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Research Article

Educational Interventions on Diabetic Foot Self-Care: A Study Protocol for a Pragmatic Randomized Controlled Trial

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References

  • Abrar, E. A., Yusuf, S., Sjattar, E. L., & Rachmawaty, R. (2020). Development and evaluation educational videos of diabetic foot care in traditional languages to enhance knowledge of patients diagnosed with diabetes and risk for diabetic foot ulcers. Primary Care Diabetes, 14(2), 104–110. https://doi.org/10.1016/j.pcd.2019.06.005
  • Abu Abed, M., Himmel, W., Vormfelde, S., & Koschack, J. (2014). Video-assisted patient education to modify behavior: A systematic review. Patient Education & Counseling, 97(1), 16–22. https://doi.org/10.1016/j.pec.2014.06.015
  • Al-Kaabi, J. M., Al Maskari, F., Cragg, P., Afandi, B., & Souid, A.-K. (2015). Illiteracy and diabetic foot complications. Primary Care Diabetes, 9(6), 465–472. https://doi.org/10.1016/j.pcd.2015.04.008
  • American Diabetes Association [ADA]. (2021). 2. Classification and diagnosis of diabetes: Standards of medical care in diabetes—2021. Diabetes Care, 44(Supplement 1), S15–33. https://doi.org/10.2337/dc21-S002
  • American Family Physician. (2000). Patient education. American academy of family physicians. American Family Physician, 62(7), 1712–1714. https://www.aafp.org/pubs/afp/issues/2000/1001/p1712.html
  • Anilvince, V., & Rao, P. N. S. (2015). A study to assess the impact of foot care instruction on diabetic foot practices in a selected community. International Journal of Scientific & Research Publications, 5(8), 1–6. https://www.ijsrp.org/research-paper-0815/ijsrp-p4462.pdf
  • Bandura, A. (1973). Aggression: A social learning analysis. Prentice-Hall.
  • Bandura, A. (1978). Self-efficacy: Toward a unifying theory of behavioral change. Advances in Behaviour Research and Therapy, 1(4), 139–161. https://doi.org/10.1016/0146-6402(78)90002-4
  • Bandura, A., & Menlove, F. L. (1968). Factors determining vicarious extinction of avoidance behavior through symbolic modeling. Journal of Personality & Social Psychology, 8(2), 99–108. https://doi.org/10.1037/h0025260
  • Bandura, A., & Mischel, W. (1965). Modifications of self-imposed delay of reward through exposure to live and symbolic models. Journal of Personality & Social Psychology, 2(5), 698–705. https://doi.org/10.1037/h0022655
  • Bandura, A., Ross, D., & Ross, S. A. (1963a). Imitation of film-mediated aggressive models. Journal of Abnormal & Social Psychology, 66(1), 3–11. https://doi.org/10.1037/h0048687
  • Bandura, A., Ross, D., & Ross, S. A. (1963b). Vicarious reinforcement and imitative learning. Journal of Abnormal & Social Psychology, 67(6), 601–607. https://doi.org/10.1037/h0045550
  • Bastos, F., Severo, M., & Lopes, C. (2007). Propriedades psicométricas da Escala de Autocuidado com a Diabetes traduzida e adaptada [Psychometric analysis of Diabetes Self-care Scale (Trans. and adapted to Portuguese)]. Acta Médica Portuguesa, 20(1), 11–20. https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/836/512
  • Bell, R. A., Arcury, T. A., Snively, B. M., Smith, S. L., Stafford, J. M., Dohanish, R., & Quandt, S. A. (2005). Diabetes foot self-care practices in a rural, tri ethnic population. The Diabetes Educator, 31(1), 75–83. https://doi.org/10.1177/0145721704272859
  • Bennett, P., Patterson, C., Wearing, S., & Baglioni, T. (1998). Development and validation of a questionnaire designed to measure foot-health status. Journal of the American Podiatric Medical Association, 88(9), 419–428. https://doi.org/10.7547/87507315-88-9-419
  • Berkman, N. D., Sheridan, S. L., Donahue, K. E., Halpern, D. J., & Crotty, K. (2011). Low health literacy and health outcomes: An updated systematic review. Annals of Internal Medicine, 155(2), 97–107. https://doi.org/10.7326/0003-4819-155-2-201107190-00005
  • Bonner, T., Foster, M., & Spears Lanoix, E. (2016). Type 2 diabetes–related foot care knowledge and foot self-care practice interventions in the United States: A systematic review of the literature. Diabetic Foot & Ankle, 7(1), 29758. https://doi.org/10.3402/dfa.v7.29758
  • Boutron, I., Altman, D. G., Moher, D., Schulz, K. F., Ravaud, P., & for the CONSORT NPT Group. (2017). Consort statement for randomized trials of nonpharmacologic treatments: A 2017 update and a consort extension for nonpharmacologic trial abstracts. Annals of Internal Medicine, 167(1), 40–47. https://doi.org/10.7326/M17-0046
  • Boyko, E. J., & Monteiro-Soares, M. (2020). Epidemiology and economic impact of foot ulcers. In A. J. Boulton, G. Rayman & D. Wukich (Eds.), The foot in diabetes (5th ed., pp. 1–16). John Wiley & Sons Ltd.
