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Protocol for a clinical trial of telehealth-based social communication skills training for people with traumatic brain injury and their communication partners

Published online by Cambridge University Press:  29 May 2019

Rachael Rietdijk*
Affiliation:
The University of Sydney, Faculty of Health Sciences, Sydney, New South Wales, Australia
Emma Power
Affiliation:
The University of Sydney, Faculty of Health Sciences, Sydney, New South Wales, Australia The University of Technology Sydney, Graduate School of Health, Sydney, New South Wales, Australia
Melissa Brunner
Affiliation:
The University of Technology Sydney, Graduate School of Health, Sydney, New South Wales, Australia
Leanne Togher
Affiliation:
The University of Sydney, Faculty of Health Sciences, Sydney, New South Wales, Australia
*
*Corresponding author. Email: rman7827@uni.sydney.edu.au
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Abstract

Background: A previous clinical trial of training communication partners of people with traumatic brain injury (TBI) demonstrated positive outcomes [Togher, Power, McDonald, Tate, & Rietdijk (2009). Brain Impairment, 10(2), 188-204]. Adapting communication partner training for delivery via telehealth could improve access to this intervention.

Objectives: To compare outcomes across in-person communication partner training, telehealth communication partner training and a control group

Method: Protocol for a partially randomised controlled trial. People with moderate-severe TBI will be allocated to either an in-person or telehealth-based training program. Comparison data will be drawn from the original trial control group, which was recruited using the same eligibility criteria as this protocol. Outcomes after training will be compared between the in-person training group, the telehealth training group and the historical control group.

Discussion: This protocol uses specific design features with the aim of maximising the study’s power, including a partially randomised allocation process and a historical control group. The results will inform about the feasibility and effectiveness of delivering TBI rehabilitation via telehealth.

Trial registration: Australian and New Zealand Clinical Trials Registry: ACTRN12615001024538.

Type
Research Protocol
Copyright
© Australasian Society for the Study of Brain Impairment 2019 

