Telehealth Transition Assistance Program for Acute Spinal Cord Injury Caregivers: Protocol for a Mixed-Methods, Randomized Controlled Trial

Paul B Perrin, Scott D McDonald, Jack D Watson, Bradford S Pierce, Timothy R Elliott, Paul B Perrin, Scott D McDonald, Jack D Watson, Bradford S Pierce, Timothy R Elliott

Abstract

Background: While spinal cord injury (SCI) caregiving can be a rewarding experience, caregivers often experience reduced mental and physical health.

Objective: This article describes the methodology of a study examining the efficacy of a newly developed telehealth Transition Assistance Program (TAP) for caregivers of individuals with acute SCI.

Methods: A mixed-methods, randomized controlled trial is comparing TAP outcomes to that of a standard-of-care control. The study is recruiting for 48 months and incorporating quantitative outcome measures.

Results: This study was funded by the Craig H. Neilsen Foundation in April 2017. It was approved by the institutional review boards at Virginia Commonwealth University and the Hunter Holmes McGuire Veterans Affairs Medical Center that same year. Participant recruitment and data collection began in 2018.

Conclusions: This study is implementing and testing an SCI caregiver intervention unlike any created before, targeting a critical time period that, until now, other SCI caregiver interventions have overlooked. Research personnel intend to disseminate the intervention and study findings through the publication of manuscripts and presentations at conferences. If the current study shows improvements in caregiver or patient well-being, the TAP for SCI caregivers could become part of the standard of care for acute SCI.

Trial registration: ClinicalTrials.gov NCT03244098; https://www.clinicaltrials.gov/ct2/show/NCT03244098.

International registered report identifier (irrid): DERR1-10.2196/28256.

Keywords: caregiver; methodology; spinal cord injury; telehealth.

Conflict of interest statement

Conflicts of Interest: None declared.

©Paul B Perrin, Scott D McDonald, Jack D Watson, Bradford S Pierce, Timothy R Elliott. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 29.03.2021.

Figures

Figure 1
Figure 1
Randomized controlled trial timeline.

References

    1. Spinal Cord Injury Facts and Figures at a Glance. National Spinal Cord Injury Statistical Center. 2020. [2021-03-07]. .
    1. Priebe MM, Chiodo AE, Scelza WM, Kirshblum SC, Wuermser L, Ho CH. Spinal cord injury medicine. 6. Economic and societal issues in spinal cord injury. Arch Phys Med Rehabil. 2007 Mar;88(3 Suppl 1):S84–8. doi: 10.1016/j.apmr.2006.12.005.
    1. Harper LA, Coleman JA, Perrin PB, Olivera SL, Perdomo JL, Arango JA, Arango-Lasprilla JC. Comparison of mental health between individuals with spinal cord injury and able-bodied controls in Neiva, Colombia. J Rehabil Res Dev. 2014;51(1):127–136. doi: 10.1682/jrrd.2013.04.0086.
    1. Vissers M, van den Berg-Emons R, Sluis T, Bergen M, Stam H, Bussmann H. Barriers to and facilitators of everyday physical activity in persons with a spinal cord injury after discharge from the rehabilitation centre. J Rehabil Med. 2008 Jun;40(6):461–7. doi: 10.2340/16501977-0191.
    1. Coleman J, Harper L, Perrin PB, Olivera SL, Perdomo JL, Arango JA, Arango-Lasprilla JC. The relationship between physical and mental health variables in individuals with spinal cord injury from Latin America. PM R. 2015 Jan;7(1):9–16. doi: 10.1016/j.pmrj.2014.07.009.
    1. Chen H, Boore JRP. Living with a relative who has a spinal cord injury: A grounded theory approach. J Clin Nurs. 2009 Jan;18(2):174–82. doi: 10.1111/j.1365-2702.2008.02355.x.
    1. Elliott TR, Berry JW, Richards JS, Shewchuk RM. Resilience in the initial year of caregiving for a family member with a traumatic spinal cord injury. J Consult Clin Psychol. 2014 Dec;82(6):1072–86. doi: 10.1037/a0037593.
    1. Schulz R, Newsom J, Mittelmark M, Burton L, Hirsch C, Jackson S. Health effects of caregiving: The caregiver health effects study: An ancillary study of the cardiovascular health study. Ann Behav Med. 1997 Jun;19(2):110–116. doi: 10.1007/bf02883327.
    1. Gajraj-Singh P. Psychological impact and the burden of caregiving for persons with spinal cord injury (SCI) living in the community in Fiji. Spinal Cord. 2011 Aug 8;49(8):928–34. doi: 10.1038/sc.2011.15.
    1. Post MWM, Bloemen J, de Witte LP. Burden of support for partners of persons with spinal cord injuries. Spinal Cord. 2005 May 1;43(5):311–9. doi: 10.1038/sj.sc.3101704.
    1. Schulz R, Czaja SJ, Lustig A, Zdaniuk B, Martire LM, Perdomo D. Improving the quality of life of caregivers of persons with spinal cord injury: A randomized controlled trial. Rehabil Psychol. 2009 Feb;54(1):1–15. doi: 10.1037/a0014932.
    1. Boschen KA, Tonack M, Gargaro J. The impact of being a support provider to a person living in the community with a spinal cord injury. Rehabil Psychol. 2005;50(4):397–407. doi: 10.1037/0090-5550.50.4.397.
    1. Conti A, Garrino L, Montanari P, Dimonte V. Informal caregivers' needs on discharge from the spinal cord unit: Analysis of perceptions and lived experiences. Disabil Rehabil. 2016 Apr 10;38(2):159–67. doi: 10.3109/09638288.2015.1031287.
    1. Shewchuk RM, Richards JS, Elliott TR. Dynamic processes in health outcomes among caregivers of patients with spinal cord injuries. Health Psychol. 1998;17(2):125–129. doi: 10.1037/0278-6133.17.2.125.
    1. Gan C, Gargaro J, Brandys C, Gerber G, Boschen K. Family caregivers' support needs after brain injury: A synthesis of perspectives from caregivers, programs, and researchers. NeuroRehabilitation. 2010 Jul 06;27(1):5–18. doi: 10.3233/nre-2010-0577.
    1. Rodgers ML, Strode AD, Norell DM, Short RA, Dyck DG, Becker B. Adapting multiple-family group treatment for brain and spinal cord injury intervention development and preliminary outcomes. Am J Phys Med Rehabil. 2007 Jun;86(6):482–92. doi: 10.1097/PHM.0b013e31805c00a1.
    1. Kurylo MF, Elliott TR, Shewchuk RM. FOCUS on the family caregiver: A problem-solving training intervention. J Couns Dev. 2011 Dec 23;79(3):275–81. doi: 10.1002/j.1556-6676.2001.tb01972.x.
    1. Elliott TR, Berry JW. Brief problem-solving training for family caregivers of persons with recent-onset spinal cord injuries: A randomized controlled trial. J Clin Psychol. 2009 Apr;65(4):406–22. doi: 10.1002/jclp.20527.
