Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001353684p
Ethics application status
Submitted, not yet approved
Date submitted
3/12/2023
Date registered
21/12/2023
Date last updated
21/12/2023
Date data sharing statement initially provided
21/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of Telehealth vs Face-to-Face Group Memory Intervention for Neurocognitive Disorders
Scientific title
Memory Intervention for Neurocognitive Disorders: Comparing the effectiveness of an Online Telehealth versus Face-to-Face Treatment Program using a Semi-randomised Controlled Trial
Secondary ID [1] 311086 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neurocognitive Disorder 332239 0
Condition category
Condition code
Neurological 328956 328956 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be delivered a manualised group rehabilitation program adapted from Radford et al.’s (2010) ‘Making the Most of your Memory: an Everyday Memory Skills Program’ for telehealth delivery (as detailed by Withiel et al., 2019). The program entails six weekly two-hour sessions, which includes psychoeducation on the impact of neurological conditions on memory, training in compensatory memory strategy, and education of the impact of lifestyle factors (e.g., diet, exercise, sleep). Participants will also engage in interactive activities within the session and homework tasks between sessions in order to practice and apply learned skills in their daily contexts. This program will be delivered by an experienced neuropsychologist. A booster session (1-2hrs) will be offered to the group before the six-week follow-up assessment, administered by the same clinician who delivered the main intervention program. The booster group session will entail a summary of the main program along with discussion on the application of strategies within participant’s contexts.

The intervention will be delivered over videoconferencing to group/s consisting of around 6 participants.
Intervention code [1] 327538 0
Rehabilitation
Intervention code [2] 327646 0
Treatment: Other
Intervention code [3] 327647 0
Behaviour
Comparator / control treatment
A wait-list control and face-to-face group.

The face-to-face group will be held at Westmead Hospital. Participants will be notified about the specific location prior to the commencement of the group

The wait-list control will be semi-randomised (see randomisation details) to either the face-to-face or telehealth group after the 6 week follow-up assessments have been completed,
Control group
Active

Outcomes
Primary outcome [1] 336750 0
Participant-centred rehabilitation goals using Goal Attainment Scaling (GAS)
Timepoint [1] 336750 0
Pre-intervention and post-intervention (i.e., within one to two week starting the intervention and after completing the intervention) and 6-week follow-up
Secondary outcome [1] 429548 0
Everyday Memory Questionnaire-Revised (EMQ-R; Royle & Lincoln, 2008)
Timepoint [1] 429548 0
Pre-intervention and post-intervention (i.e., within one to two week starting the intervention and after completing the intervention) and 6-week follow-up
Secondary outcome [2] 429550 0
Part A of the Comprehensive Assessment of Prospective Memory (CAPM; Shum & Fleming, 2012).
Timepoint [2] 429550 0
Pre-intervention and post-intervention (i.e., within one to two week starting the intervention and after completing the intervention) and 6-week follow-up
Secondary outcome [3] 429553 0
Episodic memory/new learning
Timepoint [3] 429553 0
Pre-intervention and post-intervention (i.e., within one to two week starting the intervention and after completing the intervention) and 6-week follow-up
Secondary outcome [4] 429555 0
Royal Prince Alfred Prospective Memory Test (RPA- ProMem; Radford et al., 2011)
Timepoint [4] 429555 0
Pre-intervention and post-intervention (i.e., within one to two week starting the intervention and after completing the intervention) and 6-week follow-up
Secondary outcome [5] 429557 0
TBI Self-efficacy Scale (Huckans et al., 2010).
Timepoint [5] 429557 0
Pre-intervention and post-intervention (i.e., within one to two week starting the intervention and after completing the intervention) and 6-week follow-up
Secondary outcome [6] 429559 0
Satisfaction with Participation in Social Roles
Timepoint [6] 429559 0
Pre-intervention and post-intervention (i.e., within one to two week starting the intervention and after completing the intervention) and 6-week follow-up
Secondary outcome [7] 429562 0
Strategy Use Checklist. This checklist will be used to record participant use of external strategies (e.g., lists, smartphone applications). The frequency of use of each strategy was estimated, from “Daily” to “Not at all”.
Timepoint [7] 429562 0
Pre-intervention and post-intervention (i.e., within one to two week starting the intervention and after completing the intervention) and 6-week follow-up
Secondary outcome [8] 429564 0
Strategy Use Checklist. This checklist will be used to record participant use of internal strategies (e.g., mental rehearsal, face-name association). The frequency of use of each strategy was estimated, from “Daily” to “Not at all”.
Timepoint [8] 429564 0
Pre-intervention and post-intervention (i.e., within one to two week starting the intervention and after completing the intervention) and 6-week follow-up
Secondary outcome [9] 429567 0
Feasibility of the intervention
Timepoint [9] 429567 0
Weekly throughout the intervention program (6 weeks)
Secondary outcome [10] 429568 0
Acceptability of the intervention
Timepoint [10] 429568 0
Within a week or two post-completion of intervention program for the participant.
Secondary outcome [11] 429570 0
Treatment fidelity.
Timepoint [11] 429570 0
Weekly post each session of the intervention (6 weeks)