  • Brown, C. L., & Venetis, M. K. (2022). Communicative pathways predicting adherence in type II diabetic patients: A mediation analysis. Health Communication, 1–18. https://doi.org/10.1080/10410236.2022.2131980
  • Burke, J. A., Earley, M., Dixon, L. D., Wilke, A., & Puczynski, S. (2006). Patients with diabetes speak: Exploring the implications of patients’ perspectives for their diabetes appointments. Health Communication, 19(2), 103–114. https://doi.org/10.1207/s15327027hc1902_2
  • Bus, S. A., & Van Netten, J. J. (2016). A shift in priority in diabetic foot care and research: 75% of foot ulcers are preventable. Diabetes/Metabolism Research and Reviews, 32(Supplement 1), 195–200. https://doi.org/10.1002/dmrr.2738
  • Carrard, V., Schmid Mast, M., & Cousin, G. (2016). Beyond “one size fits all”: Physician nonverbal adaptability to patients’ need for paternalism and its positive consultation outcomes. Health Communication, 31(11), 1327–1333. https://doi.org/10.1080/10410236.2015.1052871
  • Chan, A.-W., Tetzlaff, J. M., Gotzsche, P. C., Altman, D. G., Mann, H., Berlin, J. A., Dickersin, K., Hrobjartsson, A., Schulz, K. F., Parulekar, W. R., Krleza-Jeric, K., Laupacis, A., & Moher, D. (2013). SPIRIT 2013 explanation and elaboration: Guidance for protocols of clinical trials. The BMJ, 346, e7586. https://doi.org/10.1136/bmj.e7586
  • Claros Gómez, I. D., & Cobos Pérez, R. (2015). Del vídeo educativo a objetos de aprendizaje multimedia interactivos: Un entorno de aprendizaje colaborativo basado en redes sociales. Tendencias Pedagógicas, 22, 59–72. https://revistas.uam.es/tendenciaspedagogicas/article/view/2042
  • Coffey, L., Mahon, C., & Gallagher, P. (2019). Perceptions and experiences of diabetic foot ulceration and foot care in people with diabetes: A qualitative meta‐synthesis. International Wound Journal, 16(1), 183–210. https://doi.org/10.1111/iwj.13010
  • Dantas, M. J. (2018). Pé di@bético: Soluções para um grande problema [Diabetic Foot: Solutions for a big problem] (1st ed.). Bial.
  • Epstein, R. M. (2000). The science of patient-centered care. The Journal of Family Practice, 49(9), 805–807.
  • Epstein, R. M., & Street, R. L. (2007). Patient-centered communication in cancer care: Promoting healing and reducing suffering. National Cancer Institute. http://outcomes.cancer.gov/areas/pcc/communication
  • Fan, L., Sidani, S., Cooper-Brathwaite, A., & Metcalfe, K. (2014). Improving foot self-care knowledge, self-efficacy, and behaviors in patients with type 2 diabetes at low risk for foot ulceration: A pilot study. Clinical Nursing Research, 23(6), 627–643. https://doi.org/10.1177/1054773813491282
  • Figueiras, M., Marcelino, D. S., Claudino, A., Cortes, M. A., Maroco, J., & Weinman, J. (2010). Patients’ illness schemata of hypertension: The role of beliefs for the choice of treatment. Psychology & Health, 25(4), 507–517. https://doi.org/10.1080/08870440802578961
  • Gardner, L., & Leshner, G. (2016). The role of narrative and other-referencing in attenuating psychological reactance to diabetes self-care messages. Health Communication, 31(6), 738–751. https://doi.org/10.1080/10410236.2014.993498
  • GISEF, Grupo de Investigação em Saúde & Família [Health & Family Research Group]. (2020a) . Foot health status questionnaire: Portuguese research version. School of Psychology, University of Minho.
  • GISEF, Grupo de Investigação em Saúde & Família [Health & Family Research Group]. (2020b) . Questionnaire on knowledge of diabetic foot care: Portuguese research version. School of Psychology, University of Minho.
  • GISEF, Grupo de Investigação em Saúde & Família [Health & Family Research Group]. (2020c) . The Nottingham Assessment of Functional Footcare (NAFF): Portuguese research version. School of Psychology, University of Minho.
  • Gravely, S. S., Hensley, B. K., & Hagood-Thompson, C. (2011). Comparison of three types of diabetic foot ulcer education plans to determine patient recall of education. Journal of Vascular Nursing, 29(3), 113–119. https://doi.org/10.1016/j.jvn.2011.06.001
  • Hasnain, S., & Sheikh, N. H. (2009). Knowledge and practices regarding foot care in diabetic patients visiting diabetic clinic in Jinnah hospital, Lahore. Journal of the Pakistan Medical Association, 59(10), 687–690. https://jpma.org.pk/PdfDownload/1826
  • Indrayana, S., Guo, S.-E., Lin, C.-L., & Fang, S.-Y. (2019). Illness perception as a predictor of foot care behavior among people with type 2 diabetes mellitus in Indonesia. Journal of Transcultural Nursing, 30(1), 17–25. https://doi.org/10.1177/1043659618772347
  • International Diabetes Federation [IDF]. (2021). IDF diabetes atlas (10th ed.). https://diabetesatlas.org
  • Joseph, R. M., Sparks, L., & Robinson, J. D. (2010). Diabetic foot health education and amputation prevention. Health Communication, 25(6–7), 607–608. https://doi.org/10.1080/10410236.2010.496841
  • Li, R., Yuan, L., Guo, X.-H., Lou, Q.-Q., Zhao, F., Shen, L., Zhang, M.-X., & Sun, Z.-L. (2014). The current status of foot self-care knowledge, behaviours, and analysis of influencing factors in patients with type 2 diabetes mellitus in China. International Journal of Nursing Sciences, 1(3), 266–271. https://doi.org/10.1016/j.ijnss.2014.05.023
  • Lincoln, N., Jeffcoate, W., Ince, P., Smith, M., & Radford, K. (2007). Validation of a new measure of protective footcare behaviour: The Nottingham Assessment of Functional Footcare (NAFF). Practical Diabetes International, 24(4), 207–211. https://doi.org/10.1002/pdi.1099
  • Martins-Mendes, D., Monteiro-Soares, M., Boyko, E. J., Ribeiro, M., Barata, P., Lima, J., & Soares, R. (2014). The independent contribution of diabetic foot ulcer on lower extremity amputation and mortality risk. Journal of Diabetes and Its Complications, 28(5), 632–638. https://doi.org/10.1016/j.jdiacomp.2014.04.011
  • Meppelink, C. S., Smit, E. G., Buurman, B. M., & Van Weert, J. C. M. (2015). Should we be afraid of simple messages? The effects of text difficulty and illustrations in people with low or high health literacy. Health Communication, 30(12), 1181–1189. https://doi.org/10.1080/10410236.2015.1037425
  • Neves, J., & Penedo, J. (2015). Pé diabético: Uma visão prática [Diabetic Foot: A Practical Overview]. Schülke.
  • Obilor, H. N., Achore, M., & Woo, K. (2022). Use of information communication technology tools in diabetic foot ulcer prevention programs: A scoping review. Canadian Journal of Diabetes, 46(5), 535–548. https://doi.org/10.1016/j.jcjd.2021.11.009
  • Paiva, D., Silva, S., Severo, M., Ferreira, P., Santos, O., Lunet, N., & Azevedo, A. (2014). Cross-cultural adaptation and validation of the health literacy assessment tool METER in the Portuguese adult population. Patient Education & Counseling, 97(2), 269–275. https://doi.org/10.1016/j.pec.2014.07.024
  • Pandis, N. (2012). Randomization. Part 3: Allocation concealment and randomization implementation. American Journal of Orthodontics and Dentofacial Orthopedics, 141(1), 126–128. https://doi.org/10.1016/j.ajodo.2011.09.003
  • Pedras, S., Carvalho, R., & Pereira, M. G. (2016). Sociodemographic and clinical characteristics of patients with diabetic foot ulcer. Revista Da Associação Médica Brasileira, 62(2), 171–178. https://doi.org/10.1590/1806-9282.62.02.171
  • Peltola, M., & Isotalus, P. (2020). Competing discourses of professional-patient relationships in type 2 diabetes management. Health Communication, 35(14), 1811–1820. https://doi.org/10.1080/10410236.2019.1663586
  • Piaggio, G., Elbourne, D. R., Pocock, S. J., Evans, S. J. W., Altman, D. G., & for the CONSORT Group. (2012). Reporting of noninferiority and equivalence randomized trials: Extension of the consort 2010 statement. JAMA, 308(24), 2594.
