Mental Ill-healthLEPPICNCT03140618
The Light- and Environment Project in Psychiatric Inpatient Care
A study testing The light and environment project in psychiatric inpatient care in people with Mental Ill-health and Care Environment, run by Umeå University at 1 site in Sweden.
Trial summary
The care environment influences both patients' experiences of care as well as staff's experiences of the work environment. A radical change in physical environment is planned at a psychiatric ward, aiming at creating a care environment that supports patients' opportunities for recovery from mental ill-health and to… Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Mental Ill-health, Care Environment, Light Installations
- What is being tested?
- The light and environment project in psychiatric inpatient care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSweden
- Study dates
- 15 May 2017to 31 Dec 2020
- 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 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Admitted to the wards during either A phase, B phase and/or follow-up
- Regularly employed at the ward during A and B phase and/or follow-up.
Who cannot join
- Does not master the Swedish language well enough to complete questionnaires and participate in interviews
- Staff employed by the hour
Trial locations and contacts
1 site in 1 country.
About this study
The care environment influences both patients' experiences of care as well as staff's experiences of the work environment. A radical change in physical environment is planned at a psychiatric ward, aiming at creating a care environment that supports patients' opportunities for recovery from mental ill-health and to create a better and more attractive work environment for the staff. The rebuilding involves a new ward layout and new innovations such as light installations, a comfort room and an activity room.
The study uses a single-system design to evaluate the effects of the intervention - the rebuilt ward. Both quantitative and qualitative data will be used in the evaluation. Data will be collected using questionnaires measuring dimensions of patients' well-being and experiences of the care environment, staff's experiences of work-related stress and work environment, quality of care, a device measuring physical activity, existing clinical registers and data from medical files, staff' sick leave, participant observations, and semi-structured interviews.
This evaluation study, to our knowledge the first of it's kind in Sweden, is expected to generate important knowledge of the effect of the change process that can be used at other psychiatric wards to design the inpatient care environment. In the long run, the study could lead to a better reputation of psychiatric nursing and to more attractive workplaces.
- Conditions
- Mental Ill-health, Care Environment, Light Installations
- Being tested
- The light and environment project in psychiatric inpatient care
- Keywords
- single-system-design, mixed methods, psychiatric inpatient care, work environment, rebuilding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The light and environment project in psychiatric inpatient careOther
Complete rebuilding of a hospital ward.
The ward layout is remodeled and different devices and services are installed such as light, sound, and color settings, increased opportunities for physical activity, social harmony, privacy, peace, and quiet. A comfort room and a activity room will be built.
| Study group | Role | What they receive |
|---|---|---|
| LEPPIC | Experimental | The light and environment project in psychiatric inpatient care Receives: Other: The light and environment project in psychiatric inpatient care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome Rating Scale [patients]
The Outcome Rating Scale measures self-assessed satisfaction with life on four visual-analogue scales.
Measured: Changes during baseline and intervention period (measured regularly for 12 weeks)
Perceived stress [staff]
PSS consists of 10 items answered on a 5-point Likert scale
Measured: Changes during baseline and intervention period (measured regularly for 12 weeks)
Secondary outcomes (6)
Quality of interactions [patients]
This is measured using The Caring Professional Scale (CPS) that consists of 14 items answered on a 5-point Likert scale.
Measured: Changes during baseline and intervention period (measured regularly for 12 weeks)
Anxiety and depressive symptoms [patients]
The Hospital Anxiety and Depression Scale (HAD) will be used to measure anxiety and depressive symptoms. All items are scored on a 4-point scale.
Measured: Changes during baseline and intervention period (measured regularly for 12 weeks)
Quality in psychiatric care [patients]
The QPC-IP measures quality of care on 30 items using a 4-point scale.
Measured: Changes during baseline and intervention period (measured regularly for 12 weeks)
Stress of Conscience [staff]
The Stress of Conscience Questionnaire (SCQ) will be used to measure the frequencies of stressful situations and the degree to which these lead to stress of conscience among staff.
Measured: Changes during baseline and intervention period (measured regularly for 12 weeks)
Quality of care [staff]
The Quality in Psychiatric Care- Inpatient Staff (QPC-IPS) questionnaire will be used to measure quality of care.
Measured: Changes during baseline and intervention period (measured regularly for 12 weeks)
Physical activity [patients and staff]
An electronic device measuring physical activity will be carried by participants during one week before and after rebuilding the ward.
Measured: Changes in physical activity between baseline and intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start15 May 2017
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Ill-healthStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Västerbotten County Council, Sweden
- Responsible party
- Sponsor
- Investigators
- Britt-Marie Lindgren, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140618
- Sponsor's protocol ID
- 3500LJUSMILJO
- Acronym
- LEPPIC
- Status last verified
- Oct 2021
- First submitted
- 2 May 2017
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lindgren BM, Molin J, Lundstrom M, Stromback M, Salander Renberg E, Ringner A. Does a new spatial design in psychiatric inpatient care influence patients' and staff's perception of their care/working environment? A study protocol of a pilot study using a single-system experimental design. Pilot Feasibility Stud. 2018 Dec 26;4:191. doi: 10.1186/s40814-018-0383-4. eCollection 2018.
