Clinical trial NCT03297268: Behavioral and Environmental Sensing and Intervention
Official title: Behavioral and Environmental Sensing and Intervention for Dementia Caregiver Empowerment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Behavioral and Psychiatric Symptoms of Dementia
Dementia
Caregivers
Keywords: Dementia Caregiver Empowerment
Caregiver Burden
Agitation in Dementia
Environmental Sensors
Wearable Technology
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Carilion Clinic
name: North Carolina Agriculture & Technical State University
First posted: 2017-09-29
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample of people with dementia living at home with unpaid caregivers.

Brief summary: This 3-phase research plan to employ Behavioral and Environmental Sensing and Intervention (BESI) will overcome the fundamental scientific barriers to realizing prediction of agitation episodes and detection early stages of dementia related agitation. The goal of which is empowering caregivers to intervene early and ultimately reduce agitation, thus reducing caregiver burden and extending aging-in-place and improving the associated quality-of-life and cost benefits.

Detailed description: The dementia syndrome of Alzheimer's disease and other disorders is rapidly expanding due to the aging of society and the longevity of citizens. In its varying stages, care of the dementia syndrome requires differing sets of skills from the caregivers, and more skilled intervention is required as the disease progresses. These caregivers experience increased burden due to the challenges and stresses of caring. A recent systematic review of caregiver burden factors revealed dementia-related agitation to be the most prevalent factor leading caregivers to institutionalize community-dwelling loved ones with dementia. Tools that empower caregivers to proactively reduce the incidents and severity of agitation would reduce stress and increase self-efficacy, thereby extending aging-in-place and the associated quality-of-life and cost benefits.

This project proposes to develop, deploy, and evaluate such a tool and to address the fundamental scientific challenges to realizing the benefits of such a technology to caregivers and persons with dementia (PWD). The tool - BESI: Behavioral and Environmental Sensing and Intervention - will be an empowerment tool for caregivers of community-dwelling PWD. BESI comprises:

1. a system of body-worn inertial sensors and in-home acoustic, light, temperature, and motion sensors,
2. data analysis techniques to detect and assess agitation and environmental context from these sensor streams,
3. models for the relationship between agitation and the environment that are trained for each PWD-caregiver dyad based on a\&b, and
4. automated real-time notifications to the caregiver based on b\&c (e.g., detection of early agitation stages or of an environment (cumulative and/or instantaneous based on the models) that has led to agitation in the past), empowering the caregiver to intervene before agitation escalation.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of dementia
* Living in one home for at least 2 months without hospitalization
* Caregiver seeking support for caregiving needs
* Have a stable caregiver
* Be able to provide consent or assent

Exclusion Criteria:

* Hospitalization in the last 2 months
* Multiple and inconsistent caregivers
* Living in multiple homes
* Unable to provide consent or assent
* No known dementia

