Development and evaluation of an eHealth self-management intervention for patients with chronic kidney disease in China: protocol for a mixed-method hybrid type 2 trial

Hongxia Shen, Rianne van der Kleij, Paul J M van der Boog, Xiaoyue Song, Wenjiao Wang, Tongtong Zhang, Zhengyan Li, Xiaoping Lou, Niels Chavannes, Hongxia Shen, Rianne van der Kleij, Paul J M van der Boog, Xiaoyue Song, Wenjiao Wang, Tongtong Zhang, Zhengyan Li, Xiaoping Lou, Niels Chavannes

Abstract

Background: Chronic kidney disease (CKD) is a significant public health concern. In patients with CKD, interventions that support disease self-management have shown to improve health status and quality of life. At the moment, the use of electronic health (eHealth) technology in self-management interventions is becoming more and more popular. Evidence suggests that eHealth-based self-management interventions can improve health-related outcomes of patients with CKD. However, knowledge of the implementation and effectiveness of such interventions in general, and in China in specific, is still limited. This study protocol aims to develop and tailor the evidence-based Dutch 'Medical Dashboard' eHealth self-management intervention for patients suffering from CKD in China and evaluate its implementation process and effectiveness.

Methods: To develop and tailor a Medical Dashboard intervention for the Chinese context, we will use an Intervention Mapping (IM) approach. A literature review and mixed-method study will first be conducted to examine the needs, beliefs, perceptions of patients with CKD and care providers towards disease (self-management) and eHealth (self-management) interventions (IM step 1). Based on the results of step 1, we will specify outcomes, performance objectives, and determinants, select theory-based methods and practical strategies. Knowledge obtained from prior results and insights from stakeholders will be combined to tailor the core interventions components of the 'Medical Dashboard' self-management intervention to the Chinese context (IM step 2-5). Then, an intervention and implementation plan will be developed. Finally, a 9-month hybrid type 2 trial design will be employed to investigate the effectiveness of the intervention using a cluster randomized controlled trial with two parallel arms, and the implementation integrity (fidelity) and determinants of implementation (IM step 6).

Discussion: Our study will result in the delivery of a culturally tailored, standardized eHealth self-management intervention for patients with CKD in China, which has the potential to optimize patients' self-management skills and improve health status and quality of life. Moreover, it will inform future research on the tailoring and translation of evidence-based eHealth self-management interventions in various contexts.

Trial registration: Clinicaltrials.gov NCT04212923 ; Registered December 30, 2019.

Keywords: China; Chronic kidney disease; Hybrid design; Implementation; Self-management; eHealth.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Adapted version of the theoretical framework of Brakema et al (submitted). A combination of concepts of the Health Beliefs Model (green) and the Theory of Planned Behavior (blue)
Fig. 2
Fig. 2
Methods and examples of the possible output of Intervention Mapping step 2–5. Step 2 (blue), step 3(red), step 4(green), step 5(purple)
Fig. 3
Fig. 3
Guidance for specifying implementation strategies of Proctor EK et al. [52]
Fig. 4
Fig. 4
Study schema
Fig. 5
Fig. 5
CONSORT flow diagram for our trial

