Improving Self-Management Skills Among People With Spinal Cord Injury: Protocol for a Mixed-Methods Study

W Ben Mortenson, Patricia Branco Mills, Jared Adams, Gurkaran Singh, Megan MacGillivray, Bonita Sawatzky, W Ben Mortenson, Patricia Branco Mills, Jared Adams, Gurkaran Singh, Megan MacGillivray, Bonita Sawatzky

Abstract

Background: Most people with spinal cord injury will develop secondary complications with potentially devastating consequences. Self-management is a key prevention strategy for averting the development of secondary complications and their recurrence. Several studies have shown that self-management programs improve self-management behaviors and health outcomes in individuals living with chronic conditions such as asthma, diabetes, hypertension, and arthritis. Given the burgeoning health care costs related to secondary complications, we developed an alternative electronic health-based implementation to facilitate the development of self-management skills among people with spinal cord injury.

Objective: This study aims to evaluate the efficacy of a self-management app in spinal cord injury populations. The primary outcome is attainment of self-selected, self-management goals. Secondary outcomes include increases in general and self-management self-efficacy and reductions in self-reported health events, health care utilization, and secondary complications related to spinal cord injury. This study also aims to explore how the intervention was implemented and how the app was experienced by end users.

Methods: This study will employ a mix of qualitative and quantitative methods. The quantitative portion of our study will involve a rater-blinded, randomized controlled trial with a stepped wedge design (ie, delayed intervention control group). The primary outcome is successful goal attainment, and secondary outcomes include increases in self-efficacy and reductions in self-reported health events, health care utilization, and secondary conditions related to spinal cord injury. The qualitative portion will consist of semistructured interviews with a subsample of the participants.

Results: We expect that the mobile self-management app will help people with spinal cord injury to attain their self-management goals, improve their self-efficacy, reduce secondary complications, and decrease health care utilization.

Conclusions: If the results are positive, this study will produce credible new knowledge describing multiple outcomes that people with spinal cord injury realize from an app-based self-management intervention and support its implementation in clinical practice.

Trial registration: ClinicalTrials.gov NCT03140501; https://ichgcp.net/clinical-trials-registry/NCT03140501 (Archived by WebCite at http://www.webcitation.org/73Gw0ZlWZ).

International registered report identifier (irrid): PRR1-10.2196/11069.

Keywords: eHealth; mHealth; self-management; spinal cord injury.

Conflict of interest statement

Conflicts of Interest: The authors WBM, GS, MM, PBM, and BS report no real or perceived conflicts of interest. JA has a conflict of interest as he works as a research and development officer for Self Care Catalysts, a company that may benefit from the research on this mobile app. Conflict of interest will be mitigated by Self Catalysts (including JA) having no access to any research data, which will remain on the University of British Columbia premises. JA will not be involved in the analysis of collected data but will be involved in reviewing future manuscripts on this study.

©W Ben Mortenson, Patricia Branco Mills, Jared Adams, Gurkaran Singh, Megan MacGillivray, Bonita Sawatzky. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 14.11.2018.

Figures

Figure 1
Figure 1
Study design.
Figure 2
Figure 2
Detailed overview of the study procedures.

References

    1. Singh A, Tetreault L, Kalsi-Ryan S, Nouri A, Fehlings MG. Global prevalence and incidence of traumatic spinal cord injury. Clin Epidemiol. 2014;6:309–31. doi: 10.2147/CLEP.S68889. doi: 10.2147/CLEP.S68889.
    1. Aghayan H, Arjmand B, Yaghoubi M, Moradi-Lakeh M, Kashani H, Shokraneh F. Clinical outcome of autologous mononuclear cells transplantation for spinal cord injury: a systematic review and meta-analysis. Med J Islam Repub Iran. 2014;28:112.
    1. Sabapathy V, Tharion G, Kumar S. Cell therapy augments functional recovery subsequent to spinal cord injury under experimental conditions. Stem Cells Int. 2015;2015:132172. doi: 10.1155/2015/132172. doi: 10.1155/2015/132172.
    1. Noreau L, Proulx P, Gagnon L, Drolet M, Laramée MT. Secondary impairments after spinal cord injury: a population-based study. Am J Phys Med Rehabil. 2000;79(6):526–35. doi: 10.1097/00002060-200011000-00009.
    1. Anson CA, Shepherd C. Incidence of secondary complications in spinal cord injury. Int J Rehabil Res. 1996 Mar;19(1):55–66. doi: 10.1097/00004356-199603000-00006.
    1. McKinley WO, Jackson AB, Cardenas DD, DeVivo MJ. Long-term medical complications after traumatic spinal cord injury: a regional model systems analysis. Arch Phys Med Rehabil. 1999 Nov;80(11):1402–10. doi: 10.1016/S0003-9993(99)90251-4.
    1. Dryden DM, Saunders LD, Rowe BH, May LA, Yiannakoulias N, Svenson LW, Schopflocher DP, Voaklander DC. Depression following traumatic spinal cord injury. Neuroepidemiology. 2005;25(2):55–61. doi: 10.1159/000086284.
    1. Savic G, Charlifue S, Glass C, Soni BM, Gerhart KA, Jamous MA. British Ageing with SCI study: changes in physical and psychosocial outcomes over time. Top Spinal Cord Inj Rehabil. 2010 Jan;15(3):41–53. doi: 10.1310/sci1503-41.
    1. Sibbald R, Chapman P, Contreras-Ruiz J. The role of bacteria in pressure ulcers. In: Romanelli M, Clark M, Cherry G, Colin D, Defloor T, editors. Science and Practice of Pressure Ulcer Management. London: Springer-Verlag; 2006. pp. 139–62.
    1. Palese A, Luisa S, Ilenia P, Laquintana D, Stinco G, Di Giulio P, PARI-ETLD Group What is the healing time of stage II pressure ulcers? Findings from a secondary analysis. Adv Skin Wound Care. 2015 Feb;28(2):69–75. doi: 10.1097/01.ASW.0000459964.49436.ce.
    1. Azimian J, Dehghan Nayeri N, Pourkhaleghi E, Ansari M. Transdermal wound oxygen therapy on pressure ulcer healing: a single-blind multi-center randomized controlled trial. Iran Red Crescent Med J. 2015 Nov;17(11):e20211. doi: 10.5812/ircmj.20211.
    1. Moore ZE, Webster J, Samuriwo R. Wound-care teams for preventing and treating pressure ulcers. Cochrane Database Syst Rev. 2015 Sep 16;(9):CD011011. doi: 10.1002/14651858.CD011011.pub2.
    1. Lorig KR, Sobel DS, Stewart AL, Brown Jr BW, Bandura A, Ritter P, Gonzalez VM, Laurent DD, Holman HR. Evidence suggesting that a chronic disease self-management program can improve health status while reducing hospitalization: a randomized trial. Med Care. 1999 Jan;37(1):5–14.
    1. Barlow J, Wright C, Sheasby J, Turner A, Hainsworth J. Self-management approaches for people with chronic conditions: a review. Patient Educ Couns. 2002;48(2):177–87. doi: 10.1016/S0738-3991(02)00032-0.
    1. Hirsche RC, Williams B, Jones A, Manns P. Chronic disease self-management for individuals with stroke, multiple sclerosis and spinal cord injury. Disabil Rehabil. 2011;33(13-14):1136–46. doi: 10.3109/09638288.2010.523103.
