Validation of PreMentricS smartphone app: patient and clinician acceptability of using an electronic method for measuring premenstrual symptoms

• Register: ISRCTN
• Last refreshed on: 27 May 2019
• Main ID: ISRCTN14743304
• Date of registration: 14/06/2018
• Prospective Registration: No
• Primary sponsor: University of Alberta
• Public title: Validation of PreMentricS smartphone app: patient and clinician acceptability of using an electronic method for measuring premenstrual symptoms
• Scientific title: Validation of PreMentricS smartphone app: patient and clinician acceptability of using an electronic method for premenstrual symptom quantification
• Date of first enrolment: 18/03/2018
• Target sample size: 100
• Recruitment status: Ongoing
• URL: http://isrctn.com/ISRCTN14743304
• Study type: Interventional
• Study design: Interventional single-centre randomised control trial with no masking (Other)
• Phase: Not Applicable

Countries of recruitment

Australia, Canada, France, India, United Kingdom, United States of America

Contacts

• Name: Deepthi Lavu

Key inclusion & exclusion criteria

Inclusion criteria:
1. Women from the general public between 18 -50 years age will be included in the study.
We will be recruiting from the public as we intend to see which method of symptom recording is preferred in the general population (paper vs electronic method of data capture).
The women recruited will be over the age of 18 years and under 50 years. Above 18 years is to ensure that recruited women have regular cycles and ovulation. The upper age limit exists as most women experience menopause around the age of 50 and we are studying disorders surrounding menstruation.

2. For the second part of the study:
Qualified gynaecology doctors (male and female) will be recruited as they are specialists in the area and will have experience in being able to diagnose premenstrual disorders.

Exclusion criteria:
1. Males
2. Women < 18 years of age
3. Pregnant women
4. Post menopausal women
5. Women on gonadotrophin releasing hormone analogues
6. Women who have used either method of symptom scoring previously
7. Women who lack capacity
8. Women who have special communication needs/who do not understand written English

For the second part of the study:
1. Doctors (male or female) who are in training and not completed their qualifying exams (junior doctors in gynaecology)


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Premenstrual disorders
Signs and Symptoms

Intervention(s)

The study is a user acceptability and usability study which will enable us to move on to validate the PreMentricS app.

The study will:
1. Determine numbers and power calculation if a larger study is needed.
2. Determine if this electronic method of symptom quantification is acceptable to women and clinicians (the users)
2. Inform the trialists on what advice to seek (statistical/methodological) based on the problems encountered in this study

There are two parts to this project:

Participant acceptability:
Participants (100) will include members of the general public (women) including staff and faculty of the Department of Family Medicine at the University of Alberta. Following consent, the participants will be randomised at arm's length using methods like the coin flip or computer randomisation to one of two groups. Based on which arm of the study they are allocated to, the participants will be given standard paper-based booklets for recording their symptoms on paper or be given access to download the PreMentricS app on their smartphone. One arm of the study will record their symptoms (or absence of symptoms) daily for the duration of one menstrual cycle (approximately one month) using the Royal College of Obstetricians and Gynaecologists (RCOG) recommended paper charts, Daily Record of Severity of Problems (DRSP charts). The other arm will record their symptoms daily using the PreMentricS app. Although participants may or may not suffer from premenstrual symptoms, all participants will be required to complete all components of the symptom scoring daily for the duration of the study.
All participants will complete questionnaires regarding the acceptability and ease of use of their method of symptom scoring at the end of a month of symptom scoring. The completed scores (paper and app scores) and the questionnaires will be

Primary Outcome(s)

The primary objective is to initiate the validation of the PreMentricS app against the current paper method of recording premenstrual symptoms, Daily Record of Severity of Problems (DRSP) charts. The current Royal College of Obstetricians and Gynaecologists Clinical Guideline on premenstrual disorders recognises the new PreMentricS app but also implies that it should be validated against the DRSP. Determination of the user (participant and clinician) acceptability and usability of PreMentricS app is the first step in this validation process.

Acceptability will be measured using the affective attitude of the participants towards the methods (both women using the methods and clinicians using data collected by those methods) and the burden of the method on the participants. The data will be captured in the questionnaires which seek information on the participants' perception of the different methods. This will be analysed in the data analysis stage (Dec 2018 - Jan 2019).

Secondary Outcome(s)

1. Perceived concurrent validity measured from answers provided in the study questionnaires (completed by all participants - women using the methods and clinicians who will use those methods to make a diagnosis of premenstrual disorders). This will be measured in the data analysis stage (Dec 2018 - Jan 2019)
2. Construct validity of the app: concordance of the clinician's diagnosis with the diagnosis suggested by the app. Sensitivity, specificity, positive and negative predictive values will be assessed. This will be measured in the data analysis stage (Dec 2018 - Jan 2019)
3. Difference in proportion of days of prospective symptom recording completed between both methods. The app does not allow retrospective recording and women given the paper forms will be informed not to fill in information retrospectively. This will be measured in the data analysis stage (Dec 2018 - Jan 2019)
4. Proportion of women returning the paper forms and app results. This will be measured in the data analysis stage (Dec 2018 - Jan 2019)

Secondary ID(s)

Pro00077340_AME3

Source(s) of Monetary Support

Investigator initiated and funded

Ethics review

Status:
Approval date:
Contact:

Health Research Ethics Board - Health Panel, University of Alberta, Edmonton, 07/02/2018, Study ID: Pro00077340

Results

• Results available: Yes
• Date Completed: 30/05/2019