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BEHANDLING-God og treffsikker diagnostikk, behandling og rehabilitering

Virtual darkness and digital phenotyping in specialized and municipal dementia care: The DARK.DEM randomized controlled trial.

Alternative title: DARK.DEM

Awarded: NOK 10.6 mill.

Behavioral and psychological symptoms of dementia (BPSD) describe changes in behavior and mental state which is caused by the dementia syndrome, and encompasses symptoms such as anxiety, depression, psychosis and agitation. These symptoms are prevalent among persons with dementia, often treatment resistant, resource demanding and contributes to worsening of cognition, independency, reduced quality of life and increased mortality. By merging expertise in elderly medicine, psychiatry, psychology, chronotherapy, computer science and hermeneutics, the DARK.DEM trial will improve diagnostics and treatment of BPSD management in both specialized and municipal dementia care. In the first part of the project, we will use artificial intelligence to examine if data from smart watches can provide accurate measures of agitation, depression and sleep disturbances in persons with dementia admitted to NKS Olaviken Gerontopsychiatric Hospital. In the second part of the project, we will conduct a randomized controlled trial to determine if treatment with virtual darkness in the evening and night, that is, light without blue wavelengths, can alleviate agitation and other BPSD among inpatients at the hospital. The new treatment will be added to the regular treatment, and we will explore if it reduces the need for psychotropic drugs, use of coercion, and length of hospital stay. In the final part of the project, we will conduct individual interviews and focus group interviews with staff at NKS Olaviken Gerontopsychiatric Hospital and staff affiliated with "Etat for sykehjem" in Bergen municipality to explore expiriences, barriers and enablers for implementation of the new methods in municipal dementia care. As such, the project will lead to improved diagnostics and treatment of BPSD compared to today’s practices. Moreover, these new services can be utilized regardless of level of care, and as such, reduce inequalities in access to specialized health care services. By september 2024 we have hired two Ph.D. students, one post-doc and a research nurse. We have reiceved ethical approval, developed a DPIA and registered the trial on clinicaltrials.gov and helsenorge.no. Inclusion of the first patients is expected in september 2024.

Behavioral and psychological symptoms of dementia (BPSD) such as anxiety, depression, psychosis and agitation, are prevalent, often treatment resistant, resource demanding and significantly deteriorates cognition, independency, quality of life and mortality in these vulnerable patients. By merging expertise in elderly medicine, psychiatry, psychology, chronotherapy, computer science and hermeneutics, DARK.DEM will overcome the current challenges of BPSD management both in specialized and municipal dementia care through three work packages (WPs): WP1: DIG.DEM will determine the convergent validity of data from Empatica E4 wristband against established psychometric scales for BPSD admitted to NKS Olaviken gerontopsychiatric hospital and evaluate the feasibility of use in a clinical setting applying semi structured focus group interviews with staff. WP2: DARK.DEM is an open label single blinded randomized controlled trial to determine the effectiveness, feasibility and safety of virtual darkness as adjunctive treatment of agitation in patients with dementia admitted to the hospital. We will randomize minimum 72 patients to treatment as usual (psychotropic drugs, psychological and environmental interventions) or 14 days of virtual darkness therapy, that is, exposure to light deprived of blue wavelengths from 18.00-08.00, provided in a secluded patient unit with circadian lightening. Primary outcome is 14 days change in agitation assessed with Cohen-Mansfield Agitation Inventory and change in diurnal variation of motor activity assessed with Empatica E4 wristband. Secondary outcomes are change in other BPSD, activities of daily living, quality of life, use of psychotropic drugs, use of restraints and coercion, length of hospital stay and resource utilization. WP3: DECIDE.DEM will conduct focus group interviews with managers and staff in nursing homes to explore barriers, enablers and adaptions to support implementation of the new methods in municipal dementia care.

Funding scheme:

BEHANDLING-God og treffsikker diagnostikk, behandling og rehabilitering