Virtual Darkness and Digital Phenotyping in Specialized and Municipal Dementia Care: The DARK.DEM Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Cohen-Mansfield Agitation Inventory (CMAI)
研究概览
简要总结
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
详细描述
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 DARK.DEM 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to NKS Olaviken gerontopsychiatric hospital
- •Diagnosis of dementia, all stages and etiologies,
- •≥50 years
- •both genders
- •Clinically significant agitation (CMAI ≥45)
排除标准
- •Total blindness/diminished bilateral red reflex.
- •Use of melatonin
- •Clinically significant pain (MOBID-2≥3)
结局指标
主要结局
Cohen-Mansfield Agitation Inventory (CMAI)
时间窗: Change from baseline to day 14
The CMAI is a clinically validated agitation rating scale that measures the frequency of 29 items on agitated behaviors, encompassing four clusters of behavior: 1) aggressive behavior (e.g. hitting, kicking, screaming), 2) physically non-aggressive behavior (e.g. pacing, trying to get to a different place, restlessness), 3) verbally agitated behavior (complaining, constant requests for attention, repetitive questions) and 4) hiding and hoarding. Each of the 29 items are scored from 1 (no) to 7 (severe) evaluating the past 14 days. Scale range from 29-203, high score indicates severe symptoms. The CMAI correlates with other neuropsychiatric symptom scales, has high internal consistency and adequate inter-rater reliability with regard to physical aggression and verbal agitation.
次要结局
- Use of drugs, numbers, use regularly(Change from baseline to day 7, change from baseline to day 14)
- Use of drugs, doses, use regularly(Change from baseline to day 7, change from baseline to day 14)
- Use of drugs, numbers, use on demand(Change from baseline to day 7, change from baseline to day 14)
- Use of drugs, doses, use on demand(Change from baseline to day 7, change from baseline to day 14)
- Decisions on coercion according the The Mental Health Act(Change from baseline to day 7, change from baseline to day 14, change from baseline to until the date of discharge assessed up to 1 year)
- Living situation(Change from baseline to until the date of discharge assessed up to 1 year)
- Length of hospital stay(Change from baseline to until the date of discharge assessed up to 1 year)
- Cohen-Mansfield Agitation Inventory (CMAI)(Change from baseline to day 7)
- Nevropsychiatric Inventory Nursing Home Version NPI-NH(Change from baseline to day 7, change from baseline to day 14)
- Cornell Scale for Depression in Dementia (CSDD)(Change from baseline to day 7, change from baseline to day 14)
- Sleep Disorder Inventory (SDI)(Change from baseline to day 7, change from baseline to day 14)
- Digital biomarker for circadian rhythm in dementia(Change from baseline to day 7, change from baseline to day 14)
- Confusion Assessment Method (CAM)(Change from baseline to day 7, change from baseline to day 14)
- Quality of life in dementia (QUALIDEM)(Change from baseline to day 7, change from baseline to day 14)
- Clinical Global Impression scale, CGI(Change from baseline to day 7, change from baseline to day 14)
- Personal activities of daily living, P-ADL(Change from baseline to day 7, change from baseline to day 14)
- Direct care time(Change from baseline to day 7, change from baseline to day 14)
- Digital biomarker for agitation in dementia(Change from baseline to day 7, change from baseline to day 14)
- Digital biomarker for depression in dementia(Change from baseline to day 7, change from baseline to day 14)
- Digital biomarker for sleep in dementia(Change from baseline to day 7, change from baseline to day 14)
- Treatment emergent adverse events(Change from baseline to day 7, change from baseline to day 14)