  • Portuguese General Direction for Health. (2010). Circular Normativa No:05/PNPCD: Pé Diabético, Programa Nacional de Prevenção e Controlo da Diabetes (PNPCD) [Standard Circular No:05/PNPCD: Diabetic Foot, National Programme for Prevention and Control of Diabetes (PNPCD)]. http://www.dgs.pt/?cr=15718
  • Rahaman, H., Jyotsna, V., Sreenivas, V., Krishnan, A., & Tandon, N. (2018). Effectiveness of a patient education module on diabetic foot care in outpatient setting: An open-label randomized controlled study. Indian Journal of Endocrinology and Metabolism, 22(1), 74–78. https://doi.org/10.4103/ijem.IJEM_148_17
  • Raposo, J. F. (2020). Diabetes: Factos e números 2016, 2017 e 2018. [Diabetes: Facts and numbers 2016, 2017 and 2018]. Revista Portuguesa de Diabetes, 15(1), 19–27. http://www.revportdiabetes.com/wp-content/uploads/2020/05/RPD-Mar%C3%A7o-2020-Revista-Nacional-p%C3%A1gs-19-27.pdf
  • Ribu, L., Hanestad, B. R., Moum, T., Birkeland, K., & Rustoen, T. (2007). Health-related quality of life among patients with diabetes and foot ulcers: Association with demographic and clinical characteristics. Journal of Diabetes and Its Complications, 21(4), 227–236. https://doi.org/10.1016/j.jdiacomp.2007.02.001
  • Sakpal, T. V. (2010). Sample size estimation in clinical trial. Perspectives in Clinical Research, 1(2), 67–69. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3148614/pdf/PCR-1-67.pdf
  • Saleh, F., Mumu, S. J., Ara, F., Hafez, M. A., & Ali, L. (2014). Non-adherence to self-care practices & medication and health related quality of life among patients with type 2 diabetes: A cross-sectional study. BMC Public Health, 14(1), 431. https://doi.org/10.1186/1471-2458-14-431
  • Saltar, L., & Sahar, J. (2020). The intervention of foot care education in the prevention of diabetic foot ulcers: A literature review. International Conference on Health and Well-Being, Surakarta, Indonesia, 79–88.
  • Sarafino, E., & Smith, T. (2017). Health psychology: Biopsychosocial interactions (9th ed.). John Wiley & Sons.
  • Schaper, N. C., Netten, J. J., Apelqvist, J., Bus, S. A., Hinchliffe, R. J., Lipsky, B. A., & IWGDF Editorial Board. (2020). Practical guidelines on the prevention and management of diabetic foot disease (IWGDF 2019 update). Diabetes/Metabolism Research and Reviews, 36(Supplement 1), e3266.
  • Senussi, M., Lincoln, N., & Jeffcoate, W. (2011). Psychometric properties of the Nottingham Assessment of Functional Footcare (NAFF). International Journal of Therapy and Rehabilitation, 18(6), 330–334. https://doi.org/10.12968/ijtr.2011.18.6.330
  • Stolt, M., Gattinger, H., Boström, C., & Suhonen, R. (2020). Foot health educational interventions for patients and healthcare professionals: A scoping review. Health Education Journal, 79(4), 390–416. https://doi.org/10.1177/0017896919888952
  • Toobert, D. J., Hampson, S. E., & Glasgow, R. E. (2000). The summary of diabetes self-care activities measure: Results from 7 studies and a revised scale. Diabetes Care, 23(7), 943–950. https://doi.org/10.2337/diacare.23.7.943
  • Tuong, W., Larsen, E. R., & Armstrong, A. W. (2014). Videos to influence: A systematic review of effectiveness of video-based education in modifying health behaviors. Journal of Behavioral Medicine, 37(2), 218–233. https://doi.org/10.1007/s10865-012-9480-7
  • Van Netten, J. J., Bus, S. A., Apelqvist, J., Lipsky, B. A., Hinchliffe, R. J., Game, F., Rayman, G., Lazzarini, P. A., Forsythe, R. O., Peters, E. J. G., Senneville, É., Vas, P., Monteiro‐soares, M., Schaper, N. C., & on behalf of the International Working Group on the Diabetic Foot. (2020). Definitions and criteria for diabetic foot disease. Diabetes/Metabolism Research and Reviews, 36(Supplement 1), e3268.
