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Clinical Trials/NCT05336097
NCT05336097CompletedNot Applicable

Minder Stress en Armoede, Meer Ervaren Gezondheid en Participatie

Radboud University Medical Center2 sites in 1 country35 target enrollmentStarted: April 4, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
35
Locations
2
Primary Endpoint
Change in score on Perceived Stress Scale (PSS)

Study Overview

Brief Summary

The general purpose of this feasibility study is to evaluate the potential impact of Pathways to Empowerment (PTE) on the four constitutional conditions of social quality for persons living in persistent poverty. PTE is a strengths-based methodology developed for social care professionals to support persons in vulnerable positions with their recovery. PTE was chosen for evaluation based on in-depth interviews about appropriate support, a literature search, and participatory action research in which the wishes of each participating municipality were explored.

Detailed Description

This study is conducted with a team of participation coaches in the municipality of Nijmegen, the Netherlands. Participation coaches guide long-term recipients of social assistance benefits to a form of participation (e.g., volunteer work, sport activities, (language) courses). The team of participation coaches will be trained in PTE and will recruit participants for this study.

Participants are persons living in persistent poverty who started a support trajectory with a participation coach. Participation coaches will conduct personal conversations with potential participants, during which they will explain what this study entails, and will hand them an information letter. When potential participants express interest in participation, an interviewer will contact them by phone to provide more information about the study, to answer any questions and to schedule an interview.

Data will be collected using computer-assisted personal interviews (CAPI). These interviews will mainly be conducted by video conferencing, although participants can also be interviewed by phone or in person if they prefer. Participants are interviewed at the start of their professional support trajectory, and six months later.

At the start and at follow-up, survey data will be collected on participants' outcomes in various domains. In addition, a third semi-structured interview will be conducted with clients about their experiences with and the experienced impact of the professional support they received. This interview will be conducted around the same time as the follow-up survey, unless the provision of professional support stops before this moment. In that case, this interview is planned as soon as the participation coaches notify the research team of ending the support trajectory. Furthermore, a survey and a semi-structured interview will be conducted among participation coaches and the team manager to map their individual and job characteristics (e.g., years of working experience, caseload), and gain insight into model fidelity of PTE.

All data will be stored on secured servers of Radboudumc, for a period of 15 years. Only researchers affiliated with this project will have access to these data.

Study Design

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

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Participants are 18 years of age or older;
  • Participants started a support trajectory at one of the participating teams during the recruitment period;
  • Participants are living in persistent poverty. This means that participants have been having insufficient means for minimum living expenses and social participation for at least three years.

Exclusion Criteria

  • Being unable to provide reliable answers (e.g., having a psychotic episode);
  • No informed consent.

Outcomes

Primary Outcomes

Change in score on Perceived Stress Scale (PSS)

Time Frame: Baseline, 9 months (area of Nieuwegein) or 7 months (area of Nijmegen)

The PSS is a 10-item instrument that measures frequency of thoughts and feelings related to perceived stress. Answers are expressed on a scale ranging from (0) "never" to (4) "very often". The PSS has been validated and widely used in the general population.

Secondary Outcomes

  • Change in care needs(Baseline, 9 months (area of Nieuwegein) or 7 months (area of Nijmegen))
  • Change in score on Pearlin Mastery Scale (PMS)(Baseline, 9 months (area of Nieuwegein) or 7 months (area of Nijmegen))
  • Change in sense of societal belonging(Baseline, 9 months (area of Nieuwegein) or 7 months (area of Nijmegen))
  • Change in score on Mental Health Inventory 5 (MHI-5)(Baseline, 9 months (area of Nieuwegein) or 7 months (area of Nijmegen))
  • Change in social participation(Baseline, 9 months (area of Nieuwegein) or 7 months (area of Nijmegen))
  • Change in score on Multidimensional Scale of Perceived Social Support (MSPSS)(Baseline, 9 months (area of Nieuwegein) or 7 months (area of Nijmegen))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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