The TECH@HOME study, a technological intervention to reduce caregiver burden for informal caregivers of people with dementia: study protocol for a randomized controlled trial

Agneta Malmgren Fänge, Steven M Schmidt, Maria H Nilsson, Gunilla Carlsson, Anna Liwander, Caroline Dahlgren Bergström, Paolo Olivetti, Per Johansson, Carlos Chiatti, TECH@HOME Research Group, Agneta Malmgren Fänge, Steven M Schmidt, Maria H Nilsson, Gunilla Carlsson, Anna Liwander, Caroline Dahlgren Bergström, Paolo Olivetti, Per Johansson, Carlos Chiatti, TECH@HOME Research Group

Abstract

Background: It is estimated that global dementia rates will more than triple by 2050 and result in a staggering economic burden on families and societies. Dementia carries significant physical, psychological and social challenges for individuals and caregivers. Informal caregiving is common and increasing as more people with dementia are being cared for at home instead of in nursing homes. Caregiver burden is associated with lower perceived health, lower social coherence, and increased risk of morbidity and mortality. The aim of this trial is to evaluate the effects of information and communication technology (ICT) on caregiver burden among informal caregivers of people with dementia by reducing the need for supervision.

Methods/design: This randomized controlled trial aims to recruit 320 dyads composed of people with dementia living in community settings and their primary informal caregivers. In the intervention group, people with dementia will have a home monitoring kit installed in their home while dyads in the control group will receive usual care. The ICT kit includes home-leaving sensors, smoke and water leak sensors, bed sensors, and automatic lights that monitor the individual's behavior. Alerts (text message and/or phone call) will be sent to the caregiver if anything unusual occurs. All study dyads will receive three home visits by project administrators who have received project-specific training in order to harmonize data collection. Home visits will take place at enrollment and 3 and 12 months following installation of the ICT kit. At every home visit, a standardized questionnaire will be administered to all dyads to assess their health, quality of life and resource utilization. The primary outcome of this trial is the amount of informal care support provided by primary informal caregivers to people with dementia.

Discussion: This is the first randomized controlled trial exploring the implementation of ICT for people with dementia in a large sample in Sweden and one of the first at the international level. Results hold the potential to inform regional and national policy-makers in Sweden and beyond about the cost-effectiveness of ICT and its impact on caregiver burden.

Trial registration: ClinicalTrials.gov, NCT02733939 . Registered on 10 March 2016.

Keywords: Caregiver burden; Cognitive impairment; Health-economic evaluation; Informal care.

Figures

Fig. 1
Fig. 1
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) figure of TECH@HOME
Fig. 2
Fig. 2
Concept of the monitoring kit used in the project

References

    1. World Health Organization. Dementia: a public health priority. 2012. 27 Jul 2015. Available from: .
    1. OECD . Addressing dementia: the OECD response. Paris: OECD Publishing; 2015.
    1. Swedish Council on Technology Assessment in Health Care. Dementia—etiology and epidemiology: a systematic review Volume 1. Stockholm: The Swedish Council on Technology Assessment in Health Care; 2008.
    1. Socialstyrelsen. Demenssjukdomarnas samhällskostnader i Sverige 2012 3 Jun 2014: 1–63 pp. Available from: .
    1. Nordberg G, von Strauss E, Kåreholt I, Johansson L, Wimo A. The amount of informal and formal care among non-demented and demented elderly persons—results from a Swedish population-based study. Int J Geriatr Psychiatry. 2005;20:862–71. doi: 10.1002/gps.1371.
    1. Chiatti C, Furneri G, Rimland JM, Demma F, Bonfranceschi F, Cassetta L, et al. The economic impact of moderate stage Alzheimer’s disease in Italy: evidence from the UP-TECH randomized trial. Int Psychogeriatr. 2015;27(9):1563–72. doi: 10.1017/S104161021500040X.
    1. Jonsson L, Wimo A. The cost of dementia in Europe: a review of the evidence, and methodological considerations. Pharmacoeconomics. 2009;27(5):391–403. doi: 10.2165/00019053-200927050-00004.
    1. Brookmeyer R, Corrada MM, Curriero FC, Kawas C. Survival following a diagnosis of Alzheimer disease. Arch Neurol. 2002;59(11):1764–7. doi: 10.1001/archneur.59.11.1764.
    1. Vitaliano P, Zhang J, Scanlan J. Is caregiving hazardous to one’s physical health? A meta-analysis. Psychol Bull. 2003;129(6):946–72. doi: 10.1037/0033-2909.129.6.946.
    1. Andrén S, Elmståhl S. The relationship between caregiver burden, caregivers’ perceived health and their sense of coherence in caring for elders with dementia. J Clin Nurs. 2008;17(6):790–9. doi: 10.1111/j.1365-2702.2007.02066.x.
    1. Etters L, Goodall D, Harrison BE. Caregiver burden among dementia patient caregivers: a review of the literature. J Am Acad Nurse Pract. 2008;20(8):423–8. doi: 10.1111/j.1745-7599.2008.00342.x.
    1. Pinquart M, Sörensen S. Helping caregivers of persons with dementia: which interventions work and how large are their effects? Int Psychogeriatr. 2006;18(04):577–95. doi: 10.1017/S1041610206003462.
    1. Hepburn KW, Tornatore J, Center B, Ostwald SW. Dementia family caregiver training: affecting beliefs about caregiving and caregiver outcomes. J Am Geriatr Soc. 2001;49(4):450–7. doi: 10.1046/j.1532-5415.2001.49090.x.
    1. Marriott A, Donaldson C, Tarrier N, Burns A. Effectiveness of cognitive-behavioural family intervention in reducing the burden of care in carers of patients with Alzheimer’s disease. Br J Psychiatry. 2000;176:557–62. doi: 10.1192/bjp.176.6.557.
    1. Beinart N, Weinman J, Wade D, Brady R. Caregiver burden and psychoeducational interventions in Alzheimer’s disease: a review. Dement Geriatr Cogn Disord. 2012;2(1):638–48. doi: 10.1159/000345777.
    1. Callahan CM, Boustani MA, Unverzagt FW, et al. Effectiveness of collaborative care for older adults with Alzheimer disease in primary care: a randomized controlled trial. JAMA. 2006;295(18):2148–57. doi: 10.1001/jama.295.18.2148.
    1. Gitlin LN, Belle SH, Burgio LD, Czaja SJ, Mahoney D, Gallagher-Thompson D, et al. Effect of multicomponent interventions on caregiver burden and depression: the REACH multisite initiative at 6-month follow-up. Psychol Aging. 2003;18(3):361–74. doi: 10.1037/0882-7974.18.3.361.
    1. Carswell W, McCullagh PJ, Augusto JC, Martin S, Mulvenna MD, Zheng H, et al. A review of the role of assistive technology for people with dementia in the hours of darkness. Technol Health Care. 2009;17(4):281–304.
    1. Chiatti C, Masera F, Rimland JM, Cherubini A, Scarpino O, Spazzafumo L. The UP-TECH project, an intervention to support caregivers of Alzheimer’s disease patients in Italy: study protocol for a randomized controlled trial. Trials. 2013;14(1):1–11. doi: 10.1186/1745-6215-14-155.
    1. Barbabella F, Chiatti C, Masera F, Bonfranceschi F, Rimland J, Bartulewicz K, et al.. Experimentation of an Integrated System of Services and AAL Solutions for Alzheimer’s Disease Patients and Their Caregivers in Marche: The UP-TECH Project. in S. Longhi, P. Siciliano, M. Germani and A. Monteriù (editors). Ambient Assisted Living: Italian Forum 2013. Cham, Springer International Publishing: 2014; 157-165.
    1. Olivetti PCC, Rimland JM, Spinsante S, Bonfranceschi F, Masera F, Rossi L, Gambi E, Lattanzio F, on behalf of the Up-Tech research group . Acceptability of an integrated system of services and AAL solutions tested on Alzheimer’s disease patients and their caregivers in Marche: the results of the UP-TECH project. Lecco: Proceedings of the 6th Italian Forum on Ambient Assisted Living (ForITAAL 2015); 2015.
    1. Leroi I, Woolham J, Gathercole R, Howard R, Dunk B, Fox C, et al. Does telecare prolong community living in dementia? a study protocol for a pragmatic, randomised controlled trial. Trials. 2013;14(1):1–20. doi: 10.1186/1745-6215-14-349.
