Women's eHealth And Telemedicine for Endometriosis StudyStudy).

NCT06976957 | Completed DMC

• 1 other identifier: IIBSP-TEL-2021-111
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Keywords

Endometriosis; Mobile Health; Management; Telemedicine

Outcome Measures

Primary Outcomes (2)

• Satisfaction with the assistance received assessed through the Client Satisfaction Questionnaire (CSQ-8)

  Patient's satisfaction with the follow-up carried out through the study period. It will be measured through the Client Satisfaction Questionnaire (CSQ-8) at the beginning and at 6 months. The Client Satisfaction Questionnaire is an 8 item measure of client satisfaction with services. The items for the CSQ-8 were selected on the basis of ratings by mental health professionals of a number of items that could be related to client satisfaction and by subsequent factor analysis. The CSQ-8 is unidimensional, yielding a homogenous estimate of general satisfaction with services. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.

  6 months

• Satisfaction with the assistance received through a 5-point Likert-type survey designed for the study

  Patient's satisfaction with the follow-up carried out through the study period. It will be measured through a 5-point Likert-type survey designed for the study (Annex 2) at the beginning and at 6 months.

  6 months

Secondary Outcomes (11)

• Therapeutic adherence assessed through Adherence to Refills and Medications Scale (ARMS-e) questionnaire

  At the beginning, at 3 and at 6 months.

• Therapeutic adherence using the Haynes-Sackett questionnaire

  At the beginning, at 3 and at 6 months.

• Changes on quality of life (Endometriosis specific) assessed through theEndometriosis Health Profile-30 (EHP-30)

  At the beginning, at 3 and at 6 months.

• Changes on quality of life assessed through the EuroQol5D (EQ-5D) questionnaire

  At the beginning, at 3 and at 6 months.

• Number of reconsultations to the healtcare system assessed through medical assistance electronic records

  at 90 and 180 days:

Study Arms (2)

Usual Care Route

NO INTERVENTION

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

Telemdicine Route

EXPERIMENTAL

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

Device: MyPlan / Movisalud App

Interventions

MyPlan / Movisalud App 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

Telemdicine Route

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Josep Estadella

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Unicentric, longitudinal, prospective, experimental intervention study

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: May 16, 2025
• Study Start: March 30, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 16, 2025

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)