  • Vas, P. R. J., & Edmonds, M. E. (2020). Approach to a new diabetic foot ulceration. In A. J. Boulton, G. Rayman & D. Wukich (Eds.), The foot in diabetes (5th ed., pp. 481–494). John Wiley & Sons Ltd.
  • Vatankhah, N., Khamseh, M. E., Jahangiri Noudeh, Y., Aghili, R., Baradaran, H. R., & Safai Haeri, N. (2009). The effectiveness of foot care education on people with type 2 diabetes in Tehran, Iran. Primary Care Diabetes, 3(2), 73–77. https://doi.org/10.1016/j.pcd.2009.05.003
  • Vedhara, K., Dawe, K., Miles, J. N. V., Wetherell, M. A., Cullum, N., Dayan, C., Drake, N., Price, P., Tarlton, J., Weinman, J., Day, A., Campbell, R., Reps, J., & Soria, D. (2016). Illness beliefs predict mortality in patients with diabetic foot ulcers. PLOS ONE, 11(4), e0153315. https://doi.org/10.1371/journal.pone.0153315
  • Vedhara, K., Dawe, K., Wetherell, M. A., Miles, J. N. V., Cullum, N., Dayan, C., Drake, N., Price, P., Tarlton, J., Weinman, J., Day, A., & Campbell, R. (2014). Illness beliefs predict self-care behaviours in patients with diabetic foot ulcers: A prospective study. Diabetes Research & Clinical Practice, 106(1), 67–72. https://doi.org/10.1016/j.diabres.2014.07.018
  • Vileikyte, L., Leventhal, H., Gonzalez, J. S., Peyrot, M., Rubin, R. R., Ulbrecht, J. S., Garrow, A., Waterman, C., Cavanagh, P. R., & Boulton, A. J. M. (2005). Diabetic peripheral neuropathy and depressive symptoms: The association revisited. Diabetes Care, 28(10), 2378–2383. https://doi.org/10.2337/diacare.28.10.2378
  • Vileikyte, L., Rubin, R. R., & Leventhal, H. (2004). Psychological aspects of diabetic neuropathic foot complications: An overview. Diabetes/Metabolism Research and Reviews, 20(Supplement 1), S13–18. https://doi.org/10.1002/dmrr.437
  • Wanzer, M. B., Booth-Butterfield, M., & Gruber, K. (2004). Perceptions of health care providers’ communication: Relationships between patient-centered communication and satisfaction. Health Communication, 16(3), 363–384. https://doi.org/10.1207/S15327027HC1603_6
  • Wilson, E. A. H., Park, D. C., Curtis, L. M., Cameron, K. A., Clayman, M. L., Makoul, G., Vom Eigen, K., & Wolf, M. S. (2010). Media and memory: The efficacy of video and print materials for promoting patient education about asthma. Patient Education & Counseling, 80(3), 393–398. https://doi.org/10.1016/j.pec.2010.07.011
  • Winston, K., Grendarova, P., & Rabi, D. (2018). Video-based patient decision aids: A scoping review. Patient Education & Counseling, 101(4), 558–578. https://doi.org/10.1016/j.pec.2017.10.009
  • Zhang, X., Foo, S., Majid, S., Chang, Y.-K., Dumaual, H. T. J., & Suri, V. R. (2020). Self-care and health-information-seeking behaviours of diabetic patients in Singapore. Health Communication, 35(8), 994–1003. https://doi.org/10.1080/10410236.2019.1606134
  • Zhao, X. (2014). Relationships between sources of health information and diabetes knowledge in the U.S. Hispanic population. Health Communication, 29(6), 574–585. https://doi.org/10.1080/10410236.2013.784937
  • Zwarenstein, M., Treweek, S., Gagnier, J. J., Altman, D. G., Tunis, S., Haynes, B., Oxman, A. D., Moher, D., & for the CONSORT and Pragmatic Trials in Healthcare (Practihc) groups. (2008). Improving the reporting of pragmatic trials: An extension of the CONSORT statement. The BMJ, 337, a2390. https://doi.org/10.1136/bmj.a2390

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