Improving Health-Related Quality of Life of Patients With an Ostomy Using a Novel Digital Wearable Device: Protocol for a Pilot Study

Dara Rouholiman, Jamison G Gamble, Sylvie D Dobrota, Ellen M Encisco, Ashish G Shah, Francisco J Grajales Iii, Larry F Chu, Dara Rouholiman, Jamison G Gamble, Sylvie D Dobrota, Ellen M Encisco, Ashish G Shah, Francisco J Grajales Iii, Larry F Chu

Abstract

Background: Ostomy surgeries involving the placement of an ostomy bag (eg, colostomy, ileostomy, urostomy, etc) have been shown to have a negative impact on health-related quality of life. To date, no studies have been conducted examining what impact, if any, wearable biosensors have on the health-related quality of life of ostomy patients.

Objective: In the present study, we plan to assess the quality of life of ostomy patients using the Ostom-i alert sensor, a portable, wearable, Bluetooth-linked biosensor that facilitates easier ostomy bag output measurements. We hypothesize that using the Ostom-i alert sensor will result in an improved, ostomy-specific, health-related quality of life as compared to baseline measurement before the use of the sensor.

Methods: A total of 20 ostomy patients will be screened and recruited to participate in this prospective, observational, cross-over pilot study using an Ostom-i alert sensor for one month. The primary outcome of this study will compare ostomy-specific, health-related quality of life at baseline (prior to Ostom-i alert sensor use) to ostomy-specific, health-related quality of life after 2 and 4 weeks of Ostom-i use by utilizing the City of Hope Quality of Life Questionnaire for Patients with an Ostomy. Secondary outcomes of general health-related quality of life and adjustment to ostomy will be evaluated using the Medical Outcomes Study 36-item short form health survey and the Olbrisch Ostomy Adjustment Scale Short Form 2.

Results: The project was funded by the Department of Anesthesiology, Perioperative and Pain Medicine at Stanford University School of Medicine. Enrollment is currently underway and data analysis is expected to be completed in 2018.

Conclusions: Proposed benefits of mobile, internet-linked personal health monitors, such as the Ostom-i, include a reduction in the cost of care by reducing resource utilization and infection rates, improving patient-provider communication, reducing time spent as an inpatient as well as improved quality of life. Prior studies have demonstrated decreased health-related quality of life in patients with an ostomy bag. We aim to examine the extent to which the Ostom-i alert sensor affects the health-related quality of life of its users. The Ostom-i alert sensor has the potential to improve quality of life of users by giving them the freedom and confidence to partake in daily activities with the knowledge that they can check how full their ostomy bag is in a private, discrete manner.

Trial registration: ClinicalTrials.gov NCT02319434; https://ichgcp.net/clinical-trials-registry/NCT02319434 (Archived at WebCite at http://www.webcitation.org/6xhFDThmq).

Keywords: eHealth; ostomy; quality of life.

Conflict of interest statement

Conflicts of Interest: The authors have no conflicts of interest to report and will not be rewarded in any way, either financially or other by 11 Health Technologies, LLC. Ostom-i alert sensors will be donated by 11 Health Technologies, LLC for use by enrolled study participants only.

©Dara Rouholiman, Jamison G Gamble, Sylvie D Dobrota, Ellen M Encisco, Ashish G Shah, Francisco J Grajales III, Larry F Chu. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 26.03.2018.

Figures

Figure 1
Figure 1
Screenshots from the Ostom-i patient app showing status, hydration, and graph.
Figure 2
Figure 2
Screenshot from the Ostom-i patient app showing user interface, status, hydration, and graph.
Figure 3
Figure 3
Participant flowchart. QOL-Ostomy: Quality of Life Questionnaire for a Patient with an Ostomy.

