The effects of a digital health intervention on patient activation in chronic kidney disease
GBD Chronic Kidney Disease Collaboration. Global, regional, and national burden of chronic kidney disease, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet 395, 709-733 (2020).
Kidney Research UK. Kidney disease: A UK public health emergency. The health economics of kidney disease to 2033. (2023).
Hull, S. A., Nitsch, D., Caplin, B., Griffith, K. & Wheeler, D. C. The National CKD Audit: a primary care condition that deserves more attention. Br. J. Gen. Pract. : J. R. Coll. Gen. Practitioners 68, 356–357 (2018).
Google Scholar
Kovesdy, C. P. Epidemiology of chronic kidney disease: an update 2022. Kidney Int Suppl. (2011) 12, 7–11 (2022).
Google Scholar
Greer, R. C., Crews, D. C. & Boulware, L. E. Challenges perceived by primary care providers to educating patients about chronic kidney disease. J. Ren. Care 38, 174–181 (2012).
Google Scholar
Tuot, D. S. et al. CKD awareness in the general population: performance of CKD-specific questions. Kidney Med. 1, 43–50 (2019).
Google Scholar
Evans, M. et al. A narrative review of chronic kidney disease in clinical practice: current challenges and future perspectives. Adv. Ther. 39, 33–43 (2022).
Google Scholar
NHS England. The NHS Long Term Plan (2019).
National Institute for Health and Care Excellence (NICE). Chronic Kidney Disease: Assessment And Management (2021).
Lightfoot, C. J. et al. Patient activation: the cornerstone of effective self-management in chronic kidney disease? Kidney Dialysis 2, 91–105 (2022).
Google Scholar
Hibbard, J. H., Stockard, J., Mahoney, E. R. & Tusler, M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv. Res. 39, 1005–1026 (2004).
Google Scholar
Lightfoot, C. J. et al. The codevelopment of “My Kidneys & Me”: a digital self-management program for people with chronic kidney disease. J. Med. Internet Res. 24, e39657 (2022).
Google Scholar
Lightfoot, C. J., Wilkinson, T. J., Yates, T., Davies, M. J. & Smith, A. C. ‘Self-Management Intervention through Lifestyle Education for Kidney health’ (the SMILE-K study): protocol for a single-blind longitudinal randomised controlled trial with nested pilot study. BMJ Open 12, e064916 (2022).
Google Scholar
Hibbard, J. H., Greene, J. & Tusler, M. Improving the outcomes of disease management by tailoring care to the patient’s level of activation. Am. J. Manag Care 15, 353–360 (2009).
Lindsay, A., Hibbard, J. H., Boothroyd, D. B., Glaseroff, A. & Asch, S. M. Patient activation changes as a potential signal for changes in health care costs: cohort study of US high-cost patients. J. Gen. Intern. Med. 33, 2106–2112 (2018).
Google Scholar
Miller, V. M. et al. Increasing patient activation through diabetes self-management education: Outcomes of DESMOND in regional Western Australia. Patient Educ. Couns. 103, 848–853 (2020).
Google Scholar
Shah, V. O. et al. A home-based educational intervention improves patient activation measures and diabetes health indicators among Zuni Indians. PLoS ONE 10, e0125820 (2015).
Google Scholar
Deen, D., Lu, W.-H., Rothstein, D., Santana, L. & Gold, M. R. Asking questions: the effect of a brief intervention in community health centers on patient activation. Patient Educ. Couns. 84, 257–260 (2011).
Google Scholar
Lightfoot, C. J., Wilkinson, T. J., Memory, K. E., Palmer, J. & Smith, A. C. Reliability and validity of the patient activation measure in kidney disease: results of rasch analysis. Clin. J. Am. Soc. Nephrol. 16, 880–888 (2021).
Google Scholar
Narva, A. S., Norton, J. M. & Boulware, L. E. Educating patients about CKD: the path to self-management and patient-centered care. Clin. J. Am. Soc. Nephrol. 11, 694–703 (2016).
Google Scholar
Tuot, D. S. et al. Variation in patients’ awareness of CKD according to how they are asked. Clin. J. Am. Soc. Nephrol. 11, 1566–1573 (2016).
