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).
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Satisfaction with the assistance received assessed through the Client Satisfaction Questionnaire (CSQ-8)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Usual Care Route
Usual care control according to the protocol of the center for follow-up on-site visits of endometriosis affected patients.
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
Intervention: MyPlan / Movisalud App (Device)
Outcomes
Primary Outcomes
Satisfaction with the assistance received assessed through the Client Satisfaction Questionnaire (CSQ-8)
Time Frame: 6 months
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.
Satisfaction with the assistance received through a 5-point Likert-type survey designed for the study
Time Frame: 6 months
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.
Secondary Outcomes
- Satisfaction with mobile health platform(At study completion (6 months).)
- 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:)
- Changes on Dysmenorrhoea pain scores assessed through a numerical rating scale (NRS)(At the beginning, at 3 and at 6 months.)
- Changes on Dyspareunia pain score assessed through a numerical rating scale (NRS)(At the beginning, at 3 and at 6 months.)
- Changes on Dyschezia pain score assessed through a numerical rating scale (NRS)(At the beginning, at 3 and at 6 months.)
- Changes on Dysuria pain score assessed through a numerical rating scale (NRS)(At the beginning, at 3 and at 6 months.)
- Changes on Omalgia pain score assessed through a numerical rating scale (NRS)(At the beginning, at 3 and at 6 months.)