    1. Redmond BF. Wikispaces.psu. 2016. [2018-10-15]. Self-Efficacy and Social Cognitive Theories .
    1. McAlister AL, Perry CL, Parcel GS. How individuals, environments, and health behaviors interact: social cognitive theory. In: Glanz K, Rimer BK, Viswanath K, editors. Health Behavior and Health Education: Theory, Research, and Practice. San Francisco, CA: Jossey-Bass; 2008. pp. 169–188.
    1. de Jongh T, Gurol-Urganci I, Vodopivec-Jamsek V, Car J, Atun R. Mobile phone messaging for facilitating self-management of long-term illnesses. Cochrane Database Syst Rev. 2012 Dec 12;12:CD007459. doi: 10.1002/14651858.CD007459.pub2.
    1. Wangberg SC. An internet-based diabetes self-care intervention tailored to self-efficacy. Health Educ Res. 2008 Feb;23(1):170–9. doi: 10.1093/her/cym014.
    1. Lewis TL, Boissaud-Cooke MA, Aungst TD, Eysenbach G. Consensus on use of the term “App” versus “Application” for reporting of mHealth research. J Med Internet Res. 2014 Jul 17;16(7):e174. doi: 10.2196/jmir.3460.
    1. Lorig KR, Ritter PL, Laurent DD, Plant K. Internet-based chronic disease self-management: a randomized trial. Med Care. 2006 Nov;44(11):964–71. doi: 10.1097/01.mlr.0000233678.80203.c1.
    1. Wantland DJ, Portillo CJ, Holzemer WL, Slaughter R, McGhee EM. The effectiveness of web-based vs non-web-based interventions: a meta-analysis of behavioral change outcomes. J Med Internet Res. 2004 Nov 10;6(4):e40. doi: 10.2196/jmir.6.4.e40.
    1. Heron KE, Smyth JM. Ecological momentary interventions: incorporating mobile technology into psychosocial and health behaviour treatments. Br J Health Psychol. 2010;15(1):1–39. doi: 10.1348/135910709X466063.
    1. Horan PP, Yarborough MC, Besigel G, Carlson DR. Computer-assisted self-control of diabetes by adolescents. Diabetes Educ. 1990;16(3):205–11. doi: 10.1177/014572179001600311.
    1. Quinn CC, Shardell MD, Terrin ML, Barr EA, Ballew SH, Gruber-Baldini AL. Cluster-randomized trial of a mobile phone personalized behavioral intervention for blood glucose control. Diabetes Care. 2011;34(9):1934–42. doi: 10.2337/dc11-0366.
    1. Bell AM, Fonda SJ, Walker MS, Schmidt V, Vigersky RA. Mobile phone-based video messages for diabetes self-care support. J Diabetes Sci Technol. 2012;6(2):310–9. doi: 10.1177/193229681200600214.
    1. Shetty AS, Chamukuttan S, Nanditha A, Raj RK, Ramachandran A. Reinforcement of adherence to prescription recommendations in Asian Indian diabetes patients using short message service (SMS)--a pilot study. J Assoc Physicians India. 2011 Nov;59:711–4.
    1. Zolfaghari M, Mousavifar SA, Pedram S, Haghani H. The impact of nurse short message services and telephone follow-ups on diabetic adherence: which one is more effective? J Clin Nurs. 2012;21(13-14):1922–31. doi: 10.1111/j.1365-2702.2011.03951.x.
    1. Wilde MH, McMahon JM, McDonald MV, Tang W, Wang W, Brasch J, Fairbanks E, Shah S, Zhang F, Chen DD. Self-management intervention for long-term indwelling urinary catheter users: randomized clinical trial. Nurs Res. 2015;64(1):24–34. doi: 10.1097/NNR.0000000000000071.
    1. Tung JY, Stead B, Mann W, Pham Ba', Popovic MR. Assistive technologies for self-managed pressure ulcer prevention in spinal cord injury: a scoping review. J Rehabil Res Dev. 2015;52(2):131–46. doi: 10.1682/JRRD.2014.02.0064.
    1. Mortenson WB, Sawatzky B, Mahsa S, Adams J, Mills P. Development of an App to Improve Self-management Skills among People with Spinal Cord Injury. Praxis 2016; April 25, 2016; Vancouver. 2016.
    1. Creswell J, Clark V. Designing and Conducting Mixed-Methods Research. Thousand Oaks, CA: Sage Publications; 2006.
    1. Brown CA, Lilford RJ. The stepped wedge trial design: a systematic review. BMC Med Res Methodol. 2006 Nov 08;6:54. doi: 10.1186/1471-2288-6-54.
    1. Oakley A, Strange V, Bonell C, Allen E, Stephenson J, RIPPLE Study Team Process evaluation in randomised controlled trials of complex interventions. Br Med J. 2006 Feb 18;332(7538):413–6. doi: 10.1136/bmj.332.7538.413.
    1. Martin Ginis KA, Phang SH, Latimer AE, Arbour-Nicitopoulos KP, Lewin S, Glenton C, Oxman AD. Use of qualitative methods alongside randomised controlled trials of complex healthcare interventions: methodological study. Br Med J. 2009;339:b3496. doi: 10.1136/bmj.b3496.
    1. Streubert H, Carpenter D. Qualitative Research in Nursing: Advancing the Humanistic Imperative. Philadelphia: Lippincott Williams and Wilkins; 2003. Triangulation as a qualitative research strategy.
    1. Schulz KF, Altman DG, Moher D, CONSORT Group CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 2010 Mar 24;8:18. doi: 10.1186/1741-7015-8-18.
    1. Robinson JH, Callister LC, Berry JA, Dearing KA. Patient-centered care and adherence: definitions and applications to improve outcomes. J Am Acad Nurse Pract. 2008 Dec;20(12):600–7. doi: 10.1111/j.1745-7599.2008.00360.x.
    1. Cott CA, Teare G, McGilton KS, Lineker S. Reliability and construct validity of the client-centred rehabilitation questionnaire. Disabil Rehabil. 2006 Nov 30;28(22):1387–97. doi: 10.1080/09638280600638398.
    1. Stewart M, Brown JB, Donner A, McWhinney IR, Oates J, Weston WW, Jordan J. The impact of patient-centered care on outcomes. J Fam Pract. 2000 Sep;49(9):796–804.
    1. Ruble L, McGrew JH, Toland MD. Goal attainment scaling as an outcome measure in randomized controlled trials of psychosocial interventions in autism. J Autism Dev Disord. 2012 Sep;42(9):1974–83. doi: 10.1007/s10803-012-1446-7.
    1. Kiresuk TJ, Sherman RE. Goal attainment scaling: a general method for evaluating comprehensive community mental health programs. Community Ment Health J. 1968 Dec;4(6):443–53. doi: 10.1007/BF01530764.
    1. Higano K, Shibayama T, Ichikawa M, Motomura M, Shimano H, Kawakami Y, Furuya K, Kawaguchi T. The effects of telenursing with goal attainment scaling in diabetic patients: a case report. Int J Nurs Clin Pract. 2015 Feb 18;2:117. doi: 10.15344/2394-4978/2015/117.
    1. Anderson AR, Christison-Lagay J, Procter-Gray E. Self-management goal setting in a community health center: the impact of goal attainment on diabetes outcomes. Diabetes Spectr. 2010 May 13;23(2):97–105. doi: 10.2337/diaspect.23.2.97.
    1. Turner-Stokes L, Baguley IJ, De Graaff S, Katrak P, Davies L, McCrory P, Hughes A. Goal attainment scaling in the evaluation of treatment of upper limb spasticity with botulinum toxin: a secondary analysis from a double-blind placebo-controlled randomized clinical trial. J Rehabil Med. 2010 Jan;42(1):81–9. doi: 10.2340/16501977-0474.
    1. Koski J, Richards LG. Reliability and sensitivity to change of goal attainment scaling in occupational therapy nonclassroom educational experiences. Am J Occup Ther. 2015;69 Suppl 2:6912350030p1–5. doi: 10.5014/ajot.2015.016535.