Eligibility
Key inclusion criteria
The study will recruit participants who:
• Are 18 years old and over;
• Have been diagnosed with a neurocognitive disorder or suspected neurocognitive disorder;
• Report memory difficulties confirmed by self, close-others, or referring clinicians;
• Have a Eastern Cooperative Oncology Group (ECOG) Performance Status Scale score of 0 to 1 or Karnofsky Performance Scale Index of >70;
• Have access to a device (not mobile phone) that has a microphone, a webcam and can access online videoconferencing,
• Are able to understand and speak English at a proficient level to participate in the intervention
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria entails the diagnosis of a neurodegenerative disorder or severe language/cognitive deficits that would prohibit adequate engagement with the intervention or assessment measures.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Semi-randomised Controlled Trial will be employed. Given that some participants may have limitations with accessibility in attending face-to-face delivery of the memory interventions, participants will have the option to either elect telehealth only or telehealth/face-to-face. Only those choosing to participant in either telehealth or face-to-face will be randomised into either option. Randomisation will be performed with an online random sequence generator (e.g., http://www.randomization.com) in advance of the study.

Around 20-25 participants will be allocated to the wait-list control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed with an online random sequence generator (e.g., http://www.randomization.com) in advance of the study.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/01/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
65
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25907 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 41742 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 315344 0
Hospital
Name [1] 315344 0
Westmead Hospital
Country [1] 315344 0
Australia
Funding source category [2] 315349 0
University
Name [2] 315349 0
Western Sydney University
Country [2] 315349 0
Australia
Primary sponsor type
Individual
Name
Chiara Pawela
Address
Westmead Hospital, Cnr Hawkesbury Road and, Darcy Rd, Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 317407 0
Individual
Name [1] 317407 0
Dr Travis Wearne
Address [1] 317407 0
Western Sydney University, Kingswood, NSW 2747
Country [1] 317407 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314267 0
Western Sydney Local Health District HREC
Ethics committee address [1] 314267 0
Ethics committee country [1] 314267 0
Australia
Date submitted for ethics approval [1] 314267 0
27/10/2023
Approval date [1] 314267 0
Ethics approval number [1] 314267 0

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

Contacts
Principal investigator
Name 130990 0
Ms Chiara Pawela
Address 130990 0
Westmead Hospital, Cnr Hawkesbury Road and, Darcy Rd, Westmead NSW 2145
Country 130990 0
Australia
Phone 130990 0
+61 2 8890 6686
Fax 130990 0
Email 130990 0
[email protected]
Contact person for public queries
Name 130991 0
Chiara Pawela
Address 130991 0
Westmead Hospital, Cnr Hawkesbury Road and, Darcy Rd, Westmead NSW 2145
Country 130991 0
Australia
Phone 130991 0
+61 2 8890 6686
Fax 130991 0
Email 130991 0
[email protected]
Contact person for scientific queries
Name 130992 0
Chiara Pawela
Address 130992 0
Westmead Hospital, Cnr Hawkesbury Road and, Darcy Rd, Westmead NSW 2145
Country 130992 0
Australia
Phone 130992 0
+61 2 8890 6686
Fax 130992 0
Email 130992 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
after de-identification, individual participant data underlying published results only
When will data be available (start and end dates)?
After the publication of the study results (no end date)
Available to whom?
Case-by-case basis at the discretion of Principal Investigator.
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
Deidentified data may be made publicly available in an online repository, as this is becoming a more common practice for journal publication. Contact the Principal Investigator Chiara Pawela, [email protected].


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.