PubMed 30607254
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Light- and Environment Project in Psychiatric Inpatient Care
- ClinicalTrials.gov ID
- NCT03140618
- Acronym / sponsor ID
- LEPPIC / 3500LJUSMILJO
- Conditions
- Mental Ill-health, Care Environment, Light Installations
- Keywords
- single-system-design, mixed methods, psychiatric inpatient care, work environment, rebuilding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Västerbotten County Council, Sweden
- Study start
- 15 May 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 4 May 2017 (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 care environment influences both patients' experiences of care as well as staff's experiences of the work environment. A radical change in physical environment is planned at a psychiatric ward, aiming at creating a care environment that supports patients' opportunities for recovery from mental ill-health and to create a better and more attractive work environment for the staff. The rebuilding involves a new ward layout and new innovations such as light installations, a comfort room and an activity room.
The study uses a single-system design to evaluate the effects of the intervention - the rebuilt ward. Both quantitative and qualitative data will be used in the evaluation. Data will be collected using questionnaires measuring dimensions of patients' well-being and experiences of the care environment, staff's experiences of work-related stress and work environment, quality of care, a device measuring physical activity, existing clinical registers and data from medical files, staff' sick leave, participant observations, and semi-structured interviews.
This evaluation study, to our knowledge the first of it's kind in Sweden, is expected to generate important knowledge of the effect of the change process that can be used at other psychiatric wards to design the inpatient care environment. In the long run, the study could lead to a better reputation of psychiatric nursing and to more attractive workplaces.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LEPPIC | Experimental | Other: The light and environment project in psychiatric inpatient careThe light and environment project in psychiatric inpatient care |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- Admitted to the wards during either A phase, B phase and/or follow-up
- Regularly employed at the ward during A and B phase and/or follow-up.
Key exclusion criteria (2 listed)
- Does not master the Swedish language well enough to complete questionnaires and participate in interviews
- Staff employed by the hour
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 |
|---|---|---|
| The light and environment project in psychiatric inpatient careComplete rebuilding of a hospital ward. The ward layout is remodeled and different devices and services are installed such as light, sound, and color settings, increased opportunities for physical activity, social harmony, privacy, peace, and quiet. A comfort room and a activity room will be built. | Other | LEPPIC |
Primary outcome
Outcome Rating Scale [patients]
Time frame: Changes during baseline and intervention period (measured regularly for 12 weeks)
The Outcome Rating Scale measures self-assessed satisfaction with life on four visual-analogue scales.
Perceived stress [staff]
Time frame: Changes during baseline and intervention period (measured regularly for 12 weeks)
PSS consists of 10 items answered on a 5-point Likert scale
6 secondary outcomes
Quality of interactions [patients]
Time frame: Changes during baseline and intervention period (measured regularly for 12 weeks)
Anxiety and depressive symptoms [patients]
Time frame: Changes during baseline and intervention period (measured regularly for 12 weeks)
Quality in psychiatric care [patients]
Time frame: Changes during baseline and intervention period (measured regularly for 12 weeks)
Stress of Conscience [staff]
Time frame: Changes during baseline and intervention period (measured regularly for 12 weeks)
Quality of care [staff]
Time frame: Changes during baseline and intervention period (measured regularly for 12 weeks)
Physical activity [patients and staff]
Time frame: Changes in physical activity between baseline and intervention
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 4 Oct 2021.
- Derived from this study: PubMed 30607254Lindgren BM, Molin J, Lundstrom M, Stromback M, Salander Renberg E, Ringner A. Does a new spatial design in psychiatric inpatient care influence patients' and staff's perception of their care/working environment? A study protocol of a pilot study using a single-system experimental design. Pilot Feasibility Stud. 2018 Dec 26;4:191. doi: 10.1186/s40814-018-0383-4. eCollection 2018.
- Individual participant dataSharing planned: Undecided
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Recruiting
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Mental Ill-health
Not yet recruiting
Feasibility of "Mer Aktiv"
Mental Ill-health
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.
Britt-Marie Lindgren principal investigator
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The light and environment project in psychiatric inpatient care in people with Mental Ill-health and Care Environment, run by Umeå University at 1 site in Sweden.
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 4 Oct 2021. 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 Sweden. 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?
Outcome Rating Scale [patients] (time frame: Changes during baseline and intervention period (measured regularly for 12 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03140618, which also lists 1 linked publication.
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 4 Oct 2021; AzTrials last refreshed its copy on 6 Nov 2026.