The UP-TECH project, an intervention to support caregivers of Alzheimer's disease patients in Italy: study protocol for a randomized controlled trial

Carlos Chiatti, Filippo Masera, Joseph M Rimland, Antonio Cherubini, Osvaldo Scarpino, Liana Spazzafumo, Fabrizia Lattanzio, UP-TECH research group, Diletta Baldassarri, Luigina Bitti, Aurora Carosi, Maila Sabbatini, Elisabetta Paolasini, Tania Fiori, Cinzia Fronzi, Simona Giacchetta, Valeria Giacomini, Laura Giovagnoli, Giuli Lattanzi, Anna Maria Manca, Ida Marinelli, Valeria Pigini, Marina Pignotti, Maria Chiara Proietti, Antonia Quarticelli, Martina Rovedi, Letizia Tasso, Valentina Valeri, Andrea Antonioli, Mariella Barabucci, Mara Bassani, Paola Bollettini, M Cristina Bruttapasta, Carla Buccolini, Rosa Carangella, Franca Carboni, Daniela Ceccolini, Patrizia D'Incecco, Mariangela Di Felice, Lara Dini, Giordano Gioia, Giuseppe Di Prima, Giancarlo Giusepponi, Cesarina Lanciotti, Alessia Loffreda, Oriana Luciani, Laura Mariani, Francesco Mastrorilli, Roberto Moroni, Izabela Piatkowska, Roberta Rucoli, Giampaola Scoccia, Nives Teodori, Tiziana Tonelli, Rossano Angeloni, Rosa Anna Bratti, Giuseppe Bonafede, Severino Lorenzetti, Cristina Paci, Giovanna Picciotti, Donella Pezzola, Vincenzo Rea, Vittorio Scialè, Mario Signorino, Francesca Sorvillo, Pia Francesca Tomassini, Alessia Ciccola, Loena Cionfrini, Daniela Alessandrini, Antonio De Santis, Brunetta Formica, Giuliano Tacchi, Silvia Tortorelli, Gemma Marchegiani, Giovanni Santarelli, Giorgio Caraffa, Filippo Cavallo, Lucia Di Furia, Antonio Lacetera, Claudio M Maffei, Lamberto Manzoli, Demetrio Postacchini, Roberta Bevilacqua, Anna Rita Bonfigli, Franco Bonfranceschi, Silvia Bustacchini, Marina Capasso, Laura Cassetta, Patrizia Civerchia, Gianluca Furneri, Cinzia Giuli, Paolo Marinelli, Gabriella Melchiorre, Maria Elena Moraca, Andrea Principi, Cristina Rocchetti, Daniela Vincitorio, Krystian Bartulewicz, Lorena Rossi, Carlos Chiatti, Filippo Masera, Joseph M Rimland, Antonio Cherubini, Osvaldo Scarpino, Liana Spazzafumo, Fabrizia Lattanzio, UP-TECH research group, Diletta Baldassarri, Luigina Bitti, Aurora Carosi, Maila Sabbatini, Elisabetta Paolasini, Tania Fiori, Cinzia Fronzi, Simona Giacchetta, Valeria Giacomini, Laura Giovagnoli, Giuli Lattanzi, Anna Maria Manca, Ida Marinelli, Valeria Pigini, Marina Pignotti, Maria Chiara Proietti, Antonia Quarticelli, Martina Rovedi, Letizia Tasso, Valentina Valeri, Andrea Antonioli, Mariella Barabucci, Mara Bassani, Paola Bollettini, M Cristina Bruttapasta, Carla Buccolini, Rosa Carangella, Franca Carboni, Daniela Ceccolini, Patrizia D'Incecco, Mariangela Di Felice, Lara Dini, Giordano Gioia, Giuseppe Di Prima, Giancarlo Giusepponi, Cesarina Lanciotti, Alessia Loffreda, Oriana Luciani, Laura Mariani, Francesco Mastrorilli, Roberto Moroni, Izabela Piatkowska, Roberta Rucoli, Giampaola Scoccia, Nives Teodori, Tiziana Tonelli, Rossano Angeloni, Rosa Anna Bratti, Giuseppe Bonafede, Severino Lorenzetti, Cristina Paci, Giovanna Picciotti, Donella Pezzola, Vincenzo Rea, Vittorio Scialè, Mario Signorino, Francesca Sorvillo, Pia Francesca Tomassini, Alessia Ciccola, Loena Cionfrini, Daniela Alessandrini, Antonio De Santis, Brunetta Formica, Giuliano Tacchi, Silvia Tortorelli, Gemma Marchegiani, Giovanni Santarelli, Giorgio Caraffa, Filippo Cavallo, Lucia Di Furia, Antonio Lacetera, Claudio M Maffei, Lamberto Manzoli, Demetrio Postacchini, Roberta Bevilacqua, Anna Rita Bonfigli, Franco Bonfranceschi, Silvia Bustacchini, Marina Capasso, Laura Cassetta, Patrizia Civerchia, Gianluca Furneri, Cinzia Giuli, Paolo Marinelli, Gabriella Melchiorre, Maria Elena Moraca, Andrea Principi, Cristina Rocchetti, Daniela Vincitorio, Krystian Bartulewicz, Lorena Rossi