References

    1. Jha V, Modi GK. Getting to know the enemy better-the global burden of chronic kidney disease. Kidney Int. 2018;94:462–464. doi: 10.1016/j.kint.2018.05.009.
    1. Hill NR, Fatoba ST, Oke JL, Hirst JA, O'Callaghan CA, Lasserson DS, et al. Global prevalence of chronic kidney disease - a systematic review and meta-analysis. PLoS One. 2016. 10.1371/journal.pone.0158765.
    1. Nugent RA, Fathima SF, Feigl AB, Chyung D. The burden of chronic kidney disease on developing nations: a 21st century challenge in global health. Nephron Clin Pract. 2011;118:c269–c277. doi: 10.1159/000321382.
    1. Zhang QL, Rothenbacher D. Prevalence of chronic kidney disease in population-based studies: systematic review. BMC Public Health. 2008;8:117. doi: 10.1186/1471-2458-8-117.
    1. Zhang LX, Wang F, Wang L, Wang WK, Liu BC, Liu J, et al. Prevalence of chronic kidney disease in China: a cross-sectional survey. Lancet. 2012;379:815–822. doi: 10.1016/S0140-6736(12)60033-6.
    1. Kasiske BL, Wheeler DC. KDIGO clinical practice guideline for the evaluation and management of chronic kidney disease foreword. Kidney Int Suppl. 2013;3:2. doi: 10.1038/kisup.2012.74.
    1. Go AS, Chertow GM, Fan DJ, McCulloch CE, Hsu CY. Chronic kidney disease and the risks of death, cardiovascular events, and hospitalization. New Engl J Med. 2004;351:1296–1305. doi: 10.1056/NEJMoa041031.
    1. Xie Y, Bowe B, Mokdad AH, Xian H, Yan Y, Li TT, et al. Analysis of the global burden of disease study highlights the global, regional, and national trends of chronic kidney disease epidemiology from 1990 to 2016. Kidney Int. 2018;94:567–581. doi: 10.1016/j.kint.2018.04.011.
    1. Ackland P. ABC of kidney disease, 2nd Edition prevalence, detection, evaluation and management of chronic kidney disease. BMJ (Clin Res ed). 2014. 10.1136/bmj.f7688.
    1. Wyld M, Lee CMY, Chadban SJ, Zhuo X, White S, Shaw J, et al. Cost of Ckd in Australia. Nephrology. 2014;19:23. doi: 10.1111/nep.12236.
    1. Honeycutt AA, Segel JE, Zhuo XH, Hoerger TJ, Imai K, Williams D. Medical costs of CKD in the medicare population. J Am Soc Nephrol. 2013;24:1478–1483. doi: 10.1681/ASN.2012040392.
    1. Webster AC, Nagler EV, Morton RL, Masson P. Chronic kidney disease. Lancet. 2017;389:1238–1252. doi: 10.1016/S0140-6736(16)32064-5.
    1. Lorig KR, Holman HR. Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med. 2003;26:1–7. doi: 10.1207/S15324796ABM2601_01.
    1. Meuleman Y, Hoekstra T, Dekker FW, Navis G, Vogt L, van der Boog PJM, et al. Sodium restriction in patients with CKD: a randomized controlled trial of self-management support. Am J Kidney Dis. 2017;69:576–586. doi: 10.1053/j.ajkd.2016.08.042.
    1. Joboshi H, Oka M. Effectiveness of an educational intervention (the encourage autonomous self-enrichment program) in patients with chronic kidney disease: a randomized controlled trial. Int J Nurs Stud. 2017;67:51–58. doi: 10.1016/j.ijnurstu.2016.11.008.
    1. Ishani A, Christopher J, Palmer D, Otterness S, Clothier B, Nugent S, et al. Telehealth by an interprofessional team in patients with CKD: a randomized controlled trial. Am J Kidney Dis. 2016;68:41–49. doi: 10.1053/j.ajkd.2016.01.018.
    1. Kawi J. Self-management support in chronic illness care: a concept analysis. Res Theor Nurs Pract. 2012;26:108–125. doi: 10.1891/1541-6577.26.2.108.
    1. Blakeman T, Blickem C, Kennedy A, Reeves D, Bower P, Gaffney H, et al. Effect of information and telephone-guided access to community support for people with chronic kidney disease: randomised controlled trial. PLoS One. 2014. 10.1371/journal.pone.0109135.
    1. Ong SW, Jassal SV, Miller JA, Porter EC, Cafazzo JA, Seto E, et al. Integrating a smartphone-based self-management system into usual care of Advanced CKD. Clin J Am Soc Nephro. 2016;11:1054–1062. doi: 10.2215/CJN.10681015.
    1. Reese PP, Bloom RD, Trofe-Clark J, Mussell A, Leidy D, Levsky S, et al. Automated reminders and physician notification to promote immunosuppression adherence among kidney transplant recipients: a randomized trial. Am J Kidney Dis. 2017;69:400–409. doi: 10.1053/j.ajkd.2016.10.017.
    1. Shen HX, van der Kleij RMJJ, van der Boog PJM, Chang XW, Chavannes NH. Electronic health self-management interventions for patients with chronic kidney disease: systematic review of quantitative and qualitative evidence. J Med Internet Res. 2019;21:e12384. doi: 10.2196/12384.
    1. van Lint CL, van der Boog PJM, Wang W, Brinkman WP, Rovekamp TJM, Neerincx MA, et al. Patient experiences with self-monitoring renal function after renal transplantation: results from a single-center prospective pilot study. Patient Prefer Adher. 2015;9:1721–1731. doi: 10.2147/PPA.S92108.
    1. Tu J, Wang CX, Wu SL. The internet hospital: an emerging innovation in China. Lancet Glob Health. 2015;3:E445–E4E6. doi: 10.1016/S2214-109X(15)00042-X.
    1. Tian M, Zhang J, Luo R, Chen S, Petrovic D, Redfern J, et al. mHealth interventions for health system strengthening in China: a systematic review. JMIR Mhealth Uhealth. 2017;5:e32. doi: 10.2196/mhealth.6889.
    1. Xie X, Zhou W, Lin L, Fan S, Lin F, Wang L, et al. Internet hospitals in China: cross-sectional survey. J Med Internet Res. 2017;19:e239. doi: 10.2196/jmir.7854.
    1. Hong YA, Zhou Z, Fang Y, Shi L. The digital divide and health disparities in China: evidence from a National Survey and policy implications. J Med Internet Res. 2017;19:e317. doi: 10.2196/jmir.7786.
    1. Tan XD, Wu QA, Shao HY. Global commitments and China's endeavors to promote health and achieve sustainable development goals. J Health Popul Nutr. 2018;37:8. doi: 10.1186/s41043-018-0139-z.
    1. Tan X, Liu X, Shao H. Healthy China 2030: a vision for health care. Value Health Reg Issues. 2017;12:112–114. doi: 10.1016/j.vhri.2017.04.001.
    1. Bartholomew LKPG, Kok G, Gottlieb NH. Planning health promotion programs: an intervention mapping approach. 2. San Francisco: Jossey-Bass A Wiley Imprint; 2006.
    1. Duan J, Wang C, Liu D, Qiao Y, Pan S, Jiang D, et al. Prevalence and risk factors of chronic kidney disease and diabetic kidney disease in Chinese rural residents: a cross-sectional survey. Sci Rep. 2019;9:10408. doi: 10.1038/s41598-019-46857-7.
    1. Morton K, Dennison L, Bradbury K, Band RJ, May C, Raftery J, et al. Qualitative process study to explore the perceived burdens and benefits of a digital intervention for self-managing high blood pressure in primary care in the UK. BMJ Open. 2018. 10.1136/bmjopen-2017-020843.
    1. Laws RA, Kemp LA, Harris MF, Davies GP, Williams AM, Eames-Brown R. An exploration of how clinician attitudes and beliefs influence the implementation of lifestyle risk factor management in primary healthcare: a grounded theory study. Implement Sci. 2009;4:66. doi: 10.1186/1748-5908-4-66.
    1. Mosnier-Pudar H, Hochberg G, Eschwege E, Halimi S, Virally ML, Guillausseau PJ, et al. How patients' attitudes and opinions influence self-care behaviours in type 2 diabetes. Insights from the French DIABASIS survey. Diabetes Metab. 2010;36:476–483. doi: 10.1016/j.diabet.2010.08.004.
