Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06451952
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-04-03
Brief Title:
Virtual Darkness Theraphy for Agitation in Dementia
Sponsor:
University of Bergen
Organization:
University of Bergen
Study Overview
Official Title:
Virtual Darkness and Digital Phenotyping in Specialized and Municipal Dementia Care The DARKDEM Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DARKDEM
Brief 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 DARKDEM 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 1900-0800 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 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
The DARKDEM 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 1900-0800 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 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
Detailed Description:
Successful treatment of BPSD relies on precise assessment The gold standard is self-report of symptoms supplemented by proxy rating from relatives and staff This can be aided by various psychometric scales such as the Cornell Scale for Depression Cohen-Mansfield Agitation Inventory and Neuropsychiatric Inventory However these scales have weaknesses they span short time periods have moderate interrater and test-retest reliability In particular in the outpatient setting this hampers the reliability and validity of patients and caregivers reports and thereby infers the accuracy of the clinicians assessment A possible enhancement of assessment can be achieved through digital phenotyping that is characterization of human behavior by moment-by-moment monitoring with personal digital devices
First line treatment of BPSD is environmental approaches which often is resource demanding as it requires extensive staffing Second line treatment is use of psychotropic drugs however effect is modest and come with high risk of interactions and side effects particularly harmful in fragile older adults A possible enhancement of BPSD treatment lies in interventions targeting the circadian rhythm The circadian rhythm is weakened in persons with dementia and this can potentiate BPSDs Several trials have demonstrated some effect of bright light therapy on BPSD however it has been suggested that the effect is limited due to lack of sufficient light reaching the retina due to eye conditions in the elderly Therefore a more useful approach in this population might be virtual darkness that is blue wavelength depleted evening light
The DARKDEM trials primary objective is to develop and evaluate digital phenotyping and virtual darkness therapy to enhance management of BPSD in municipal and specialized dementia care
Secondary objectives are
Determine the feasibility of symptom assessment with wearable sensor technology in patients with dementia admitted to a gerontopsychiatric hospital ward
Determine the convergent validity of data obtained via sensor technology in patients with dementia against psychometric scales for assessment of BPSD
Determine the effectiveness feasibility and safety of virtual darkness in the evening and night as adjunctive treatment of agitation in patients with dementia in a gerontopsychiatric hospital ward
Explore barriers enablers and possible adaptions to support implementation of digital phenotyping and virtual darkness therapy in nursing homes
The investigators will apply a multidisciplinary approach with methods from computer science hermeneutics and medicine in three work packages WP
WP1 DIGDEM will determine the convergent validity of data from Empatica Embrace plus wristband against established psychometric scales for BPSD in patients admitted to NKS Olaviken gerontopsychiatric hospital The investigators will use correlation analyses and knowledge based AI to develop novel digital biomarkers for BPSD
WP2 DARKDEM 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 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 1900-0800 provided in a secluded patient unit with circadian lightening Inclusion criteria is patients with dementia admitted to the hospital both genders above 50 years and CMAI score equal or above 45 points exclusion criteria is total blindnessdiminished bilateral red reflex use of beta-blockers andor melatonin and clinically significant pain MOBID-2 score equal or above 3 points 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 Empatica Embrace wristband 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 DECIDEDEM 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 The investigators will use a mixed methods explanatory sequential design hermeneutical methodology
First line treatment of BPSD is environmental approaches which often is resource demanding as it requires extensive staffing Second line treatment is use of psychotropic drugs however effect is modest and come with high risk of interactions and side effects particularly harmful in fragile older adults A possible enhancement of BPSD treatment lies in interventions targeting the circadian rhythm The circadian rhythm is weakened in persons with dementia and this can potentiate BPSDs Several trials have demonstrated some effect of bright light therapy on BPSD however it has been suggested that the effect is limited due to lack of sufficient light reaching the retina due to eye conditions in the elderly Therefore a more useful approach in this population might be virtual darkness that is blue wavelength depleted evening light
The DARKDEM trials primary objective is to develop and evaluate digital phenotyping and virtual darkness therapy to enhance management of BPSD in municipal and specialized dementia care
Secondary objectives are
Determine the feasibility of symptom assessment with wearable sensor technology in patients with dementia admitted to a gerontopsychiatric hospital ward
Determine the convergent validity of data obtained via sensor technology in patients with dementia against psychometric scales for assessment of BPSD
Determine the effectiveness feasibility and safety of virtual darkness in the evening and night as adjunctive treatment of agitation in patients with dementia in a gerontopsychiatric hospital ward
Explore barriers enablers and possible adaptions to support implementation of digital phenotyping and virtual darkness therapy in nursing homes
The investigators will apply a multidisciplinary approach with methods from computer science hermeneutics and medicine in three work packages WP
WP1 DIGDEM will determine the convergent validity of data from Empatica Embrace plus wristband against established psychometric scales for BPSD in patients admitted to NKS Olaviken gerontopsychiatric hospital The investigators will use correlation analyses and knowledge based AI to develop novel digital biomarkers for BPSD
WP2 DARKDEM 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 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 1900-0800 provided in a secluded patient unit with circadian lightening Inclusion criteria is patients with dementia admitted to the hospital both genders above 50 years and CMAI score equal or above 45 points exclusion criteria is total blindnessdiminished bilateral red reflex use of beta-blockers andor melatonin and clinically significant pain MOBID-2 score equal or above 3 points 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 Empatica Embrace wristband 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 DECIDEDEM 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 The investigators will use a mixed methods explanatory sequential design hermeneutical methodology
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 697405 | OTHER | REK VEST Ethical approval | None |