Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000716763
Ethics application status
Approved
Date submitted
2/02/2022
Date registered
18/05/2022
Date last updated
18/05/2022
Date data sharing statement initially provided
18/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The development, implementation and evaluation of the Walk, Talk and Listen over Zoom program for hearing-impaired older adults.
Scientific title
The development, implementation and evaluation of the Walk, Talk and Listen over Zoom program for hearing-impaired older adults.
Secondary ID [1] 306330 0
Nil known
Universal Trial Number (UTN)
Trial acronym
WTL-Zoom
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Loneliness 325121 0
Condition category
Condition code
Public Health 322530 322530 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In Phase 1 of this study, the Research Assistant will conduct face-to-face audio-recorded semi-structured interviews with older adults with hearing loss. Participants will primarily recruited from Macquarie University's MQ Speech and Hearing clinic, however other sources of recruitment include flyers posted around the Australian Hearing Hub (Macquarie University), word-of-mouth, and advertisement of the study on the Macquarie University Hearing website and email network. Interviews can be conducted over-the-phone if preferred. Interviews are expected to last 20-30 minutes and explore the barriers and facilitators to participating in WTL-Zoom. Upon completion of Phase 1, findings from the interviews will be used to inform the adaptation of the WTL-Zoom from the existing WTL program.

Once WTL-Zoom has been adapted, participants for Phase 2 will be recruited from the same recruitment sources as Phase 1. The anticipated time between the Phase 2 start date relative to Phase 1 is 2 months. Participants from Phase 1 will also be invited to participate in Phase 2 and if interested, will be provided the Participant Information and Consent Form. Written consent is required before enrolment into Phase 2. A draft form of WTL-Zoom program delivered in Phase 2 will involve the following: Participants will be divided into subgroups based on their preference of available sessions (morning/afternoon). The WTL-Zoom program will be delivered via Zoom. The Research Assistant will contact participants at least 24 hours before their scheduled session with a Zoom link and any other relevant material e.g., activity material that has been specifically designed for this study. The Research Assistant’s phone number will also be provided in case any participant has difficulty accessing Zoom. Sessions will run for up to 60-minutes once/week over ten-weeks in groups of up to 10 participants. Sessions will include informal socialisation, and physical activity with social interaction (PASI) or group auditory rehabilitation (GAR) on alternate weeks. WTL-Zoom will include five PASI sessions that are designed to improve strength, coordination, and balance. The exercises will not require any equipment other than a chair and will be facilitated by the Research Assistant (with an exercise-related qualification) and a research student who will be enrolled in a medical/allied health degree. Each physical activity session will include mindful breathing, warm-up exercises (e.g. stretching and bodyweight strengthening exercises), moderate-to-vigorous intensity shadow boxing, and cool down exercises (e.g. bodyweight strengthening, balance exercises). Exercise intensity will be assessed using the Borg Rating of Perceived Exertion scale. WTL-Zoom will include five GAR sessions that are based on the Ida Institute’s GROUP (Group Rehabilitation Online Utility Pack) program (https://idainstitute.com/tools/group_ar/group_ar_session_plans/). The proposed GAR sessions as part of WTL-Zoom will run for approximately 30-45 minutes and include: 1) GAR overview, communication of shared experiences, and goal setting using the Client Oriented Scale of Improvement (COSI) questionnaire 2); 2) education on understanding hearing loss and impacts on communication; 3) communication strategies: conversational fluency and assertiveness; 4) stress management and personal adjustment; and 5) communication programs and consumer support organisations, review of goals from session 1. A few minutes at the start sessions 2-5 will review the content covered in the previous session.
Intervention code [1] 322764 0
Lifestyle
Intervention code [2] 322765 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330321 0
The primary outcome of this intervention is any change in loneliness. This outcome will be assessed using the De Jong Gierveld Scale.
Timepoint [1] 330321 0
Baseline and immediately post-intervention (week 10)
Secondary outcome [1] 405817 0
The secondary outcome is any change in depression. This outcome will be assessed using the Center for Epidemiologic Studies Depression Scale (CESD-10).
Timepoint [1] 405817 0
Baseline and immediately post-intervention (week 10)
Secondary outcome [2] 405818 0
Another secondary outcome of this intervention is any change in falls-self-efficacy. This outcome will be measured using the Falls Self-Efficacy Scale.
Timepoint [2] 405818 0
Baseline and immediately post-intervention (week 10).
Secondary outcome [3] 405819 0
Another secondary outcome is any change in physical activity. This outcome will be assessed using the Active Australia Survey which captures leisure-time physical activity.
Timepoint [3] 405819 0
Baseline and immediately post-intervention (week 10).
Secondary outcome [4] 405820 0
Another secondary outcome is any change in quality of life. This will be assessed using the EuroQol EQ-5D-5L.
Timepoint [4] 405820 0
Baseline and immediately post-intervention (week 10)
Secondary outcome [5] 405821 0
Another secondary outcome is attitudes towards the intervention. This will be assessed using the Attitudes to Falls-Related Intervention Scale.
Timepoint [5] 405821 0
Immediately post-intervention (week 10)
Secondary outcome [6] 405822 0
Another secondary outcome is hearing handicap. This will be assessed using the Hearing Handicap Inventory for Elderly (HHIE).
Timepoint [6] 405822 0
Immediately post-intervention (week 10)
Secondary outcome [7] 405823 0
Program acceptability and feasibility will be collected via group discussions and a post-intervention feedback form that has been designed by the researchers for this study.
Timepoint [7] 405823 0
Immediately post-intervention (week 10)
Secondary outcome [8] 405824 0
Program adherence will be assessed using an attendance checklist. This data will help to inform program acceptability.
Timepoint [8] 405824 0
Immediately post-intervention (week 10)
Secondary outcome [9] 406199 0
Evaluation of the Group Auditory Rehabilitation component using the International Outcome Inventory for Alternative Interventions (IOI-AI).
Timepoint [9] 406199 0
Immediately post-intervention (week 10).

