Condition category
Not Applicable
Date applied
19/12/2012
Date assigned
28/01/2013
Last edited
11/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The national fundamental values in elderly care were legislated in Sweden in 2011. They state that care of older people should focus on ensuring a sense of dignity and well-being. This means respect for the individual’s personal integrity, self-determination and participation. In addition, care provision and social services for older people should be individualized and of good quality, and older people and their relatives should always be treated well. A sense of well-being means a sense of meaningfulness and safety. Research in elderly care has shown that residents’ influence and participation in decision-making concerning their care and social services must be improved. Furthermore, care is often task oriented and less time is allotted to being present and to conversation. Research on staff in elderly care has shown that staff members sometimes have feelings of abandoning older people and that ‘stress of conscience‘ is sometimes present. Research has also shown that structural conditions need to be improved.
The aim of the study is to examine whether an intervention – aimed at staff working in residential living facilities and concerning the national fundamental values in elderly care – can improve the person-centered climate and increase well-being among older people and staff as well as increase the sense of dignity among older people.

Who can participate?
Residents living permanently in the residential living facility who are able to, by themselves or with assistance in reading and writing, answer the questionnaire and for some also participate in an interview.
Staff (registered nurses, licensed practical nurses and nurse’s aides) working in the residential living facilities.

What does the study involve?
Participants will be randomly allocated to either a ‘intervention’ group or a ‘control’ group. The intervention consists of seminars concerning the national fundamental values in elderly care, discussions of working methods and support for staff members working on improvements based on needs identified in the seminar discussions. Questionnaires and semi-structured interviews will be used to collect pre- and post-intervention data on the residents’ assessment of the person-centered climate in the unit, empowerment and life satisfaction as well as on the staff members’ assessment of the person-centered climate, person-centered care, structural conditions, psychological empowerment, thriving at work, stress symptoms and ‘stress of conscience’. Nursing documentation of the residents will also be followed. During interviews with the residents, their experiences of the care and social services provided and assessment of their own well-being and dignity will be discussed. During interviews with staff, the intervention and the care and social services provided at the unit will be discussed.

What are the possible benefits and risks of participation?
The benefits are that staff members in the intervention group will be given time to discuss and reflect on their working methods and the national fundamental values, and receive support when working on improvements. It is assumed that this, in turn, will improve the person-centered climate and care at the unit and thus residents’ and staff members’ well-being. When the residents answer questions concerning their perceptions and experiences of the care and social services provided in the unit and their well-being and dignity, there is a risk that negative emotions and memories will be mentioned. There is also a risk for negative emotions among staff when they reflect on their current approach to older people during the intervention.

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

When is the study starting and how long is it expected to run for?
The study started in November 2012 and will last until May 2014. The participants have already been recruited and recruitment is closed.

Who is funding the study?
University of Gävle, Gävleborg region and Ulrika Chroné Foundation (Sweden)

Who is the main contact?
Ms Charlotte Roos
charlotte.roos@hig.se

Trial website

Contact information

Type

Scientific

Primary contact

Ms Charlotte Roos

ORCID ID

Contact details

Faculty of Health and Occupational Studies
Department of Health and Caring Sciences
Gävle
801 76
Sweden
-
cheros@hig.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

National fundamental values in elderly care – the perspectives of older people living in residential living facilities and staff members: a cluster-randomized controlled trial

Acronym

Study hypothesis

A caregiver intervention concerning the national fundamental values will:
1. Improve the person-centered climate, empowerment and life satisfaction among older people living in residential living facilities.
2. Improve the person-centered climate, person-centered care, structural conditions, psychological empowerment, job satisfaction and thriving at work and reduce the stress symptoms and ‘stress of conscience’ among staff working in residential living facilities.

Ethics approval

The Regional Ethical Review Board, Uppsala, Sweden, 20/07/2012, Ref. no. 2012/248

Study design

Cluster-randomized controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Elderly care / Residential living facilities

Intervention

The 20 residential living facilities/units will be randomized into either an intervention or a control group.

