Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-25 @ 4:36 AM
NCT ID:
NCT05406518
Eligibility Criteria:
1. Families: the call will be made with relatives of users currently linked to the SRC and with whom some type of contact has been previously established and who have been presented, both by the user and by themselves, as a reference relative. It is assumed that their similarities with the research topic (all will have a family member with TMS diagnosis who is carrying out an RPS process) will already generate sufficient homogeneity and it will not be necessary to perform a segmentation. Bear in mind that, as the age of some family members may be high or their health situation may be delicate, special care will be taken that their participation does not pose a clinical risk, something especially relevant in the current context of the COVID-19 pandemic. The following inclusion and exclusion criteria will be followed:
Inclusion criteria
* Be of legal age (18 years).
* Have a family member cared for in the SRC with a minimum relationship of 3 months.
* Have had previous contact with the SRC, having been presented as a family member of reference.
* Understand, accept and voluntarily sign the informed consent.
* Properly understand the reasons of the group and the project.
Exclusion criteria
* Present severe communication or cognitive problems that prevent the understanding of the questions or the possibility of participating in group communication.
* It is assessed that, due to age or health situation, participation in the group may pose some clinical risk.
2. Users: those who are currently linked to the SRC and who have active family ties may participate. It is assumed that their similarities with the research topic (all will have relatives susceptible to being cared for by the SRC) will already generate sufficient homogeneity and it will not be necessary to carry out a segmentation. As one of the objectives of the SRC is to work on communication skills and some users may have deficits in these areas, it will be especially important to value having a minimum skill to be able to participate in the focus group properly. Also note that since the SRC Dr. Pi i Molist places in its "Program of reception and linkage", the time of incorporation to the center in 3 months, the participants of the focus group will be selected from that time of linkage. The following inclusion and exclusion criteria will be followed:
Inclusion criteria
* Be of legal age (18 years).
* Minimum linkage in the SRC (more than 3 months).
* Have previously presented a family member to the service as a reference relative.
* Understand, accept and sign the informed consent.
* Properly understand the reasons of the group and the project.
Exclusion criteria
* Present severe communication or cognitive problems that prevent the understanding of the questions or the possibility of participating in group communication.
* It is assessed that, due to age or health situation, participation in the group may pose some clinical risk.
3. Professionals: will be those who perform direct assistance in the SRC Dr. Pi i Molist with users and / or relatives. Following the recommendations of Morgan (2019) for the realization of focus groups where members know each other and there may be hierarchical relationships, authority figures (director and coordinators) will not be included with whom, on the other hand, previous contacts have been made transmitting the institutional mandate that has given rise to this study, and they have been informed, their ideas and suggestions have been heard and integrated and this research plan has been approved. The greatest participation and representativeness of the participants will also be sought. Beyond this, the following inclusion and exclusion criteria are followed:
Inclusion criteria
* Perform tasks of assistance to users and / or relatives in the SRC.
* Minimum time in the SRC (more than 3 months).
* Understand, accept and sign the informed consent.
* Properly understand the reasons of the group and the project.
Exclusion criteria
\- Management staff of the center.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05406518
Study Brief:
Protocol Section:
NCT05406518