Eligibility
Key inclusion criteria
Phase 1 (semi-structured interviews) eligibility: 1) aged >= 50 years with any hearing loss, 2) fluent English, 3) consent to participate in the study (including audio recording).
Phase 2 (pilot study) eligibility: 1) aged >= 50 years with any hearing loss, 2) fluent English, 3) access to a smart phone, tablet or laptop with a front-facing camera; 4) technical ability to use Zoom or have someone to help; 4) clearance to safely participate in the physical activity components of the intervention (i.e. Physical Activity Readiness Questionnaire (PARQ+) or written physician clearance for participation; 5) written informed consent to participate.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Phase 2 exclusion criteria: 1) unable to ambulate/walk for exercise; 2) serious illness limiting their ability to exercise or complete the trial; 3) contraindications to exercise (i.e. failure to fulfil the prerequisites of the PARQ+); 4) uncontrolled hypertension (>=160/>90 mmHg); 5) signs or symptoms of alcohol/substance abuse and; 6) unable to commit to attending at least 80% of the sessions.

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)
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
Statistical methods / analysis
Phase 1: Recruitment of participants until data saturation achieved, approximately 16 participants required to achieve this. Verbatim transcripts of the focus groups/semi-structured interviews will be analysed iteratively to ensure analytic reflexivity. Transcripts will be coded separately by the research assistant and research student, using the Capability, Opportunity, Motivation and Behaviour (COM-B) model of the behaviour change wheel and discussed with the investigators. The research assistant and student will then establish themes under each subset of the COM-B model relating to barriers and facilitators to participating in an interactive online program. Phase 1 findings will inform the design of the program.
Phase 2: At least 52 participants are required to achieve a pre-post change in quality of life assuming a 0.4 effect size according to Cohen’s d and 80% power (G*Power 3.1 software). Statistical analysis will be carried out using IBM SPSS Statistics V.25. Descriptive statistics will be used to assess the acceptability and feasibility of WTL-Zoom. T-tests will be carried out to assess the pre-post intervention improvement in loneliness, depression, quality of life, falls efficacy, physical activity, and hearing handicap.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/05/2022
Actual
Date of last participant enrolment
Anticipated
30/09/2022
Actual
Date of last data collection
Anticipated
16/12/2022
Actual
Sample size
Target
68
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 36554 0
2109 - Macquarie University

