Virtual Darkness and Digital Phenotyping in Specialized and Municipal Dementia Care: The DARK.DEM Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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 people with dementia. The DARK.DEM trial aims at developing new diagnostics and treatment for BPSD in both specialized and municipal dementia care. The investigators will develop digital phenotyping by determining the convergent validity of data from a smartwatch against established psychometric scales for BPSD for patients admitted to NKS Olaviken gerontopsychiatric hospital. The investigators will conduct 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. The investigators 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 19.00-08.00, provided in a secluded patient unit with circadian lightening. Primary outcome is 14 days change in agitation assessed with Cohen-Mansfield Agitation Inventory. Secondary outcomes are change in diurnal variation of motor activity assessed with a smartwatch and sleep monitor, 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. The investigators 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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• Patients admitted to NKS Olaviken gerontopsychiatric hospital

• Diagnosis of dementia, all stages and etiologies,

• ≥50 years

• both genders

• Clinically significant agitation (CMAI ≥45)

Locations
Other Locations
Norway
NKS Olaviken Gerontopsychiatric Hospital
RECRUITING
Askøy
Contact Information
Primary
Line Iden Berge, M.D., PhD.
line.berge@uib.no
+4798857354
Backup
Sunniva Vibe Skagen, M. Psychol
sunniva.skagen@uib.no
+47 94154315
Time Frame
Start Date: 2024-09-30
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 72
Treatments
Experimental: Virtual darkness
Exclusive exposure to light deprived of blue wavelengths from 19.00-08.00 for 14 consecutive days as add-on to treatment as usual (TAU). This will be provided in an ordinary part of the hospital ward with circadian lightening delivered by Chromawiso. This lightening is CE approved. The intervention will be delivered in two separate patient units, each of them will include one living room, one bedroom and a bathroom, area ranging from 58m2- 60 m2. If patients are able to wear blue blocking glasses (amber lenses), they can stay outside the units from 19.00-08.00. Between 08.00-19.00 the patients in the intervention groups can stay inside or outside the units as they wish.
No_intervention: Control condition
Treatment as usual for agitation in specialized dementia health services encompasses use of psychotropic drugs (anxiolytic agents, antipsychotic agents, antidementia agents), environmental interventions, music therapy and use of medical restraints
Related Therapeutic Areas
Sponsors
Collaborators: NKS Olaviken Gerontopsychiatric Hospital
Leads: University of Bergen

This content was sourced from clinicaltrials.gov