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References

American Speech-Language-Hearing Association. (2018). Traumatic brain injury in adults practice portal. Retrieved from https://www.asha.org/PRPSpecificTopic.aspx?folderid=8589935337&section=Overview.Google Scholar
Australian Government Department of Human Services. (2019). Telehealth areas. Retrieved from https://www.humanservices.gov.au/organisations/health-professionals/services/medicare/mbs-and-telehealth/about/telehealth-areas.Google Scholar
Avramovic, P., Kenny, B., Power, E., McDonald, S., Tate, R., Hunt, L., … Togher, L. (2017). Exploring the relationship between cognition and functional verbal reasoning in adults with severe traumatic brain injury at six months post injury. Brain Injury, 31(4), 502516. doi: 10.1080/02699052.2017.1280854.CrossRefGoogle ScholarPubMed
Babbitt, E. M., Heinemann, A. W., Semik, P., & Cherney, L. R. (2011). Psychometric properties of the Communication Confidence Rating Scale for Aphasia (CCRSA): Phase 2. Aphasiology, 25(6–7), 727735. doi: 10.1080/02687038.2010.537347.CrossRefGoogle Scholar
Baker-Sparr, C., Hart, T., Bergquist, T., Bogner, J., Dreer, L., Juengst, S. B., … Whiteneck, G. G. (2018). Internet and social media use after traumatic brain injury: A Traumatic Brain Injury Model Systems study. Journal of Head Trauma Rehabilitation, 33(1), E9E17. doi: 10.1097/HTR.0000000000000305.CrossRefGoogle ScholarPubMed
Behn, N., Togher, L., Power, E., & Heard, R. (2012). Evaluating communication training for paid carers of people with traumatic brain injury. Brain Injury, 26(13–14), 17021715. doi: 10.3109/02699052.2012.722258.CrossRefGoogle ScholarPubMed
Bogart, E., Togher, L., Power, E., & Docking, K. (2012). Casual conversations between individuals with traumatic brain injury and their friends. Brain Injury, 26(3), 221233. doi: 10.3109/02699052.2011.648711.CrossRefGoogle ScholarPubMed
Bogner, J. A., Whiteneck, G. G., MacDonald, J., Juengst, S. B., Brown, A. W., Philippus, A. M., … Arenth, P. (2017). Test-retest reliability of traumatic brain injury outcome measures: A Traumatic Brain Injury Model Systems study. Journal of Head Trauma Rehabilitation, 32(5), E1E16. doi: 10.1097/HTR.0000000000000291.CrossRefGoogle ScholarPubMed
Bond, F., & Godfrey, H. P. D. (1997). Conversation with traumatically brain-injured individuals: A controlled study of behavioural changes and their impact. Brain Injury, 11(5), 319329. doi: 10.1080/026990597123476.CrossRefGoogle ScholarPubMed
Braun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology, 3, 77101.CrossRefGoogle Scholar
Brown, A. W., Moessner, A. M., Bergquist, T. F., Kendall, K. S., Diehl, N. N., & Mandrekar, J. (2015). A randomized practical behavioural trial of curriculum-based advocacy training for individuals with traumatic brain injury and their families. Brain Injury, 29(13–14), 15301538. doi: 10.3109/02699052.2015.1075173.CrossRefGoogle ScholarPubMed
Cahill, J., Stiles, W. B., Barkham, M., Hardy, G. E., Stone, G., Agnew-Davies, R., & Unsworth, G. (2012). Two short forms of the Agnew Relationship Measure: The ARM-5 and ARM-12. Psychotherapy Research, 22(3), 241255. doi: 10.1080/10503307.2011.643253.CrossRefGoogle ScholarPubMed
Cassel, A., McDonald, S., Kelly, M., & Togher, L. (2019). Learning from the minds of others: A review of social cognition treatments and their relevance to traumatic brain injury. Neuropsychological Rehabilitation, 29(1), 2255. doi: 10.1080/09602011.2016.1257435.CrossRefGoogle ScholarPubMed
Chan, A.-W., Tetzlaff, J. M., Altman, D. G., Laupacis, A., Gøtzsche, P. C., Krleža-Jerić, K., … Berlin, J. A. (2013). SPIRIT 2013 statement: Defining standard protocol items for clinical trials. Annals of Internal Medicine, 158(3), 200207.CrossRefGoogle ScholarPubMed
Cherney, L. R., Babbitt, E. M., Semik, P., & Heinemann, A. W. (2011). Psychometric properties of the Communication Confidence Rating Scale for Aphasia (CCRSA): Phase 1. Topics in Stroke Rehabilitation, 18(4), 352362. doi: 10.1310/tsr1804-352.CrossRefGoogle ScholarPubMed
Damianakis, T., Tough, A., Marziali, E., & Dawson, D. R. (2016). Therapy online: A web-based video support group for family caregivers of survivors with traumatic brain injury. Journal of Head Trauma Rehabilitation, 31(4), E12E20. doi: 10.1097/HTR.0000000000000178.CrossRefGoogle ScholarPubMed
Douglas, J. M., Bracy, C. A., & Snow, P. C. (2007). Measuring perceived communicative ability after traumatic brain injury: The reliability and validity of the La Trobe Communication Questionnaire. Journal of Head Trauma Rehabilitation, 22(1), 3138.CrossRefGoogle ScholarPubMed
