Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000469617
Ethics application status
Approved
Date submitted
26/04/2023
Date registered
8/05/2023
Date last updated
31/08/2023
Date data sharing statement initially provided
8/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a Smart Health Community for menopausal women in Australia - Pilot feasibility and acceptability study
Scientific title
Evaluation of a Smart Health Community for menopausal women in Australia - Pilot feasibility and acceptability study
Secondary ID [1] 309523 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Menopause 329806 0
Condition category
Condition code
Reproductive Health and Childbirth 326707 326707 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be allocated to either the group + digital intervention, one to one + digital intervention or digital intervention alone.
1. Group Intervention
The women in the Group Intervention will receive the digital intervention as well as a 1.5-hour telehealth meeting each week, with a Registered Nurse and General Practitioner, for 6 consecutive weeks. This meeting will be conducted via Telehealth and will be GP led and nurse supported. Session attendance checklists will be used to monitor attendance.
The purpose of the Group appointment will be to enable women to share their lived experience of the Menopause, understand their clinical symptoms and engage in psychoeducation and behavioural interventions, to assist their transition. The digital intervention will serve as a prompt for exploring behaviours. i.e., which ever video they watched that week, we will encourage questions and explore motivation for change on that topic. Session attendance checklists will be used to monitor attendance.
2. One on one intervention
Participants in the one-on-one program, will be enrolled in the Digital Intervention and undertake an additional 1-hour comprehensive assessment by a General Practitioner followed by a 6-week 30-minute telehealth behavioural coaching program.
The one-on-one comprehensive assessment will be undertaken by a General Practitioner and Registered Nurse in a clinic setting. It will include Menopausal medical history, screening and health behaviour assessment and development of treatment plan according to patient centred goals. The following 6 weeks will involve a 30 min Telehealth consultation with a Naturopath or Registered Nurse. These consultations will be psychoeducation and motivational interviewing to encourage behavioural modification based on the treatment plan and prompted by the weekly digital content. If deemed clinically appropriate, the General Practitioner will also attend the sessions to answer any questions and guide the treatment plan. Session attendance checklists will be used to monitor attendance.

All Telehealth is conducted via the functionality embedded within the secure Electronic Health Record. All Face-to-face clinical encounters will be conducted in a COVID safe manner.
The clinical team will not be engaging in the prescribing of Menopausal Hormonal Therapy or any other Medication, for the purpose of this trial. The General Practitioner will oversee all levels of care and refer to the participants regular General Practitioner, via written communication, any areas of clinical concern that are outside the scope of this trial.
Intervention code [1] 325954 0
Lifestyle
Intervention code [2] 325955 0
Behaviour
Comparator / control treatment
The Digital Intervention consists of a series of pre-recorded videos delivered over a 6 week period. The videos are conversational style. Each last between 10-20 mins . The videos cover menopause psychoeducation including information around sleep, diet and exercise. The videos will be delivered, embedded in an email each week, on a Sunday afternoon and include a summary statement and an inspirational quote. Email opening tracking software will be used to monitor attendance.
Control group
Active

Outcomes
Primary outcome [1] 334569 0
Participant drop out rates assessed by attendance reports
Timepoint [1] 334569 0
Post-completion of 6 week program
Primary outcome [2] 334570 0
Participant session attendance assessed by attendance reports
Timepoint [2] 334570 0
Post-completion of 6 week program
Primary outcome [3] 334571 0
Qualitative interview data (participants reports of acceptability and feasibility assessed via interview). The format will be semi-structured and ask questions regarding the content of the program. The interviews will be conducted by a trained member of the research team who was not involved in conducting the intervention and will be audio recorded.
Timepoint [3] 334571 0
Post-completion of 6 week program
Secondary outcome [1] 421251 0
Hot flash severity (Hot Flash Related Daily Interference Scale)
Timepoint [1] 421251 0
Assessed at baseline and post-completion of 6 week program
Secondary outcome [2] 421252 0
Menopause symptoms (Greene Climacteric Scale)
Timepoint [2] 421252 0
Baseline and post-completion of 6 week program
Secondary outcome [3] 421253 0
Quality of life (Utian Quality of Life Scale)
Timepoint [3] 421253 0
Baseline and post-completion of 6 week program
Secondary outcome [4] 421254 0
Beliefs about menopause (Menopause Representations Questionnaire)
Timepoint [4] 421254 0
Baseline and post-completion of 6 week program

