Clinical trial NCT06283225: Pilot Study to Investigate the Effect of a Dysmenorrhoea App
Official title: Pilot Study to Investigate the Influence of a Dysmenorrhoea App on the Quality of Life and Symptoms of Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dysmenorrhea
Keywords: digital
app
dysmenorrhea
quality of life
Lead sponsor: Endo Health GmbH
Sponsor class: INDUSTRY
First posted: 2024-02-28
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: intervention group and control group
Primary purpose: SUPPORTIVE_CARE

Brief summary: The pilot study investigates the influence of a dysmenorrhoea app on the quality of life and symptoms of women with dysmenorrhoea. The intervention group can use the app over the study period of 12 weeks in addition to usual care, while the control group only receives the usual standard care. The aim is to evaluate the effectiveness of the app and to gain insights for the design of future studies. The study is expected to last seven months and include 100-200 participants.

Detailed description: The pilot study aims to investigate the effect of a dysmenorrhoea app on the quality of life and symptoms of women with dysmenorrhoea. Dysmenorrhoea, defined as painful menstruation, is a widespread and distressing health problem that can significantly affect the quality of life and well-being of affected women. Research into digital health applications has shown the potential to provide innovative solutions to improve care and self-management of chronic conditions.

The present study is designed as a single-blind, two-arm, randomised controlled trial in which participants will either receive the dysmenorrhoea app over a 12-week period in addition to usual care (intervention group) or only usual care as typically available (control group). The study will be conducted online. The aim is to evaluate the effectiveness of the app by analysing various questionnaires as endpoints, which were completed at T0 (baseline) and after 4 (T1), 8 (T2) and 12 weeks (T3).

The DSI, MDQ, VAS pain, FSS, FESS, PDI and DASS-21 questionnaires are defined as endpoints. The difference between the intervention group and the control group is compared in terms of the changes (change score) between the time points T0 (baseline) and T3 (post-treatment: twelve weeks). The aim was to show the superiority of the intervention. The evaluation was carried out additionally at the time points T0 and T1 (4 weeks after the start of the study) and T0 and T2 (8 weeks after the start of the study).

The hypotheses for the individual endpoints are defined as follows, whereby the respective hypothesis is to be analysed using an ANCOVA with baseline values as covariates:

Null hypothesis (H0): There is no difference between the intervention group and the control group.

Alternative hypothesis (HA): There is a difference between the intervention and control group.

In addition, this study should provide important insights for the planning of future studies. This includes aspects such as the selection of suitable endpoints, hypothesis formation and statistical analysis methods.

The planned duration of the study is expected to be seven months, starting in February 2024 and ending in August 2024. The study intends to enrol between 100 and 200 participants, aiming for an adequate sample size to ensure statistically significant results.

Overall, this pilot study is expected to provide important insights into whether and to what extent a dysmenorrhoea app can have a positive impact on the quality of life and symptoms of women with dysmenorrhoea. These results may not only help to improve patient care, but also lay the foundation for further research activities in the field of digital health applications and gynaecological health.

Eligibility criteria: Inclusion Criteria:

* Legal capacity
* Resident in Germany
* Female
* Age ≥18 years of age
* Known and medically confirmed dysmenorrhoea
* Ownership of an internet-enabled mobile phone and ability to use it
* Internet access for the app application and questionnaire
* Answering email address for registration
* Willingness to complete questionnaires online
* Motivation to use the app regularly
* Sufficient knowledge of the German language
* Absence of exclusion criteria

Exclusion Criteria:

* Pregnancy existing at the time of interview
* Gynaecological abdominal surgery planned in the next 12 weeks or gynaecological abdominal surgery performed within the last 8 weeks before study start
* Previous or existing access to the Endo app or other comparable digital health applications or current active prescription
* Current participation in other clinical studies
* Non-compliance with inclusion criteria

Primary outcomes:
measure: Dysmenorrhea Symptom Interference Scale (DSI)
timeFrame: 12 weeks
measure: Moos Menstrual Distress Questionnaire, Form C (MDQ)
timeFrame: 12 weeks
measure: Visual analog scale (VAS)
timeFrame: 12 weeks
measure: Depression Anxiety Stress Scale mit 21 Items (DASS-21)
timeFrame: 12 weeks
measure: German Version of Pain Self-Efficacy Questionnaire (FESS)
timeFrame: 12 weeks
measure: Fatigue Severity Scale (FSS)
timeFrame: 12 weeks
measure: Pain Disability Index (PDI)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Endo Health GmbH
name: Nadine Rohloff, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: