Primary care screening to identify symptomatic menopausal women
| ISRCTN | ISRCTN13287757 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13287757 |
| IRAS number | 265355 |
| Secondary identifying numbers | CPMS 44336, IRAS 265355 |
- Submission date
- 02/02/2021
- Registration date
- 13/08/2021
- Last edited
- 12/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
The menopause represents a normal physiological change that occurs on average occurs in women aged 50. Though not strictly an illness, the low levels of oestrogen associated with the menopause commonly results in vasomotor symptoms such as hot flushes and night sweats. In addition, some also experience sleep disturbance, depression, mood changes, musculoskeletal pain, vaginal dryness and low libido.
Menopausal symptoms can be easily managed with hormone replacement therapy (HRT) however the potential increased risk of breast and other cancers, although very slight, has led to concerns among many women so that uptake of HRT is relatively low and women remain symptomatic.
The purpose of the present study is to make use of a validated screening tool to identify women eligible for treatment with HRT and who, according to the screening tool, experience moderate to severe menopausal symptoms. These women will be offered an appointment with a practice pharmacist to discuss the benefits and any possible risks from using HRT to enable them to make an informed choice on whether they wish to manage their symptoms with treatment.
We are interested in exploring the proportion of eligible symptomatic women who subsequently decide to use HRT and the extent to which the symptom burden is reduced by treatment.
Who can participate?
All women between the ages of 47 and 53 who are currently not prescribed any form of hormone replacement therapy and who have no medical reason not to use the treatment.
What does the study involve?
After giving informed consent participants will complete the menopausal symptom rating (MRS) scale and a quality of life questionnaire (Men QoL) online, both should take less than 5 to 10 minutes to complete. If the result from the rating scale shows that they have moderate to severe symptoms, they will be invited to have a discussion with their practice pharmacist about using HRT to manage symptoms, this consultation will take place online. The pharmacist will provide information on the benefits and any risks associated with using HRT, to allow participants to make an informed decision. If they want to try using HRT, the pharmacist will discuss the various treatment options and participants will have a follow-up online appointment with the pharmacist after three months to assess whether or not the treatment is working.
What are the possible benefits and risks of participating?
Hormone replacement therapy is indicated for the relief of menopausal symptoms although it is associated with some risks including blood clots, stroke, endometrial cancer, breast cancer and ovarian cancer. However, these risks are small.
Where is the study run from?
Rotherham, Doncaster, and South Humber NHS Foundation Trust (RDaSH) (UK)
When is the study starting and how long is it expected to run for?
January 2019 to December 2021
Who is funding the study?
Besins Healthcare (UK) Limited
Who is the main contact?
Miss Jeannie McKie, j.mckie@nhs.net
Dr Rod Tucker, rodtucker.tucker@gmail.com
Contact information
Scientific
Grounded Research Hub
Rotherham Doncaster and South Humber NHS Foundation Trust
2 St Catherines Close
Tickhill Road Hospital
Balby
Doncaster
DN4 8QN
United Kingdom
 ORCID ID |
0000-0003-4327-9681 |
|---|---|
| Phone | +44 (0)7818 560176 |
| j.mckie@nhs.net |
Scientific
Grounded Research Hub
Rotherham Doncaster and South Humber NHS Foundation Trust
2 St Catherines Close
Tickhill Road Hospital
Balby
Doncaster
DN4 8QN
United Kingdom
| Phone | +44 (0)7969155658 |
|---|---|
| rodtucker.tucker@gmail.com |
Study information
| Study design | Interventional non-randomized |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | GP practice |
| Study type | Screening |
| Participant information sheet | 39388 HRT-STUDY-participant-information-sheet-v1.4 17Aug2020.pdf |
| Scientific title | The use of a screening tool in primary care to identify menopausal and perimenopausal women who could benefit from hormone replacement therapy |
| Study objectives | Providing women with moderate to severe menopausal symptoms with educational support from their practice pharmacist will support them to make informed treatment choices and reduce symptom severity. |
| Ethics approval(s) | Approved 20/03/2020, North West - Greater Manchester Central Research Ethics Committee (Barlow House, 3rd Floor, 4 Minshull Street, Manchester, M1 3DZ, UK; +44 (0)207 1048 007; gmcentral.rec@hra.nhs.uk), ref: 19/NW/0745 |
| Health condition(s) or problem(s) studied | Primary care screening to identify symptomatic menopausal women |
| Intervention | This will be an uncontrolled before and after intervention study with participants recruited from primary care. The intervention consists of the use of the menopause rating scale (MRS) combined with the educational input from the practice pharmacists. Recruitment/Data collection 1. Practice databases will be searched to identify women aged 47 to 53 not currently/previously prescribed any form of HRT. Patients identified from the search will be sent (from the practice) a letter of invite to the study, an information leaflet, consent form and copies of the MRS/MenQol scales and asked to return the completed forms (consent, MRS, MenQol) to the practice. Non-responders will be sent a follow-up two weeks after the initial letter has been sent. 2. The practice (administrative staff) will collate the completed MRS/MenQol forms and invite those with a score ≥8 (on the MRS) for an appointment with the practice pharmacist to discuss use of HRT. 3. Eligible participants willing to use HRT will be invited back for a follow-up appointment after 3 months to review the impact of HRT on MRS and MenQol scores 4. Practices will be asked to record the number of patients identified in the database search/current treatments/No of non-responders/refusals 5. Participant demographics & current treatment will be transcribed onto an anonymised data collection form 6. Participants opting for a trial of HRT will be asked to return to the practice after 3 months for a treatment review and asked to complete a second menopausal rating scale and QOL questionnaire. 7. Any known adverse effects reported by women will be documented in the medical notes and new or unrecognised effects will be reported using the yellow card scheme. Pharmacist training To ensure that all participating clinical pharmacists are prepared to participate in the study, we will produce a bespoke training pack that will cover background information on the menopause, symptomology and any national guidance around treatment recommendations and information to help complete the study paperwork. Data Analysis Both demographics and current treatments used by women will be analysed descriptively. Means and standard deviations will be used for normally distributed continuous variables, medians and interquartile ranges will be used for non-normally distributed continuous variable, and counts and percentages will be used to describe categorical variables. Changes in total MRS/MenQol scores will be assessed using paired t-tests if the data are normally distributed or nonparametric equivalents if the data are skewed. |
| Intervention type | Behavioural |
| Primary outcome measure | Menopause symptom severity measures using the MRS and MenQol scales at 3 months |
| Secondary outcome measures | Uptake of HRT measured using self report at 3 months |
| Overall study start date | 18/01/2019 |
| Completion date | 31/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 47 Years |
| Upper age limit | 53 Years |
| Sex | Female |
| Target number of participants | Planned Sample Size: 60; UK Sample Size: 60 |
| Total final enrolment | 63 |
| Key inclusion criteria | All women between the ages of 47 and 53 years who are currently not prescribed any form of hormone replacement therapy and who have no recorded contra-indications to using the treatment |
| Key exclusion criteria | 1. Current, past or suspected breast cancer 2. Known or suspected oestrogen-sensitive cancer 3. Undiagnosed vaginal bleeding 4. Untreated endometrial hyperplasia 5. Previous idiopathic or current deep vein thrombosis or pulmonary embolism unless on anticoagulant therapy. 6. Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction) 7. Untreated hypertension 8. Active liver disease with abnormal liver function tests 9. Porphyria cutanea tarda 10. Pregnancy |
| Date of first enrolment | 06/02/2021 |
| Date of final enrolment | 31/12/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Rotherham
S65 1DA
United Kingdom
Northallerton
DL7 8AW
United Kingdom
Balby
Doncaster
DN4 0TG
United Kingdom
Sponsor information
Hospital/treatment centre
St. Catherine's House
St. Catherine's Hospital
Tickhill Road
Doncaster
DN4 8QN
England
United Kingdom
| Phone | +44 (0)1302 798456 |
|---|---|
| Rdash.groundedresearch@nhs.net |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to the small size of the trial. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.4 | 17/08/2020 | 10/08/2021 | No | Yes |
| Protocol file | version 1.5 | 17/08/2020 | 30/12/2021 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Other unpublished results | 23/11/2023 | No | No | ||
| Results article | 19/03/2024 | Yes | No | ||
| Plain English results | 12/04/2024 | No | Yes |
Additional files
Editorial Notes
12/04/2024: The plain English results were uploaded as an additional file.
19/03/2024: Publication reference added.
23/11/2023: The following changes were made to the trial record:
1. The overall end date was changed from 01/05/2022 to 31/12/2021.
2. The intention to publish date was changed from 01/05/2023 to 31/12/2023.
3. The plain English summary was updated to reflect these changes.
4. A file of unpublished results was added.
07/02/2022: The total final enrolment was changed from 61 to 63.
30/12/2021: The total final enrolment number was added. Uploaded protocol (not peer reviewed).
28/09/2021: The study contact has been updated and the plain English summary has been updated accordingly.
02/02/2021: Trial’s existence confirmed by National Institute for Health Research (NIHR)
