Clinical trial NCT06205654: Effect of Improved Indoor Lighting on Residents of Residential Care Homes with Dementia
Official title: Invloed Van Verlichting (en Daglicht) Op Bewoners Met Dementie in Woonzorgcentra
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dementia
Keywords: Lighting
Integrative lighting
Dementia
Nursing home
Residential care home
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Odisee University College
First posted: 2024-01-16
Enrollment: 98
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Two residential care homes are participating in this study. In one residential care home, improved lighting was implemented in two living rooms. The intervention group consists of participants living in one of these living rooms. The control group consists of participants living in the other residential care home (where improved lighting was not implemented).

Brief summary: Elderly with dementia living in residential care homes often have limited access to adequate lighting (daylight). Light can however positively impact the individual on a number of factors, including sleep quality and mental health. The proposed non-invasive study seeks to evaluate the impact of an improved lighting environment in the living areas of residential care home residents with dementia on both the physical and mental well-being of these individuals. To assess sleep quality, an actigraphy device will be used from which a number of parameters corresponding to sleep quality can be obtained. Mental health/behaviour of the participants will be assessed by validated questionnaires. These questionnaires will be filled for each participant independently by 2 members of the nursing staff.

Two groups of residential care home residents will be observed during this study: an intervention group and a control group. In the intervention group, innovative lighting designs are already implemented in the living area. The control group will experience no significant modifications to their lighting conditions. Extra luminaires (floor lamp/table lamp) will be employed without significantly improving the light exposure during the day.

It is hypothesized that the introduction of enhanced lighting during the day in the living area of the intervention group will result in improved sleep quality and enhanced mental well-being.


Eligibility criteria: Inclusion Criteria:

1. Diagnosed with dementia
2. Residing in the selected living area

Exclusion Criteria:

1. Blind individuals
2. Not residing in the selected living area
3. Not diagnosed with dementia

Primary outcomes:
measure: Change from Baseline in sleep efficiency at Week 15
timeFrame: Baseline + Week 15
measure: Change from Baseline in Fragmentation Index at Week 15
timeFrame: Baseline + Week 15
measure: Change from Baseline in interdaily stability at Week 15
timeFrame: Baseline + Week 15
measure: Change from Baseline in Intradaily variability at Week 15
timeFrame: Baseline + Week 15
measure: Change from Baseline in L5 average at Week 15
timeFrame: Baseline + Week 15
measure: Change from Baseline in M10 average at Week 15
timeFrame: Baseline + Week 15
measure: Change from Baseline in number of naps at Week 15
timeFrame: Baseline + Week 15
measure: Change from Baseline in agitation on the Cohen-Mansfield Agitation Inventory at Week 15
timeFrame: Baseline + Week 15
measure: Change from Baseline in depression on the Cornell Scale for Depression in Dementia at Week 15
timeFrame: Baseline + Week 15
measure: Change from Baseline in pain on the Doloplus Scale-2 at Week 15
timeFrame: Baseline + Week 15
measure: Change from Baseline in neuropsychiatric symptoms on the Neuropsychiatric Inventory at Week 15
timeFrame: Baseline + Week 15
Secondary outcomes:
measure: Age of participant
timeFrame: Baseline measurement
measure: Gender of participant
timeFrame: Baseline measurement
measure: Length of stay in the nursing home of participant
timeFrame: Baseline measurement
measure: Marital status of participant
timeFrame: Baseline measurement
measure: Frequency of visitors of participant
timeFrame: Baseline measurement
measure: Mini-mental state examination of participant
timeFrame: Baseline measurement
measure: Diagnosis of dementia of participant
timeFrame: Baseline measurement
measure: Diagnosis of Parkinson's disease of participant
timeFrame: Baseline measurement
measure: Diagnosis of cancer of participant
timeFrame: Baseline measurement
measure: Diagnosis of Chronic obstructive pulmonary disease of participant
timeFrame: Baseline measurement
measure: Diagnosis of cardiovascular diseases of participant
timeFrame: Baseline measurement
measure: Diagnosis of cerebral vascular accident of participant
timeFrame: Baseline measurement
measure: Diagnosis of diabetes of participant
timeFrame: Baseline measurement
measure: Diagnosis of depression of participant
timeFrame: Baseline measurement
Other outcomes:
Locations:
city: Wingene
country: Belgium
facility: Curando vzw
state: West-Vlaanderen
Study officials:
References: