The Effects of the Digital Platform Support Monitoring and Reminder Technology for Mild Dementia (SMART4MD) for People With Mild Cognitive Impairment and Their Informal Carers: Protocol for a Pilot Randomized Controlled Trial

Peter Anderberg, Pilar Barnestein-Fonseca, Jose Guzman-Parra, Maite Garolera, María Quintana, Fermin Mayoral-Cleries, Evi Lemmens, Johan Sanmartin Berglund, Peter Anderberg, Pilar Barnestein-Fonseca, Jose Guzman-Parra, Maite Garolera, María Quintana, Fermin Mayoral-Cleries, Evi Lemmens, Johan Sanmartin Berglund

Abstract

Background: Many countries are witnessing a trend of growth in the number and proportion of older adults within the total population. In Europe, population aging has had and will continue to have major social and economic consequences. This is a fundamentally positive development where the added life span is of great benefit for both the individual and the society. Yet, the risk for the individual to contract noncommunicable diseases and disability increases with age. This may adversely affect the individual's ability to live his or her life in the way that is desired. Cognitive conditions constitute a group of chronic diseases that predominantly affects older people. Recent technology advancements can help support the day-to-day living activities at home for people with cognitive impairments.

Objective: A digital platform (Support Monitoring and Reminder for Mild Dementia; SMART4MD) is created to improve or maintain the quality of life for people with mild cognitive impairment (PwMCI) and their carers. The platform will provide reminders, information, and memory support in everyday life, with the purpose of giving structure and lowering stress. In the trial, we will include participants with a diagnosed neurocognitive disorder as well as persons with an undiagnosed subjective memory problem and cognitive impairment, that is, 20 to 28 points on the Mini-Mental State Examination.

Methods: A pragmatic, multicenter RCT is being conducted in Spain, Sweden, and Belgium. The targets for recruitment are 1200 dyads-split into an intervention group and a control group that are in usual care. Intervention group participants will be provided with a data-enabled computer tablet with the SMART4MD app. Its core functionalities, intended to be used daily at home, are based on reminders, cognitive supporting activities, and sharing health information.

Results: Inclusion of participants started in December 2017, and recruitment is expected to end in February 2019. Furthermore, there will be 3 follow-up visits at 6, 12, and 18 months after the baseline visit.

Conclusions: This RCT is expected to offer benefits at several levels including in-depth knowledge of the possibilities of introducing a holistic multilayered information and communication technology solution for this group. SMART4MD has been developed in a process involving the structured participation of PwMCI, their informal carers, and clinicians. The adoption of SMART4MD faces the challenge of this age group's relative unfamiliarity with digital devices and services. However, this challenge can also be an opportunity for developing a digital device tailored to a group at risk of digital exclusion. This research responds to the wider call for the development of digital devices which are accessible and affordable to older people and this full scale RCT can hopefully serve as a model for further studies in this field.

Trial registration: ClinicalTrials.gov NCT03325699; https://ichgcp.net/clinical-trials-registry/NCT03325699.

International registered report identifier (irrid): DERR1-10.2196/13711.

Keywords: app; carer; dementia; eHealth; mHealth; mild cognitive impairment; tablet.

Conflict of interest statement

Conflicts of Interest: None declared.

©Peter Anderberg, Pilar Barnestein-Fonseca, Jose Guzman-Parra, Maite Garolera, María Quintana, Fermin Mayoral-Cleries, Evi Lemmens, Johan Sanmartin Berglund. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 21.06.2019.

References

    1. World Health Organization . Dementia: A Public Health Priority. Geneva, Switzerland: World Health Organization; 2012.
    1. Sachdev PS, Lipnicki DM, Kochan NA, Crawford JD, Thalamuthu A, Andrews G, Brayne C, Matthews FE, Stephan BC, Lipton RB, Katz MJ, Ritchie K, Carrière I, Ancelin M, Lam LC, Wong CH, Fung AW, Guaita A, Vaccaro R, Davin A, Ganguli M, Dodge H, Hughes T, Anstey KJ, Cherbuin N, Butterworth P, Ng TP, Gao Q, Reppermund S, Brodaty H, Schupf N, Manly J, Stern Y, Lobo A, Lopez-Anton R, Santabárbara J, Cohort Studies of Memory in an International Consortium (COSMIC) The prevalence of mild cognitive impairment in diverse geographical and ethnocultural regions: the COSMIC collaboration. PLoS One. 2015;10(11):e0142388. doi: 10.1371/journal.pone.0142388.
    1. Prince M, Wimo A, Guerchet M, Ali GC, Wu YT, Prina M. Alzheimer's Disease International. 2015. World Alzheimer Report 2015: The Global Impact of Dementia. An Analysis of Prevalence, Incidence, Cost and Trends .
    1. Hedman A, Kottorp A, Nygård L. Patterns of everyday technology use and activity involvement in mild cognitive impairment: a five-year follow-up study. Aging Ment Health. 2018;22(5):603–10. doi: 10.1080/13607863.2017.1297361.
    1. Martínez-Alcalá CI, Pliego-Pastrana P, Rosales-Lagarde A, Lopez-Noguerola JS, Molina-Trinidad EM. Information and communication technologies in the care of the elderly: systematic review of applications aimed at patients with dementia and caregivers. JMIR Rehabil Assist Technol. 2016 May 2;3(1):e6. doi: 10.2196/rehab.5226.
    1. Brims L, Oliver K. Effectiveness of assistive technology in improving the safety of people with dementia: a systematic review and meta-analysis. Aging Ment Health. 2018 Apr 10;:1–10. doi: 10.1080/13607863.2018.1455805. (forthcoming)
    1. Keränen NS, Kangas M, Immonen M, Similä H, Enwald H, Korpelainen R, Jämsä T. Use of information and communication technologies among older people with and without frailty: a population-based survey. J Med Internet Res. 2017;19(2):e29. doi: 10.2196/jmir.5507.
    1. Joddrell P, Astell AJ. Studies involving people with dementia and touchscreen technology: a literature review. JMIR Rehabil Assist Technol. 2016 Nov 4;3(2):e10. doi: 10.2196/rehab.5788.
    1. Malinowsky C, Fallahpour M, Lund ML, Nygård L, Kottorp A. Skill clusters of ability to manage everyday technology among people with and without cognitive impairment, dementia and acquired brain injury. Scand J Occup Ther. 2018 Mar;25(2):99–107. doi: 10.1080/11038128.2017.1298665.
    1. Eisapour M, Cao S, Domenicucci L, Boger J. Participatory Design of a Virtual Reality Exercise for People With Mild Cognitive Impairment. Extended Abstracts of the 2018 CHI Conference on Human Factors in Computing Systems; CHI EA'18; April 21-26, 2018; Montreal QC, Canada. 2018.
    1. Meiland F, Innes A, Mountain G, Robinson L, van der Roest H, García-Casal JA, Gove D, Thyrian JR, Evans S, Dröes RM, Kelly F, Kurz A, Casey D, Szcześniak D, Dening T, Craven MP, Span M, Felzmann H, Tsolaki M, Franco-Martin M. Technologies to support community-dwelling persons with dementia: a position paper on issues regarding development, usability, effectiveness and cost-effectiveness, deployment, and ethics. JMIR Rehabil Assist Technol. 2017 Jan 16;4(1):e1. doi: 10.2196/rehab.6376.
    1. Meiland FJ, Hattink BJ, Overmars-Marx T, de Boer ME, Jedlitschka A, Ebben PW, Stalpers-Croeze II, Flick S, van der Leeuw J, Karkowski IP, Dröes RM. Participation of end users in the design of assistive technology for people with mild to severe cognitive problems; the European Rosetta project. Int Psychogeriatr. 2014 May;26(5):769–79. doi: 10.1017/S1041610214000088.
    1. Bleijlevens MH, Stolt M, Stephan A, Zabalegui A, Saks K, Sutcliffe C, Lethin C, Soto ME, Zwakhalen SM, RightTimePlaceCare Consortium Changes in caregiver burden and health-related quality of life of informal caregivers of older people with dementia: evidence from the European RightTimePlaceCare prospective cohort study. J Adv Nurs. 2015 Jun;71(6):1378–91. doi: 10.1111/jan.12561.
    1. Johansson MM, Marcusson J, Wressle E. Cognitive impairment and its consequences in everyday life: experiences of people with mild cognitive impairment or mild dementia and their relatives. Int Psychogeriatr. 2015 Jun;27(6):949–58. doi: 10.1017/S1041610215000058.
    1. Fisher GG, Franks MM, Plassman BL, Brown SL, Potter GG, Llewellyn D, Rogers MA, Langa KM. Caring for individuals with dementia and cognitive impairment, not dementia: findings from the aging, demographics, and memory study. J Am Geriatr Soc. 2011 Mar;59(3):488–94. doi: 10.1111/j.1532-5415.2010.03304.x.
    1. Zarit SH, Todd PA, Zarit JM. Subjective burden of husbands and wives as caregivers: a longitudinal study. Gerontologist. 1986 Jun;26(3):260–6. doi: 10.1093/geront/26.3.260.
    1. Chiao CY, Wu HS, Hsiao CY. Caregiver burden for informal caregivers of patients with dementia: a systematic review. Int Nurs Rev. 2015 Sep;62(3):340–50. doi: 10.1111/inr.12194.
    1. Winblad B, Amouyel P, Andrieu S, Ballard C, Brayne C, Brodaty H, Cedazo-Minguez A, Dubois B, Edvardsson D, Feldman H, Fratiglioni L, Frisoni GB, Gauthier S, Georges J, Graff C, Iqbal K, Jessen F, Johansson G, Jönsson L, Kivipelto M, Knapp M, Mangialasche F, Melis R, Nordberg A, Rikkert MO, Qiu C, Sakmar TP, Scheltens P, Schneider LS, Sperling R, Tjernberg LO, Waldemar G, Wimo A, Zetterberg H. Defeating Alzheimer's disease and other dementias: a priority for European science and society. Lancet Neurol. 2016 Apr;15(5):455–532. doi: 10.1016/S1474-4422(16)00062-4.
    1. Pot AM, Willemse BM, Horjus S. A pilot study on the use of tracking technology: feasibility, acceptability, and benefits for people in early stages of dementia and their informal caregivers. Aging Ment Health. 2012;16(1):127–34. doi: 10.1080/13607863.2011.596810.
    1. Evans J, Brown M, Coughlan T, Lawson G, Craven M. A Systematic Review of Dementia Focused Assistive Technology. Human-Computer Interaction: Interaction Technologies; International Conference on Human-Computer Interaction; August 2-7, 2015; Los Angeles, CA, USA. Springer International Publishing; 2015. pp. 406–17.
    1. Daly Lynn J, Rondón-Sulbarán J, Quinn E, Ryan A, McCormack B, Martin S. A systematic review of electronic assistive technology within supporting living environments for people with dementia. Dementia (London) 2017 Jan 1;:1471301217733649. doi: 10.1177/1471301217733649. (forthcoming)
    1. Yousaf K, Mehmood Z, Saba T, Rehman A, Munshi AM, Alharbey R, Rashid M. Mobile-health applications for the efficient delivery of health care facility to people with dementia (PwD) and support to their carers: a survey. Biomed Res Int. 2019;2019:7151475. doi: 10.1155/2019/7151475. doi: 10.1155/2019/7151475.
    1. Hedman A, Kottorp A, Almkvist O, Nygård L. Challenge levels of everyday technologies as perceived over five years by older adults with mild cognitive impairment. Int Psychogeriatr. 2018;30(10):1447–54. doi: 10.1017/S1041610218000285.
    1. Schmidt LI, Wahl HW. Predictors of performance in everyday technology tasks in older adults with and without mild cognitive impairment. Gerontologist. 2019 Dec;59(1):90–100. doi: 10.1093/geront/gny062.
    1. Cooper C, Mukadam N, Katona C, Lyketsos CG, Ames D, Rabins P, Engedal K, de Mendonça Lima C, Blazer D, Teri L, Brodaty H, Livingston G, World Federation of Biological Psychiatry – Old Age Taskforce Systematic review of the effectiveness of non-pharmacological interventions to improve quality of life of people with dementia. Int Psychogeriatr. 2012 Jun;24(6):856–70. doi: 10.1017/S1041610211002614.
    1. The WHOQOL Group The world health organization quality of life assessment (WHOQOL): position paper from the world health organization. Soc Sci Med. 1995 Nov;41(10):1403–9. doi: 10.1016/0277-9536(95)00112-K.
    1. The WHOQOL Group The world health organization quality of life assessment (WHOQOL): development and general psychometric properties. Soc Sci Med. 1998 Jun;46(12):1569–85. doi: 10.1016/S0277-9536(98)00009-4.
    1. Li R, Cooper C, Bradley J, Shulman A, Livingston G. Coping strategies and psychological morbidity in family carers of people with dementia: a systematic review and meta-analysis. J Affect Disord. 2012 Jun;139(1):1–11. doi: 10.1016/j.jad.2011.05.055.
    1. Khosravi P, Ghapanchi AH. Investigating the effectiveness of technologies applied to assist seniors: a systematic literature review. Int J Med Inform. 2016 Jan;85(1):17–26. doi: 10.1016/j.ijmedinf.2015.05.014.
    1. van der Roest HG, Wenborn J, Pastink C, Dröes RM, Orrell M. Assistive technology for memory support in dementia. Cochrane Database Syst Rev. 2017;6:CD009627. doi: 10.1002/14651858.CD009627.pub2.
    1. Torkamani M, McDonald L, Saez Aguayo I, Kanios C, Katsanou MN, Madeley L, Limousin PD, Lees AJ, Haritou M, Jahanshahi M, ALADDIN Collaborative Group A randomized controlled pilot study to evaluate a technology platform for the assisted living of people with dementia and their carers. J Alzheimers Dis. 2014;41(2):515–23. doi: 10.3233/JAD-132156.
    1. Schulz KF, Altman DG, Moher D, CONSORT Group CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Br Med J. 2010 Mar 23;340:c332. doi: 10.1136/bmj.c332.
    1. Logsdon RG, Gibbons LE, McCurry SM, Teri L. Quality of life in Alzheimer's disease: patient and caregiver reports. J Aging Ment Health. 1999;5(1):21–32. doi: 10.1002/adma.201202148.
    1. Goeman D, Comans T, Enticott JC, Renehan E, Beattie E, Kurrle S, Koch S. Evaluating the efficacy of the 'support for life' program for people with dementia and their families and carers' to enable them to live well: a protocol for a cluster stepped wedge randomized controlled trial. Front Public Health. 2016;4:245. doi: 10.3389/fpubh.2016.00245. doi: 10.3389/fpubh.2016.00245.
    1. Brady R, Weinman J. Adherence to cholinesterase inhibitors in Alzheimer's disease: a review. Dement Geriatr Cogn Disord. 2013;35(5-6):351–63. doi: 10.1159/000347140.
    1. Campbell NL, Boustani MA, Skopelja EN, Gao S, Unverzagt FW, Murray MD. Medication adherence in older adults with cognitive impairment: a systematic evidence-based review. Am J Geriatr Pharmacother. 2012 Jun;10(3):165–77. doi: 10.1016/j.amjopharm.2012.04.004.
    1. Yesavage JA, Brink TL, Rose TL, Lum O, Huang V, Adey M, Leirer VO. Development and validation of a geriatric depression screening scale: a preliminary report. J Psychiatr Res. 1982;17(1):37–49. doi: 10.1016/0022-3956(82)90033-4.
    1. Thorgrimsen L, Selwood A, Spector A, Royan L, de Madariaga Lopez M, Woods RT, Orrell M. Whose quality of life is it anyway? The validity and reliability of the quality of life-Alzheimer's disease (QoL-AD) scale. Alzheimer Dis Assoc Disord. 2003;17(4):201–8. doi: 10.1097/00002093-200310000-00002.
    1. Logsdon RG, Gibbons LE, McCurry SM, 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. Haynes RB, Taylor DW, Sackett DL, Gibson ES, Bernholz CD, Mukherjee J. Can simple clinical measurements detect patient noncompliance? Hypertension. 1980;2(6):757–64. doi: 10.1161/01.HYP.2.6.757.
    1. Hansen RA, Kim MM, Song L, Tu W, Wu J, Murray MD. Comparison of methods to assess medication adherence and classify nonadherence. Ann Pharmacother. 2009 Mar;43(3):413–22. doi: 10.1345/aph.1L496.
    1. Folstein MF, Folstein SE, McHugh PR. 'Mini-mental state'. A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189–98. doi: 10.1016/0022-3956(75)90026-6.
    1. Doody RS, Ferris SH, Salloway S, Sun Y, Goldman R, Watkins WE, Xu Y, Murthy AK. Donepezil treatment of patients with MCI: a 48-week randomized, placebo-controlled trial. Neurology. 2009 May 5;72(18):1555–61. doi: 10.1212/01.wnl.0000344650.95823.03.
    1. O'Bryant SE, Humphreys JD, Smith GE, Ivnik RJ, Graff-Radford NR, Petersen RC, Lucas JA. Detecting dementia with the mini-mental state examination in highly educated individuals. Arch Neurol. 2008 Jul;65(7):963–7. doi: 10.1001/archneur.65.7.963.
    1. Anderberg P, Eivazzadeh S, Berglund JS. A novel instrument for measuring older people's attitudes toward technology (TechPH): development and validation. J Med Internet Res. 2019 May 23;21(5):e13951. doi: 10.2196/13951.
    1. Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649–55. doi: 10.1093/geront/20.6.649.
    1. Bédard 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.
    1. IBM Corp. 2018. IBM SPSS Statistics for Windows, Version 25.0 .
    1. Hoe J, Katona C, Orrell M, Livingston G. Quality of life in dementia: care recipient and caregiver perceptions of quality of life in dementia: the LASER-AD study. Int J Geriatr Psychiatry. 2007 Oct;22(10):1031–6. doi: 10.1002/gps.1786.
    1. Larson EB. Prevention of late-life dementia: no magic bullet. Ann Intern Med. 2018;168(1):77–9. doi: 10.7326/M17-3026.
    1. Corbett A, Stevens J, Aarsland D, Day S, Moniz-Cook E, Woods R, Brooker D, Ballard C. Systematic review of services providing information and/or advice to people with dementia and/or their caregivers. Int J Geriatr Psychiatry. 2012 Jun;27(6):628–36. doi: 10.1002/gps.2762.
    1. Logsdon RG, Pike KC, McCurry SM, Hunter P, Maher J, Snyder L, Teri L. Early-stage memory loss support groups: outcomes from a randomized controlled clinical trial. J Gerontol B Psychol Sci Soc Sci. 2010 Nov;65(6):691–7. doi: 10.1093/geronb/gbq054.
    1. Leung P, Orrell M, Orgeta V. Social support group interventions in people with dementia and mild cognitive impairment: a systematic review of the literature. Int J Geriatr Psychiatry. 2015 Jan;30(1):1–9. doi: 10.1002/gps.4166.
    1. Birks J, Harvey RJ. Donepezil for dementia due to Alzheimer's disease. Cochrane Database Syst Rev. 2006 Jan 25;(1):CD001190. doi: 10.1002/14651858.CD001190.pub2.
    1. Loy C, Schneider L. Galantamine for Alzheimer's disease and mild cognitive impairment. Cochrane Database Syst Rev. 2006 Jan 25;(1):CD001747. doi: 10.1002/14651858.CD001747.pub3.
    1. Cutler C, Hicks B, Innes A. Does digital gaming enable healthy aging for community-dwelling people with dementia? Games Cult. 2015 Aug;11(1-2):104–29. doi: 10.1177/1555412015600580.
    1. Smith KL, Crete-Nishihata M, Damianakis T, Baecker RM, Marziali E. Multimedia biographies: a reminiscence and social stimulus tool for persons with cognitive impairment. J Technol Hum Serv. 2009;27(4):287–306. doi: 10.1080/15228830903329831.
    1. Hill NT, Mowszowski L, Naismith SL, Chadwick VL, Valenzuela M, Lampit A. Computerized cognitive training in older adults with mild cognitive impairment or dementia: a systematic review and meta-analysis. Am J Psychiatry. 2017 Apr 1;174(4):329–40. doi: 10.1176/appi.ajp.2016.16030360.
    1. Beinart N, Weinman J, Wade D, Brady R. Caregiver burden and psychoeducational interventions in Alzheimer's disease: a review. Dement Geriatr Cogn Dis Extra. 2012 Jan;2(1):638–48. doi: 10.1159/000345777.
    1. Sheikh F, Ismail Z, Mortby ME, Barber P, Cieslak A, Fischer K, Granger R, Hogan DB, Mackie A, Maxwell CJ, Menon B, Mueller P, Patry D, Pearson D, Quickfall J, Sajobi T, Tse E, Wang M, Smith EE, PROMPT registry investigators Prevalence of mild behavioral impairment in mild cognitive impairment and subjective cognitive decline, and its association with caregiver burden. Int Psychogeriatr. 2018;30(2):233–44. doi: 10.1017/S104161021700151X.
    1. Smith D, Lovell J, Weller C, Kennedy B, Winbolt M, Young C, Ibrahim J. A systematic review of medication non-adherence in persons with dementia or cognitive impairment. PLoS One. 2017;12(2):e0170651. doi: 10.1371/journal.pone.0170651.
    1. Damant J, Knapp M. LSE Research Online. London, UK: Government Office for Science; 2015. [2018-11-28]. What are the Likely Changes in Society and Technology Which Will Impact Upon the Ability of Older Adults to Maintain Social (Extra-Familial) Networks of Support Now, in 2025 and in 2040? .

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