Google Scholar
Devraj, R., Borrego, M. E., Vilay, A. M., Pailden, J. & Horowitz, B. Awareness, self-management behaviors, health literacy and kidney function relationships in specialty practice. World J. Nephrol. 7, 41–50 (2018).
Google Scholar
Wilkinson, T. J., Memory, K., Lightfoot, C. J., Palmer, J. & Smith, A. C. Determinants of patient activation and its association with cardiovascular disease risk in chronic kidney disease: a cross-sectional study. Health Expect. 24, 843–852 (2021).
Google Scholar
Magadi, W. et al. Patient activation and its association with symptom burden and quality of life across the spectrum of chronic kidney disease stages in England. BMC Nephrol. 23, 45 (2022).
Google Scholar
Johnson, M. L. et al. Patient activation with knowledge, self-management and confidence in chronic kidney disease. J. Ren. Care 42, 15–22 (2016).
Google Scholar
Vélez-Bermúdez, M., Christensen, A. J., Kinner, E. M., Roche, A. I. & Fraer, M. Exploring the relationship between patient activation, treatment satisfaction, and decisional conflict in patients approaching end-stage renal disease. Ann. Behav. Med. 53, 816–826 (2019).
Gair, R. M. et al. Transforming Participation In Chronic Kidney Disease: Programme Report (Renal Association, 2019).
Greenwood, S. A. et al. Evaluating the effect of a digital health intervention to enhance physical activity in people with chronic kidney disease (Kidney BEAM): a multicentre, randomised controlled trial in the UK. The Lancet Digital Health, 6, e23–e32 (2023).
Barker, F., Atkins, L. & de Lusignan, S. Applying the COM-B behaviour model and behaviour change wheel to develop an intervention to improve hearing-aid use in adult auditory rehabilitation. Int. J. Audiol. 55, S90–S98 (2016).
Google Scholar
O’Connor, S. et al. Understanding factors affecting patient and public engagement and recruitment to digital health interventions: a systematic review of qualitative studies. BMC Med. Inform. Decis. Mak. 16, 120 (2016).
Google Scholar
Smekal, M. D. et al. Enhancing primary care capacity in chronic kidney disease management: a quality improvement educational initiative. BMJ Open 11, e046068 (2021).
Google Scholar
Shlipak, M. G. et al. The case for early identification and intervention of chronic kidney disease: conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference. Kidney Int. 99, 34–47 (2021).
Google Scholar
NHS England & NHS Improvement. The Interface Between Primary And Secondary Care: Key Messages For NHS Clinicians And Managers (NHS, 2017).
Mallinckrodt, C. H., Watkin, J. G., Molenberghs, G. & Carroll, R. J. Choice of the primary analysis in longitudinal clinical trials. Pharm. Stat. 3, 161–169 (2004).
Google Scholar
Siddiqui, O., Hung, H. M. J. & O’Neill, R. MMRM vs. LOCF: a comprehensive comparison based on simulation study and 25 NDA datasets. J. Biopharm. Stat. 19, 227–246 (2009).
Google Scholar
Fitzmaurice, G. M., Laird, N. M. & Ware, J. H. Applied Longitudinal Analysis (John Wiley & Sons, 2004).
Dinh, P. & Yang, P. Handling baselines in repeated measures analyses with missing data at random. J. Biopharm. Stat. 21, 326–341 (2011).
Google Scholar
Lightfoot, C. J. et al. Improving self-management behaviour through a digital lifestyle intervention: an internal pilot study. J. Ren. Care 50, 283–296 (2024).
Google Scholar
Kanu, C., Brown, C., Barner, J., Chapman, C. & Walker, H. The effect of a tailored patient activation intervention in inflammatory bowel disease patients. J. Contemp. Pharm. Pract. 66, 11–21 (2020).
Google Scholar
Schulz, K. F., Altman, D. G. & Moher, D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. PLoS Med. 7, e1000251 (2010).
Google Scholar
Hadjiconstantinou, M. et al. Using Intervention Mapping to Develop a Digital Self-Management Program for People With Type 2 Diabetes: Tutorial on MyDESMOND. J. Med. Internet Res. 22, e17316 (2020).