Primary outcomes:
measure: Improved Caregiver Self-Efficacy
timeFrame: 30 days
measure: Decreased Caregiver Burden
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References:
citation: Alzheimer's Association. 2016 Alzheimer's disease facts and figures. Alzheimers Dement. 2016 Apr;12(4):459-509. doi: 10.1016/j.jalz.2016.03.001.
citation: Friedman EM, Shih RA, Langa KM, Hurd MD. US Prevalence And Predictors Of Informal Caregiving For Dementia. Health Aff (Millwood). 2015 Oct;34(10):1637-41. doi: 10.1377/hlthaff.2015.0510.
citation: Cohen-Mansfield J, Billig N. Agitated behaviors in the elderly. I. A conceptual review. J Am Geriatr Soc. 1986 Oct;34(10):711-21. doi: 10.1111/j.1532-5415.1986.tb04302.x.
citation: Cummings J, Mintzer J, Brodaty H, Sano M, Banerjee S, Devanand DP, Gauthier S, Howard R, Lanctot K, Lyketsos CG, Peskind E, Porsteinsson AP, Reich E, Sampaio C, Steffens D, Wortmann M, Zhong K; International Psychogeriatric Association. Agitation in cognitive disorders: International Psychogeriatric Association provisional consensus clinical and research definition. Int Psychogeriatr. 2015 Jan;27(1):7-17. doi: 10.1017/S1041610214001963. Epub 2014 Oct 14.
citation: Cohen-Mansfield J, Marx MS, Rosenthal AS. A description of agitation in a nursing home. J Gerontol. 1989 May;44(3):M77-84. doi: 10.1093/geronj/44.3.m77.
citation: Colombo M, Vitali S, Cairati M, Vaccaro R, Andreoni G, Guaita A. Behavioral and psychotic symptoms of dementia (BPSD) improvements in a special care unit: a factor analysis. Arch Gerontol Geriatr. 2007;44 Suppl 1:113-20. doi: 10.1016/j.archger.2007.01.017.
citation: Steinberg M, Shao H, Zandi P, Lyketsos CG, Welsh-Bohmer KA, Norton MC, Breitner JC, Steffens DC, Tschanz JT; Cache County Investigators. Point and 5-year period prevalence of neuropsychiatric symptoms in dementia: the Cache County Study. Int J Geriatr Psychiatry. 2008 Feb;23(2):170-7. doi: 10.1002/gps.1858.
citation: Sansoni J, Anderson KH, Varona LM, Varela G. Caregivers of Alzheimer's patients and factors influencing institutionalization of loved ones: some considerations on existing literature. Ann Ig. 2013 May-Jun;25(3):235-46. doi: 10.7416/ai.2013.1926.
citation: Fonareva I, Oken BS. Physiological and functional consequences of caregiving for relatives with dementia. Int Psychogeriatr. 2014 May;26(5):725-47. doi: 10.1017/S1041610214000039. Epub 2014 Feb 10.
citation: Mausbach BT, Chattillion EA, Roepke SK, Patterson TL, Grant I. A comparison of psychosocial outcomes in elderly Alzheimer caregivers and noncaregivers. Am J Geriatr Psychiatry. 2013 Jan;21(1):5-13. doi: 10.1016/j.jagp.2012.10.001. Epub 2013 Jan 2.
citation: Epstein-Lubow G, Gaudiano B, Darling E, Hinckley M, Tremont G, Kohn R, Marino LJ Jr, Salloway S, Grinnell R, Miller IW. Differences in depression severity in family caregivers of hospitalized individuals with dementia and family caregivers of outpatients with dementia. Am J Geriatr Psychiatry. 2012 Sep;20(9):815-9. doi: 10.1097/JGP.0b013e318235b62f.
citation: Bankole A, Anderson M, Smith-Jackson T, Knight A, Oh K, Brantley J, Barth A, Lach J. Validation of noninvasive body sensor network technology in the detection of agitation in dementia. Am J Alzheimers Dis Other Demen. 2012 Aug;27(5):346-54. doi: 10.1177/1533317512452036.
citation: Rowe M, Lane S, Phipps C. CareWatch: A Home Monitoring System for Use in Homes of Persons With Cognitive Impairment. Top Geriatr Rehabil. 2007 Jan 1;23(1):3-8. doi: 10.1097/00013614-200701000-00003.
citation: Sacco G, Joumier V, Darmon N, Dechamps A, Derreumaux A, Lee JH, Piano J, Bordone N, Konig A, Teboul B, David R, Guerin O, Bremond F, Robert P. Detection of activities of daily living impairment in Alzheimer's disease and mild cognitive impairment using information and communication technology. Clin Interv Aging. 2012;7:539-49. doi: 10.2147/CIA.S36297. Epub 2012 Dec 4.
