Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000820101
Ethics application status
Approved
Date submitted
17/05/2019
Date registered
6/06/2019
Date last updated
10/06/2021
Date data sharing statement initially provided
6/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exploring the impact of attention training experienced by older adults with or without MCI

MCI- Mild cognitive impairment
Scientific title
Exploring the impact of attention training on attention difficulties experienced by older adults with or without Mild Cognitive Impairment (MCI).
Secondary ID [1] 298346 0
Nil known
Universal Trial Number (UTN)
U1111-1230-5654
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild Cognitive Impairment 312109 0
Condition category
Condition code
Mental Health 310667 310667 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study has a mixed design.
1. A quasi-experimental design (which is an empirical interventional study used to estimate the causal impact of an intervention on target population without random assignment) for data collected pre and post intervention training offered to the sample of participants with Mild Cognitive Impairment (MCI- Group 1).
2. Randomized control trial with data collected pre and post trainings offered to both the treatment and control groups of the sample of healthy older adults (Group 2).
For Group 1, participants with a new diagnosis of Mild Cognitive Impairment (MCI) recruited from the Memory Clinic, GARSS, Toowoomba Hospital, and from Geriatricians in their private practises as well as General Practitioners from the community will be recruited. All participants will be aged between 60-80 years.
Participants from the community (MCI and Healthy Older Adult participants) will have their assessments and training at the University of Southern Queensland and participants from the Memory Clinic will have their assessments and training at the Toowoomba Hospital.
After consent interviews and eligibility assessment with the aid of the Repeatable Battery for the Assessment of Neuropsychological Status- RBANS Update (Form A), the participants will be administered the additional pre-training measure - Test of Everyday Attention (TEA). Eligible participants’ RBANS Update A scores will be included as a pre-training measure.
After completion of the pre-training assessments, eligible participants of Group 1 (people with MCI) will be offered the intervention training (Attention Training) individually or in groups of 2-3 participants maximum depending on the number of participants recruited. On the other hand, after completion of pre-training assessments, participants of Group 2 (healthy older adult participants) will be randomly assigned to either the Attention Training group or the Relaxation Training group using a computer-generated randomization numbers available at random.org, with each group receiving equal number of participants (Haahr, M., 1999 and Snippe, et al., 2016).
For the healthy older adult population (Group 2), all training programs will be offered in groups of maximum 8 participants.
Participants in the treatment groups (both healthy older adults and people with MCI groups) will receive 10 weeks, 2 hrs per week session of structured Attention Training program.
Each treatment session will consist of: psychoeducation, an individual attention training task, a group attention training task- both of which primarily targets one or more aspects of attention namely selective, sustained and alternating attention but not divided attention, followed by discussion and feedback. The group facilitator (Principal Researcher) will keep a record of the individual participants’ performance on each individual task completed for the entire 10 weeks program.
Participants of the control group of Group 2 (only healthy older adults) will be offered group Relaxation training (10 sessions each 2 hourly) in groups of maximum 8 participants. This comparison group will allow us to understand whether the attention training tasks help improve attention abilities of the treatment groups but not the control groups, keeping other factors constant.
After completion of the group or individual training programs (Attention training program for the treatment groups and Relaxation Training program for the control groups), each participant will be re-administered the alternate form of the TEA and the RBANS- Update Form B.
Following completion of the relaxation training program, interested healthy older participants will be offered the same 'Attention Training' intervention (10 weekly sessions x 2 hrs each) in groups of 8 participants maximum, after a minimum of 2 weeks washout period.
Control group participants for the healthy older adults population (Group 2) who choose to participate in the crossover study will have post outcome assessments taken twice: firstly after completion of the relaxation training (control group) and secondly after completion of the cross over training (Attention Training) thereafter. The same assessment tools (RBANS and TEA) with alternate forms will be used for this purpose.
Intervention code [1] 314002 0
Treatment: Other
Comparator / control treatment
Control group training is offered only to the Health Older adult sample population (Group 2).
Relaxation training is the control group treatment. These sessions will consist of psychoeducation on the following topics: education on the brain and neuroplasticity, general functions of the brain, factors impacting brain health, stress as we understand it, relaxation, breathing and relaxation, types of relaxation, progressive muscle relaxation, guided imagery and visualisation and how we can keep healthy and training in relaxation techniques.
Relaxation training that will be delivered, include the following: autogenic breathing, progressive muscle relaxation with and without tension, visualization, guided imagery, mindful walking and relaxed socialization.
This group will also be provided by the Principal Investigator who is a psychologist with clinical endorsement from the APS and has the necessary skills to provide the above program. This training will be delivered in 10 sessions- once weekly for 2 hours. The training will be manualised so that the exact same training is delivered in all sessions including follow-up sessions.
Following completion of the relaxation training program, interested healthy older participants will be offered the same 'Attention Training' intervention (10 weekly sessions x 2 hrs each) in groups of 8 participants maximum, after a minimum of 2 weeks washout period.
Control group participants for the healthy older adults population (Group 2) who choose to participate in the crossover study will have post outcome assessments taken twice: firstly after completion of the relaxation training (control group) and secondly after completion of the cross over training (Attention Training) thereafter. The same assessment tools (RBANS and TEA) with alternate forms will be used for this purpose.
Control group
Active

