Clinical trial NCT06976957: Women's eHealth And Telemedicine for Endometriosis StudyStudy).
Official title: Evaluation of the Healthcare Impact of Telemedicine Through Mobile Health App in the Follow-up and Management of Women Affected by Endometriosis (Women's eHealth And Telemedicine for Endometriosis Study - WHAT-END Study).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis
Keywords: Endometriosis
Mobile Health
Management
Telemedicine
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Unicentric, longitudinal, prospective, experimental intervention study
Primary purpose: SUPPORTIVE_CARE

Brief summary: The working hypothesis that is intended to be evaluated with this study is that the use of mobile health applications and telemedicine in the follow-up of patients affected by endometriosis offers greater satisfaction and improves the quality of care.

The patients included in the control group will be followed up according to the center's usual care protocol. Those patients included in the intervention group will be monitored through telemedicine tools including mobile health.

To evaluate the satisfaction of the application of a telemedicine program (mobile health and eConsulta) in the follow-up of the patient affected by endometriosis.

Detailed description: Endometriosis is a chronic inflammatory disease that affects women where the endometrial tissue is located outside its normal location, predominantly in the pelvis, including the ovaries, pelvic ligaments and peritoneal surfaces, as well as the bladder or intestine. The presentation of the disease is diverse and ranges from superficial peritoneal lesions, ovarian endometriotic cysts, to nodules that infiltrate the tissues \>5mm (deep endometriosis), all accompanied by fibrotic processes and pelvic adhesions.

The clinic of this entity is characterized by cyclical pelvic pain coinciding with menstruation, which can be accompanied by dyspareunia, dyschezia, dysuria, hematuria or rectal bleeding. In addition to the serious impact on their quality of life, these patients have much higher rates of infertility compared to the general population.

The incidence of endometriosis in the general population is difficult to quantify due to the fact that the definitive diagnosis is achieved after the direct visualization of lesions at the time of surgery, and after its anatomo-pathological study. Despite this, it is estimated that this disease affects 10% of the general population, reaching figures of 35% in symptomatic patients.

The non-specificity of the symptoms causes a diagnostic delay of approximately 8 years from the patient's first consultation, causing this disease to be detected in more advanced stages. An early diagnosis, quick access to specialized units and correct follow-up are essential to improve the quality of life of patients affected by endometriosis.

The treatments currently available for endometriosis are divided into analgesic treatments for pain control, hormonal treatments to stop the progression of the disease, and surgical treatments in patients refractory to medical treatments. Due to the fact that it is a chronic disease with the possibility of progression, the patient may require long periods of medical treatment. The side effects associated with these, the variation in response to these and the possibility of needing surgery, require a regular follow-up of these patients in the medical consultation(7,8).

Due to the need to take an anamnesis, complete physical examination and a pelvic ultrasound for the initial evaluation of the patient with suspected endometriosis, the first visit should always be done in person. Once the case has been identified and medical treatment instituted, the second visits are limited to a follow-up to assess symptoms, control adherence to treatment and the need to modify therapeutic guidelines. These follow-up visits do not require a mandatory presence and can be replaced by remote visits through information and communication technologies (ICTs).

The working hypothesis that is intended to be evaluated with this study is that the redefinition of the current care route for the patient affected by endometriosis through the incorporation of new interdisciplinary digital health tools will improve the degree of satisfaction of the users involved (patients and professionals healthcare), reduce the consumption of healthcare resources and improve the clinical management of patients.

Main objective To evaluate the satisfaction of patients affected by endometriosis after the incorporation of a follow-up program based on telemedicine (mobile health and eConsulta) by means of a randomized, longitudinal, prospective experimental, interventional clinical trial.

Secondary objectives

- To evaluate the healthcare impact of a telemedicine program (mobile health and eConsulta) in patients affected by endometriosis during follow-up in a randomized, longitudinal, prospective experimental, interventional clinical trial. Assistance impact is understood as the impact of the program on the following specific objectives:

* Reduce face-to-face care activity and consumption of health resources.
* Improve the patient's quality of life, understood as:
* Early detection of symptoms associated with clinical complications or the appearance of adverse effects associated with medication.
* Early intervention against episodes of clinical worsening.
* Reduction in the number of episodes of intense pain.
* Reduction in the intensity of pain episodes.
* Improvement of the patient's experience with regard to his pharmacological treatment (therapeutic adherence, side effects, knowledge of the therapy, discomfort of the therapy).
* Better control of lifestyles.
* Improvement of quality of life, anxiety and stress.
* Validate the sensitivity of the EQ-5D quality of life scale in endometriosis

Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18 years.
* Patients diagnosed with endometriosis and referred for follow-up at our center and who have made at least one first face-to-face visit to the Endometriosis Unit of the HSCSP.
* That the patient has a mobile device compatible with the MyPlan web or mobile application and access to Wi-Fi or mobile data enabling the use of the technological platform from home.

Exclusion Criteria:

* Not being able to understand the nature of the study and/or the procedures to be followed.
* Not signing the informed consent.
* Be under 18 years old.
* Important language barrier.
* Lack of patient e-skills for proper use of study procedures through digital platforms.
* Impossibility of carrying out the necessary questionnaires or interviews defined in the methods of this study.

Primary outcomes:
measure: Satisfaction with the assistance received assessed through the Client Satisfaction Questionnaire (CSQ-8)
timeFrame: 6 months
measure: Satisfaction with the assistance received through a 5-point Likert-type survey designed for the study
timeFrame: 6 months
Secondary outcomes:
measure: Therapeutic adherence assessed through Adherence to Refills and Medications Scale (ARMS-e) questionnaire
timeFrame: At the beginning, at 3 and at 6 months.
measure: Therapeutic adherence using the Haynes-Sackett questionnaire
timeFrame: At the beginning, at 3 and at 6 months.
measure: Changes on quality of life (Endometriosis specific) assessed through theEndometriosis Health Profile-30 (EHP-30)
timeFrame: At the beginning, at 3 and at 6 months.
measure: Changes on quality of life assessed through the EuroQol5D (EQ-5D) questionnaire
timeFrame: At the beginning, at 3 and at 6 months.
measure: Number of reconsultations to the healtcare system assessed through medical assistance electronic records
timeFrame: at 90 and 180 days:
measure: Satisfaction with mobile health platform
timeFrame: At study completion (6 months).
measure: Changes on Dysmenorrhoea pain scores assessed through a numerical rating scale (NRS)
timeFrame: At the beginning, at 3 and at 6 months.
measure: Changes on Dyspareunia pain score assessed through a numerical rating scale (NRS)
timeFrame: At the beginning, at 3 and at 6 months.
measure: Changes on Dyschezia pain score assessed through a numerical rating scale (NRS)
timeFrame: At the beginning, at 3 and at 6 months.
measure: Changes on Dysuria pain score assessed through a numerical rating scale (NRS)
timeFrame: At the beginning, at 3 and at 6 months.
measure: Changes on Omalgia pain score assessed through a numerical rating scale (NRS)
timeFrame: At the beginning, at 3 and at 6 months.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Josep Estadella
role: PRINCIPAL_INVESTIGATOR
References: