 15 minutes..
Timepoint [2] 305372 0
24-hours after the second training sessions and four-weeks following the second training session.
Primary outcome [3] 305373 0
The number of places remembered on a map - Participants will be presented with a map with 15 locations and have 10 minutes to study the map before being asked to recall the name and position of the location on a blank map.
Timepoint [3] 305373 0
24-hours after the second training sessions, and four-weeks following the second training session.
Secondary outcome [1] 344969 0
Variations in speech samples V1 -The participants will be given a visual stimulus depicting a street scene. They then must describe what is happening in that street scene for two minutes. Those two minutes is then recorded and analysed for its propositional content.
Timepoint [1] 344969 0
One week pre-intervention, 24-hours after the second training sessions, and four-weeks following the second training session.
Secondary outcome [2] 344970 0
Variations in speech sample (v2) - Participants will be asked a question, such as, “Using complete sentence, can you tell me about your favourite holiday?”, and then must talk about the subject for two minutes.
Timepoint [2] 344970 0
One week pre-intervention, 24-hours after the second training sessions, and four-weeks following the second training session.
Secondary outcome [3] 344971 0
Change in scores on the Hayling Sentence Completion Test, a measure of executive functioning, measuring verbal response initiation and response suppression times, and suppression errors
Timepoint [3] 344971 0
One week pre-intervention, and four-weeks following the second training session.
Secondary outcome [4] 344972 0
Change in score on the the Brixton Spatial Anticipation Test, a nonverbal measure visuospatial test involving rule changes
Timepoint [4] 344972 0
24-hours post-intervention
Secondary outcome [5] 344973 0
The Reminder's Questionnaire – This measure examines how effective the messaged reminders, and the texting back of the number of strategy use during their day. There questions are on a Likert scale ranging from 1 (‘not useful at all’) to 5 (‘extremely useful’). A third question is shown asking participants to state whether they would recommend the program and then explain why they choose that answer. The outcome being measured is satisfaction with the reminders and the memory training program as a whole.
Timepoint [5] 344973 0
Four-weeks after the second training session
Secondary outcome [6] 344974 0
The number of strategies used during the day - Between post-testing and follow-up testing participants will be sent daily texts between 5pm and 7pm asking them to reply with the number of strategies they used throughout the day.
Timepoint [6] 344974 0
Daily for the four weeks after the second training session.
Secondary outcome [7] 344976 0
Anxiety measured by score on the Geriatric Anxiety Inventory
Timepoint [7] 344976 0
One week pre-intervention
Secondary outcome [8] 344977 0
Depression measured by score on the Geriatric Depression Scale
Timepoint [8] 344977 0
One week pre-intervention
Secondary outcome [9] 344978 0
Cognitive function measured by score on the Montreal Cognitive Assessment
Timepoint [9] 344978 0
One week pre-Intervention
Secondary outcome [10] 344979 0
Participants personal belief about memory by score on the Personal Belief about Memory Instrument
Timepoint [10] 344979 0
One week pre-intervention.
Secondary outcome [11] 344981 0
Memory examined by score on the Boston Naming Test
Timepoint [11] 344981 0
One week pre-intervention
Secondary outcome [12] 344982 0
Memory examined by score on the Verbal Naming Task
Timepoint [12] 344982 0
This is now pre-intervention

Eligibility
Key inclusion criteria
(1) Aged 60 years and above
(2) Have unimpaired or corrected sight and hearing
(3) Able to travel to the University of Queensland or other community-based study sites
(4) Have access to a mobile phone that can receive and send texts
(5) Are available all time-points needed for one round of the study.
(6) Have no diagnosed neurological issues
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Fifteen lists containing six 1’s (with a 1 signifying an individual in the experimental group) and 2’s (with a 2 signifying an individual in the control group) making the following list 111111222222 . Six was chosen as the number of potential participants in each group due to testing limitations. The lists will then be entered into a website which randomises items where the order will be randomized for each one of the 15 lists. Each round of study will be allocated one of these lists in numerical order, with the first round being allocated list 1. Once a participant has indicated that they are available and willing to join a round of the study (so both the control and experimental group), they will be allocated to the next position available on the randomized list chosen for that round. If the next position is a 1 then the participant is allocated to the experimental group, if the next position is a 2 then the participant is allocated to the control group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
G*Power (Faul, Erdfelder, Lang, & Buchner, 2007) was used to estimate the minimal sample size needed. As estimate of eighty-two participants (41 per group) was calculated using an effect size of .30, determined by using the effect size reported in a similar study minus 10% for margin (Bottiroli et al., 2013), 2 x 2 mixed measures ANOVA analyses, and a power level of 0.80. A 2 x 2 mixed ANOVA was chosen for the calculation as it was analyses requiring the most participants to find an effect bar one analysis requiring a number of participants beyond the scope of this study.