Douglas, J. M., Bracy, C. A., & Snow, P. C. (2016). Return to work and social communication ability following severe traumatic brain injury. Journal of Speech, Language, and Hearing Research, 59, 511520. doi: 10.1044/2015_JSLHR-L-15-0025.CrossRefGoogle ScholarPubMed
Finch, E., French, A., Ou, R. J., & Fleming, J. (2016). Participation in communication activities following traumatic brain injury: A time use diary study. Brain Injury, 30(7), 883890. doi: 10.3109/02699052.2016.1146959.CrossRefGoogle ScholarPubMed
Galusha-Glasscock, J. M., Horton, D. K., Weiner, M. F., & Cullum, C. M. (2016). Video teleconference administration of the repeatable battery for the assessment of neuropsychological status. Archives of Clinical Neuropsychology, 31(1), 811. doi: 10.1093/arclin/acv058.CrossRefGoogle ScholarPubMed
Gan, C., Gargaro, J., Brandys, C., Gerber, G., & Boschen, K. (2010). Family caregivers’ support needs after brain injury: A synthesis of perspectives from caregivers, programs, and researchers. NeuroRehabilitation, 27(1), 518. doi: 10.3233/NRE-2010-0577.CrossRefGoogle ScholarPubMed
Hawthorne, G., Kaye, A. H., Gruen, R., Houseman, D., & Bauer, I. (2011). Traumatic brain injury and quality of life: Initial Australian validation of the QOLIBRI. Journal of Clinical Neuroscience, 18(2), 197202. doi: 10.1016/j.jocn.2010.06.015.CrossRefGoogle ScholarPubMed
Hines, M., Lincoln, M., Ramsden, R., Martinovich, J., & Fairweather, C. (2015). Speech pathologists’ perspectives on transitioning to telepractice: What factors promote acceptance? Journal of Telemedicine and Telecare, 21(8), 469473. doi: 10.1177/1357633X15604555.CrossRefGoogle ScholarPubMed
Hoepner, J. K., & Olson, S. E. (2018). Joint video self-modeling as a conversational intervention for an individual with traumatic brain injury and his everyday partner: A pilot investigation. Clinical Archives of Communication Disorders, 3(1), 2241. doi: 10.21849/cacd.2018.00262.CrossRefGoogle Scholar
Hoffmann, T. C., Glasziou, P. P., Boutron, I., Milne, R., Perera, R., Moher, D., … Michie, S. (2014). Better reporting of interventions: Template for intervention description and replication (TIDieR) checklist and guide. BMJ, 348, g1687. doi: 10.1136/bmj.g1687.CrossRefGoogle ScholarPubMed
Honan, C. A., McDonald, S., Tate, R., Ownsworth, T., Togher, L., Fleming, J., … Ponsford, J. (2017). Outcome instruments in moderate-to-severe adult traumatic brain injury: Recommendations for use in psychosocial research. Neuropsychological Rehabilitation, 121. doi: 10.1080/09602011.2017.1339616.Google ScholarPubMed
IBM Corp. (2016). IBM SPSS statistics for windows (Version 24.0). Armonk, NY: Author.Google Scholar
Jagnoor, J., & Cameron, I. D. (2014). Traumatic brain injury – support for injured people and their carers. Australian Family Physician, 43(11), 758763.Google ScholarPubMed
Kreitzer, N., Kurowski, B. G., & Bakas, T. (2018). Systematic review of caregiver and dyad interventions after adult traumatic brain injury. Archives of Physical Medicine and Rehabilitation, 99(11), 23422354. doi: 10.1016/j.apmr.2018.04.016.CrossRefGoogle ScholarPubMed
Maas, A. I., Menon, D. K., Adelson, P. D., Andelic, N., Bell, M. J., Belli, A., … Chesnut, R. M. (2017). Traumatic brain injury: Integrated approaches to improve prevention, clinical care, and research. The Lancet Neurology, 16(12), 9871048. doi: 10.1016/S1474-4422(17)30371-X.CrossRefGoogle ScholarPubMed
MacDonald, S. (2005). Functional assessment of verbal reasoning and executive strategies. Ontario, Canada: CCD Publishing.Google ScholarPubMed
MacDonald, S. (2017). Introducing the model of cognitive-communication competence: A model to guide evidence-based communication interventions after brain injury. Brain Injury, 31(13–14), 17601780. doi: 10.1080/02699052.2017.1379613.CrossRefGoogle Scholar
Moriarty, H., Winter, L., Robinson, K., Piersol, C. V., Vause-Earland, T., Iacovone, D. B., … Gitlin, L. N. (2016). A randomized controlled trial to evaluate the veterans’ in-home program for military veterans with traumatic brain injury and their families: Report on impact for family members. PM&R, 8(6), 495509. doi: 10.1016/j.pmrj.2015.10.008.Google ScholarPubMed
Murphy, A., Huang, H., Montgomery, E. B., & Turkstra, L. S. (2014). Conversational turn-taking in adults with acquired brain injury. Aphasiology, 29(2), 151168. doi: 10.1080/02687038.2014.959411.CrossRefGoogle Scholar