Abstract

Background: The epidemic of Alzheimer's disease (AD) represents a significant challenge for the health care and social service systems of many developed countries. AD affects both patients and family caregivers, on whom the main burden of care falls, putting them at higher risk of stress, anxiety, mortality and lower quality of life. Evidence remains controversial concerning the effectiveness of providing support to caregivers of AD patients, through case management, counseling, training, technological devices and the integration of existing care services. The main objectives of the UP-TECH project are: 1) to reduce the care burden of family caregivers of AD patients; and 2) to maintain AD patients at home.

Methods/design: A total of 450 dyads comprising AD patients and their caregivers in five health districts of the Marche region, Italy, will be randomized into three study arms. Participants in the first study arm will receive comprehensive care and support from a case manager (an ad hoc trained social worker) (UP group). Subjects in the second study arm will be similarly supported by a case manager, but in addition will receive a technological toolkit (UP-TECH group). Participants in the control arm will only receive brochures regarding available services. All subjects will be visited at home by a trained nurse who will assess them using a standardized questionnaire at enrollment (M0), 6 months (M6) and 12 months (M12). Follow-up telephone interviews are scheduled at 24 months (M24). The primary outcomes are: 1) caregiver burden, measured using the Caregiver Burden Inventory (CBI); and 2) the actual number of days spent at home during the study period, defined as the number of days free from institutionalizations, hospitalizations and stays in an observation unit of an emergency room.

Discussion: The UP-TECH project protocol integrates previous evidence on the effectiveness of strategies in dementia care, that is, the use of case management, new technologies, nurse home visits and efforts toward the integration of existing services in an ambitious holistic design. The analysis of different interventions is expected to provide sound evidence of the effectiveness and cost of programs supporting AD patients in the community.

Trial registration: ClinicalTrials.gov: NCT01700556.

Figures

Figure 1
Figure 1
The recruitment process in the UP-TECH project.
Figure 2
Figure 2
The design of the UP-TECH kit.

References

    1. Wimo A, Prince M. The World Alzheimer Report 2010: The Global Economic Impact of Dementia. London: Alzheimer’s Disease International; 2010.
    1. National Institute of Statistics (Istat) Health and Use of Health Services in 2005. Rome: Istat; 2008.
    1. Larson EB. Dementia in the elderly: the "silent epidemic" no more. Trans Am ClinClimatolAssoc. 2001;112:136–146.
    1. Cherubini A, Ruggiero C, Dell’Aquila G, Eusebi P, Gasperini B, Zengarini E, Cerenzia A, Zuliani G, Guaita A, Lattanzio F. Underrecognition and undertreatment of dementia in Italian nursing homes. J Am Med Dir Assoc. 2012;13:759. e7–e13.
    1. Vellas B, Hausner L, Frölich L, Cantet C, Gardette V, Reynish E, Gillette S, Agüera-Morales E, Auriacombe S, Boada-Rovira M, Bullock R, Byrne J, Camus V, Cherubini A, Costa-Tsolaki M, Eriksdotter-Jönhagen M, Frisoni GB, Hasselbalch S, Jones RW, Martinez-Lage P, OldeRikkert M, Ousset PJ, Pasquier F, Ribera-Casado JM, Rigaud AS, Robert P, Rodriguez G, Salmon E, Salva A, Scheltens P. et al.Progression of Alzheimer disease in Europe: Data from the European ICTUS study. Curr Alzheimer Res. 2012;9:902–912. doi: 10.2174/156720512803251066.
    1. Gaugler JE, Duval S, Anderson KA, Kane RL. Predicting nursing home admission in the U.S.: a meta-analysis. BMC Geriatr. 2007;7:13. doi: 10.1186/1471-2318-7-13.
    1. Smith GC, Tobin SS, Robertson-Tchabo EA, Power PW. Strengthening Aging Families: Diversity in Practice and Policy. Thousand Oaks, CA: Sage Publications; 1995.
    1. Schulz R, Burgio L, Burns R, Eisdorfer C, Gallagher-Thompson D, Gitlin LN, Mahoney DF. Resources for Enhancing Alzheimer's Caregiver Health (REACH): overview, site-specific outcomes, and future directions. Gerontologist. 2003;43:514–520. doi: 10.1093/geront/43.4.514.
    1. Hooker K, Bowman SR, Coehlo DP, Lim SR, Kaye J, Guariglia R, Li F. Behavioral change in persons with dementia: relationships with mental and physical health of caregivers. J Gerontol B PsycholSciSocSci. 2002;57:P453–P460. doi: 10.1093/geronb/57.5.P453.
    1. Vitaliano PP, Zhang J, Scanlan JM. Is caregiving hazardous to one's physical health? A meta-analysis. Psychol Bull. 2003;129:946–972.
    1. Thompson CCA, Spilsbury K. Withdrawn: Support for carers of people with Alzheimer's type dementia. Cochrane Database Syst Rev. 2007;3:CD000454.
    1. Parker D, Mills S, Abbey J. Effectiveness of interventions that assist caregivers to support people with dementia living in the community: a systematic review. Int J Evid Based Healthc. 2008;6:137–172. doi: 10.1111/j.1744-1609.2008.00090.x.
    1. Brodaty H, McGilchrist C, Harris L, Peters KE. Time until institutionalization and death in patients with dementia. Role of caregiver training and risk factors. Arch Neurol. 1993;50:643–650. doi: 10.1001/archneur.1993.00540060073021.
    1. Brodaty H, Gresham M, Luscombe G. The Prince Henry Hospital dementia caregivers' training programme. Int J Geriatr Psychiatry. 1997;12:183–192. doi: 10.1002/(SICI)1099-1166(199702)12:2<183::AID-GPS584>;2-J.
    1. Eloniemi-Sulkava U, Notkola IL, Hentinen M, Kivela SL, Sivenius J, Sulkava R. Effects of supporting community-living demented patients and their caregivers: a randomized trial. J Am GeriatrSoc. 2001;49:1282–1287. doi: 10.1046/j.1532-5415.2001.49255.x.
    1. Mittelman MS, Haley WE, Clay OJ, Roth DL. Improving caregiver well-being delays nursing home placement of patients with Alzheimer disease. Neurology. 2006;67:1592–1599. doi: 10.1212/01.wnl.0000242727.81172.91.
    1. Andrén S, Elmståhl S. Effective psychosocial intervention for family caregivers lengthens time elapsed before nursing home placement of individuals with dementia: a five-year follow-up study. IntPsychogeriatr. 2008;20:1177–1192.
    1. Gormley N. The role of dementia training programmes in reducing care-giver burden. Psychiatrist. 2000;24:41–42.
    1. Tremont G, Davis JD, Bishop DS, Fortinsky RH. Telephone-delivered psychosocial intervention reduces burden in dementia caregivers. Dementia. 2008;7:503–520. doi: 10.1177/1471301208096632.
    1. Martin S, Kelly G, Kernohan W, McCreight B, Nugent C. Smart home technologies for health and social care support. Cochrane Database Syst Rev. 2008;4:CD006412.
    1. Fänge A, Iwarsson S. Changes in ADL dependence and aspects of usability following housing adaptation - a longitudinal perspective. Am J OccupTher. 2005;59:296–304.
    1. Cuddihy P, Hinman R, Avestruz A, Lupton E, Livshin G, Rodriguez J, Leeb S, Clark C, Horvath K, Volicer L, Landfeldt B, Kay J, Kummerfeld R, Quigley A, West D, Apted T, Sinclair G, Haniff D, Kalawsky R, Atkins D, Lewin M, Brown S, Shahmehri N, Aberg J, Maciuszek D, Chisalita I. Successful Aging. IEEE Pervasive Computing. 2004;3:48–50.
    1. ROSETTA.
    1. ENABLE.
    1. Gitlin LN, Belle SH, Burgio LD, Czaja SJ, Mahoney D, Gallagher-Thompson D, Burns R, Hauck WW, Zhang S, Schulz R, Ory MG. Effect of multicomponent interventions on caregiver burden and depression: the REACH multisite initiative at 6-month follow-up. Psychol Aging. 2003;18:361–374.
    1. Elliott AF, Burgio LD, Decoster J. Enhancing caregiver health: findings from the resources for enhancing Alzheimer's caregiver health II intervention. J Am GeriatrSoc. 2010;58:30–37. doi: 10.1111/j.1532-5415.2009.02631.x.
    1. Branch LG, Coulam RF, Zimmerman YA. The PACE evaluation: initial findings. Gerontologist. 1995;35:349–359. doi: 10.1093/geront/35.3.349.
    1. Challis D, Darton R, Johnson L, Stone M, Traske K. An evaluation of an alternative to long-stay hospital care for frail elderly patients: I. The model of care. Age Ageing. 1991;20:236–244. doi: 10.1093/ageing/20.4.236.
    1. Hébert R, Raîche M, Dubois M-F, Gueye NR, Dubuc N, Tousignant M. PRISMA Group. Impact of PRISMA, a coordination-type integrated service delivery system for frail older people in Quebec (Canada): A quasi-experimental study. J Gerontol B PsycholSciSocSci. 2010;65B:107–118. doi: 10.1093/geronb/gbp027.
    1. Béland F, Bergman H, Lebel P, Clarfield AM, Tousignant P, Contandriopoulos A-P, Dallaire L. A system of integrated care for older persons with disabilities in Canada: results from a randomized controlled trial. J Gerontol A BiolSci Med Sci. 2006;61:367–373. doi: 10.1093/gerona/61.4.367.
    1. Shutes I, Chiatti C. Migrant Workers and Emerging Care Markets in Italy and UK. J Eur Soc Pol. 2012;22:392–405. doi: 10.1177/0958928712449773.
    1. Albert MS, Dekosky ST, Dickson D, Dubois B, Feldman HH, Fox NC, Gamst A, Holtzman DM, Jagust WJ, Petersen RC, Snyder PJ, Carrillo MC, Thies B, Phelps CH. The diagnosis of mild cognitive impairment due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011;7:270–279. doi: 10.1016/j.jalz.2011.03.008.
    1. McKhann GM, Knopman DS, Chertkow H, Hyman BT, Jack CR, Kawas CH, Klunk WE, Koroshetz WJ, Manly JJ, Mayeux R, Mohs RC, Morris JC, Rossor MN, Scheltens P, Carrillo MC, Thies B, Weintraub S, Phelps CH. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011;7:263–269. doi: 10.1016/j.jalz.2011.03.005.
    1. Sperling RA, Aisen PS, Beckett LA, Bennett DA, Craft S, Fagan AM, Iwatsubo T, Jack CR, Kaye J, Montine TJ, Park DC, Reiman EM, Rowe CC, Siemers E, Stern Y, Yaffe K, Carrillo MC, Thies B, Morrison-Bogorad M, Wagster MV, Phelps CH. Toward defining the preclinical stages of Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011;7:280–292. doi: 10.1016/j.jalz.2011.03.003.
