Clinical trial NCT05336097: Pathways to Empowerment for Persons Living in Persistent Poverty
Official title: Minder Stress en Armoede, Meer Ervaren Gezondheid en Participatie
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perceived Stress
Persistent Poverty
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Movisie
name: Municipality of Meppel, the Netherlands
name: Municipality of Midden-Groningen, the Netherlands
name: Municipality of Nieuwegein, the Netherlands
name: Municipality of Nijmegen, the Netherlands
name: Municipality of Oss, the Netherlands
name: Stichting Lezen en Schrijven
name: Vereniging Valente
name: Voedselbanken Nederland
name: Wageningen University and Research
First posted: 2022-04-20
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Note: Originally, two service settings participated in the study: (1) three teams of ambulatory care workers of an organization called 'Santé Partners', situated in the municipalities of Nieuwegein, Houten and IJsselstein, the Netherlands; and (2) one team of participation coaches employed at the municipality of Nijmegen, the Netherlands. The study design was altered in two crucial ways: In the first service setting, the study was terminated, and in the second service setting, the design was changed to a feasibility study and supplemented with a qualitative impact assessment.

In the first setting, ambulatory care workers in the intervention group did not take on new (eligible) clients during the recruitment period due to staff shortage. Later, the team was disbanded, as they did not receive next year's tender. Despite efforts of the researchers, it turned out to be impossible to find a substitute for this team. The study was consequently terminated in this setting.

In the second setting, the recruitment of participants by participation coaches was slower than expected. The study design was therefore changed to a feasibility study. The survey was shortened, and the quantitative data were supplemented with a qualitative evaluation of the impact of professional support based on PTE. In addition, to increase the number of participants, the recruitment period was extended. As a result, the time between baseline and follow-up was shortened from seven to six months.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in score on Perceived Stress Scale (PSS)
timeFrame: Baseline, 9 months (area of Nieuwegein) or 7 months (area of Nijmegen)
Secondary outcomes:
measure: Change in score on Mental Health Inventory 5 (MHI-5)
timeFrame: Baseline, 9 months (area of Nieuwegein) or 7 months (area of Nijmegen)
measure: Change in score on Pearlin Mastery Scale (PMS)
timeFrame: Baseline, 9 months (area of Nieuwegein) or 7 months (area of Nijmegen)
measure: Change in sense of societal belonging
timeFrame: Baseline, 9 months (area of Nieuwegein) or 7 months (area of Nijmegen)
measure: Change in score on Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: Baseline, 9 months (area of Nieuwegein) or 7 months (area of Nijmegen)
measure: Change in social participation
timeFrame: Baseline, 9 months (area of Nieuwegein) or 7 months (area of Nijmegen)
measure: Change in care needs
timeFrame: Baseline, 9 months (area of Nieuwegein) or 7 months (area of Nijmegen)
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud university medical center
state: Gelderland
Study officials:
affiliation: Impuls - Netherlands Center for Social Care Research, Radboudumc
name: Judith Wolf, PhD
role: PRINCIPAL_INVESTIGATOR
References: