Condition category
Not Applicable
Date applied
21/02/2020
Date assigned
03/05/2020
Last edited
04/05/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
In Sweden today, unemployment is high among foreign-born Swedes. There is an increasing need for a competent workforce in the healthcare sector. A low level of education may make it difficult for many foreign-born individuals to enter these jobs. However, many of these individuals have professional experiences from their home countries that could be used. If this group is given the opportunity to validate their professional experience and get a certificate of their knowledge/skills, it may be a faster way for them to enter the workforce. It can also lead to improved self-esteem and elevated status, which may increase job satisfaction and well-being and increase the motivation for further education.

In this study, we aim to determine whether validation of real skills can improve personal assistants’ experience of their work environment, well-being, and confidence in their own ability to perform their work.

Who can participate?
Foreign-born Swedes or long-term unemployed people

What does the study involve?
Participants will take part in activities where practical skills are tested in relation to simulated everyday workplace situations. These sessions will be video recorded and assessed. Participants may then have an opportunity to receive supplementary skills training based on the assessment of their activity performance. Participants will also complete a semi-structured interview together with a questionnaire immediately after the activity and subsequent training program. Some participants will also complete questionnaires to self-assess competence and well-being are measured prior to the activity and at one, six, and twelve months into employment. At the follow-up sessions, measurements of physical load in the workplace and questionnaires about work environment factors will also be taken.

What are the possible benefits and risks of participating?
The risk of physical injury or discomfort is minimal. The physical load assessments are not invasive, and not expected to cause pain or physical discomfort. Should this happen, the person can remove the measurement equipment at any time. The measurement methods used in this study have no record of complications when used in previous studies.

Some psychological discomfort may arise through questions about a person's well-being. If this occurs, participants can contact the research leader and/or an independent contact person of the research project who can give advice and/or referrals for professional help. This information is provided in the written information.

Participation is voluntary and participants can leave the study at any time.

For participants who are not working, there may be benefits of being able to make use of their experiences when they enter the Labour Market. This may also lead to the benefit of being integrated into society faster.

Where is the study run from?
Bollnäs Folkhögskola (Sweden) and University of Gävle (Sweden)

When is the study starting and how long is it expected to run for?
March 2018 to January 2022

Who is funding the study?
Region Gävleborg (Sweden) and University of Gävle (Sweden)

Who is the main contact?
Dr Annika Nilsson
ans@hig.se

Trial website

Contact information

Type

Scientific

Primary contact

Dr Annika Nilsson

ORCID ID

http://orcid.org/0000-0003-1969-0163

Contact details

Primulavägen 62
Gävle
806 38
Sweden
+46 0736223525
ans@hig.se

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

HIG-FORSK 2019/3

Study information

Scientific title

The experience and effects of practical assessments and training programs for personal assistants’ perceived competence and well-being, ValidX

Acronym

ValidX

Study hypothesis

Current study hypothesis as of 04/05/2020:
1. Validators who have completed the validation and the subsequent training program will reach greater improvements in their working life and well-being than personal assistants who have not participated in the validation and the training program.
2. Can the validation of real skills improve personal assistants’ experience of the work environment, well-being, and confidence in their own ability to perform their work?
3. What are the validators’ experiences of the validation of real basic competence for the profession, their skill development, and their well-being?
4. Do physical loads, psychosocial work environment factors, health and well-being change over time among validators who stay in the profession? To what extent does it differ between validators and personal assistants who have not been validated?

Previous study hypothesis:
1. Validators who have completed the validation and the subsequent training program will reach greater improvements in their working life and well-being than personal assistants who have not participated in the validation and the training program.
2. Can the validation of real skills improve personal assistants’ experience of the work environment, well-being, and confidence in their own ability to perform their work?
3. What are the validators’ experiences of the validation of real basic competence for the profession, their skill development, and their well-being?
4. Do physical loads, psychosocial work environment factors, health and well-being change over time among validators who stay in the profession? To what extent does it differ between validators and personal assistants who have not been validated?
5. What opinions do managers have for validating basic skills for the profession of personal assistants?

Ethics approval

Approved 20/01/2020, the Swedish Ethical Review Authority
(Box 2110, S-750 02, Uppsala, Sweden; +4610-475 08 00), ref: dnr 2019-05960.

Study design

A two-arm (intervention and comparison) non-randomized interventional study, pre- and post-measurements

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Professional competence, well-being, and confidence

Intervention

In Study I, data are gathered using a semi-structured interview together with a questionnaire immediately after the validation and subsequent training program. In Study II, self-assessed competence and well-being are measured prior to the validation and at follow-up time points of 1, 6 and 12 months in the profession. At the follow-ups, measurements of physical load and questionnaires about work environment factors will also be added.

The intervention has been developed by formally trained teachers and staff working as personal assistants. For comparison, identical measurements will be performed in a control group that does not participate in the validation.

Validation:
The validation intervention will be carried out in a test environment and monitored with video technology. The intervention will involve two assessments of morning and lunch activities where practical skills are tested in relation to simulated everyday situations. There will be supplementary skills training which will also be monitored with video technology.

The practical assessments are conducted in a specifically designed apartment with video cameras and cover six professional qualifications:
1. Functional impairments
2. Communication - Response/Treat and Community service
3. Leisure time and activities
4. Technical aids and ergonomics
5. Health perspectives
6. Rules, quality assurance, and work environment.
The assessments are performed by creating two everyday situations (reflecting morning and lunch activities) and take approximately 40minutes/person/situation.

In the morning situation, the persons work with an adult-size doll. During the lunch situation, they work with a person posing as a care recipient. A qualified teacher supervises the assessments via video transmission, with both audio transfer and picture. The teacher also judges the person’s performance based on checkpoints for each situation. In the assessments, the competence needs are identified at an individual level and form the basis for the training program that is tailored to every person’s needs.

The subsequent training program will be based on the results from the validation, a training program is tailored by the teacher to cover the competence area or areas in need of practice. For each professional qualification, an education module is available based on literature and films. Depending on the coverage of the training program, it may take 4 to 10 weeks to finish. The teacher's task is to coach when the person needs guidance and/or support. When the person is ready to take the practical assessments again, he/she contacts the teacher.

Data collection will involve semi-structured interviews and questionnaires.

Baseline measurements (prior to the validation and the subsequent training program) using questionnaires will be collected to study the effects of the intervention (i.e., the validation and subsequent training program) in Study II. Self-assessed competence is measured using a study-specific questionnaire divided into six areas based on the professional qualifications. The response alternatives are presented on a 7-point scale and a higher value represents higher competence. The study-specific questionnaire is based on findings from focus group interviews/workshops with representatives from employers, employees, trade union representatives, user organizations, employment services and education organizers in Region Gävleborg (Sweden). In the interviews/workshops, important competences were identified and checked with Swedish employers/stakeholders within personal assistance in two rounds to reach consensus (Delphi study) regarding which competences to keep (unpublished data). Well-being is assessed using the WHO-Five Well-being Index, where the response alternatives are presented on a 6-point scale where higher values represent higher well-being.

After validation and, if needed, the subsequent training program, a semi-structured interview is conducted with each person. The main interview questions are “I want you to think back to the first time you heard about the validation and the subsequent training program, what were your first thoughts? Based on these, talk about your first thoughts concerning how you felt before, during and after the validation. How did you feel when you were sitting outside the apartment and what were your thoughts in the apartment and afterwards? I want you to think back to the first time you heard about the subsequent training program, what were your first thoughts? Is there anything you would like to add? Regarding well-being, there are questions like “how do you experience your well-being after validation/training program”? In addition to the interview, the participants’ will be given a study-specific questionnaire, to give their opinions about the subsequent training program.