    1. Nur KRM. Illness perception and cardiovascular health behaviour among persons with ischemic heart disease in Indonesia. Int J Nurs Sci. 2018;5:174–180.
    1. Rosenstock IM, Strecher VJ, Becker MH. Social learning theory and the health belief model. Health Educ Q. 1988;15:175–183. doi: 10.1177/109019818801500203.
    1. Ajzen I. The theory of planned behavior. Organ Behav Hum. 1991;50:179–211. doi: 10.1016/0749-5978(91)90020-T.
    1. Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006;60:631–637. doi: 10.1016/j.jpsychores.2005.10.020.
    1. Lin CC, Wu CC, Wu LM, Chen HM, Chang SC. Psychometric evaluation of a new instrument to measure disease self-management of the early stage chronic kidney disease patients. J Clin Nurs. 2013;22:1073–1079. doi: 10.1111/j.1365-2702.2011.04048.x.
    1. Ma Z, Wu M. The psychometric properties of the Chinese eHealth literacy scale (C-eHEALS) in a Chinese rural population: cross-sectional validation study. J Med Internet Res. 2019;21:e15720. doi: 10.2196/15720.
    1. Palinkas LA, Horwitz SM, Green CA, Wisdom JP, Duan N, Hoagwood K. Purposeful sampling for qualitative data collection and analysis in mixed method implementation research. Adm Policy Ment Hlth. 2015;42:533–544. doi: 10.1007/s10488-013-0528-y.
    1. Goodman LA. Snowball sampling. Ann Math Stat. 1961;32:148–170. doi: 10.1214/aoms/1177705148.
    1. Patton MQ. Qualitative research and evaluation methods. 2. Newbury Park: Sage; 1990.
    1. Aldiabat KM, Le Navenec CL. Data saturation: the mysterious step in grounded theory methodology. Qual Rep. 2018;23:245–261.
    1. Lynch J, Moore M, Moss-Morris R, Kendrick T. Are patient beliefs important in determining adherence to treatment and outcome for depression? Development of the beliefs about depression questionnaire. J Affect Disorders. 2011;133:29–41. doi: 10.1016/j.jad.2011.03.019.
    1. Mcleroy KR, Bibeau D, Steckler A, Glanz K. An ecological perspective on health promotion programs. Health Educ Quart. 1988;15:351–377. doi: 10.1177/109019818801500401.
    1. Michie S, Johnston M, Francis J, Hardeman W, Eccles M. From theory to intervention: mapping theoretically derived behavioural determinants to behaviour change techniques. Appl Psychol-Int Rev. 2008;57:660–680. doi: 10.1111/j.1464-0597.2008.00341.x.
    1. Nierkens V, Hartman MA, Nicolaou M, Vissenberg C, Beune EJ, Hosper K, et al. Effectiveness of cultural adaptations of interventions aimed at smoking cessation, diet, and/or physical activity in ethnic minorities. a systematic review. PLoS One. 2013. 10.1371/journal.pone.0073373.
    1. Jaspers MWM, Steen T, van den Bos C, Geenen M. The think aloud method: a guide to user interface design. Int J Med Inform. 2004;73:781–795. doi: 10.1016/j.ijmedinf.2004.08.003.
    1. Campeau-Vallerand C, Michaud F, Routhier F, Archambault PS, Letourneau D, Gelinas-Bronsard D, et al. Development of a web-based monitoring system for power tilt-in-space wheelchairs: formative evaluation. JMIR Rehabil Assist Technol. 2019;6:e13560. doi: 10.2196/13560.
    1. Wu J, Tombor I, Shahab L, West R. Usability testing of a smoking cessation smartphone application ('SmokeFree Baby'): a think-aloud study with pregnant smokers. Digit Health. 2017. 10.1177/2055207617704273.
    1. Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014. 10.1136/bmj.g1687.
