EndometriosisWHAT-ENDNCT06976957
Women's eHealth And Telemedicine for Endometriosis StudyStudy).
A study testing MyPlan / Movisalud App in people with Endometriosis, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- MyPlan / Movisalud App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 30 Mar 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
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.
Read the 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
- Being tested
- MyPlan / Movisalud App
- Keywords
- Endometriosis, Mobile Health, Management, Telemedicine
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyPlan / Movisalud AppDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: MyPlan / Movisalud App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Secondary outcomes (11)
Therapeutic adherence assessed through Adherence to Refills and Medications Scale (ARMS-e) questionnaire
The Adherence to Refills and Medications Scale (ARMS-e) questionnaire is a validated tool designed to measure patient adherence to medication regimens, particularly focusing on refill behaviors and proper medication intake. It is widely used in clinical and research contexts to assess adherence among patients with chronic conditions or complex medication schedules. The ARMS-e is composed of items addressing difficulties patients face in obtaining and taking their medications as prescribed, including forgetfulness, understanding instructions, or logistical barriers like transportation.
Scores for the ARMS-e range from a minimum of 12 (indicating perfect adherence with no issues) to a maximum of 48 (indicating severe non-adherence and significant challenges in following the prescribed regimen). Lower scores reflect better adherence, while higher scores suggest greater non-adherence.
Measured: At the beginning, at 3 and at 6 months.
Therapeutic adherence using the Haynes-Sackett questionnaire
The Haynes-Sackett Questionnaire is a tool used to evaluate patient adherence to prescribed medical treatments. Commonly applied in clinical and research settings, it identifies whether patients consistently follow therapeutic recommendations. The questionnaire includes questions designed to explore patient behaviors and attitudes toward medication adherence, often addressing reasons for non-adherence and the frequency of missed doses. Scores range from 0 to 100, with 0 indicating no adherence and 100 reflecting full adherence. High scores (80-100) suggest consistent adherence, which is typically associated with better clinical outcomes. Moderate scores (50-79) indicate partial adherence, highlighting areas where improvements may be necessary. Low scores (<50) reveal significant non-adherence, which can compromise treatment effectiveness. Clinically, the Haynes-Sackett Questionnaire is used to identify barriers to adherence, such as side effects or financial challenges, design interve
Measured: At the beginning, at 3 and at 6 months.
Changes on quality of life (Endometriosis specific) assessed through theEndometriosis Health Profile-30 (EHP-30)
The Endometriosis Health Profile-30 (EHP-30) questionnaire is a condition-specific tool designed to assess the health-related quality of life (HRQoL) in individuals with endometriosis. It captures the physical, emotional, and social impact of the condition through 30 items divided into five core domains: pain, control and powerlessness, emotional well-being, social support, and self-image. Additionally, optional modular sections address areas like work, sexual relationships, and treatment concerns, providing a comprehensive understanding of how endometriosis affects daily life.
Each domain is scored on a scale from 0 to 100, with 0 representing the best possible HRQoL (no impact of endometriosis) and 100 indicating the worst HRQoL (severe impact). Higher scores reflect greater impairment or distress caused by endometriosis in specific areas of life.
Measured: At the beginning, at 3 and at 6 months.
Changes on quality of life assessed through the EuroQol5D (EQ-5D) questionnaire
The EQ-5D questionnaire is a standardized instrument developed to measure health-related quality of life (HRQoL). It is widely used in clinical settings, research, and health economic evaluations to assess the impact of diseases and treatments on an individual's overall health. The EQ-5D consists of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has levels of severity, typically ranging from no problems to extreme problems.
The responses are combined into a single health state that can be converted into a utility score using a scoring algorithm. Utility scores range from -0.59 to 1, where 1 indicates perfect health and 0 represents a state equivalent to death.
Measured: At the beginning, at 3 and at 6 months.
