Perceived StressNCT05336097
Pathways to Empowerment for Persons Living in Persistent Poverty
A study testing Pathways to Empowerment in people with Perceived Stress and Persistent Poverty, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Perceived Stress, Persistent Poverty
- What is being tested?
- Pathways to Empowerment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 Apr 2022to 10 Jul 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Being unable to provide reliable answers (e.g., having a psychotic episode);
- No informed consent.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud university medical center
Nijmegen, Gelderland, 6500 HB
About this study
Official title: Minder Stress en Armoede, Meer Ervaren Gezondheid en Participatie
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.
Read the 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.
- Conditions
- Perceived Stress, Persistent Poverty
- Being tested
- Pathways to Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pathways to EmpowermentOther
Also called Krachtwerk
Pathways to Empowerment (PTE) is a program for person-centered intervention. PTE is rooted in the Strengths Model by Rapp and Goscha (2011), and in the Social Quality Approach as described by Van der Maesen and Walker (2005). The general aim of PTE is to improve the quality of the daily lives of persons who experience loss of control in their lives by focusing on their strengths and stimulating their personal agency, participation in society, and self-direction in life. The main task of professionals is to help create the conditions in which growth and recovery are likely to occur.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants will receive support from participation coaches trained in Pathways to Empowerment (PTE).
These participation coaches received a four-day training program with two weeks in between each training day, allowing them to immediately implement their acquired set of knowledge and skills. At the end of the training program, participation coaches had to successfully pass an end assignment to become PTE-certified.
In order to ensure the implementation of PTE, the training will be supplemented with a learning cycle. This cycle consists of two workshops on poverty and stress, and of on-the-job coaching. The coaching is tailored to the wishes and needs of the team. Receives: Other: Pathways to Empowerment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in score on Perceived Stress Scale (PSS)
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.
Measured: Baseline, 9 months (area of Nieuwegein) or 7 months (area of Nijmegen)
Secondary outcomes (6)
Change in score on Mental Health Inventory 5 (MHI-5)
MHI-5 is a 5-item instrument that measures mental health status. The instrument includes items on (1) anxiety, (2) general positive affect, (3) depression, and (4) behavioral/emotional control.
Measured: Baseline, 9 months (area of Nieuwegein) or 7 months (area of Nijmegen)
Change in score on Pearlin Mastery Scale (PMS)
The PMS is a 7-item instrument that measures the degree to which people perceive they can control factors that influences their lives (i.e., sense of mastery).
Measured: Baseline, 9 months (area of Nieuwegein) or 7 months (area of Nijmegen)
Change in sense of societal belonging
Sense of societal belonging measures how strongly participants feel part of society on an 11-point Likert scale, ranging from 0 to 10. A higher score indicates a stronger sense of societal belonging.
Measured: Baseline, 9 months (area of Nieuwegein) or 7 months (area of Nijmegen)
Change in score on Multidimensional Scale of Perceived Social Support (MSPSS)
The MSPSS is a 12-item instrument that measures social support from (1) family, (2) friends, and (3) a significant other.
Measured: Baseline, 9 months (area of Nieuwegein) or 7 months (area of Nijmegen)
Change in social participation
Social participation measures whether participants engage in daily activities such as paid employment, volunteer work, education and caregiving.
Measured: Baseline, 9 months (area of Nieuwegein) or 7 months (area of Nijmegen)
Change in care needs
Care needs are measured on several domains, including housing \& daily life, finances \& daily activities, physical \& mental health, and social relationships. For each domain, participants were asked to indicate whether they wanted help, whether they received help (and if yes, from whom), and whether this was the right help.
