Development of a Complex Intervention to Improve Adherence to Antidiabetic Medication in Older People Using an Anthropomorphic Virtual Assistant Software

Isa Brito Félix, Mara Pereira Guerreiro, Afonso Cavaco, Ana Paula Cláudio, Anabela Mendes, João Balsa, Maria Beatriz Carmo, Nuno Pimenta, Adriana Henriques, Isa Brito Félix, Mara Pereira Guerreiro, Afonso Cavaco, Ana Paula Cláudio, Anabela Mendes, João Balsa, Maria Beatriz Carmo, Nuno Pimenta, Adriana Henriques

Abstract

Introduction: Improving adherence to antidiabetic medication is crucial, resulting in improved health outcomes, cost reduction, and minimization of waste. A lack of underlying theory in existing interventions may explain the limited success in sustaining behavior change. This paper describes the development of a theory and evidence-based complex intervention to improve adherence to oral antidiabetics in older people via a software prototype with an anthropomorphic virtual assistant. Methods: The Behavior Change Wheel (BCW) was used to develop a theoretical understanding of the change process, corresponding to the first phase of the Medical Research Council Framework for developing and evaluating complex interventions. At the BCW core is a model of human behavior (COM-B), which posits that human behavior (B) results from the interaction between capabilities (C), opportunities (O), and motivation (M). Literature-derived medication adherence determinants were mapped onto COM-B components. Then, intervention functions (IFs) were selected employing the APEASE criteria. Finally, standardized behavior change techniques (BCTs) were chosen based on their suitability and their effectiveness on medication adherence trials. The prototype was developed for android devices; its core was implemented in Unity3D, using a female 3D virtual assistant, named Vitória. Results: Two COM-B components were identified as main targets for behavior change-psychological capability and reflective motivation; these were linked with four IFs-education, persuasion, enablement, and environmental restructuring. Eleven BCTs were, in turn, linked with the IFs. An example of a BCT is "problem solving"; it requires users to pinpoint factors influencing non-adherence and subsequently offers strategies to achieve the desired behavior. BCTs were operationalized into the dialogues with Vitória and into supplementary software features. Vitória communicates with users verbally and non-verbally, expressing emotions. Input options consist of buttons or recording values, such as medication taken. Conclusion: The present approach enabled us to derive the most appropriate BCTs for our intervention. The use of an explicit bundle of BCTs, often overlooked in interventions promoting medication adherence, is expected to maximize effectiveness and facilitates replication. The first prototype is being refined with users and health professionals' contributions. Future work includes subjecting the prototype to usability tests and a feasibility trial.

Keywords: behavior change wheel; complex intervention; intervention development; medication adherence; older adult; relational agent; type 2 diabetes; virtual assistant.

Figures

Figure 1
Figure 1
Medical Research Council framework (Craig et al., 2008).
Figure 2
Figure 2
Calendar depicting antidiabetics-taking for one oral antidiabetic, two daily doses; question mark means no self-reported data (“feedback on behavior”).
Figure 3
Figure 3
Chart to present blood glucose levels (“biofeedback”).
Figure 4
Figure 4
Virtual assistant collecting information on antidiabetics-taking (“self-monitoring of behavior”).
Figure 5
Figure 5
Virtual assistant listing factors that influence antidiabetics adherence (“problem-solving”).