    1. Proctor EK, Powell BJ, McMillen JC. Implementation strategies: recommendations for specifying and reporting. Implement Sci. 2013;8:139. doi: 10.1186/1748-5908-8-139.
    1. Powell BJ, Waltz TJ, Chinman MJ, Damschroder LJ, Smith JL, Matthieu MM, et al. A refined compilation of implementation strategies: results from the expert recommendations for implementing change (ERIC) project. Implement Sci. 2015;10:21. doi: 10.1186/s13012-015-0209-1.
    1. Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012;50:217–226. doi: 10.1097/MLR.0b013e3182408812.
    1. Nguyen NT, Douglas C, Bonner A. Effectiveness of self-management programme in people with chronic kidney disease: a pragmatic randomized controlled trial. J Adv Nurs. 2019;75:652–664.
    1. Lin CC, Tsai FM, Lin HS, Hwang SJ, Chen HC. Effects of a self-management program on patients with early-stage chronic kidney disease: a pilot study. Appl Nurs Res. 2013;26:151–156. doi: 10.1016/j.apnr.2013.01.002.
    1. Chan A-W, 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;158:200–207. doi: 10.7326/0003-4819-158-3-201302050-00583.
    1. Pinnock H, Barwick M, Carpenter CR, Eldridge S, Grandes G, Griffiths CJ, et al. Standards for reporting implementation studies (StaRI) statement. BMJ. 2017. 10.1136/bmj.i6795.
    1. Lin CC, Wu CC, Anderson RM, Chang CS, Chang SC, Hwang SJ, et al. The chronic kidney disease self-efficacy (CKD-SE) instrument: development and psychometric evaluation. Nephrol Dial Transpl. 2012;27:3828–3834. doi: 10.1093/ndt/gfr788.
    1. Broadbent E, Wilkes C, Koschwanez H, Weinman J, Norton S, Petrie KJ. A systematic review and meta-analysis of the brief illness perception questionnaire. Psychol Health. 2015;30:1361–1385. doi: 10.1080/08870446.2015.1070851.
    1. Gorodetskaya I, Zenios S, McCulloch CE, Bostrom A, Hsu CY, Bindman AB, et al. Health-related quality of life and estimates of utility in chronic kidney disease. Kidney Int. 2005;68:2801–2808. doi: 10.1111/j.1523-1755.2005.00752.x.
    1. Cohen DE, Lee A, Sibbel S, Benner D, Brunelli SM, Tentori F. Use of the KDQOL-36 for assessment of health-related quality of life among dialysis patients in the United States. BMC Nephrol. 2019;20:112. doi: 10.1186/s12882-019-1295-0.
    1. Chow SK, Tam BM. Is the kidney disease quality of life-36 (KDQOL-36) a valid instrument for Chinese dialysis patients? BMC Nephrol. 2014;15:199. doi: 10.1186/1471-2369-15-199.
    1. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67:361–370. doi: 10.1111/j.1600-0447.1983.tb09716.x.
    1. Chen YC, Chang LC, Liu CY, Ho YF, Weng SC, Tsai TI. The roles of social support and health literacy in self-management among patients with chronic kidney disease. J Nurs Scholarsh. 2018;50:265–275. doi: 10.1111/jnu.12377.
    1. Rosner B. Fundamentals of biostatistics. 7. Boston: Brooks/Cole; 2011.
    1. Gaglio B, Shoup JA, Glasgow RE. The RE-AIM framework: a systematic review of use over time. Am J Public Heath. 2013;103:E38–E46. doi: 10.2105/AJPH.2013.301299.
    1. Fleuren MAH, Paulussen TGWM, Van Dommelen P, Van Buuren S. Towards a measurement instrument for determinants of innovations. Int J Qual Health C. 2014;26:501–510. doi: 10.1093/intqhc/mzu060.
    1. Huijg JM, Gebhardt WA, Dusseldorp E, Verheijden MW, van der Zouwe N, Middelkoop BJC, et al. Measuring determinants of implementation behavior: psychometric properties of a questionnaire based on the theoretical domains framework. Implement Sci. 2014;9:33. doi: 10.1186/1748-5908-9-33.
