Preventing frailty with the support of a home-monitoring and communication platform among older adults-a study protocol for a randomised-controlled pilot study in Sweden

Minna Teriö, Rodrigo Pérez-Rodríguez, Tania Guevara Guevara, Myriam Valdes-Aragonés, Maksims Kornevs, Sanna Bjälevik-Chronan, Marina Taloyan, Sebastiaan Meijer, Susanne Guidetti, Minna Teriö, Rodrigo Pérez-Rodríguez, Tania Guevara Guevara, Myriam Valdes-Aragonés, Maksims Kornevs, Sanna Bjälevik-Chronan, Marina Taloyan, Sebastiaan Meijer, Susanne Guidetti

Abstract

Background: POSITIVE (i.e. maintaining and imPrOving the intrinSIc capaciTy Involving primary care and caregiVErs) is a new intervention program consisting of home-monitoring equipment and a communication platform to support treatment of frailty symptoms initially in primary care and prevent disability in older adults.

Methods: The primary objectives are to estimate the potential efficacy of the POSITIVE system on improving frailty in at least one point in Fried's criteria and five points in Frailty Trait Scale. The secondary objectives are to (A) assess the recruitment, retention, drop-out rates, compliance with the intervention and the intervention mechanisms of impact; (B) evaluate the usability and acceptance of the POSITIVE system, and to get estimations on; (C) the potential efficacy of the intervention on improving the participants' physical performance, cognitive functions, mood, independency level in activities in daily living, the impact on quality of life and number of falls during the follow-up period; (D) the impact on the caregiver quality of life and caregiver burden; and (E) on the consumption of health care resources, participants' perception of health and level of care received, and healthcare professionals' workload and satisfaction. A randomised controlled, assessor-blinded pilot study design recruiting from a primary care centre in Stockholm Region will be conducted. Fifty older adults identified as pre-frail or frail will be randomised into a control or an intervention group. Both groups will receive a medical review, nutritional recommendations and Vivifrail physical exercise program. The intervention group will receive the POSITIVE-system including a tablet, the POSITIVE application and portable measurement devices. The participants receiving the POSITIVE program will be monitored remotely by a primary care nurse during a 6-month follow-up. Data will be collected at baseline, 3 and 6 months into the intervention though the platform, standardised assessments and surveys. A process evaluation as per Medical Research Council guidance will be conducted after the 6-month follow-up period.

Discussion: The implications of the study are to provide estimations on the potential efficacy of the POSITIVE system in improving frailty among older adults and to provide relevant data to inform powered studies of potential efficacy and effectiveness, as well as to inform about the feasibility of the current study design.

Trial registration: ClinicalTrials.gov.

Registration number: NCT04592146 . October 19, 2020.

Keywords: Disability; Fragility; Frailty; Healthcare; ICT; Information and Communication Technology; Monitoring; Prevention; eHealth.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
POSITIVE pilot study CONSORT-style flowchart
Fig. 2
Fig. 2
Schedule for enrolment, interventions and assessments. t-1, before allocation; t0, allocated; t1, baseline; t2, week 2; t3, week 12; t4, week 24; t5, post-follow-up. MNA-S, Mini Nutritional Assessment Short Version; SPPB, Short Physical Performance Battery; Whodas, World Health Organization Disability Assessment Schedule; MoCA, Montreal Cognitive Assessment; GDS-S, Geriatric Depression Scale Swedish Version; EQ-5D-5L, EuroQol- 5D-5L; HCRS, Health Care resources consumption; QSOM, Questionnaire on the Organisational Model; Acceptability questionnaires, Acceptability QS; SUS, System Usability Scale; UEQS, User Experience Questionnaire
Fig. 3
Fig. 3
The POSITIVE system and its different components and users
Fig. 4
Fig. 4
The POSITIVE mobile measurement devices

References

    1. World Health Organization . World report on ageing and health. 2015. pp. 1–260.
    1. Chen CY, Gan P, How CH. Approach to frailty in the elderly in primary care and the community. Singapore Med J. 2018 ;59(5):240–5. 10.11622/smedj.2018052. Erratum in: Singapore Med J. 2018 Jun;59(6):338. PMID: 29799055; PMCID: PMC5966632.
    1. Documento de consenso sobre prevención de fragilidad y caídas en la persona mayor Estrategia de Promoción de la Salud y Prevención en el SNS [Internet]. 2014. Available from:
    1. Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, et al. Frailty in older adults: evidence for a phenotype. J Geronterol. 2001;56A(3):M146–M157. doi: 10.1093/gerona/56.3.M146.
    1. García-García FJ, Carcaillon L, Fernandez-Tresguerres J, Alfaro A, Larrion JL, Castillo C, et al. A new operational definition of frailty: the Frailty Trait Scale. J Am Med Dir Assoc. 2014;15(5):371–3e7. doi: 10.1016/j.jamda.2014.01.004.
    1. ADVANTAGE JA. A frailty prevention approach part I. Core document. 2018; [Internet ] Available at: [Accessed 20 Jan 2021].
    1. Dedeyne L, Deschodt M, Verschueren S, Tournoy J, Gielen E. Effects of multi-domain interventions in (pre) frail elderly on frailty, functional, and cognitive status: a systematic review. Clin Interv Aging. 2017;12:873–896. doi: 10.2147/CIA.S130794.
    1. Silva RB, Aldoradin-Cabeza H, Eslick GD, Phu S, Duque G. The effect of physical exercise on frail older persons: a systematic review. J Frailty Aging. 2017;6(2):91–96.
    1. Apóstolo J, Cooke R, Bobrowicz-Campos E, Santana S, Marcucci M, Cano A, et al. Effectiveness of interventions to prevent pre-frailty and frailty progression in older adults: a systematic review. JBI Database System Rev Implement Rep. 2018;16(1):140–232. doi: 10.11124/JBISRIR-2017-003382.
    1. Yannakoulia M, Ntanasi E, Anastasiou CA, Scarmeas N. Frailty and nutrition: from epidemiological and clinical evidence to potential mechanisms. Metabolism. 2017;68:64–76. Available from. 10.1016/j.metabol.2016.12.005.
    1. Cruz-Jentoft AJ, Kiesswetter E, Drey M, Sieber CC. Nutrition, frailty, and sarcopenia. Aging Clin Exp Res. 2017;29(1):43–48. doi: 10.1007/s40520-016-0709-0.
    1. Caballero Mora MÁ, Rodriguez Mañas L. the concept of frailty and functional decline. In: Roller-wirnsberger R, Singler K, Polidori M, editors. Learning geriatric medicine. Practical issues in geriatrics. cham: Springer; 2018.
    1. Herr M, Sirven N, Grondin H, Pichetti S, Sermet C. Frailty, polypharmacy, and potentially inappropriate medications in old people: findings in a representative sample of the French population. Eur J Clin Pharmacol. 2017;73(9):1165–72. 10.1007/s00228-017-2276-5. Epub 2017 Jun 11. PMID: 28601963.
    1. Bashi N, Karunanithi M, Fatehi F, Ding H, Walters D. Remote monitoring of patients with heart failure: an overview of systematic reviews. J Med Internet Res. 2017;19(1):e18. doi: 10.2196/jmir.6571.
    1. Sirintrapun S, Lopez A. Telemedicine in cancer care. Am Soc Clin Oncol Educ Book. 2018;38:540–545. doi: 10.1200/EDBK_200141.
    1. Vegesna A, Tran M, Angelaccio M, Arcona S. Remote patient monitoring via non-invasive digital technologies: a systematic review. Telemed e-Health. 2017;23(1):3–17. doi: 10.1089/tmj.2016.0051.
    1. Gallucci A, Trimarchi P, Abbate C, Tuena C, Pedroli E, Lattanzio F, et al. ICT technologies as new promising tools for the managing of frailty: a systematic review. Aging Clin Exp Res. 2020;33(6):1453–1464. doi: 10.1007/s40520-020-01626-9.