    1. Khan F, Pallant JF, Turner-Stokes L. Use of goal attainment scaling in inpatient rehabilitation for persons with multiple sclerosis. Arch Phys Med Rehabil. 2008 Apr;89(4):652–9. doi: 10.1016/j.apmr.2007.09.049.
    1. Steenbeek D, Gorter JW, Ketelaar M, Galama K, Lindeman E. Responsiveness of Goal Attainment Scaling in comparison to two standardized measures in outcome evaluation of children with cerebral palsy. Clin Rehabil. 2011 Dec;25(12):1128–39. doi: 10.1177/0269215511407220.
    1. Tennant A. Goal attainment scaling: current methodological challenges. Disabil Rehabil. 2007;29(20-21):1583–8. doi: 10.1080/09638280701618828.
    1. Palisano RJ, Haley SM, Brown D. Goal attainment scaling as a measure of change in infants with motor delays. Phys Ther. 1992 Jun;72(6):432–7.
    1. Lynch J, Lorig K, Stewart Al, Gonzalez V, Ritter P. Outcome Measures for Health Education and Other Health Care Interventions. Thousand Oaks, CA: Sage Publications, Inc; 1996.
    1. Lorig KR, Sobel DS, Ritter PL, Laurent D, Hobbs M. Effect of a self-management program on patients with chronic disease. Eff Clin Pract. 2001;4(6):256–62.
    1. Pang MY, Eng JJ, Lin KH, Tang PF, Hung C, Wang YH. Association of depression and pain interference with disease-management self-efficacy in community-dwelling individuals with spinal cord injury. J Rehabil Med. 2009 Nov;41(13):1068–73. doi: 10.2340/16501977-0455.
    1. Lester K, Stepleman L, Hughes M. The association of illness severity, self-reported cognitive impairment, and perceived illness management with depression and anxiety in a multiple sclerosis clinic population. J Behav Med. 2007 Apr;30(2):177–86. doi: 10.1007/s10865-007-9095-6.
    1. Dal Bello-Haas V, Klassen L, Sheppard MS, Metcalfe A. Psychometric properties of activity, self-efficacy and quality-of-life measures in individuals with parkinson disease. Physiother Can. 2011;63(1):47–57. doi: 10.3138/ptc.2009-08.
    1. Kalpakjian CZ, Scelza WM, Forchheimer MB, Toussaint LL. Preliminary reliability and validity of a Spinal Cord Injury Secondary Conditions Scale. J Spinal Cord Med. 2007;30(2):131–9. doi: 10.1080/10790268.2007.11753924.
    1. Brooks R. EuroQol: the current state of play. Health Policy. 1996 Jul;37(1):53–72. doi: 10.1016/0168-8510(96)00822-6.
    1. Conner-Spady BL, Marshall DA, Bohm E, Dunbar MJ, Loucks L, Al Khudairy A, Noseworthy TW. Reliability and validity of the EQ-5D-5L compared to the EQ-5D-3L in patients with osteoarthritis referred for hip and knee replacement. Qual Life Res. 2015 Jul;24(7):1775–84. doi: 10.1007/s11136-014-0910-6.
    1. Miller W, Chan C. Scireproject. [2018-02-15]. Spinal Cord Independence Measure (SCIM)
    1. Payne TJ, Andrew M, Butler KR, Wyatt SB, Dubbert PM, Mosley TH. Psychometric evaluation of the Interpersonal Support Evaluation List–Short Form in the ARIC study cohort. SAGE Open. 2012 Sep 26;2(3):215824401246192–8. doi: 10.1177/2158244012461923.
    1. Williams GC, Grow VM, Freedman ZR, Ryan RM, Deci EL. Motivational predictors of weight loss and weight-loss maintenance. J Pers Soc Psychol. 1996 Jan;70(1):115–26. doi: 10.1037/0022-3514.70.1.115.
    1. Stoyanov SR, Hides L, Kavanagh DJ, Zelenko O, Tjondronegoro D, Mani M. Mobile app rating scale: a new tool for assessing the quality of health mobile apps. JMIR Mhealth Uhealth. 2015 Mar 11;3(1):e27. doi: 10.2196/mhealth.3422.