Measured: Baseline, 9 months (area of Nieuwegein) or 7 months (area of Nijmegen)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start4 Apr 2022
- Primary completion10 Jul 2023
- Study completion10 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perceived StressStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Movisie, Municipality of Meppel, the Netherlands, Municipality of Midden-Groningen, the Netherlands, Municipality of Nieuwegein, the Netherlands, Municipality of Nijmegen, the Netherlands, Municipality of Oss, the Netherlands, Stichting Lezen en Schrijven, Vereniging Valente, Voedselbanken Nederland, Wageningen University and Research
- Responsible party
- Sponsor
- Investigators
- Judith Wolf, PhD, Principal investigator, Impuls - Netherlands Center for Social Care Research, Radboudumc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05336097
- Sponsor's protocol ID
- R0005311
- Other IDs
- NWA.1239.18.003
- Status last verified
- Nov 2023
- First submitted
- 5 Apr 2022
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study examines vulnerable individuals living in persistent poverty. As the IPD contain sensitive information and publishing these data may deter potential participants, IPD will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minder Stress en Armoede, Meer Ervaren Gezondheid en Participatie
- ClinicalTrials.gov ID
- NCT05336097
- Acronym / sponsor ID
- R0005311
- Conditions
- Perceived Stress, Persistent Poverty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Movisie, Municipality of Meppel, the Netherlands, Municipality of Midden-Groningen, the Netherlands, Municipality of Nieuwegein, the Netherlands, Municipality of Nijmegen, the Netherlands, Municipality of Oss, the Netherlands, Stichting Lezen en Schrijven, Vereniging Valente, Voedselbanken Nederland, Wageningen University and Research
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 20 Apr 2022 (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 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Pathways to EmpowermentParticipants will receive support from participation coaches trained in Pathways to Empowerment (PTE). These participation coaches received a four-day training program with two weeks in between each training day, allowing them to immediately implement their acquired set of knowledge and skills. At the end of the training program, participation coaches had to successfully pass an end assignment to become PTE-certified. In order to ensure the implementation of PTE, the training will be supplemented with a learning cycle. This cycle consists of two workshops on poverty and stress, and of on-the-job coaching. The coaching is tailored to the wishes and needs of the team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Being unable to provide reliable answers (e.g., having a psychotic episode);
- No informed consent.
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 |
|---|---|---|
| Pathways to EmpowermentAlso: KrachtwerkPathways to Empowerment (PTE) is a program for person-centered intervention. PTE is rooted in the Strengths Model by Rapp and Goscha (2011), and in the Social Quality Approach as described by Van der Maesen and Walker (2005). The general aim of PTE is to improve the quality of the daily lives of persons who experience loss of control in their lives by focusing on their strengths and stimulating their personal agency, participation in society, and self-direction in life. The main task of professionals is to help create the conditions in which growth and recovery are likely to occur. | Other | Intervention group |
Primary outcome
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.
6 secondary outcomes
Change in score on Mental Health Inventory 5 (MHI-5)
Time frame: Baseline, 9 months (area of Nieuwegein) or 7 months (area of Nijmegen)
Change in score on Pearlin Mastery Scale (PMS)
Time frame: Baseline, 9 months (area of Nieuwegein) or 7 months (area of Nijmegen)
Change in sense of societal belonging
Time frame: Baseline, 9 months (area of Nieuwegein) or 7 months (area of Nijmegen)
Change in score on Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: Baseline, 9 months (area of Nieuwegein) or 7 months (area of Nijmegen)
Change in social participation
Time frame: Baseline, 9 months (area of Nieuwegein) or 7 months (area of Nijmegen)
Change in care needs
Time frame: Baseline, 9 months (area of Nieuwegein) or 7 months (area of Nijmegen)
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 28 Nov 2023.
- Individual participant dataSharing planned: No. This study examines vulnerable individuals living in persistent poverty. As the IPD contain sensitive information and publishing these data may deter potential participants, IPD will not be shared with other researchers.
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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.
Judith Wolf, PhD principal investigator
Impuls - Netherlands Center for Social Care Research, Radboudumc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pathways to Empowerment in people with Perceived Stress and Persistent Poverty, run by Radboud University Medical Center at 1 site in Netherlands.
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 2 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 28 Nov 2023. 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 Netherlands. 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?
Change in score on Perceived Stress Scale (PSS) (time frame: Baseline, 9 months (area of Nieuwegein) or 7 months (area of Nijmegen)). 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 28 Nov 2023.