Independent-samples t-tests will be used to examine whether there is any significant difference between groups on gender, age, GDS score, GAI score, and MoCA score. The Chi-square test will be used to examine if there are any significant difference between the groups on ethnicity and level of education. If groups significantly differ on any demographics, then it will be entered as a covariate for further analyses that compare groups.
A 2 x 3 group (experimental; control) x time (pre-training; post-training; follow up) mixed measures analysis of variance (ANOVA) will be used to assess changes in the name-face task and two-minute speech samples (version one and two), and the HSCT. If significant, any main effects or interactions will be reported. A 2 x 2 group (experimental; control) x time (post-training; follow up) mixed measures ANOVA will be used to assess changes in the place-learning task and text-learning task. Post-hoc analysis of resulting simple main effects, or main effects in the absence of an interaction, for the above analyses will be corrected using a Sidak adjustment (Abdi, 2007). Statistical test, p values and effect sizes will be reported for each analysis. If covariates must be used, then mixed measures analysis of covariance, along with the associated post hoc tests, will also be reported for these measures.
The Reliable Change Index (Jacobson & Truax, 1991) will be used to examine number of participants who significantly differ on the name-face task at post-testing compared to pre-testing (baseline).
A 2 x 2 group (experimental; control) x time (post-training; follow up) mixed measure multivariate analysis of variance (MANOVA) will be used to compare the participant mean scores on the nine sections of the PBMI. Any significant interactions or main effects in the absence of interactions will be followed up with Sidak adjusted post hoc tests (Abdi, 2007). If covariates are needed, a mixed measure multivariate analysis of covariance, with associated a post hoc tests, will also be reported if there are any covariates.
Hotelling's T2 will be used to examined difference between the experimental groups on the four-possible category of responses on the BNT as the categories examine the same underlying concept
Pearson’s correlation will be used to compare correct responses under 20 seconds on the BNT to correct responses under 10 seconds on the verbal naming task. The data on the remaining possible answers will be presented along with alternative answers given for each item. The number of errors on the BSAT will be analysed using an independent-samples t-test unless a demographic factor must be used as a covariate. Here a one-way analysis of covariance will be used instead.
Regarding the Reminders Questionnaire, the composite mean, median, mode, and range of both groups will be reported for the Likert questions. There is no expected difference between scores as both groups complete the same training. Inductive content analysis will be used to analyse the content of the two short answer questions. Descriptive statistics will also be used to analyse daily strategy use. The composite mean from all participants for each day will be presented along with the median, mode and range of number of reported use of strategies. Missing data will not be replaced for this descriptive analysis but the number of missing data for each day will be recorded.
If data points are missing for any measures and an analysis between the two groups demonstrates the data is missing completely at random or missing at random, multiple imputations will be used to fill in those data points. To examine the impact of attrition on repeated measures assessment thoroughly, intention to treat, and linear trend at point approaches will also be used in conjunction with multiple imputation. The results of the three imputation approaches will be compared to results based on original data sets to cross check the influence of the missing data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/04/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
82
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 22249 0
4072 - University Of Queensland
Recruitment postcode(s) [2] 22250 0
4067 - St Lucia

Funding & Sponsors
Funding source category [1] 299105 0
University
Name [1] 299105 0
The University of Queensland
Country [1] 299105 0
Australia
Primary sponsor type
Individual
Name
Hannah Jensen-Fielding
Address
Level 3, McElwain Building, 24A
School of Psychology
The University of Queensland
St Lucia Qld 4072
Australia
Country
Australia
Secondary sponsor category [1] 298360 0
None
Name [1] 298360 0
Address [1] 298360 0
Country [1] 298360 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300037 0
University of Queensland Human Research Ethics Committee A
Ethics committee address [1] 300037 0
Ethics committee country [1] 300037 0
Australia
Date submitted for ethics approval [1] 300037 0
Approval date [1] 300037 0
08/05/2017
Ethics approval number [1] 300037 0
2016001497

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

Contacts
Principal investigator
Name 82346 0
Ms Hannah Jensen-Fielding
Address 82346 0
Level 3, McElwain Building (24A)
School of Psychology
The University of Queensland'
St Lucia, 4072
QLD
Country 82346 0
Australia
Phone 82346 0
+61 425207506
Fax 82346 0
Email 82346 0
[email protected]
Contact person for public queries
Name 82347 0
Hannah Jensen-Fielding
Address 82347 0
Level 3, McElwain Building (24A)
School of Psychology
The University of Queensland
St Lucia, 4072
QLD
Country 82347 0
Australia
Phone 82347 0
+ 61 425207506
Fax 82347 0
Email 82347 0
[email protected]
Contact person for scientific queries
Name 82348 0
Hannah Jensen-Fielding
Address 82348 0
Level 3, McElwain Building (24A)
School of Psychology
The University of Queensland'
St Lucia, 4072
QLD
Country 82348 0
Australia
Phone 82348 0
+61 425207506
Fax 82348 0
Email 82348 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
To prevent bias, participants are given a code which is not linked to their personal details. This also means we cannot link the participant data to the participant.


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.