References

    1. Pittman J, Rawl SM, Schmidt CM, Grant M, Ko CY, Wendel C, Krouse RS. Demographic and clinical factors related to ostomy complications and quality of life in veterans with an ostomy. J Wound Ostomy Continence Nurs. 2008;35(5):493–503. doi: 10.1097/01.WON.0000335961.68113.cb.
    1. Pemberton JH, Phillips SF, Ready RR, Zinsmeister AR, Beahrs OH. Quality of life after Brooke ileostomy and ileal pouch-anal anastomosis. Comparison of performance status. Ann Surg. 1989 May;209(5):620–6; discussion 626.
    1. Souza Andrade R, Pinheiro de Medeiros L, Souza Freitas L, Galvão Queiroz C, Silva de Mesquita Xavier S, Paiva Lucena SK, de Vasconcelos Torres G, Fernandes Costa Assunção IK. Quality Of Life Regarding People With An Ostomy: Integrative Review About Related Factors. Int Arch Med. 2016 doi: 10.3823/2073.
    1. Maggard MA, Zingmond D, O'Connell JB, Ko CY. What proportion of patients with an ostomy (for diverticulitis) get reversed? Am Surg. 2004 Oct;70(10):928–31.
    1. Richbourg L, Fellows J, Arroyave WD. Ostomy pouch wear time in the United States. J Wound Ostomy Continence Nurs. 2008;35(5):504–8. doi: 10.1097/01.WON.0000335962.75737.b3.
    1. Husain SG, Cataldo TE. Late stomal complications. Clin Colon Rectal Surg. 2008 Feb;21(1):31–40. doi: 10.1055/s-2008-1055319.
    1. Sun V, Grant M, McMullen CK, Altschuler A, Mohler MJ, Hornbrook MC, Herrinton LJ, Baldwin CM, Krouse RS. Surviving colorectal cancer: long-term, persistent ostomy-specific concerns and adaptations. J Wound Ostomy Continence Nurs. 2013;40(1):61–72. doi: 10.1097/WON.0b013e3182750143.
    1. Miller KD, Siegel RL, Lin CC, Mariotto AB, Kramer JL, Rowland JH, Stein KD, Alteri R, Jemal A. Cancer treatment and survivorship statistics, 2016. CA Cancer J Clin. 2016 Jul;66(4):271–89. doi: 10.3322/caac.21349. doi: 10.3322/caac.21349.
    1. Jansen F, van UCF, Braakman JA, van KPM, Witte BI, Verdonck-de LIM. A mixed-method study on the generic and ostomy-specific quality of life of cancer and non-cancer ostomy patients. Support Care Cancer. 2015 Jun;23(6):1689–97. doi: 10.1007/s00520-014-2528-1.
    1. Sprangers MA, Taal BG, Aaronson NK, te VA. Quality of life in colorectal cancer. Stoma vs. nonstoma patients. Dis Colon Rectum. 1995 Apr;38(4):361–9.
    1. Krouse RS, Grant M, Rawl SM, Mohler MJ, Baldwin CM, Coons SJ, McCorkle R, Schmidt CM, Ko CY. Coping and acceptance: the greatest challenge for veterans with intestinal stomas. J Psychosom Res. 2009 Mar;66(3):227–33. doi: 10.1016/j.jpsychores.2008.09.009.
    1. Marquis P, Marrel A, Jambon B. Quality of life in patients with stomas: the Montreux Study. Ostomy Wound Manage. 2003 Feb;49(2):48–55.
    1. Castles T. Google Patents. 2004. Feb 24, [2017-05-02]. Portable ostomy management device
    1. Grant M, Ferrell B, Dean G, Uman G, Chu D, Krouse R. Revision and psychometric testing of the City of Hope Quality of Life-Ostomy Questionnaire. Qual Life Res. 2004 Oct;13(8):1445–57. doi: 10.1023/B:QURE.0000040784.65830.9f.
    1. Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473–83.
    1. Olbrisch M, Ziegler S W. Psychological adjustment and patient information in inflammatory bowel disease: development of two assessment instruments. J Chronic Dis. 1982;35(8):649–58.