    1. Martin Ginis KA, Phang SH, Latimer AE, Arbour-Nicitopoulos KP. Reliability and validity tests of the leisure time physical activity questionnaire for people with spinal cord injury. Arch Phys Med Rehabil. 2012 Apr;93(4):677–82. doi: 10.1016/j.apmr.2011.11.005.
    1. Parasuraman A. Technology Readiness Index (Tri): a multiple-item scale to measure readiness to embrace new technologies. J Serv Res. 2016 Jun 29;2(4):307–20. doi: 10.1177/109467050024001.
    1. Lenker JA, Fuhrer MJ, Jutai JW, Demers L, Scherer MJ, DeRuyter F. Treatment theory, intervention specification, and treatment fidelity in assistive technology outcomes research. Assist Technol. 2010;22(3):129–38. doi: 10.1080/10400430903519910.
    1. Borrelli B, Sepinwall D, Ernst D, Bellg AJ, Czajkowski S, Breger R, DeFrancesco C, Levesque C, Sharp DL, Ogedegbe G, Resnick B, Orwig D. A new tool to assess treatment fidelity and evaluation of treatment fidelity across 10 years of health behavior research. J Consult Clin Psychol. 2005 Oct;73(5):852–60. doi: 10.1037/0022-006X.73.5.852.
    1. Katzman R, Brown T, Fuld P, Peck A, Schechter R, Schimmel H. Validation of a short Orientation-Memory-Concentration Test of cognitive impairment. Am J Psychiatry. 1983 Jun;140(6):734–9. doi: 10.1176/ajp.140.6.734.
    1. Mortenson WB, Oliffe JL. Mixed methods research in occupational therapy: a survey and critique. OTJR (Thorofare N J) 2009 Jan;29(1):14–23. doi: 10.1177/153944920902900103.
    1. Tashakkori AM, Teddlie CB. Mixed Methodology: Combining Qualitative and Quantitative Approaches (Applied Social Research Methods Series #46) Thousand Oaks, CA: Sage Publications; 1998.
    1. Hammell KW, Carpenter C, Dyck I. Using Qualitative Research: A Practical Introduction for Occupational and Physical Therapists. London: Elsevier Health Sciences; 2000.
    1. Diggle P, Zeger SL, Liang KY, Heagerty P. Analysis of Longitudinal Data (Oxford Statistical Science Series) Oxford: Oxford University Press; 2018.
    1. Morse JM, Feild PA. Qualitative Research Methods for Health Professionals. Thousand Oaks, CA: Sage Publications; 2006.
    1. Sandelowski M. Sample size in qualitative research. Res Nurs Health. 1995 Apr;18(2):179–83. doi: 10.1002/nur.4770180211.
    1. Pinheiro JC, Glynn IM. Mixed Effects Models in S and S-Plus. New York: Springer-Verlag; 2000.
    1. Breslow NE, Clayton DG. Approximate inference in generalized linear mixed models. J Am Stat Assoc. 1993 Mar;88(421):9–25. doi: 10.2307/2290687.
    1. IBM SSPS Statistics. Armonk, New York: IBM Corp; 2012.
    1. Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006 Jan;3(2):77–101. doi: 10.1191/1478088706qp063oa.
    1. Sibbald B, Roland M. Understanding controlled trials. Why are randomised controlled trials important? Br Med J. 1998 Jan 17;316(7126):201.
    1. Krefting L. Rigor in qualitative research: the assessment of trustworthiness. Am J Occup Ther. 1991 Mar;45(3):214–22. doi: 10.5014/ajot.45.3.214.
    1. Mortenson B, MacGillivray M, Sadeghi M, Singh G, Adams J, Mills P, Sawatzky B. Effect of a mobile application on the self-management skills of people with spinal cord injury. Canadian Association of Occupational Therapists National Conference; June 19, 2018; Charlottetown, PEI. 2018.

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