    1. Vollenbroek-Hutten M, Jansen-Kosterink S, Tabak M, Feletti LC, Zia G, N'dja A, et al. SPRINTT Consortium. Possibilities of ICT-supported services in the clinical management of older adults. Aging Clin Exp Res. 2017;29(1):49–57. doi: 10.1007/s40520-016-0711-6.
    1. World Health Organization Regional Office For Europe . Strategy and action plan for healthy ageing in Europe, 2012–2020 [Internet] Copenhagen: WHO; 2012.
    1. Lettermark Y. Långtidsutredningen Hälso- och sjukvården 2040. Region Stockholm. 2020; Available from: .
    1. Pérez-Rodríguez R, Guevara-Guevara T, Moreno-Sánchez PA, Villalba-Mora E, Valdés-Aragonés M, et al. Monitoring and intervention technologies to manage diabetic older persons: the CAPACITY case—a pilot study. Front. Endocrinol. 2020;11:300. doi: 10.3389/fendo.2020.00300.
    1. Izquierdo M. Multicomponent physical exercise program: Vivifrail. Nutr Hospital. 2019;36(Spec No2):50–56. doi: 10.20960/nh.02680.
    1. Izquierdo M, Rodriguez-Mañas L, Sinclair AJ. Editorial: what is new in exercise regimes for frail older people - how does the Erasmus Vivifrail project take us forward? J Nutr Health Aging. 2016;20(7):736–737. doi: 10.1007/s12603-016-0702-5.
    1. Ángel B-R, García-Conesa S, Pallarés JG, Courel-Ibáñez J. Efectos de 4 semanas del programa de entrenamiento multicomponente (Vivifrail) en la fragilidad y capacidad funcional en adultos mayores que viven en una residencia de ancianos. CPD. 20(3):74–81 Available from: . 22 de julio de 2020 [citado 20 de enero de 2021].
    1. Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–207. doi: 10.7326/0003-4819-158-3-201302050-00583.
    1. Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, et al. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015;350:h1258. doi: 10.1136/bmj.h1258.
    1. Det svenska sjukvårdssystemet - stöd och information om kliniska studier [Internet]. . 2020 [cited 21 December 2020]. Available from:
    1. Brennan DM, Mawson S, Brownsell S. Telerehabilitation: enabling the remote delivery of healthcare, rehabilitation, and self-management. Stud Health Technol Inform. 2009;145:231–248. doi: 10.3233/978-1-60750-018-6-231.
    1. Billingham SA, Whitehead AL, Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database. BMC Med Res Methodol. 2013;13:104. doi: 10.1186/1471-2288-13-104.
    1. Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, et al. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010;10:1. doi: 10.1186/1471-2288-10-1.
    1. Collin C, Wade DT, Davies S, Horne V. The barthel ADL index: a reliability study. Disabil Rehabil. 1988;10(2):61–3. doi: 10.3109/09638288809164103.
    1. Gill TM, Gahbauer EA, Allore HG, Han L. Transitions between frailty states among community-living older persons. Arch Intern Med. 2006;166(4):418–23. 10.1001/archinte.166.4.418. PMID: 16505261.
    1. Trevisan C, Veronese N, Maggi S, Baggio G, Toffanello ED, Zambon S, et al. Factors influencing transitions between frailty states in elderly adults: the Progetto Veneto Anziani longitudinal study. J Am Geriatr Soc. 2017;65(1):179–184. doi: 10.1111/jgs.14515.
    1. Izquierdo M, Casas-Herrero A, Zambom-Ferraresi F, Martínez-Velilla N, Alonso-Bouzón C, Rodríguez-Mañas L. VIVIFRAIL multi-component physical training prescription guide. . 2021 [cited 20 January 2021]. Available from:
    1. Voigt P, von dem Bussche A. The EU General Data Protection Regulation (GDPR) a practical guide [Internet]. 1st ed. Springer Cham; 2017 [cited 21 June 2022]. Available from: 10.1007/978-3-319-57959-7
    1. Freiberger E, Devreede P, Schoene D, Rydwik E, Mueller V, Frändin K, et al. Performance-based physical function in older community-dwelling persons: a systematic review of instruments. Age Ageing. 2012;41(6):712–721. doi: 10.1093/ageing/afs099.
    1. Graham JE, Ostir GV, Kuo YF, Fisher SR, Ottenbacher KJ. Relationship between test methodology and mean velocity in timed walk tests: a review. Arch Phys Med Rehabil. 2008;89(5):865–872. doi: 10.1016/j.apmr.2007.11.029.
    1. Savva GM, Donoghue OA, Horgan F, O’Regan C, Cronin H, Kenny RA. Using timed up-and-go to identify frail members of the older population. J Gerontol Ser A Biol Sci Med Sci. 2013;68(4):441–446. doi: 10.1093/gerona/gls190.
    1. Wallace M, Shelkey M. Hartford Institute for Geriatric Nursing. Katz Index of Independence in Activities of Daily Living (ADL) Urol Nurs. 2007;27(1):93–94.
    1. Vergara I, Bilbao A, Orive M, Garcia-Gutierrez S, Navarro G, Quintana JM. Validation of the Spanish version of the Lawton IADL Scale for its application in elderly people. Health Qual Life Outcomes. 2012;10:130. 10.1186/1477-7525-10-130. PMID: 23110491; PMCID: PMC3541128.
    1. WHO Disability Assessment Schedule (WHODAS 2.0) [Internet]. . 2010 [cited 20 January 2021]. Available from:
    1. Nasreddine ZS, Phillips NA, Bédirian V, Charbonneau S, Whitehead V, Collin I, et al. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005;53(4):695–9. 10.1111/j.1532-5415.2005.53221.x. Erratum in: J Am Geriatr Soc. 2019 Sep;67(9):1991. PMID: 15817019.
    1. Shulman KI. Clock drawing: is it the ideal cognitive screening test? Int J Geriatr Psychiatry. 2000;15(March):548–561. doi: 10.1002/1099-1166(200006)15:6<548::AID-GPS242>;2-U.
    1. Gottfries GG, Noltorp S, Nørgaard N. Experience with a Swedish version of the Geriatric Depression Scale in primary care centres. Int J Geriatr Psychiatry. 1997;12(10):1029–34. 10.1002/(sici)1099-1166(199710)12:10<1029::aid-gps683>;2-D. PMID: 9395935.
    1. Lilamand M, Kelaiditi E, Cesari M, Raynaud-Simon A, Ghisolfi A, Guyonnet S, Vellas B, van Kan GA, Toulouse Frailty Platform Team Validation of the mini nutritional assessment-short form in a population of frail elders without disability. Analysis of the Toulouse Frailty Platform Population in 2013. J Nutr Health Aging. 2015;19(5):570–574. doi: 10.1007/s12603-015-0457-4.
    1. Group TE EuroQol - a new facility for the measurement of health-related quality of life. Health Policy (New York). 1990;16(3):199–208. doi: 10.1016/0168-8510(90)90421-9.
    1. ICHOM | Healthcare improvement | patient-reported outcomes [Internet]. ICHOM – International Consortium for Health Outcomes Measurement. 2020 [cited 2 October 2020]. Available from:
    1. Brooke J. SUS - a quick and dirty usability scale. Usability Eval Ind. 1996;189(194):4–7.
    1. Pandey RN, Halder SK, Rath PK. Development and Validation of “Caregiver Burden Scale-Indian Population”. Int J Prev Med. 2019;10:31. doi: 10.4103/ijpvm.IJPVM_500_17.
    1. TLX @ NASA Ames - NASA TLX Paper/Pencil Version [Internet]. . 2020 [cited 2 October 2020]. Available from:
    1. Graneheim U, Lundman B. Qualitative content analysis in nursing research: concepts, procedures and measures to achieve trustworthiness. Nurse Educ Today. 2004;24(2):105–112. doi: 10.1016/j.nedt.2003.10.001.

Source: PubMed

スポンサーと協力者

医学的状態

薬物療法

3
購読する