    1. Qualtrics. Provo, Utah: 2005. [2017-05-02]. Stanford Medicine Qualtrics .
    1. Doerken S, Mockenhaupt M, Naldi L, Schumacher M, Sekula P. The case-crossover design via penalized regression. BMC Med Res Methodol. 2016 Dec 22;16:103. doi: 10.1186/s12874-016-0197-0.
    1. Friedman LM, Furberg C, DeMets DL. Fundamentals of Clinical Trials. Switzerland: Springer; 2015. Basic Study Design; pp. 89–121.
    1. Spectra Symbol Flex Sensors. 2017. May 02, [2018-03-12].
    1. Burckhardt CS. The Ostomy Adjustment Scale: Further evidence of reliability and validity. Rehabilitation Psychology. 1990;35(3):149–155. doi: 10.1037/h0079056.
    1. Gemmill R, Sun V, Ferrell B, Krouse RS, Grant M. Going with the flow: quality-of-life outcomes of cancer survivors with urinary diversion. J Wound Ostomy Continence Nurs. 2010;37(1):65–72. doi: 10.1097/WON.0b013e3181c68e8f.
    1. Krouse RS, Grant M, McCorkle R, Wendel CS, Cobb MD, Tallman NJ, Ercolano E, Sun V, Hibbard JH, Hornbrook MC. A chronic care ostomy self-management program for cancer survivors. Psychooncology. 2016 May;25(5):574–81. doi: 10.1002/pon.4078.
    1. Sun V, Grant M, Wendel CS, McMullen CK, Bulkley JE, Herrinton LJ, Hornbrook MC, Krouse RS. Sexual Function and Health-Related Quality of Life in Long-Term Rectal Cancer Survivors. J Sex Med. 2016 Dec;13(7):1071–9. doi: 10.1016/j.jsxm.2016.05.005.
    1. Chongpison Y, Hornbrook MC, Harris RB, Herrinton LJ, Gerald JK, Grant M, Bulkley JE, Wendel CS, Krouse RS. Self-reported depression and perceived financial burden among long-term rectal cancer survivors. Psychooncology. 2016 Nov;25(11):1350–1356. doi: 10.1002/pon.3957.
    1. Liu L, Herrinton LJ, Hornbrook MC, Wendel CS, Grant M, Krouse RS. Early and late complications among long-term colorectal cancer survivors with ostomy or anastomosis. Dis Colon Rectum. 2010 Feb;53(2):200–12. doi: 10.1007/DCR.0b013e3181bdc408.
    1. Mohler MJ, Coons SJ, Hornbrook MC, Herrinton LJ, Wendel CS, Grant M, Krouse RS. The health-related quality of life in long-term colorectal cancer survivors study: objectives, methods and patient sample. Curr Med Res Opin. 2008 Jul;24(7):2059–70. doi: 10.1185/03007990802118360.
    1. McHorney CA, Ware JE, Rachel Lu JF, Sherbourne CD. The MOS 36-ltem Short-Form Health Survey (SF-36): III. Tests of Data Quality, Scaling Assumptions, and Reliability Across Diverse Patient Groups. Medical Care. 1994;32(1):40–66. doi: 10.1097/00005650-199401000-00004.
    1. McHorney C A, Ware J E, Raczek A E. The MOS 36-Item Short-Form Health Survey (SF-36): II. Psychometric and clinical tests of validity in measuring physical and mental health constructs. Med Care. 1993 Mar;31(3):247–63.
    1. Jenkinson C, Wright L, Coulter A. Criterion validity and reliability of the SF-36 in a population sample. Qual Life Res. 1994 Feb;3(1):7–12.
    1. Ware JE. SF-36 health survey update. Spine (Phila Pa 1976) 2000 Dec 15;25(24):3130–9.
    1. Brydolf M, Berndtsson I, Lindholm E, Berglund B. Evaluation of a Swedish version of the Ostomy Adjustment Scale. Scand J Caring Sci. 1994;8(3):179–83.