References

    1. Allemann S. S., Nieuwlaat R., van den Bemt B. J., Hersberger K. E., Arnet I. (2016). Matching adherence interventions to patient determinants using the theoretical domains framework. Front. Pharmacol. 7, 429. 10.3389/fphar.2016.00429
    1. Anglada-Martinez H., Riu-Viladoms G., Martin-Conde M., Rovira-Illamola M., Sotoca-Momblona J. M., Codina-Jane C. (2015). Does MHealth Increase adherence to medication? Results of a systematic review. Int. J. Clin. Pract. 69 (1), 9–32. 10.1111/ijcp.12582
    1. Arnhold M., Quade M., Kirch W. (2014). Mobile applications for diabetics: a systematic review and expert-based usability evaluation considering the special requirements of diabetes patients age 50 years or older. J. Med. Internet Res. 16 (4), 1–185. 10.2196/jmir.2968
    1. Bickmore T. W., Caruso L., Clough-Gorr K. (2005. a). Acceptance and usability of a relational agent interface by urban older adults. CHI ’05 Extended Abstracts on Human Factors in Computing Systems - CHI ’05, 1212. 10.1145/1056808.1056879
    1. Bickmore T. W., Caruso L., Clough-Gorr K., Heeren T. (2005. b). ‘It’s just like you talk to a friend’ relational agents for older adults. Interact. Comput. 17 (6), 711–735. 10.1016/j.intcom.2005.09.002
    1. Bickmore T. W., Mitchell S. E., Jack B. W., Paasche-Orlow M. K., Pfeifer L. M., O’Donnell J. (2010). Response to a relational agent by hospital patients with depressive symptoms. Interact. Comput. 22 (4), 289–298. 10.1016/j.intcom.2009.12.001
    1. Bickmore T. W., Pfeifer L. M., Byron D., Forsythe S., Henault L. E., Jack B. W., et al. (2010). Usability of conversational agents by patients with inadequate health literacy: evidence from two clinical trials. J. Health Commun. 15 (S2), 197–210. 10.1080/10810730.2010.499991
    1. Bickmore T. W., Puskar K., Schlenk E. A., Pfeifer L. M., Sereika S. M. (2010). Maintaining reality: relational agents for antipsychotic medication adherence. Interact. Comput. 22, 276–288. 10.1016/j.intcom.2010.02.001
    1. Bleijenberg N., de Man-van Ginkel J. M., Trappenburg J. C. A., Ettema R. G. A., Sino C. G., Heim N., et al. (2018). Increasing value and reducing waste by optimizing the development of complex interventions: enriching the development phase of the Medical Research Council (MRC) framework. Int. J. Nurs. Stud. 79, 86–93. 10.1016/j.ijnurstu.2017.12.001
    1. Bogner H. R., Morales K. H., de Vries H. F., Cappola A. R. (2012). Integrated management of type 2 diabetes mellitus and depression treatment to improve medication adherence: a randomized controlled trial. Ann. Fam. Med. 10 (1), 15–22. 10.1370/afm.1344
    1. Cane J., O’Connor D., Michie S. (2012). Validation of the theoretical domains framework for use in behaviour change and implementation research. Implement. Sci. 7 (37), 1–17. 10.1186/1748-5908-7-37
    1. Cane J., Richardson M., Johnston M., Ladha R., Michie S. (2015). From lists of behaviour change techniques (BCTs) to structured hierarchies: comparison of two methods of developing a hierarchy of BCTs. Br. J. Health Psychol. 20 (1), 130–150. 10.1111/bjhp.12102
    1. Capoccia K., Odegard P. S., Letassy N. (2016). Medication adherence with diabetes medication: a systematic review of the literature. Diabetes Educ. 42 (1), 34–71. 10.1177/0145721715619038
    1. Choi Y. J., Smaldone A. M. (2018). Factors associated with medication engagement among older adults with diabetes: systematic review and meta-analysis. Diabetes Educ. 44 (1), 15–30. 10.1177/0145721717747880
    1. Cláudio A. P., Carmo M. B., Pinto V., Cavaco A., Guerreiro M. P., (2015). Virtual humans for training and assessment of self-medication consultation skills in pharmacy students, in 10th International Conference on Computer Science and Education, vol. no. ICCSE, Cambridge, UK: IEEE, 175–180. 10.1109/ICCSE.2015.7250238
    1. Craig P., Dieppe P., Macintyre S., Michie S., Nazareth I., Petticrew M. (2008). Developing and evaluating complex interventions: the new medical research council guidance. BMJ 337 (a1655), 979–983. 10.1136/bmj.a1655
    1. Dworkin M. S., Lee S., Chakraborty A., Monahan C., Hightow-Weidman L., Garofalo R., et al. (2019). Acceptability, feasibility, and preliminary efficacy of a theory-based relational embodied conversational agent mobile phone intervention to promote hiv medication adherence in young hiv-positive african american msm. AIDS Educ. Prev. 31 (1), 17–37. 10.1521/aeap.2019.31.1.17
    1. Gellad W. F., Grenard J. L., Marcum Z. A. (2011). A systematic review of barriers to medication adherence in the elderly: looking beyond cost and regimen complexity. Am. J. Geriatr. Pharmacother. 9 (1), 11–23. 10.1016/j.amjopharm.2011.02.004
    1. Gilbert B. J., Goodman E., Chadda A., Hatfield D., Forman D. E., Panch T. (2015). The role of mobile health in elderly populations. Curr. Geriatr. Rep. 4 (4), 347–352. 10.1007/s13670-015-0145-6
    1. Glasziou P., Altman D. G., Bossuyt P., Boutron I., Clarke M., Julious S., et al. (2014). Reducing waste from incomplete or unusable reports of biomedical research. The Lancet 383 (9913), 267–276. 10.1016/S0140-6736(13)62228-X
    1. Gonzalez J. S., Tanenbaum M. L., Commissariat P. V. (2016). Psychosocial factors in medication adherence and diabetes self-management: implications for research and practice. Am. Psychol. 71 (7), 539–551. 10.1037/a0040388
    1. Goyal S., Morita P., Lewis G. F., Yu C., Seto E., Cafazzo J. A. (2016). The systematic design of a behavioural mobile health application for the self-management of type 2 diabetes. Can. J. Diabetes 40 (1), 95–104. 10.1016/j.jcjd.2015.06.007
    1. Hoffmann T. C., Glasziou P. P., Boutron I., Milne R., Perera R., Moher D., et al. (2014). better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ (Online) 348, 1–12. 10.1136/bmj.g1687
    1. INE (2014). Sociedade Da Informação e Do Conhecimento - Inquérito à Utilização de Tecnologias Da Informação e Da Comunicação Pelas Famílias. Lisboa.
    1. International Diabetes Federation (2017). IDF Diabetes Atlas. 8th ed Brussels, Belgium: International Diabetes Federation.
    1. Iuga A. O., McGuire M. J. (2014). Adherence and health care costs. Risk Manag. Healthc. Policy 7, 35–44. 10.2147/RMHP.S19801
    1. Juste A. M., Gimeno Miguel A., Poblador Plou B., González Rubio F., Pascual-Salcedo M. M., Menditto E., et al. (2018). Adherence to treatment of hypertension, hypercholesterolaemia and diabetes in an elderly population of a spanish cohort. Medicina Clínica 29. 10.1016/j.medcli.2018.10.023
    1. Kahwati L., Viswanathan M., Golin C. E., Kane H., Lewis M., Jacobs S. (2016). Identifying configurations of behavior change techniques in effective medication adherence interventions: a qualitative comparative analysis. Syst. Rev. 5 (83), 1–9. 10.1186/s13643-016-0255-z
    1. Kardas P., Lewek P., Matyjaszczyk M. (2013). Determinants of patient adherence: a review of systematic reviews. Front. Pharmacol. 4, 1–16. 10.3389/fphar.2013.00091
    1. Karve S., Cleves M. A., Helm M., Hudson T. J., West D. S., Martin B. C. (2009). Good and poor adherence: optimal cut-point for adherence measures using administrative claims data. Curr. Med. Res. Opin. 25 (9), 2303–2310. 10.1185/03007990903126833
    1. Kim B. Y. B., Lee J. (2017). Smart devices for older adults managing chronic disease: a scoping review. JMIR Mhealth Uhealth 5 (5), e69. 10.2196/mhealth.7141
    1. Krass I., Schieback P., Dhippayom T. (2015). Adherence to diabetes medication: a systematic review. Diabet. Med. 32, 725–737. 10.1111/dme.12651
    1. Kreuter M., Farrell D., Olevitch L., Brennan L., (2000). Tailoring Health Messages: Customizing Communication with Computer Technology. Mahwah New Jersey: Lawrence Erlbaum Associates; .
    1. Lustria M. L. A., Noar S. M., Cortese J., Van Stee S. K., Glueckauf R. L., Lee J. (2013). A meta-analysis of web-delivered tailored health behavior change interventions. J. Health Commun. 18 (9), 1039–1069. 10.1080/10810730.2013.768727
    1. Marcum Z. A., Hanlon J. T., Murray M. D. (2017). Improving medication adherence and health outcomes in older adults: an evidence-based review of randomized controlled trials. Drugs Aging 34 (3), 191–201. 10.1007/s40266-016-0433-7
    1. Martins A. I., Rosa A. F., Queirós A., Silva A., Rocha N. P. (2015). European Portuguese Validation of the System Usability Scale (SUS). Procedia Comput. Sci. 67 (Dsai), 293–300. 10.1016/j.procs.2015.09.273
    1. Mazzotta I., Novielli N., De Carolis B., (2009). “Are ECAs more persuasive than textual messages?,” in Lecture Notes in Computer Science, vol. 5773 Eds. Ruttkay Z., Kipp M., Nijholt A., Vilhjálmsson H. H. (Berlin, Heidelberg: Springer; ), 527–528. 10.1007/978-3-642-04380-2_75
    1. Menditto E., Cahir C., Aza-Pascual-Salcedo M., Bruzzese D., Poblador-Plou B., Malo S., et al. (2018). Adherence to chronic medication in older populations: application of a common protocol among three european cohorts. Patient Prefer. Adherence 12, 1975–1978. 10.2147/PPA.S164819
    1. Michie S., Atkins L., West R. (2014). The Behavior Change Wheel: A Guide To Designing Interventions. First edit London: Silverback Publishing.
    1. Michie S., Johnston M., Francis J., Hardeman W., Eccles M. (2008). From theory to intervention: mapping theoretically derived behavioural determinants to behaviour change techniques. App. Psychol. 57 (4), 660–680. 10.1111/j.1464-0597.2008.00341.x
    1. Michie S., Richardson M., Johnston M., Abraham C., Francis J., Hardeman W., et al. (2013). The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann. Behav. Med. 46, 81–95. 10.1007/s12160-013-9486-6
    1. Michie S., van Stralen M., West R. (2011). The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement. Sci. 6 (42), 1–11. 10.1186/1748-5908-6-42
    1. Migneault J. P., Farzanfar R., Wright J. A., Friedman R. H. (2006). How to write health dialog for a talking computer. J. Biomed. Inform. 39, 468–481. 10.1016/j.jbi.2006.02.009
    1. Monkaresi H., Calvo R. A., Pardo A., Chow K., Mullan B., Lam M., et al. (2013). “Intelligent diabetes lifestyle coach,” in Fifth International Workshop on Smart Healthcare and Wellness Applications (SmartHealth’13), Adelaide, Australia: OzCHI, 1–4.
