Women's eHealth And Telemedicine for Endometriosis StudyStudy).

NCT ID: NCT06976957

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-30
• Study Completion Date: 2024-12-01

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

Conditions

Endometriosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Usual Care Route

Usual care control according to the protocol of the center for follow-up on-site visits of endometriosis affected patients.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Telemdicine Route

Those patients included in the intervention group will be monitored through telemedicine tools including mobile health, in addition to the usual on-site visits

Group Type: EXPERIMENTAL

MyPlan / Movisalud App

Intervention Type: DEVICE

Those patients in experimental arm will be followed through a mobile app that offers different functionalities designed to improve clinical-patient communication, empower the patient in the management of his disease and treatment, detect symptoms early and individualize the interventions of professionals thanks to the patient records on the platform

Interventions

MyPlan / Movisalud App

Those patients in experimental arm will be followed through a mobile app that offers different functionalities designed to improve clinical-patient communication, empower the patient in the management of his disease and treatment, detect symptoms early and individualize the interventions of professionals thanks to the patient records on the platform

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Josep Estadella

Role: PRINCIPAL_INVESTIGATOR

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Locations

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Countries

Spain

Other Identifiers

IIBSP-TEL-2021-111

Identifier Type: -

Identifier Source: org_study_id