citation: Perlman CM, Hirdes JP. The aggressive behavior scale: a new scale to measure aggression based on the minimum data set. J Am Geriatr Soc. 2008 Dec;56(12):2298-303. doi: 10.1111/j.1532-5415.2008.02048.x.
citation: Hall GR, Gerdner LA, Zwygart-Stauffacher M, et al: Principles of nonpharmacological management: Caring for people with Alzheimer's disease using a conceptual model. Psychiatric Annals 1995; 25(7):432-440
citation: Smith M, Gerdner LA, Hall GR, Buckwalter KC. History, development, and future of the progressively lowered stress threshold: a conceptual model for dementia care. J Am Geriatr Soc. 2004 Oct;52(10):1755-60. doi: 10.1111/j.1532-5415.2004.52473.x.
citation: Gerdner LA, Buckwalter KC, Hall GR: Temporal patterning of agitation and stressors associated with agitation: Case profiles to illustrate the Progressively Lowered Stress Threshold model. Journal of the American Psychiatric Nurses Association 2005; 11(4):215-222
citation: Kaufer DI, Cummings JL, Ketchel P, Smith V, MacMillan A, Shelley T, Lopez OL, DeKosky ST. Validation of the NPI-Q, a brief clinical form of the Neuropsychiatric Inventory. J Neuropsychiatry Clin Neurosci. 2000 Spring;12(2):233-9. doi: 10.1176/jnp.12.2.233.
citation: Sclan SG, Reisberg B. Functional assessment staging (FAST) in Alzheimer's disease: reliability, validity, and ordinality. Int Psychogeriatr. 1992;4 Suppl 1:55-69. doi: 10.1017/s1041610292001157.
citation: Teng EL, Chui HC. The Modified Mini-Mental State (3MS) examination. J Clin Psychiatry. 1987 Aug;48(8):314-8.
citation: Morris JC. The Clinical Dementia Rating (CDR): current version and scoring rules. Neurology. 1993 Nov;43(11):2412-4. doi: 10.1212/wnl.43.11.2412-a. No abstract available.
citation: Alexopoulos GS, Abrams RC, Young RC, Shamoian CA. Cornell Scale for Depression in Dementia. Biol Psychiatry. 1988 Feb 1;23(3):271-84. doi: 10.1016/0006-3223(88)90038-8.
citation: Orme JG, Reis J, Herz EJ. Factorial and discriminant validity of the Center for Epidemiological Studies Depression (CES-D) scale. J Clin Psychol. 1986 Jan;42(1):28-33. doi: 10.1002/1097-4679(198601)42:13.0.co;2-t.
citation: Steffen AM, McKibbin C, Zeiss AM, Gallagher-Thompson D, Bandura A. The revised scale for caregiving self-efficacy: reliability and validity studies. J Gerontol B Psychol Sci Soc Sci. 2002 Jan;57(1):P74-86. doi: 10.1093/geronb/57.1.p74.
citation: Bedard M, Molloy DW, Squire L, Dubois S, Lever JA, O'Donnell M. The Zarit Burden Interview: a new short version and screening version. Gerontologist. 2001 Oct;41(5):652-7. doi: 10.1093/geront/41.5.652.
citation: MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.
citation: Duffy L, Gajree S, Langhorne P, Stott DJ, Quinn TJ. Reliability (inter-rater agreement) of the Barthel Index for assessment of stroke survivors: systematic review and meta-analysis. Stroke. 2013 Feb;44(2):462-8. doi: 10.1161/STROKEAHA.112.678615. Epub 2013 Jan 8.
citation: Logsdon RG, Gibbons LE, McCurry, et al: Quality of life in Alzheimer's disease: Patient and caregiver reports. Journal of Mental Health and Ageing 1999; 5:21-32
citation: Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
citation: Grissom RJ. Heterogeneity of variance in clinical data. J Consult Clin Psychol. 2000 Feb;68(1):155-65. doi: 10.1037//0022-006x.68.1.155.
citation: Jeste DV, Palmer BW, Appelbaum PS, Golshan S, Glorioso D, Dunn LB, Kim K, Meeks T, Kraemer HC. A new brief instrument for assessing decisional capacity for clinical research. Arch Gen Psychiatry. 2007 Aug;64(8):966-74. doi: 10.1001/archpsyc.64.8.966.
citation: Hurd MD, Martorell P, Delavande A, Mullen KJ, Langa KM. Monetary costs of dementia in the United States. N Engl J Med. 2013 Apr 4;368(14):1326-34. doi: 10.1056/NEJMsa1204629.