    1. Molazem Z, Falahati T, Jahanbin I, Jafari P, Ghadakpour S. The effect of psycho-educational interventions on the quality of life of the family caregivers of the patients with spinal cord injury: A randomized controlled trial. Int J Community Based Nurs Midwifery. 2014 Jan;2(1):31–9.
    1. Hearn JH, Cotter I, Finlay KA. Efficacy of internet-delivered mindfulness for improving depression in caregivers of people with spinal cord injuries and chronic neuropathic pain: A randomized controlled feasibility trial. Arch Phys Med Rehabil. 2019 Jan;100(1):17–25. doi: 10.1016/j.apmr.2018.08.182.
    1. Juguera Rodríguez L, Pardo Ríos M, Castillo Hermoso M, Pérez Alonso N, Leal Costa C, Díaz Agea JL. Impact of simulation-based learning on family caregivers during the rehabilitation period of individuals with spinal cord injury. Spinal Cord. 2020 Jan 20;58(1):95–105. doi: 10.1038/s41393-019-0343-8.
    1. Perrin PB, Johnston A, Vogel B, Heesacker M, Vega-Trujillo M, Anderson J, Rittman M. A culturally sensitive Transition Assistance Program for stroke caregivers: Examining caregiver mental health and stroke rehabilitation. J Rehabil Res Dev. 2010;47(7):605–17. doi: 10.1682/jrrd.2009.10.0170.
    1. Arango-Lasprilla JC, Plaza SLO, Drew A, Romero JLP, Pizarro JAA, Francis K, Kreutzer J. Family needs and psychosocial functioning of caregivers of individuals with spinal cord injury from Colombia, South America. NeuroRehabilitation. 2010 Jul 06;27(1):83–93. doi: 10.3233/nre-2010-0583.
    1. Dooley WK, Shaffer DR, Lance CE, Williamson GM. Informal care can be better than adequate: Development and evaluation of the Exemplary Care Scale. Rehabil Psychol. 2007 Nov;52(4):359–69. doi: 10.1037/0090-5550.52.4.359.
    1. Itzkovich M, Gelernter I, Biering-Sorensen F, Weeks C, Laramee MT, Craven BC, Tonack M, Hitzig SL, Glaser E, Zeilig G, Aito S, Scivoletto G, Mecci M, Chadwick RJ, El Masry WS, Osman A, Glass CA, Silva P, Soni BM, Gardner BP, Savic G, Bergström EM, Bluvshtein V, Ronen J, Catz A. The Spinal Cord Independence Measure (SCIM) version III: reliability and validity in a multi-center international study. Disabil Rehabil. 2007 Dec 30;29(24):1926–33. doi: 10.1080/09638280601046302.
    1. Eaton WW, Smith C, Ybarra M, Muntaner C, Tien A. Center for Epidemiologic Studies Depression Scale: Review and revision (CESD and CESD-R) In: Maruish ME, editor. The use of psychological testing for treatment planning and outcomes assessment: Instruments for adults. Mahwah, NJ: Lawrence Erlbaum Associates Publishers; 2004. pp. 363–377.
    1. Radloff LS. The CES-D Scale: A self-report depression scale for research in the general population. Appl Psychol Meas. 1977 Jun 01;1(3):385–401. doi: 10.1177/014662167700100306.
    1. Cousineau N, McDowell I, Hotz S, Hébert P. Measuring chronic patients' feelings of being a burden to their caregivers: Development and preliminary validation of a scale. Med Care. 2003 Jan;41(1):110–8. doi: 10.1097/00005650-200301000-00013.
    1. Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: Correlates of feelings of burden. Gerontologist. 1980 Dec 01;20(6):649–55. doi: 10.1093/geront/20.6.649.
    1. Steffen AM, McKibbin C, Zeiss AM, Gallagher-Thompson D, Bandura A. The revised scale for caregiving self-efficacy: Reliability and validity studies. J Gerontol B Psychol Sci Soc Sci. 2002 Jan 01;57(1):P74–86. doi: 10.1093/geronb/57.1.p74.
    1. Findler M, Cantor J, Haddad L, Gordon W, Ashman T. The reliability and validity of the SF-36 health survey questionnaire for use with individuals with traumatic brain injury. Brain Inj. 2009 Jul 03;15(8):715–23. doi: 10.1080/02699050118193.
    1. Bertisch H, Kalpakjian CZ, Kisala PA, Tulsky DS. Measuring positive affect and well-being after spinal cord injury: Development and psychometric characteristics of the SCI-QOL Positive Affect and Well-being bank and short form. J Spinal Cord Med. 2015 May 26;38(3):356–65. doi: 10.1179/2045772315y.0000000024.
    1. Tabachnick BG, Fidell LS, Osterlind SJ. Using Multivariate Statistics. Boston, MA: Allyn and Bacon; 2001.
    1. Sanchez Gonzalez ML, McCord CE, Dopp AR, Tarlow KR, Dickey NJ, McMaughan DK, Elliott TR. Telemental health training and delivery in primary care: A case report of interdisciplinary treatment. J Clin Psychol. 2019 Feb 27;75(2):260–70. doi: 10.1002/jclp.22719.

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