    1. Zhang J, Wong FKY, Zheng M, Hu A, Zhang H. Psychometric Evaluation of the Ostomy Adjustment Scale in Chinese Cancer Patients With Colostomies. Cancer Nurs. 2015;38(5):395–405. doi: 10.1097/NCC.0000000000000213.
    1. Indrebø KL, Andersen JR, Natvig GK. The Ostomy Adjustment Scale: translation into Norwegian language with validation and reliability testing. J Wound Ostomy Continence Nurs. 2014;41(4):357–64. doi: 10.1097/WON.0000000000000041.
    1. Harris Paul A, Taylor Robert, Thielke Robert, Payne Jonathon, Gonzalez Nathaniel, Conde Jose G. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377–81. doi: 10.1016/j.jbi.2008.08.010.
    1. US Food and Drug Administration. 2016. [2017-01-02]. CFR - Code of Federal Regulations Title 21 .
    1. Lin JY, Lu Y. Establishing a data monitoring committee for clinical trials. Shanghai Arch Psychiatry. 2014 Feb;26(1):54–6. doi: 10.3969/j.issn.1002-0829.2014.01.009.
    1. Kumar N, Khunger M, Gupta A, Garg N. A content analysis of smartphone-based applications for hypertension management. J Am Soc Hypertens. 2015 Feb;9(2):130–6. doi: 10.1016/j.jash.2014.12.001.
    1. Bednarski BK, Slack RS, Katz M, You YN, Papadopolous J, Rodriguez-Bigas MA, Skibber JM, Matin SF, Chang GJ. Assessment of Ileostomy Output Using Telemedicine: A Feasibility Trial. Dis Colon Rectum. 2018 Jan;61(1):77–83. doi: 10.1097/DCR.0000000000000945.
    1. Symer MM, Abelson JS, Milsom J, McClure B, Yeo HL. A Mobile Health Application to Track Patients After Gastrointestinal Surgery: Results from a Pilot Study. J Gastrointest Surg. 2017 Sep;21(9):1500–1505. doi: 10.1007/s11605-017-3482-2.
    1. Topouchian J, Agnoletti D, Blacher J, Youssef A, Chahine MN, Ibanez I, Assemani N, Asmar R. Validation of four devices: Omron M6 Comfort, Omron HEM-7420, Withings BP-800, and Polygreen KP-7670 for home blood pressure measurement according to the European Society of Hypertension International Protocol. Vasc Health Risk Manag. 2014 Jan;10:33–44. doi: 10.2147/VHRM.S53968. doi: 10.2147/VHRM.S53968.
    1. Nicolucci A. Comparative Efficacy of iBGStar™ Glucose Meter vs. A Traditional Glucose Meter in Type 1 Diabetes. J Diabetes Metab. 2014;05(06) doi: 10.4172/2155-6156.1000382.
    1. Garabelli P, Stavrakis S, Po S. Smartphone-based arrhythmia monitoring. Curr Opin Cardiol. 2017 Jan;32(1):53–57. doi: 10.1097/HCO.0000000000000350.
    1. Leijdekkers P, Gay V. Personal heart monitoring and rehabilitation system using smart phones. International Conference on Mobile Business; Int Conf Mob Business, IEEE; 2006; Copenhagen, Denmark. 2007. Mar 12,
    1. Free C, Phillips G, Watson L, Galli L, Felix L, Edwards P, Patel V, Haines A. The effectiveness of mobile-health technologies to improve health care service delivery processes: a systematic review and meta-analysis. PLoS Med. 2013 Jan;10(1):e1001363. doi: 10.1371/journal.pmed.1001363.
    1. Bloss CS, Wineinger NE, Peters M, Boeldt DL, Ariniello L, Kim JY, Sheard J, Komatireddy R, Barrett P, Topol EJ. A prospective randomized trial examining health care utilization in individuals using multiple smartphone-enabled biosensors. PeerJ. 2016;4:e1554. doi: 10.7717/peerj.1554. doi: 10.7717/peerj.1554.

Source: PubMed

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