Measurements will also be taken after the validation and the subsequent training program, at 1, 6 and 12 months in the profession. Self- assessed competence and well-being will be assessed as before the intervention. In addition, the subjects’ physical and psychosocial work environment will be assessed at 1, 6 and 12 months in the profession. Measurements of physical load will be made during one working day at each of the three follow-ups, using small-size tri-axial accelerometers fixed to the trunk and thigh. From the measurements, we will be able to quantify the occurrence and temporal pattern of working postures, such as sitting, standing and physical activities. The Copenhagen Psychosocial Questionnaire (COPSOQ) will be used to assess “demands and resources at work”, “satisfaction with and values at work” and “work-life balance”. The Brief Index of Affective Job satisfaction Scale (BIAJS) will be used to measure job satisfaction. Both questionnaires have response alternatives presented on a 5-point scale where higher values represent higher grade of work environment and job satisfaction respectively. Empowerment will be assessed by Spritzer’s Psychological Empowerment Scale Job satisfaction. The instrument has response alternatives on a 7-point scale, where higher values represent higher grades of empowerment.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Self-assessed competence measured using a study-specific questionnaire at baseline, 1, 6 and 12 months
2. Psychological empowerment using the Psychological Empowerment scale at baseline, 1, 6 and 12 month
3. Physical and psychosocial work environment measured at 1, 6 and 12 months. Specifically, the demands and resources at work, satisfaction with and values at work, and work-life balance measured using the Copenhagen Psychosocial Questionnaire (COPSOQ) and job satisfaction measured using the brief index of affective job satisfaction (BIAJS) scale.
4. Objective data on physical loads and activities during work will be collected at 1 day, using small-size tri-axial accelerometers fixed to the trunk and thigh and processed using customized software to quantify the occurrence and temporal pattern of arm and trunk postures, as well as of sitting, standing and physical activities.
5. Validator’s experiences of validation and the subsequent training program with regards to well-being measured through interviews at 1, 6 and 12 months
6. Managers’ opinion of the intervention measured through interviews at 1, 6 and 12 months

Secondary outcome measures

1. Stress, health, sleep pattern, burn out/exhaustion, workplace abusive behavior, work organization, and work leadership and management measured using the Copenhagen Psychosocial Questionnaire (COPSOQ) at 1, 6 and 12 months
2. Sick absences and sick attendance from work measured using data provided by employers at 1, 6 and 12 months

Overall trial start date

01/03/2018

Overall trial end date

30/01/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Foreign-born Swedes (newly arrived) or long-term unemployed people with previous experience in the sector. “Newly arrived” is defined as when a person has obtained their residence permit and has been placed in the Swedish Establishment Assignment for two years and thereafter in Jobs and development guarantee (JOB) corresponding for approximately two years. “Long term unemployed” is defined as people who for various reasons have been absent from the Labour Market for more than one year. If recruitment under the 1-year unemployment criteria proves to be difficult, people who have been unemployed for a shorter time may be recruited.
2. Able to understand and speak the Swedish language
3. Age ≥ 18 years


Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

Study 1: Validators will be included until data saturation is achieved. We estimate the number of interviewees to be 20-25 validators. Study 2: Approximately 80 persons will be included and followed over time. Of these, 40 will participate in the validation and persons constitute the control group. Study 3: 20 to 25 managers in the private and public sectors.

Participant exclusion criteria

Do not meet the inclusion criteria

Recruitment start date

29/01/2020

Recruitment end date

31/12/2022

Locations

Countries of recruitment

Sweden

Trial participating centre

Bollnäs Folkhögskola
Skolallén 10, 821 41 Bollnäs
Bollnäs
821 41
Sweden

Trial participating centre

University of Gävle
Kungsbäcksvägen 47
Gävle
801 76
Sweden

Sponsor information

Organisation

University of Gävle

Sponsor details

Kungsbäcksvägen 47
Gävle
801 76
Sweden
+46 736223525
registrator@hig.se

Sponsor type

University/education

Website

https://www.hig.se/

Organisation

The county council of Gävleborg (Region Gävleborg)

Sponsor details

REKTORSGATAN 1
Gävle
802 50
Sweden
+4626154000
ans@hig.se

Sponsor type

Hospital/treatment centre

Website

https://www.regiongavleborg.se/

Funders

Funder type

University/education

Funder name

Högskolan i Gävle

Alternative name(s)

University of Gävle, HiG

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Sweden

Funder name

Region Gävleborg

Alternative name(s)

region Gavleborg

Funding Body Type

government organisation

Funding Body Subtype

Local government

Location

Sweden

Results and Publications

Publication and dissemination plan

The results are planned to be published in relevant peer-reviewed scientific journals and presented at international and national conferences.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to the Ethical application of the study, where it was stated that unauthorized persons will not have access to the datasets.

Intention to publish date

01/12/2022

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

04/05/2020: The study hypothesis has been updated. 30/04/2020: Trial’s existence confirmed by the Swedish Ethical Review Authority.