Health TrialsbyHealthPanel

Effectiveness of an mHealth Innovation on the Impact of Menstrual Complaints in Adolescents

ConditionsDysmenorrheaHeavy Menstrual BleedingMenstrual CrampsMenstrual Bleeding, HeavyMenstrual DiscomfortMenstrual Cycle AbnormalMenstrual DisorderMenstrual HealthMobile ApplicationmHealthMenstrual Health InterventionAdolescent
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age12-21
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

About this trial

The aim of this study is to improve menstrual health-related quality of life in adolescents by using a mobile menstrual health tracker. We will perform a randomized controlled trial to evaluate the (cost)-effectiveness of this mHealth intervention.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Dutch, English, Turkish or Moroccan-Arabic speaking

Post menarche

Access to a smartphone or tablet with iOS or Android operating system

Disqualifiers

Amenorrhea

Pregnancy

No menstrual bleeding or withdrawel bleeding in the 3 months prior to inclusion.

Previously or currently under treatment by a health care provider for menstrual complaints

Trial design

Design model

Parallel

Treatments tested in this trial

  • Menstrual Tracker and Education Application

    Other intervention

    The intervention is a mobile menstrual tracker and education application developed by Amsterdam UMC researchers. The app is developed to provide insight into the users' menstrual health and contains 11 trackable domains (menstrual bleeding, pain, impact, general health, mood, urine/stool, sleep, exercise, diet, sex, notes). It is connected to an online environment where the user gets educated about normal and abnormal menstrual health.

Treatment groups

874 Participants
are divided into 2 treatment groups
Group A: App groupExperimental treatment 1 intervention
Group B: Waitlist groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Quality of Life Score

Quality of life measured at baseline and 6 months after enrollment using the validated Pediatric Quality of Life 4.0 questionnaire.

Time frame
6 months after enrollment

Secondary outcomes

1

Menstrual bleeding related quality of life

The menstrual bleeding related quality of life assessed with the (adolescent) Menstrual Bleeding Questionnaire. The adolescent (\<18) or adult version of the questionnaire will be used as appropriate.

Time frame
6, 12, 24 months after enrollment
2

Knowledge about menstrual health

The knowledge about menstrual health will be assessed with the Menstrual Health Literacy survey.

Time frame
6, 12 and 24 months after enrollment
3

School-, work-, and leisure absences

The impact of menstrual complaints on school, work and leisure activities will be measured using the iMTA Productivity Cost Questionnaire (iPCQ). Impact of menstrual complaints is also reported in the mobile menstrual tracker and education app.

Time frame
6, 12 and 24 months after enrollment
4

Societal costs

Societal costs including healthcare use and prodictivity loss will be assessed using the iMTA Productivity Cost Questionnaire (iPCQ) and the iMTA Medical Consumption Questionnaire (iMCQ).

Time frame
6, 12 and 24 months after enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: