HomeCoRe for Telerehabilitation in Mild or Major Neurocognitive Disorders: A Study Protocol for a Randomized Controlled Trial

Sara Bernini, Silvia Panzarasa, Elena Sinforiani, Silvana Quaglini, Stefano F Cappa, Chiara Cerami, Cristina Tassorelli, Tomaso Vecchi, Sara Bottiroli, Sara Bernini, Silvia Panzarasa, Elena Sinforiani, Silvana Quaglini, Stefano F Cappa, Chiara Cerami, Cristina Tassorelli, Tomaso Vecchi, Sara Bottiroli

Abstract

Background: Given the limited effectiveness of pharmacological treatments for cognitive decline, non-pharmacological interventions have gained increasing attention. Evidence exists on the effectiveness of cognitive rehabilitation in preventing elderly subjects at risk of cognitive decline and in reducing the progression of functional disability in cognitively impaired individuals. In recent years, telerehabilitation has enabled a broader application of cognitive rehabilitation programs. The purpose of this study is to test a computer-based intervention administered according to two different modalities (at the hospital and at home) using the tools CoRe and HomeCoRe, respectively, in participants with Mild or Major Neurocognitive Disorders. Methods: Non-inferiority, single-blind randomized controlled trial where 40 participants with Mild or Major Neurocognitive Disorders will be assigned to the intervention group who will receive cognitive telerehabilitation through HomeCoRe or to the control group who will receive in-person cognitive intervention through CoRe, with the therapist administering the same computer-based exercises. The rehabilitative program will last 6 weeks, with 3 sessions/week, each lasting ~45 min. All the participants will be evaluated on an exhaustive neuropsychological battery before (T0) and after (T1) the intervention; follow-up visits will be scheduled after 6 (T2) and 12 months (T3). Discussion: The results of this study will inform about the comparability (non-inferiority trial) of HomeCoRe with CoRe. Their equivalence would support the use of HomeCoRe for at distance treatment, favoring the continuity of care. Ethics and Dissemination: This study has been approved by the Local Ethics Committee and registered in https://ichgcp.net/clinical-trials-registry/NCT04889560" title="See in ClinicalTrials.gov">NCT04889560). The dissemination plan includes the scientific community through publication in open-access peer-reviewed scientific journals and presentations at national and international conferences. Trial Registration: Clinicaltrials.gov https://ichgcp.net/clinical-trials-registry/NCT04889560 (registration date: May 17, 2021).

Keywords: cognitive rehabilitation; cognitive training; computer-based telerehabilitation; dementia; mild cognitive impairment; neurocognitive disorder.

Conflict of interest statement

The authors declare that the research will be conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2021 Bernini, Panzarasa, Sinforiani, Quaglini, Cappa, Cerami, Tassorelli, Vecchi and Bottiroli.

Figures

Figure 1
Figure 1
The Consolidated Standards of Reporting Trials (CONSORT) flowchart for enrollment and randomization.
Figure 2
Figure 2
Therapist interface for monitoring performances of the participant in terms of overall Weighted Score (left) and interface of the participant for the execution of exercises (right).
Figure 3
Figure 3
Home page of the therapist side of the interface for setting the requirements for the exercise plan (left) and home page of the participant/caregiver side of the interface (right) for HomeCoRe.

References

    1. Livingston G, Sommerlad A, Orgeta V, Costafreda SG, Huntley J, Ames D, et al. . Dementia prevention, intervention, and care. Lancet. (2017) 390:2673–734. 10.1016/S0140-6736(17)31363-6
    1. Livingston G, Huntley J, Sommerlad A, Ames D, Ballard C, Banerjee S, et al. . Dementia prevention, intervention, and care: 2020 report of the Lancet Commission. Lancet. (2020) 396:413–46. 10.1016/S0140-6736(20)30367-6
    1. Petersen RC, Lopez O, Armstrong MJ, Getchius TSD, Ganguli M, Gloss D, et al. . Practice guideline update summary: mild cognitive impairment. Neurology. (2018) 90:126–35. 10.1212/WNL.0000000000004826
    1. Cotelli M, Manenti R, Brambilla M, Gobbi E, Ferrari C, Binetti G, et al. . Cognitive telerehabilitation in mild cognitive impairment, Alzheimer's disease and frontotemporal dementia: a systematic review. J Telemed Telecare. (2019) 25:67–79. 10.1177/1357633X17740390
    1. American Psychiatric Association . Diagnostic and Statistical Manual of Mental Disorders. 5th Ed. Arlington, VA: American Psychiatric Association; (2013). 10.1176/appi.journals.9780890425596
    1. Li H, Li J, Li N, Li B, Wang P, Zhou T. Cognitive intervention for persons with mild cognitive impairment: a meta-analysis. Ageing Res Rev. (2011) 10:285–96. 10.1016/j.arr.2010.11.003
    1. Hill NTM, 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) 174:329–40. 10.1176/appi.ajp.2016.16030360
    1. Maresca G, Maggio MG, De Luca R, Manuli A, Tonin P, Pignolo L, et al. . Tele-neuro-rehabilitation in italy: state of the art and future perspectives. Front Neurol. (2020) 11:563375. 10.3389/fneur.2020.563375
    1. Peel NM, Russell TG, Gray LC. Feasibility of using an in-home video conferencing system ingeriatric rehabilitation. J Rehabil Med. (2011) 43:364–6. 10.2340/16501977-0675
    1. Jeong IC, Liu J, Finkelstein J. Factors affecting adherence with telerehabilitation in patients with multiple sclerosis. Stud Health Technol Inform. (2019) 257:189–93.
    1. Gil-Pagés M, Solana J, Sánchez-Carrión R, Tormos JM, Enseñat-Cantallops A, García-Molina A. A customized home-based computerized cognitive rehabilitation platform for patients with chronic-stage stroke: study protocol for a randomized controlled trial. Trials. (2018) 19:191. 10.1186/s13063-018-2577-8
    1. Haesner M, Steinert A, O'Sullivan JL, Steinhagen-Thiessen E. Evaluating an accessible web interface for older adults – the impact of mild cognitive impairment (MCI). J Assist Technol. (2015) 9:219–32. 10.1108/JAT-11-2014-0032
    1. Hattink B, Droes R.-M, Sikkes S, Oostra E, Lemstra AW. Evaluation of the digital alzheimer center: testing usability and usefulness of an online portal for patients with dementia and their carers. JMIR Res Protoc. (2016) 5:e144. 10.2196/resprot.5040
    1. Castilla D, Suso-Ribera C, Zaragoza I, Garcia-Palacios A, Botella C. Designing ICTs for users with mild cognitive impairment: a usability study. Int J Environ Res Public Health. (2020) 17:5153. 10.3390/ijerph17145153
    1. De Cola MC, Maresca G, D'Aleo G, Carnazza L, Giliberto S, Maggio MG, et al. . Teleassistance for frail elderly people: a usability and customer satisfaction study. Geriatr Nurs. (2020) 41:463–7. 10.1016/j.gerinurse.2020.01.019
    1. Kim H, Lee S.-H., Cho N.-B., You H, et al. . User-dependent usability and feasibility of a swallowing training mhealth app for older adults: mixed methods pilot study. JMIR mHealth uHealth. (2020) 8:e19585. 10.2196/19585
    1. Taylor ME, Close JCT, Lord SR, Kurrle SE, Webster L, Savage R, et al. . Pilot feasibility study of a home-based fall prevention exercise program (StandingTall) delivered through a tablet computer (iPad) in older people with dementia. Australas J Ageing. (2020) 39:e278–87. 10.1111/ajag.12717
    1. Bloem BR, Dorsey ER, Okun MS. The coronavirus disease 2019 crisis as catalyst for telemedicine for chronic neurological disorders. JAMA Neurol. (2020) 77:927–8. 10.1001/jamaneurol.2020.1452
    1. Mantovani E, Zucchella C, Bottiroli S, Federico A, Giugno R, Sandrini G, et al. . Telemedicine and virtual reality for cognitive rehabilitation: a roadmap for the COVID-19 pandemic. Front Neurol. (2020) 11:926. 10.3389/fneur.2020.00926
    1. Platz T, Sandrini G. Specialty grand challenge for neurorehabilitation research. Front Neurol. (2020) 11:349. 10.3389/fneur.2020.00349
    1. Matamala-Gomez M, Bottiroli S, Realdon O, Riva G, Galvagni L, Platz T, et al. . Telemedicine and virtual reality at time of COVID-19 pandemic: an overview for future perspectives in neurorehabilitation. Front Neurol. (2021) 12:646902. 10.3389/fneur.2021.646902
    1. Stasolla F, Matamala-Gomez M, Bernini S, Caff ò AO, Bottiroli S. Virtual reality as a technological-aided solution to support communication in persons with neurodegenerative diseases and acquired brain injury during COVID-19 pandemic. Front Public Heal. (2021) 8:635426. 10.3389/fpubh.2020.635426
    1. Alloni A, Sinforiani E, Zucchella C, Sandrini G, Bernini S, Cattani B, et al. . Computer-based cognitive rehabilitation: the CoRe system. Disabil Rehabil. (2017) 39:407–17. 10.3109/09638288.2015.1096969
    1. Alloni A, Quaglini S, Panzarasa S, Sinforiani E, Bernini S. Evaluation of an ontology-based system for computerized cognitive rehabilitation. Int J Med Inform. (2018) 115:64–72. 10.1016/j.ijmedinf.2018.04.005
    1. Bernini S, Alloni A, Panzarasa S, Picascia M, Quaglini S, Tassorelli C, et al. . A computer-based cognitive training in Mild Cognitive Impairment in Parkinson's Disease. NeuroRehabilitation. (2019) 44:555–67. 10.3233/NRE-192714
    1. Bernini S, Panzarasa S, Barbieri M, Sinforiani E, Quaglini S, Tassorelli C, et al. . A double-blind randomized controlled trial of the efficacy of cognitive training delivered using two different methods in mild cognitive impairment in Parkinson's disease: preliminary report of benefits associated with the use of a computerized tool. Aging Clin Exp Res. (2021) 33:1567–75. 10.1007/s40520-020-01665-2
    1. Rodella C, Bernini S, Panzarasa S, Sinforiani E, Picascia M, Quaglini S, et al. . A double-blind randomized controlled trial combining cognitive training (CoRe) and neurostimulation (tDCS) in the early stages of cognitive impairment. Aging Clin Exp Res. (2021). 10.1007/s40520-021-01912-0. [Epub ahead of print].
    1. Quaglini S, Panzarasa S, Alloni A, Sacchi M, Sinforiani E, Bottiroli S, et al. . HomeCore: bringing cognitive rehabilitation at home. Stud Health Technol Inform. (2019) 264:1755–6. 10.3233/SHTI190632
    1. Bernini S, Stasolla F, Panzarasa S, Quaglini S, Sinforiani E, Sandrini G, et al. . Cognitive telerehabilitation for older adults with neurodegenerative diseases in the COVID-19 era: a perspective study. Front Neurol. (2021) 11:623933. 10.3389/fneur.2020.623933
    1. Hughes CP, Berg L, Danziger W, Coben LA, Martin RL. A new clinical scale for the staging of dementia. Br J Psychiatry. (1982) 140:566–72. 10.1192/bjp.140.6.566
    1. Magni E, Binetti G, Bianchetti A, Rozzini R, Trabucchi M. Mini-Mental State Examination: a normative study in Italian elderly population. Eur J Neurol. (1996) 3:198–202. 10.1111/j.1468-1331.1996.tb00423.x
    1. Conti S, Bonazzi S, Laiacona M, Masina M, Coralli MV. Montreal Cognitive Assessment (MoCA)-Italian version: regression based norms and equivalent scores. Neurol Sci. (2015) 36:209–14. 10.1007/s10072-014-1921-3
    1. Novelli G, Papagno C, Capitani E, Laiacona M, Cappa SF VG. Tre test clinici di memoria verbale a lungo termine. Taratura su soggetti normali Arch di Psicol Neurol Psychiatry. (1986) 47:278–96.
    1. Spinnler H. [Italian standardization and classification of Neuropsychological tests. The Italian Group on the neuropsychological study of aging]. Ital J Neurol Sci Suppl. (1987) 8:1–120.
    1. Carlesimo GA, Caltagirone C, Gainotti G, Al E. The mental deterioration battery: normative data, diagnositc reliability and qualitative analyses of cognitive impaiment. Eur J Neurol. (1996) 36:378–84. 10.1159/000117297
    1. Caffarra P, Vezzadini G, Dieci F, Zonato F, Venneri A. Rey-Osterrieth complex figure: normative values in an Italian population sample. Neurol Sci. (2002) 22:443–7. 10.1007/s100720200003
    1. Appollonio I, Leone M, Isella V, Piamarta F, Consoli T, Villa ML, et al. . The Frontal Assessment Battery (FAB): normative values in an Italian population sample. Neurol Sci. (2005) 26:108–16. 10.1007/s10072-005-0443-4
    1. Giovagnoli AR, Del Pesce M, Mascheroni S, Simoncelli M, Laiacona M, Capitani E. Trail making test: normative values from 287 normal adult controls. Ital J Neurol Sci. (1996) 4:305–9. 10.1007/BF01997792