Google Scholar
Davies, M. J. et al. Effectiveness of the diabetes education and self management for ongoing and newly diagnosed (DESMOND) programme for people with newly diagnosed type 2 diabetes: cluster randomised controlled trial. BMJ 336, 491–495 (2008).
Google Scholar
Corbin, J. M. & Strauss, A. Unending Work And Care: Managing Chronic Illness At Home (Jossey-Bass, 1988).
Michie, S., van Stralen, M. M. & West, R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement. Sci. 6, 42 (2011).
Google Scholar
Michie, S. et al. 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 (2013).
Google Scholar
Schwarzer, R. Self-efficacy: Thought Control Of Action. p. 217-243 (Hemisphere Publishing Corp, 1992).
Leventhal, H., Meyer, D. & Nerenz, D. Medical Psychology (S., RACHMAN, 1980).
Bandura, A. Social cognitive theory of self-regulation. Organ Behav. Hum. Decis. Process 50, 248–287 (1991).
Google Scholar
Hibbard, J. H., Mahoney, E. R., Stockard, J. & Tusler, M. Development and testing of a short form of the patient activation measure. Health Serv. Res. 40, 1918–1930 (2005).
Google Scholar
Devraj, R. & Wallace, L. S. Application of the content expert process to develop a clinically useful low-literacy Chronic Kidney Disease Self-Management Knowledge Tool (CKD-SMKT). Res. Soc. Adm. Pharm. 9, 633–639 (2013).
Google Scholar
Brown, S. A. et al. Kidney symptom questionnaire: development, content validation and relationship with quality of life. J. Renal Care, 44, 162–173 (2018).
Malmstrom, T. K., Miller, D. K., Simonsick, E. M., Ferrucci, L. & Morley, J. E. SARC-F: a symptom score to predict persons with sarcopenia at risk for poor functional outcomes. J. Cachexia Sarcopenia Muscle 7, 28–36 (2016).
Google Scholar
Ahmad, S. et al. Evaluation of reliability and validity of the General Practice Physical Activity Questionnaire (GPPAQ) in 60–74 year old primary care patients. BMC Fam. Pract. 16, 113 (2015).
Google Scholar
Wilkinson, T. J., Palmer, J., Gore, E. F. & Smith, A. C. The validity of the ‘General Practice Physical Activity Questionnaire’ against accelerometery in patients with chronic kidney disease. Physiother. Theory Pract. 38, 1–10 (2020).
England, C. Y., Thompson, J. L., Jago, R., Cooper, A. R. & Andrews, R. C. Development of a brief, reliable and valid diet assessment tool for impaired glucose tolerance and diabetes: the UK Diabetes and Diet Questionnaire. Public Health Nutr. 20, 191–199 (2017).
Google Scholar
Chan, A. H. Y., Horne, R., Hankins, M. & Chisari, C. The Medication Adherence Report Scale: a measurement tool for eliciting patients’ reports of nonadherence. Br. J. Clin. Pharmacol. 86, 1281–1288 (2020).
Google Scholar
Al-Jabi, S. W. et al. Depression in patients treated with haemodialysis: a cross-sectional study. Lancet 391, 41 (2017).
Google Scholar
Kieser, M. & Friede, T. Re-calculating the sample size in internal pilot study designs with control of the type I error rate. Stat. Med. 19, 901–911 (2000).
Google Scholar
Harden, M. & Friede, T. Sample size recalculation in multicenter randomized controlled clinical trials based on noncomparative data. Biom. J. 62, 1284–1299 (2020).
Google Scholar
Wittes, J. & Brittain, E. The role of internal pilot studies in increasing the efficiency of clinical trials. Stat. Med 9, 65–71 (1990).
Google Scholar
Friede, T. & Kieser, M. Sample size recalculation in internal pilot study designs: a review. Biom. J. 48, 537–555 (2006).
Google Scholar
Chin, R. & Lee, B. Principles And Practice Of Clinical Trial Medicine. p. 303–323 (Academic Press, 2008).
link