    1. Sachdev PS, Blacker D, Blazer DG, Ganguli M, Jeste DV, Paulsen JS, et al. Classifying neurocognitive disorders: the DSM-5 approach. Nat Rev Neurol. 2014;10(11):634–42. doi: 10.1038/nrneurol.2014.181.
    1. Reisberg B, Ferris SH, de Leon MJ, Crook T. The Global Deterioration Scale for assessment of primary degenerative dementia. Am J Psychiatry. 1982;139(9):1136–9. doi: 10.1176/ajp.139.9.1136.
    1. Chiatti C, Rimland JM, Bonfranceschi F, Masera F, Bustacchini S, Cassetta L. The UP-TECH project, an intervention to support caregivers of Alzheimer’s disease patients in Italy: preliminary findings on recruitment and caregiving burden in the baseline population. Aging Ment Health. 2014;19(6):517–25. doi: 10.1080/13607863.2014.954526.
    1. Wimo A, Wetterholm A, Mastey V, Winblad B. Evaluation of resource utilization and caregiver time in Anti-dementia drug trials—a quantitative battery. In: Wimo A, Jonsson B, Karlsson G, Winblad B, editors. The health economics of dementia. London: Wiley; 1998. pp. 465–99.
    1. Logsdon RG, Gibbons LE, McCurry SM, Teri L. Quality of life in Alzheimer’s disease: patient and caregiver reports. J Ment Health Aging. 1999;5(1):21–32.
    1. Logsdon R, Gibbons L, McCurry S, Teri L. Assessing quality of life in older adults with cognitive impairment. Psychosom Med. 2002;64(3):510–9. doi: 10.1097/00006842-200205000-00016.
    1. Delbaere K, Close JC, Mikolaizak AS, Sachdev PS, Brodaty H, Lord SR. The Falls Efficacy Scale International (FES-I). A comprehensive longitudinal validation study. Age Ageing. 2010;39(2):210–6. doi: 10.1093/ageing/afp225.
    1. Kempen GIJM, Yardley L, Van Haastregt JCM, Zijlstra GAR, Beyer N, Hauer K, et al. The Short FES-I: a shortened version of the Falls Efficacy Scale-International to assess fear of falling. Age Ageing. 2008;37(1):45–50. doi: 10.1093/ageing/afm157.
    1. Hauer K, Yardley L, Beyer N, Kempen G, Dias N, Campbell M, et al. Validation of the Falls Efficacy Scale and Falls Efficacy Scale International in geriatric patients with and without cognitive impairment: results of self-report and interview-based questionnaires. Gerontology. 2010;56(2):190–9. doi: 10.1159/000236027.
    1. Nordell E, Andreasson M, Gall K, Thorngren K-G. Evaluating the Swedish version of the Falls Efficacy Scale-International (FES-I) Adv Physiother. 2009;11(2):81–7. doi: 10.1080/14038190802318986.
    1. The EuroQol Group EuroQol—a new facility for the measurement of health-related quality of life. Health Policy. 1990;16(3):199–208. doi: 10.1016/0168-8510(90)90421-9.
    1. Burström K, Egmar A, Lugne A, Eriksson M, Svartengren M. A Swedish child-friendly pilot version of the EQ-5D instrument—the development process. Eur J Pub Health. 2010;21(2):171–7. doi: 10.1093/eurpub/ckq037.
    1. Burström K, Johannesson M, Rehnberg C. Deteriorating health status in Stockholm 1998–2002: results from repeated population surveys using the EQ-5D. Qual Life Res. 2007;16(9):1547–53. doi: 10.1007/s11136-007-9243-z.
    1. Zigmond A, Snaith R. The Hospital Anxiety and Depression Scale. Acta Psychiatr Scand. 1983;67(6):361–70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
    1. De Smedt D, Clays E, Doyle F, Kotseva K, Prugger C, Pająk A, Jennings C, Wood D, De Bacquer D, EUROASPIRE Study Group Validity and reliability of three commonly used quality of life measures in a large European population of coronary heart disease patients. Int J Cardiol. 2013;167(5):2294–9. doi: 10.1016/j.ijcard.2012.06.025.
    1. Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980;20(6):649–55. doi: 10.1093/geront/20.6.649.
    1. Bedard M, Pedlar D, Martin NJ, Malott O, Stones MJ. Burden in caregivers of cognitively impaired older adults living in the community: methodological issues and determinants. Int Psychogeriatr. 2000;12(3):307–32. doi: 10.1017/S1041610200006426.
    1. Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002;52(2):69–77. doi: 10.1016/S0022-3999(01)00296-3.
    1. Wimo A, Reed C, Dodel R, Belger M, Jones R, Happich M, et al. The GERAS Study: a prospective observational study of costs and resource use in community dwellers with Alzheimer’s disease in three European countries—study design and baseline findings. J Alzheimers Dis. 2013;36(2):385–99.
    1. Drummond M, Cooke J, Walley T. Economic evaluation under managed competition: evidence from the UK. Soc Sci Med. 1997;45(4):583–95. doi: 10.1016/S0277-9536(96)00398-X.
    1. Husereau D, Drummond M, Petrou S, Carswell C, Moher D, Greenberg D, et al. Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement. BMJ. 2013;346:f1049. doi: 10.1136/bmj.f1049.
    1. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M, Medical Research Council guidance Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:a1655. doi: 10.1136/bmj.a1655.
    1. Henderson C, Knapp M, Fernández J-L, Beecham J, Hirani SP, Cartwright M, et al. Cost effectiveness of telehealth for patients with long term conditions (Whole Systems Demonstrator telehealth questionnaire study): nested economic evaluation in a pragmatic, cluster randomised controlled trial. BMJ. 2013;346:f1035. doi: 10.1136/bmj.f1035.

Source: PubMed

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