    1. Lawton M, Brody E. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. (1969) 3:179–86. 10.1093/geront/9.3_Part_1.179
    1. Beck AT, Steer RA, Brown G. Beck Depression Inventory-IIUSA. NCS Person, Inc., Italian Translation: Ghisi M. Flebus GB, Montano A, Sanavio E, et al. (2006) Adattamento Ital. Manuale. Giunti O.S. Organ. Spec. (1996). 10.1037/t00742-000
    1. Apolone G, Mosconi P. The italian SF-36 health survey. J Clin Epidemiol. (1998) 51:1025–36. 10.1016/S0895-4356(98)00094-8
    1. Nucci M, Mapelli D, Mondini S. Cognitive Reserve Index questionnaire (CRIq): a new instrument for measuring cognitive reserve. Aging Clin Exp Res. (2012) 24:218–26. 10.1037/t53917-000
    1. Marvardi M, Mattioli P, Spazzafumo L, Mastriforti R, Rinaldi P, Polidori MC, et al. . The Caregiver Burden Inventory in evaluating the burden of caregivers of elderly demented patients: results from a multicenter study. Aging Clin Exp Res. (2005) 17:46–53. 10.1007/BF03337720
    1. Hurst H, Bolton J. Assessing the clinical significance of change scores recorded on subjective outcome measures. J Manipulative Physiol Ther. (2004) 27:26–35. 10.1016/j.jmpt.2003.11.003
    1. Lumsden J, Edwards EA, Lawrence NS, Coyle D, Munafò MR. Gamification of cognitive assessment and cognitive training: a systematic review of applications and efficacy. JMIR Serious Games. (2016) 4:e11. 10.2196/games.5888
    1. Smith-Ray RL, Irmiter C, Boulter K. Cognitive Training among cognitively impaired older adults: a feasibility study assessing the potential improvement in balance. Front Public Heal. (2016) 4:219. 10.3389/fpubh.2016.00219
    1. Jelcic N, Agostini M, Meneghello F, Buss è C, Parise S, Galano A, et al. . Feasibility and efficacy of cognitive telerehabilitation in early Alzheimer's disease: a pilot study. Clin Interv Aging. (2014) 9:1605–11. 10.2147/CIA.S68145
    1. World Health Organization . Global Action Plan on the Public Health Response to Dementia 2017–2025. Geneva (2017).
    1. Chirra M, Marsili L, Wattley L, Sokol LL, Keeling E, Maule S, et al. . Telemedicine in neurological disorders: opportunities and challenges. Telemed e-Health. (2019) 25:541–50. 10.1089/tmj.2018.0101
    1. Nesbitt TS, Hilty DM, Kuenneth CA, Siefkin A. Development of a telemedicine program: a review of 1,000 videoconferencing consultations. West J Med. (2000) 173:169–74. 10.1136/ewjm.173.3.169-a
    1. Zampolini M, Todeschini E, Bernabeu Guitart M, Hermens H, Ilsbroukx S, Macellari V, et al. . Tele-rehabilitation: present and future. Ann Ist Super Sanita. (2008) 44:125–34.
    1. Pecina JL, Vickers KS, Finnie DM, Hathaway JC, Hanson GJ, Takahashi PY. Telemonitoring increases patient awareness of health and prompts health-related action: initial evaluation of the TELE-ERA study. Telemed e-Health. (2011) 17:461–6. 10.1089/tmj.2010.0213
    1. Choi H, Kim J. Effectiveness of telemedicine: videoconferencing for low-income elderly with hypertension. Telemed e-Health. (2014) 20:1156–64. 10.1089/tmj.2014.0031
    1. De Luca R, Bramanti A, De Cola MC, Trifiletti A, Tomasello P, Torrisi M, et al. . Tele-health-care in the elderly living in nursing home: the first Sicilian multimodal approach. Aging Clin Exp Res. (2016) 28:753–9. 10.1007/s40520-015-0463-8
    1. Moo LR, Gately ME, Jafri Z, Shirk SD. Home-based video telemedicine for dementia management. Clin Gerontol. (2020) 43:193–203. 10.1080/07317115.2019.1655510
    1. Smith GE, Lunde AM, Hathaway JC, Vickers KS. Telehealth home monitoring of solitary persons with mild dementia. Am J Alzheimer's Dis Other Dementias®. (2007) 22:20–6. 10.1177/1533317506295888
    1. Nijland N, van Gemert-Pijnen J, Boer H, Steehouder MF, Seydel ER. Evaluation of internet-based technology for supporting self-care: problems encountered by patients and caregivers when using self-care applications. J Med Internet Res. (2008) 10:e13. 10.2196/jmir.957
    1. Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. (2008) 148:295. 10.7326/0003-4819-148-4-200802190-00008
    1. Boutron I, Altman DG, Moher D, Schulz KF, Ravaud P. CONSORT statement for randomized trials of nonpharmacologic treatments: a 2017 update and a CONSORT extension for nonpharmacologic trial abstracts. Ann Intern Med. (2017) 167:40. 10.7326/M17-0046

Source: PubMed

Szponzorok és közreműködők

Egészségi állapot

Kábítószer-beavatkozások

3
Iratkozz fel