Outcomes
Primary outcome [1] 319513 0
General cognition as measured by the total index score obtained from the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and interrelation between the following domains of the RBANS)- immediate memory, delayed memory, visuospatial/constructional domain, and language domain.
Timepoint [1] 319513 0
2 time points- At baseline before receiving the interventions and at end point, after completion of the intervention.
Primary outcome [2] 319549 0
Measures of Attention as obtained from the Test of Everyday Attention (TEA) - outcome from the 4 subscales of the TEA namely selective attention, sustained attention, attentional switching, and divided attention.
Timepoint [2] 319549 0
2 time points- At baseline before receiving the interventions and at end point, after completion of the intervention. .
Secondary outcome [1] 368638 0
Nil
Timepoint [1] 368638 0
Nil

Eligibility
Key inclusion criteria
Group 1: Participants will be recruited from the Memory Clinic, Geriatric Adult Rehabilitation and Stroke Services, GARSS, Toowoomba Hospital, from Geriatricians in their private practise as well as General Practitioners (GPs) from the community. All participants will have a confirmed diagnosis of MCI. MCI status need to be recent within 3 months of recruitment to this study. The MCI status in GARSS is determined by the consultant geriatrician after the patient goes through a thorough clinical assessment by the Memory Clinic team formed of the consultant geriatrician, psychologist, pharmacist and the geriatric clinical nurse consultant. Additional to their MCI status, all MCI participants, within 3 months of recruitment to this study, will be screened by the research assistant for their eligibility by using RBANS (Update form A). Their RBANS score should be between 1 and 2 SD below the mean or between 3rd and 16 percentiles for their age and education matched peers on culturally appropriate normative data (American Psychiatric Association, 2013). Cognitive impairment maybe seen in one or more cognitive domains measured by the RBANS. However, participants will be independent with all their activities of daily living as reported by them, significant others or their GP. Participants of this group will be assessed with the RBANS at regular intervals of 3 months during their participation period, to ensure that they continue to hold their eligibility status.
Age of the sample population was determined to be between 60-80 years.

Group 2: Healthy Older Adults (without MCI diagnosis):
Participants will be recruited from the community and should be aged between 60 years and 80 years, do not hold a diagnosis of Mild Cognitive Impairment (MCI) and/or Dementia in the last 3 months prior to recruitment. Their general cognition as measured by the total RBANS score should be at least equal or above the mean, for their age and education matched peers on culturally appropriate normative data (APA, 2013). If they qualify for this study, this RBANS measure obtained will be used as one of the primary outcome measure administered before delivering intervention. No reports of functional or cognitive decline as noted by client, significant other or GP. Participants will be re-assessed of their eligibility status by using RBANS, if they or their significant other or their GP report any rapid cognitive decline, during their participation period.

For both groups 1 and 2 other inclusion criteria include -age of the sample population, which is between 60-80 years and participants must be able to read and write..
Minimum age
60 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria:
Exclusion criteria for participants of Group 1 (participants with a MCI status)- exclusion will be if these participants have a current diagnosis of Dementia or they progress to having Dementia while they are a participant in this study.

Exclusion criteria for Group 2 (healthy older adults)- exclusion criteria will be if they have a diagnosis of MCI or Dementia or they progress to having MCI or Dementia during the course of their participation in this study.

Other exclusion criteria for both MCI and Healthy older adults groups include severe sensory impairment that could potentially impact on their performance, acute medical condition or a severe medical condition needing intensive treatment, and intellectual impairment. These people are excluded as such conditions will hinder their ability to participate in the interventions.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer generated randomised numbers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer computerised sequence generation from "Random.org"
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
For Group 1 participants - participants with MCI - A quasi-experimental design (which is an empirical interventional study used to estimate the causal impact of an intervention on target population without random assignment) is used.
For Group 2 participants- healthy older adults - additional to randomized controlled trial- the use of a cross over design is also utilized.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For Participants with MCI (Group 1) the following statistical analysis will be completed:
a) Sample Size:
As it was difficult to recruit to this group, a maximum of 15 participants will be recruited.
b) Paired t-test
Continuous outcome will be measured for each participant at the start and at the end of their training program (Attention Training program). For each participant, the change between the start (pre-training data) and end (post-training data) will be measured. The mean values and standard deviations between the above data (pre-post training) will be obtained. Comparison between the mean values will be completed. Qualitative analysis of individual data will also be completed.