The intervention includes seminars concerning the national fundamental values in elderly care, working methods and support in work for improvements. The intervention will be carried out through eight group meetings during a four-month period. The group meetings have three different themes: the content of the national fundamental values; person-centered care; working methods used in the residential living facility. Self-reflection and dialogue concerning the national fundamental values constitute the core of the group meetings. Through self-reflection and dialogue, staff will identify improvements that can be made in their present methods. Improvements will then be implemented by the staff at the residential living facility. The group meetings will take place one week and then the next week the researcher will visit the residential living facility to support the staff in implementing these improvements. All staff in the intervention group will receive the same intervention. After the intervention (four months), the researcher will continue to visit the residential living facility for two months to offer further support.

Data collection will be performed on two occasions (in both groups): baseline assessment and post-intervention. Data collection for the residents includes; the person-centered climate (The Person- centered Climate Questionnaire –patient version, PCQ-P), empowerment (The patient empowerment scale) and Life satisfaction (The Life Satisfaction Questionnaire, LSQ) as well as semi-structured interviews concerning the older peoples experiences of the care and social services provided, of their own well-being and dignity pre- and post-intervention. Nursing documentation of the residents will also be followed.

Data collection for the staff includes: the person-centered climate and care (The Person- centered Climate Questionnaire –staff version, PCQ-S and The Person-centered Care Assessment Tool, P-CAT), structural empowerment (The Conditions of Work Effectiveness Questionnaire, CWEQII), psychological empowerment (Spreitzers empowerment scale), thriving at work (the 10-item thriving scale), job satisfaction and stress symptoms (The Satisfaction with Work Questionnaires, SWQ), ‘stress of conscience’ (The Stress of Conscience Questionnaire, SCQ) and semi-structured interviews concerning the intervention and the care and social services provided at the unit following the intervention.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Residents:
1. Person-centered climate, empowerment and life satisfaction
1.1. Person-centered climate will be measured with the Person-centered Climate Questionnaire – patient version (PCQ-P) 1.2. Empowerment will be measured with the patient empowerment scale
1.3. Life satisfaction will be measured with the Life Satisfaction Questionnaire (LSQ)

Staff:
1. Person-centered climate, person-centered care, structural empowerment, psychological empowerment (total scales and included factors)
1.1. Person centered climate will be measured with the Person-centered Climate Questionnaire – staff version (PCQ-S)
1.2. Person centered care will be measures with the Person-centered Care Assessment Tool (P-CAT)
1.3. Structural empowerment will be measured with the Conditions of Work Effectiveness Questionnaire (CWEQII)
1.4. Psychological empowerment will be measured with Spreitzer's empowerment scale

Secondary outcome measures

Staff
1. Job satisfaction measured using the Satisfaction with Work Questionnaires (SWQ)
2. Thriving at work measured using 10-item thriving scale
3. Stress symptoms measured using the Satisfaction with Work Questionnaires (SWQ)
4. Stress of conscience measured using Stress of Conscience Questionnaire (SCQ)

Overall trial start date

19/11/2012

Overall trial end date

01/05/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Older people:
1. Having lived permanently in the residential living facility for two weeks or more
2. Assessed by the manager at the residential living facility as being able – by themselves or with help from a research assistant who reads the questions and fills in the answer given by the person – to reply to a survey and for some also to participate in an interview.

Staff:
Staff (registered nurses, licensed practical nurses and nurse’s aides) working at the residential living facility.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

A total of 337 older people are living in the 20 residential living facilities available for the study. Approximately 100 of them are estimated to meet the inclusion criteria. In total 262 staff.

Participant exclusion criteria

Older people with dementia

Recruitment start date

19/11/2012

Recruitment end date

01/05/2014

Locations

Countries of recruitment

Sweden

Trial participating centre

University of Gävle
Gävle
801 76
Sweden

Sponsor information

Organisation

University of Gävle (Sweden)

Sponsor details

Faculty of Health and Occupational Studies
Department of Health and Caring Sciences
Gävle
801 76
Sweden

Sponsor type

University/education

Website

http://www.hig.se

Funders

Funder type

University/education

Funder name

University of Gävle (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Region Gävleborg (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Ulrika Chroné Foundation (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27387954

Publication citations

Additional files

Editorial Notes

11/07/2016: Publication reference added.