    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;12:189–198. doi: 10.1016/0022-3956(75)90026-6.
    1. Novak M, Guest C. Application of a multidimensional caregiver burden inventory. Gerontologist. 1989;29:798–803. doi: 10.1093/geront/29.6.798.
    1. Marvardi M, Mattioli P, Spazzafumo L, Mastriforti R, Rinaldi P, Polidori MC, Cherubini A, Quartesan R, Bartorelli L, Bonaiuto S, Cucinotta D, Di Iorio A, Gallucci M, Giordano M, Martorelli M, Masaraki G, Nieddu A, Pettenati C, Putzu P, Solfrizzi V, Tammaro AE, Tomassini PF, Vergani C, Senin U, Mecocci P. Study Group on Brain Aging, Italian Society of Gerontology and Geriatrics. The Caregiver Burden Inventory in evaluating the burden of caregivers of elderly demented patients: results from a multicenter study. Aging ClinExp Res. 2005;17:46–53.
    1. Gandek B, Ware JE. Methods for validating and norming translations of health status questionnaires: the IQOLA Project approach. International Quality of Life Assessment. J ClinEpidemiol. 1998;51:953–959.
    1. Kodraliu G, Mosconi P, Groth N, Carmosino G, Perilli A, Gianicolo EA, Rossi C, Apolone G. Subjective health status assessment: evaluation of the Italian version of the SF-12 Health Survey. Results from the MiOS Project. J EpidemiolBiostat. 2001;6:305–316.
    1. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta PsychiatrScand. 1983;67:361–370. doi: 10.1111/j.1600-0447.1983.tb09716.x.
    1. Costantini M, Musso M, Viterbori P, Bonci F, Del ML, Garrone O, Venturini M, Morasso G. Detecting psychological distress in cancer patients: validity of the Italian version of the Hospital Anxiety and Depression Scale. Support Care Cancer. 1999;7:121–127. doi: 10.1007/s005200050241.
    1. Reis M, Nahmiash D. When seniors are abused: an intervention model. Gerontologist. 1995;35:666–671. doi: 10.1093/geront/35.5.666.
    1. Case Management Society of America (CSMA) Standards of Practice for Case Management. Little Rock: CSMA, AR; 2010.
    1. Hirdes JP, Curtin-Telegdi N, Poss JW, Gray L, Berg KO, Stolee P, Costa AP. interRAI Contact Assessment (CA) Form and User's Manual, 9.2. InterRAI: Ann Arbor, MI; 2010.
    1. Zimet G, Dahlem N, Zimet S, Farley GK. The Multidimensional Scale of Perceived Social Support. J Pers Assess. 1988;52:30–41. doi: 10.1207/s15327752jpa5201_2.
    1. Yaffe K, Fox P, Newcomer R, Sands L, Lindquist K, Dane K, Covinsky KE. Patient and caregiver characteristics and nursing home placement in patients with dementia. JAMA. 2002;287:2090–2097. doi: 10.1001/jama.287.16.2090.
    1. Chiatti C, Di Rosa M, Melchiorre MG, Manzoli L, Rimland JM, Lamura G. Migrant care workers as protective factor against caregiver burden: results from a longitudinal analysis of the EUROFAMCARE study in Italy. Aging Ment Health. 2013. [Epub ahead of print]
    1. Pickard AS, Wang Z, Walton SM, Lee TA. Are decisions using cost-utility analyses robust to choice of SF-36/SF-12 preference-based algorithm? Health Qual Life Outcomes. 2005;3:11. doi: 10.1186/1477-7525-3-11.
    1. Comunicazione Del Ministro Fazio Alla Conferenza Stato-Regioni. Documento preliminare informative sui contenuti del nuovo Piano sanitario nazionale 2010-2012. 29 April 2010 [ ]
    1. FUTURAGE: A Road Map for Ageing Research.
    1. Stuck AE, Egger M, Hammer A, Minder CE, Beck JC. Home visits to prevent nursing home admission and functional decline in elderly people: systematic review and meta-regression analysis. JAMA. 2002;287:1022–1028. doi: 10.1001/jama.287.8.1022.

Source: PubMed

Szponzorok és közreműködők

Egészségi állapot

Kábítószer-beavatkozások

3
Iratkozz fel