Number of reconsultations to the healtcare system assessed through medical assistance electronic records
Reconsultations in the healthcare system assessed through the medical assistance electronic records of the Catalan Healthcare system
Measured: at 90 and 180 days:
Satisfaction with mobile health platform
Degree of satisfaction and usability with the mobile health platform. It will be measured through an online survey designed for the different ongoing studies that are using the MyPlan platform.
Measured: At study completion (6 months).
Changes on Dysmenorrhoea pain scores assessed through a numerical rating scale (NRS)
Level of intensity of Dysmenorrhoea (NRS 0-10), with 0 representing no pain and 10 representing the worst imaginable pain
Measured: At the beginning, at 3 and at 6 months.
Changes on Dyspareunia pain score assessed through a numerical rating scale (NRS)
Level of intensity of Dyspareunia (NRS 0-10), with 0 representing no pain and 10 representing the worst imaginable pain
Measured: At the beginning, at 3 and at 6 months.
Changes on Dyschezia pain score assessed through a numerical rating scale (NRS)
Level of intensity of Dyschezia (NRS 0-10), with 0 representing no pain and 10 representing the worst imaginable pain
Measured: At the beginning, at 3 and at 6 months.
Changes on Dysuria pain score assessed through a numerical rating scale (NRS)
Level of intensity of Dysuria (NRS 0-10), with 0 representing no pain and 10 representing the worst imaginable pain
Measured: At the beginning, at 3 and at 6 months.
Changes on Omalgia pain score assessed through a numerical rating scale (NRS)
Level of intensity of Omalgia (NRS 0-10), with 0 representing no pain and 10 representing the worst imaginable pain
Measured: At the beginning, at 3 and at 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start30 Mar 2023
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Unicentric, longitudinal, prospective, experimental intervention study
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Josep Estadella, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976957
- Sponsor's protocol ID
- IIBSP-TEL-2021-111
- Acronym
- WHAT-END
- Status last verified
- Dec 2023
- First submitted
- 19 Dec 2023
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT06976957
- Acronym / sponsor ID
- WHAT-END / IIBSP-TEL-2021-111
- Conditions
- Endometriosis
- Keywords
- Endometriosis, Mobile Health, Management, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Unicentric, longitudinal, prospective, experimental intervention study
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: MyPlan / Movisalud AppThose patients included in the intervention group will be monitored through telemedicine tools including mobile health, in addition to the usual on-site visits |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyPlan / Movisalud AppThose 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 | Device | Telemdicine Route |
Primary outcome
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.
11 secondary outcomes
Therapeutic adherence assessed through Adherence to Refills and Medications Scale (ARMS-e) questionnaire
Time frame: At the beginning, at 3 and at 6 months.
Therapeutic adherence using the Haynes-Sackett questionnaire
Time frame: At the beginning, at 3 and at 6 months.
Changes on quality of life (Endometriosis specific) assessed through theEndometriosis Health Profile-30 (EHP-30)
Time frame: At the beginning, at 3 and at 6 months.
Changes on quality of life assessed through the EuroQol5D (EQ-5D) questionnaire
Time frame: At the beginning, at 3 and at 6 months.
Number of reconsultations to the healtcare system assessed through medical assistance electronic records
Time frame: at 90 and 180 days:
Satisfaction with mobile health platform
Time frame: At study completion (6 months).
Changes on Dysmenorrhoea pain scores assessed through a numerical rating scale (NRS)
Time frame: At the beginning, at 3 and at 6 months.
Changes on Dyspareunia pain score assessed through a numerical rating scale (NRS)
Time frame: At the beginning, at 3 and at 6 months.
Changes on Dyschezia pain score assessed through a numerical rating scale (NRS)
Time frame: At the beginning, at 3 and at 6 months.
Changes on Dysuria pain score assessed through a numerical rating scale (NRS)
Time frame: At the beginning, at 3 and at 6 months.
Changes on Omalgia pain score assessed through a numerical rating scale (NRS)
Time frame: At the beginning, at 3 and at 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josep Estadella principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyPlan / Movisalud App in people with Endometriosis, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction with the assistance received assessed through the Client Satisfaction Questionnaire (CSQ-8) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.