    1. Morrissey E. C., Corbett T. K., Walsh J. C., Molloy G. J. (2016). Behavior change techniques in apps for medication adherence: a content analysis. Am. J. Prev. Med. 50 (5), e143–e146. 10.1016/j.amepre.2015.09.034
    1. Mota-Pinto A., Rodrigues V., Botelho A., Veríssimo M. T., Morais A., Alves C., et al. (2010). A socio-demographic study of aging in the portuguese population: The EPEPP Study. Arch. Gerontol. Geriatr. 52 (3), 304–308. 10.1016/j.archger.2010.04.019
    1. Niess J., Diefenbach S. (2016). Communication styles of interactive tools for self-improvement. Psychol. Well Being 6 (1), 3. 10.1186/s13612-016-0040-8
    1. Nieuwlaat R., Wilczynski N., Navarro T., Hobson N., Jeffery R., Keepanasseril A., et al. (2014). Interventions for enhancingmedication adherence (review). Cochrane Database Syst. Rev. 11, 1–730. 10.1002/14651858.CD000011.pub4
    1. op den Akker R., Klaassen R., Nijholt A. (2016). “Virtual Coaches for Healthy Lifestyle,” in Toward Robotic Socially Believable Behaving Systems - Volume II. Modeling Social Signals, vol. 106 Eds. Esposito A. L., Jain C. (Switzerland: Springer International Publishing; ). 10.1016/j.neulet.2006.07.043
    1. op den Akker R., Klaassen R., Lavrysen T., Geleijnse G., van Halteren A., Schwietert H., et al. (2011). “A Personal Context-Aware Multi-Device Coaching Service That Supports a Healthy Lifestyle,” in BCS-HCI’11 Proceedings of the 25th BCS Conference on Human-Computer Interaction, Swinton, UK: British Computer Society, 443–448.
    1. Paiva D., Silva S., Severo M., Moura-Ferreira P., Lunet N., Azevedo A. (2017). Limited health literacy in portugal assessed with the newest vital sign prevalência de literacia em saúde inadequada em portugal medida com o newest vital sign. Acta Med. Port. 30 (12), 861–869. 10.20344/amp.9135
    1. Patton D. E., Hughes C. M., Cadogan C. A., Ryan C. A. (2017). Theory-based interventions to improve medication adherence in older adults prescribed polypharmacy: a systematic review. Drugs Aging 34 (2), 97–113. 10.1007/s40266-016-0426-6
    1. Pinto D. M., Santiago L. M., Maurício K., Silva I. R. (2019). Health profile and medication adherence of diabetic patients in the portuguese population. Prim. Care Diabetes 10.1016/j.pcd.2019.02.004
    1. Polonsky W. H., Henry R. R. (2016). Poor medication adherence in type 2 diabetes: recognizing the scope of the problem and its key contributors. Patient Prefer. Adherence 10, 1299–1307. 10.2147/PPA.S106821
    1. Powers M. A., Bardsley J., Cypress M., Duker P., Funnell M. M., Fischl A. H., et al. (2015). Diabetes self-management education and support in type 2 diabetes: a joint position statement of the american diabetes association, the american association of diabetes educators, and the academy of nutrition and dietetics. J. Acad. Nutr. Diet. 115 (8), 1323–1334. 10.2337/diaclin.34.2.70
    1. Presseau J., Ivers N. M., Newham J. J., Knittle K., Danko K. J., Grimshaw J. M. (2015). Using a behaviour change techniques taxonomy to identify active ingredients within trials of implementation interventions for diabetes care. Implement. Sci. 10 (55), 1–10. 10.1186/s13012-015-0248-7
    1. Proctor E. K., Powell B. J., McMillen J. C. (2013). Implementation strategies: recommendations for specifying and reporting. Implement. Sci. 8 (139), 1–11. 10.1186/1748-5908-8-139
    1. Ring L., Utami D., Bickmore T. (2014). The right agent for the job? The effects of agent visual appearance on task domain, in Lecture Notes in Computer Science, vol. 8637 Eds Bickmore T., Marsella S., Sidner C. (Switzerland: Springer, Cham; ), 374–384. 10.1007/978-3-319-09767-1_49