Funding & Sponsors
Funding source category [1] 310683 0
University
Name [1] 310683 0
Macquarie University
Country [1] 310683 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
16 University Avenue, Macquarie University NSW 2019.
Country
Australia
Secondary sponsor category [1] 311902 0
None
Name [1] 311902 0
Address [1] 311902 0
Country [1] 311902 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310268 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 310268 0
75 Talavera Road, Level 3, Macquarie University, NSW 2109, Australia
Ethics committee country [1] 310268 0
Australia
Date submitted for ethics approval [1] 310268 0
14/02/2022
Approval date [1] 310268 0
16/05/2022
Ethics approval number [1] 310268 0
520221125737321

Summary
Brief summary
Targeted lifestyle interventions that include education, behaviour change and/or group support components could be effective in improving the lifestyle risk factors, increased falls risk and poorer mental health status associated with hearing loss. This study therefore aims to develop, implement and evaluate an online intervention called Walk, Talk and Listen over Zoom (WTL-Zoom). This will be achieved over two phases: 1) a small qualitative study (semi-structured interviews) with older adults with hearing loss to determine the barriers and facilitators to participating in such a program; and 2) applying the findings from phase 1 to inform the development of the WTL-Zoom, followed by a pilot study to evaluate its feasibility and acceptability. Participants for both phases will be primarily recruited from Macquarie University's MQ Health Speech and Hearing Clinic, as well as via university-based advertisements.

For the Phase 2 intervention, participants will be divided into subgroups based on their preference of available sessions (morning/afternoon). Sessions will run for 60-minutes once/week over ten-weeks with up to 10 participants per group. Each session including informal socialising and alternating; physical activity with social interaction (PASI) and group auditory rehabilitation (GAR) sessions. In total, there will be five PASI sessions, each running for approximately 30 minutes. These sessions will include mindful breathing, warm-up exercises (e.g., stretching and bodyweight strengthening exercises), moderate-to-vigorous intensity shadow boxing, and cool down exercises (e.g., bodyweight strengthening, balance exercises). There will also be a total of five GAR sessions. These sessions are based on the Ida Institute’s GROUP (Group Rehabilitation Online Utility Pack) program and will run for approximately 30-45 minutes. These sessions will include 1) GAR overview, communication of shared experiences, and goal setting using the Client Oriented Scale of Improvement (COSI) questionnaire; 2) education on understanding hearing loss and impacts on communication; 3) communication strategies: conversational fluency and assertiveness; 4) stress management and personal adjustment; and 5) communication programs and consumer support organisations, review of goals from session 1. A few minutes at the start sessions 2-5 will review the content covered in the previous session.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117066 0
Dr Diana Tang
Address 117066 0
Room 3.514, Australian Hearing Hub, 16 University Avenue, Macquarie University, Macquarie Park NSW 2109
Country 117066 0
Australia
Phone 117066 0
+61 298507431
Fax 117066 0
Email 117066 0
d.tang@mq.edu.au
Contact person for public queries
Name 117067 0
Dr Diana Tang
Address 117067 0
Room 3.514, Australian Hearing Hub, 16 University Avenue, Macquarie University, Macquarie Park NSW 2109
Country 117067 0
Australia
Phone 117067 0
+61 298507431
Fax 117067 0
Email 117067 0
d.tang@mq.edu.au
Contact person for scientific queries
Name 117068 0
Dr Diana Tang
Address 117068 0
Room 3.514, Australian Hearing Hub, 16 University Avenue, Macquarie University, Macquarie Park NSW 2109
Country 117068 0
Australia
Phone 117068 0
+61 298507431
Fax 117068 0
Email 117068 0
d.tang@mq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
At this stage there is no patient permission to share this data outside of the study.


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.