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Evaluation of a Smart Health Community for menopausal women in Australia - Pilot feasibility and acceptability study

Evaluation of a Smart Health Community for menopausal women in Australia - Pilot feasibility and acceptability study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000469617
Enrollment
44
Registered
2023-05-08
Start date
2023-08-14
Completion date
2023-12-01
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 mon

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.

Sponsors

Western Sydney University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
45 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

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

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).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026