    1. Sabaté E. (2003). Adherence to Long-Term Therapies. Switzerland: World Health Organization. 10.1016/S1474-5151(03)00091-4
    1. Sapkota S., Brien J. A. E., Greenfield J. R., Aslani P. (2015). A systematic review of interventions addressing adherence to anti-diabetic medications in patients with type 2 diabetes - components of interventions. PLoS ONE 10 (2), 1–17. 10.1371/journal.pone.0128626
    1. Sweet S. N., Fortier M. S. (2010). Improving physical activity and dietary behaviours with single or multiple health behaviour interventions? A synthesis of meta-analyses and reviews. Int. J. Environ. Res. Public Health 7 (4), 1720–1743. 10.3390/ijerph7041720
    1. van Wissen A., Vinkers C., van Halteren A. (2016). “Developing a Virtual coach for chronic patients: a user study on the impact of similarity, familiarity and realism,” in Persuasive Technology. Eds. Meschtscherjakov A., De Ruyter B., Fuchsberger V., Murer M., Tscheligi M. (Cham: Springer International Publishing; ), 263–275. 10.1007/978-3-319-31510-2_23
    1. Velicer W., Redding C., Blissmer B., Babbin S., Paiva A., Bickmore T., et al. (2015). Using relational agents to increase engagement in computer-based interventions: preliminary outcomes. Eur. Health Psychol. 17 (S), 451.
    1. Vervloet M., Linn A. J., van Weert J. C. M., de Bakker D. H., Bouvy M. L., van Dijk L. (2012). The effectiveness of interventions using electronic reminders to improve adherence to chronic medication: a systematic review of the literature. J. Am. Med. Inform. Assoc. 19 (5), 696–704. 10.1136/amiajnl-2011-000748
    1. Vrijens B., De Geest S., Hughes D. A., Przemyslaw K., Demonceau J., Ruppar T., et al. (2012). A new taxonomy for describing and defining adherence to medications. Br. J. Clin. Pharmacol. 73 (5), 691–705. 10.1111/j.1365-2125.2012.04167.x
    1. Walker E. A., Shmukler C., Ullman R., Blanco E., Scollan-Koliopoulus M., Cohen H. W. (2011). Results of a successful telephonic intervention to improve diabetes control in urban adults. Diabetes Care 34 (1), 2–7. 10.2337/dc10-1005
    1. Webb T. L., Joseph J., Yardley L., Michie S. (2010). Using the internet to promote health behavior change: a systematic review and meta-analysis of the impact of theoretical basis, use of behavior change techniques, and mode of delivery on efficacy. J. Med. Internet Res. 12 (1), 1–18. 10.2196/jmir.1376
    1. Wells M., Williams B., Treweek S., Coyle J., Taylor J. (2012). Intervention description is not enough: evidence from an in-depth multiple case study on the untold role and impact of context in randomised controlled trials of seven complex interventions. Trials 13 (1), 1. 10.1186/1745-6215-13-95
    1. Williams J. L. S., Walker R. J., Smalls B. L., Campbell J. A., Egede L. E. (2014). Effective interventions to improve medication adherence in type 2 diabetes: a systematic review. Diabetes Manag. 4 (1), 29–48. 10.2217/dmt.13.62
    1. Yap A. F., Thirumoorthy T., Kwan Y. H. (2016). Systematic review of the barriers affecting medication adherence in older adults. Geriatr. Gerontol. Int. 16, 1093–1101. 10.1111/ggi.12616
    1. Zeber J. E., Manias E., Williams A. F., Hutchins D., Udezi W. A., Roberts C. S., et al. (2013). A systematic literature review of psychosocial and behavioral factors associated with initial medication adherence: a report of the ispor medication adherence & persistence special interest group. Value Health 16, 891–900. 10.1016/j.jval.2013.04.014
    1. Zheng Y., Ley S. H., Hu F. B. (2018). Global aetiology and epidemiology of type 2 diabetes mellitus and its complications. Nat. Rev. Endocrinol. 14 (2), 88–98. 10.1038/nrendo.2017.151

Source: PubMed

3
Subscribe