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Clinical Trials/NCT05406518
NCT05406518UnknownNot Applicable

Proposal to Improve the Program of Attention to the Families of the Community Rehabilitation Service "Dr. Pi i Molist": Implementation and Evaluation Based on a Needs Analysis

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1 site in 1 country50 target enrollmentStarted: March 25, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
Patients' family needs

Study Overview

Brief Summary

Applied research carried out in the context of the Community Rehabilitation Service "Dr. Pi i Molist". The objective is to improve the psychosocial intervention carried out with the families of the patients treated (Severe Mental Disorder). It is proposed to carry out a qualitative needs analysis with relatives, patients and professionals, with the intention of detecting possibilities for improvement. With the results obtained, together with the bibliographic recommendations, a new intervention proposal is made and the new results obtained are evaluated. The hypothesis is that a form of intervention more adjusted to the real needs of the population and more effective for the engagement of families and the improvement of the quality of life of patients and their families can be found.

Detailed Description

  1. THEORETICAL FRAMEWORK. PROBLEM STATEMENT

1.1 Conceptualization

Severe Mental Disorder (TMS) is defined from the confluence of three criteria: a clinical diagnosis of mental health considered one of the most serious, a high affectation or duration and a high presence of disability at the functional level (National Institute of Mental Health [NIMH], 1987; Servei Català de la Salut, 2003a). Its prevalence is between 3-5% of the general population (Gaebel et al., 2016; Ministry of Health, 2017; NIMH, 2019).

One of the main treatments for people with TMS is Psychosocial Rehabilitation (RPS), as reflected in most Clinical Practice Guidelines (American Psychiatric Association [APA], 2020; Ministry of Health and Consumer Affairs, 2009; National Institute for Health and Care Excellence [NICE], 2014) and in the recommendations of the administration (Generalitat de Catalunya, 2017; (World Health Organization [WHO], 2013).

The RPS is defined, rather than as a set of techniques, as a philosophy of care (Leal & Castilla, 2002; Vazquez et al., 2000) whether to conform rigidly to any model or strategy of intervention (Gisbert, C; Arias & Campus, 2002). Currently the predominant model works on the idea of Recovery (Pérez, 2012) which highlights the importance of highlighting psychosocial aspects over purely clinical ones (Anthony, 1993) and the active role of users in their improvement process (Deegan. 1988).

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.
  • •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.
  • •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.

Arms & Interventions

Intervention

Experimental

Arm of intervention

Intervention: Psychosocial intervention (Other)

Outcomes

Primary Outcomes

Patients' family needs

Time Frame: 6 months

Intervention needs in family members of users with severe mental disorders

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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