For Healthy Older Adults (Group 2) the following statistical methods will be used
a) G-power analysis:
Sample size was determined by G power analysis. This was calculated for medium effect size (.20 to .50) for 2 groups (namely one treatment and one control group of participants of healthy older adult), with one repeated measure. Hence the total number of participants was calculated to be 64 in the sample of healthy older adults with 32 in the treatment group and 32 in the control group.
b) Correlation analysis:
The correlation between the various attention measures (selective attention, sustained attention, attentional switching, and divided attention and various domains of the RBANS Update A namely immediate and delayed memory, visuospatial and language measures and overall cognition will be investigated by completing a correlation matrix. This will measure and describe the strength and direction of the relationship existing among these variables.
Two correlation matrices will be completed:
1. Correlation between pre and post training measures will be completed for the treatment group of participants.
2. Correlation with pre training measures only between the treatment and control group will also be completed.
c) Regression Slope and Correlation
For the treatment group of participants, each participant’s score for tasks completed on each session (10 sessions) was recorded. For each individual session, each participant’s score on the allocated task was the number of correct responses out of the total number of items completed within the specified time limit. Individual participant’s score on treatment intervention was the sum of the scores obtained from each individual session (10 in total).
Regression slopes will be calculated for each participant and these regression slopes will be correlated with the TEA (alternate form) change scores. This will allow the quantification of change as well as map the direction of change. Participants received training in 3 aspects of attention namely selective, sustained and alternating attention but not divided attention. This record of task performance and the measures of the TEA shared the same aspects of attention. In addition, TEA also measured divided attention, but the treatment group participants did not receive any training in it. This will help to determine whether training in the specific tasks of attention influenced participants’ attentional abilities in the 4 examined aspects of attention.
d) 2X2 Two by two repeated Analysis of Variance (ANOVA)
The “two way” or two factors in this Study were different conditions (Treatment group versus Control group) and the second factor being measurement at two different time points (pre and post training data namely the RBANS and the TEA). The independent variable in this study was the training program offered (Attention Training or Relaxation Training)- therefore the independent variable groups were: 1. Treatment group of healthy older adults, 2. Control group healthy older adults. Dependent variables in this study were 8 subtests of the TEA (namely Map Search, Elevator Counting, Elevator counting with distraction, Elevator Counting using Visual or Auditory Stimulus, Telephone Search, Telephone Search Dual task and lottery) the total RBANS score. Statistical comparisons focused on the differences noted between treatment group and the control group and reliable changes (if any) pre-versus post-intervention for both these groups. Data will be analyzed using the SPSS version 26.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
9/05/2019
Date of last participant enrolment
Anticipated
1/02/2021
Actual
21/12/2020
Date of last data collection
Anticipated
30/06/2021
Actual
26/03/2021
Sample size
Target
80
Accrual to date
Final
67
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 13461 0
Toowoomba Hospital - Toowoomba
Recruitment postcode(s) [1] 26068 0
4350 - Toowoomba

Funding & Sponsors
Funding source category [1] 302293 0
University
Name [1] 302293 0
University of Southern Queensland
Country [1] 302293 0
Australia
Funding source category [2] 302294 0
Charities/Societies/Foundations
Name [2] 302294 0
Toowoomba Hospital Foundation
Country [2] 302294 0
Australia
Primary sponsor type
Individual
Name
Mousumi Singh
Address
Toowoomba Hospital
Geriatric Adult Rehabilitation and Stroke Services
Private Mail bag 2
Toowoomba, Qld 4350
.
Country
Australia
Secondary sponsor category [1] 302169 0
None
Name [1] 302169 0
Address [1] 302169 0
Country [1] 302169 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302968 0
Darling Downs Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 302968 0
Ethics committee country [1] 302968 0
Australia
Date submitted for ethics approval [1] 302968 0
26/09/2018
Approval date [1] 302968 0
01/02/2019
Ethics approval number [1] 302968 0
HREC/19/QTDD/44877
Ethics committee name [2] 302969 0
University of Southern Queensland Human Research Ethics Committee
Ethics committee address [2] 302969 0
Ethics committee country [2] 302969 0
Australia
Date submitted for ethics approval [2] 302969 0
01/03/2019
Approval date [2] 302969 0
13/03/2019
Ethics approval number [2] 302969 0
H19REA038

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

Contacts
Principal investigator
Name 92014 0
Mrs Mousumi Singh
Address 92014 0
Toowoomba Hospital
Geriatric Adult Rehabilitation and Stroke Services
Private Mail bag 2
Toowoomba, Qld 4350
Country 92014 0
Australia
Phone 92014 0
61746166124
Fax 92014 0
Email 92014 0
[email protected]
Contact person for public queries
Name 92015 0
Mousumi Singh
Address 92015 0
Toowoomba Hospital
Geriatric Adult Rehabilitation and Stroke Services
Private Mail bag 2
Toowoomba, Qld 4350
Country 92015 0
Australia
Phone 92015 0
61746166124
Fax 92015 0
Email 92015 0
[email protected]
Contact person for scientific queries
Name 92016 0
Mousumi Singh
Address 92016 0
Toowoomba Hospital
Geriatric Adult Rehabilitation and Stroke Services
Private Mail bag 2
Toowoomba, Qld 4350
Country 92016 0
Australia
Phone 92016 0
61746166124
Fax 92016 0
Email 92016 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
For confidentiality reasons to protect interests of individual participants


What supporting documents are/will be available?




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.