    1. Fleuren M, Wiefferink K, Paulussen T. Determinants of innovation within health care organizations - literature review and Delphi study. Int J Qual Health C. 2004;16:107–123. doi: 10.1093/intqhc/mzh030.
    1. Gale NK, Heath G, Cameron E, Rashid S, Redwood S. Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC Med Res Methodol. 2013;13:117. doi: 10.1186/1471-2288-13-117.
    1. Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007;19:349–357. doi: 10.1093/intqhc/mzm042.
    1. Lazure P, Bartel RC, Biller BMK, Molitch ME, Rosenthal SM, Ross JL, et al. Contextualized analysis of a needs assessment using the theoretical domains framework: a case example in endocrinology. BMC Health Serv Res. 2014;14:319. doi: 10.1186/1472-6963-14-319.
    1. Gray-Burrows KA, Day PF, Marshman Z, Aliakbari E, Prady SL, McEachan RRC. Using intervention mapping to develop a home-based parental-supervised toothbrushing intervention for young children. Implement Sci. 2016;11:61. doi: 10.1186/s13012-016-0416-4.
    1. Hurley DA, Murphy LC, Hayes D, Hall AM, Toomey E, McDonough SM, et al. Using intervention mapping to develop a theory-driven, group-based complex intervention to support self-management of osteoarthritis and low back pain (SOLAS) Implement Sci. 2016;11:56. doi: 10.1186/s13012-016-0418-2.
    1. Park N, Rhoads M, Hou JH, Lee KM. Understanding the acceptance of teleconferencing systems among employees: an extension of the technology acceptance model. Comput Hum Behav. 2014;39:118–127. doi: 10.1016/j.chb.2014.05.048.
    1. van der Kleij RMJJ, Crone MR, Paulussen TGWM, van de Gaar VM, Reis R. A stitch in time saves nine? A repeated cross-sectional case study on the implementation of the intersectoral community approach Youth At a Healthy Weight. Bmc Public Health. 2015;15:1032. doi: 10.1186/s12889-015-2306-0.
    1. Cane J, O'Connor D, Michie S. Validation of the theoretical domains framework for use in behaviour change and implementation research. Implement Sci. 2012;7:37. doi: 10.1186/1748-5908-7-37.
    1. Davis FD. Perceived usefulness, perceived ease of use, and user acceptance of information technology. Mis Quart. 1989;13:319–340. doi: 10.2307/249008.
    1. Creswell JW, Plano Clark VL. Designing and conducting mixed methods research. 3. Thousand Oaks: Sage; 2017.
    1. Fereday J, Muir-Cochrane E. Demonstrating rigor using thematic analysis: a hybrid approach of inductive and deductive coding and theme development. Int J Qual Methods. 2006;5:80–92. doi: 10.1177/160940690600500107.
    1. Peters DH, Adam T, Alonge O, Agyepong IA, Tran N. Implementation research: what it is and how to do it. BMJ. 2013. 10.1136/bmj.f6753.
    1. Hoagwood K, Atkins M, Ialongo N. Unpacking the black box of implementation: the next generation for policy, research and practice. Adm Policy Ment Hlth. 2013;40:451–455. doi: 10.1007/s10488-013-0512-6.
    1. Geense WW, van Gaal BGI, Knoll JL, Maas NM, Kok G, Cornelissen EAM, et al. Effect and process evaluation of e-powered parents, a web-based support program for parents of children with a chronic kidney disease: feasibility randomized controlled trial. J Med Internet Res. 2018;20:e245. doi: 10.2196/jmir.9547.
    1. Garba RM, Gadanya MA. The role of intervention mapping in designing disease prevention interventions: a systematic review of the literature. PLoS One. 2017. 10.1371/journal.pone.0174438.

Source: PubMed

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

3
Abonnieren