Eligibility
Key inclusion criteria
Aged between 45 and 65 years of age; self-reported experience of menopause and impact on functioning at work.

Minimum age
45 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Experiencing significant medical or psychiatric condition (Diabetes, Any active Cancer, Ischaemic heart disease or Stroke, Chronic lung disease, Chronic kidney disease , Chronic Neurological condition; Multiple Sclerosis , Auto immune conditions or Fibromyalgia/Chronic Fatigue Syndrome; Severe anxiety or depression, psychotic disorder, bipolar disorder, PTSD).



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)
Allocation not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation using https://www.randomizer.org/
Randomisation will be conducted by a independent researcher not working on the trial
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
A sample of 36 will aim to be recruited, with 12 participants in each study arm in line with recommendations listed by Julious (2005) to assess pilot studies.
Allowing for an attrition rate of 20%, a total of 45 participants will aim to be recruited overall (15 each treatment arm).
No statistical analyses will be conducted; however confidence intervals will be calculated to inform further research studies using ANOVA or a non-parametric test alternative.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2023
Actual
14/08/2023
Date of last participant enrolment
Anticipated
1/12/2023
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 313716 0
University
Name [1] 313716 0
Western Sydney University
Country [1] 313716 0
Australia
Funding source category [2] 313717 0
Other Collaborative groups
Name [2] 313717 0
Digital Health CRC
Country [2] 313717 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Locked Bag 1797 Penrith NSW 2751
Country
Australia
Secondary sponsor category [1] 315529 0
Other Collaborative groups
Name [1] 315529 0
Digital Health CRC
Address [1] 315529 0
Suite 4 (Level 7)
3 Spring Street
Sydney NSW 2000
Country [1] 315529 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312888 0
Western Sydney University Human Research Ethics Committee
Ethics committee address [1] 312888 0
Locked Bag 1797 Penrith NSW 2751
Ethics committee country [1] 312888 0
Australia
Date submitted for ethics approval [1] 312888 0
27/04/2023
Approval date [1] 312888 0
09/08/2023
Ethics approval number [1] 312888 0
H15484

Summary
Brief summary
This study aims to assess the feasibility and acceptability of an integrated care model focusing on awareness, education, empowerment and behavioural change using a digital health platform for those experiencing the menopause transition. It will assess feasibility and acceptability outcomes for those allocated to one to one coaching ( + digital content), group coaching ( + digital content) or digital content alone using a mixed methods approach.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126230 0
Dr Tania Perich
Address 126230 0
Western Sydney University
Locked Bag 1797 Penrith NSW 2751
Country 126230 0
Australia
Phone 126230 0
+61 2 97726416
Fax 126230 0
Email 126230 0
t.perich@westernsydney.edu.au
Contact person for public queries
Name 126231 0
Dr Tania Perich
Address 126231 0
Western Sydney University
Locked Bag 1797 Penrith NSW 2751
Country 126231 0
Australia
Phone 126231 0
+61 2 97726416
Fax 126231 0
Email 126231 0
t.perich@westernsydney.edu.au
Contact person for scientific queries
Name 126232 0
Dr Tania Perich
Address 126232 0
Western Sydney University
Locked Bag 1797 Penrith NSW 2751
Country 126232 0
Australia
Phone 126232 0
+61 2 97726416
Fax 126232 0
Email 126232 0
t.perich@westernsydney.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


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.