Ownsworth, T., Arnautovska, U., Beadle, E., Shum, D. H. K., & Moyle, W. (2018). Efficacy of telerehabilitation for adults with traumatic brain injury: A systematic review. Journal of Head Trauma Rehabilitation, 33(4), E33E46. doi: 10.1097/HTR.0000000000000350.CrossRefGoogle ScholarPubMed
Pearce, B., Cartwright, J., Cocks, N., & Whitworth, A. (2016). Inhibitory control and traumatic brain injury: The association between executive control processes and social communication deficits. Brain Injury, 30(13–14), 17081717. doi: 10.1080/02699052.2016.1202450.CrossRefGoogle ScholarPubMed
Ponsford, J. L., Downing, M. G., Olver, J., Ponsford, M., Acher, R., Carty, M., & Spitz, G. (2014). Longitudinal follow-up of patients with traumatic brain injury: Outcome at two, five, and ten years post-injury. Journal of Neurotrauma, 31(1), 6477. doi: 10.1089/neu.2013.2997.CrossRefGoogle ScholarPubMed
Powell, J. M., Fraser, R., Brockway, J. A., Temkin, N., & Bell, K. R. (2016). A telehealth approach to caregiver self-management following traumatic brain injury: A randomized controlled trial. Journal of Head Trauma Rehabilitation, 31(3), 180190. doi: 10.1097/HTR.0000000000000167.CrossRefGoogle ScholarPubMed
Prutting, C. A., & Kirchner, D. M. (1987). A clinical appraisal of the pragmatic aspects of language. Journal of Speech and Hearing Disorders, 52(2), 105119. doi: 10.1044/jshd.5202.105.CrossRefGoogle ScholarPubMed
Randolph, C. (2012). RBANS update: Repeatable battery for the assessment of neuropsychological status. Bloomington, MN: PsychCorp.Google Scholar
Rietdijk, R., Power, E., Brunner, M., & Togher, L. (2017). Reliability of videoconferencing administration of a communication questionnaire to people with traumatic brain injury and their close others. Journal of Head Trauma Rehabilitation, 32(6), E38E44. doi: 10.1097/HTR.0000000000000282.CrossRefGoogle ScholarPubMed
Rietdijk, R., Power, E., Brunner, M., & Togher, L. (2018). The reliability of evaluating conversations between people with traumatic brain injury and their communication partners via videoconferencing. Neuropsychological Rehabilitation. Advance online publication. doi: 10.1080/09602011.2018.1554533.CrossRefGoogle ScholarPubMed
Rietdijk, R., Power, E., Brunner, M., & Togher, L. (2019). A single case experimental design study on improving social communication skills after traumatic brain injury using communication partner telehealth training. Brain Injury, 33(1), 94104. doi: 10.1080/02699052.2018.1531313.CrossRefGoogle Scholar
Rietdijk, R., Togher, L., & Power, E. (2012). Supporting family members of people with traumatic brain injury using telehealth: A systematic review. Journal of Rehabilitation Medicine, 44, 913921. doi: 10.2340/16501977-1058.CrossRefGoogle ScholarPubMed
Rousseaux, M., Verigneaux, C., & Kozlowski, O. (2010). An analysis of communication in conversation after severe traumatic brain injury. European Journal of Neurology, 17(7), 922929. doi: 10.1111/j.1468-1331.2009.02945.x.CrossRefGoogle ScholarPubMed
Saldert, C., Jensen, L. R., Blom Johansson, M., & Simmons-Mackie, N. (2018). Complexity in measuring outcomes after communication partner training: Alignment between goals of intervention and methods of evaluation. Aphasiology, 32(10), 11671193. doi: 10.1080/02687038.2018.1470317.CrossRefGoogle Scholar
Sealed Envelope Ltd. (2012). Power calculator for continuous outcome superiority trial. Retrieved from https://www.sealedenvelope.com/power/continuous-superiority/.Google Scholar
Shepherd-Banigan, M. E., Shapiro, A., McDuffie, J. R., Brancu, M., Sperber, N. R., Van Houtven, C. H., … Williams, J. W. (2018). Interventions that support or involve caregivers or families of patients with traumatic injury: A systematic review. Journal of General Internal Medicine, 33(7), 11771186. doi: 10.1007/s11606-018-4417-7.CrossRefGoogle ScholarPubMed
Simpson, G. K., Daher, M., Hodgkinson, A., & Strettles, B. (2016). Comparing the injury profile, service use, outcomes, and comorbidities of people with severe TBI across urban, regional, and remote populations in New South Wales: A multicentre study. Journal of Head Trauma Rehabilitation, 31(2), E26E38. doi: 10.1097/HTR.0000000000000160.CrossRefGoogle ScholarPubMed
Sinnakaruppan, I., Downey, B., & Morrison, S. (2005). Head injury and family carers: A pilot study to investigate an innovative community-based educational programme for family carers and patients. Brain Injury, 19(4), 283308. doi: 10.1080/02699050400003924.CrossRefGoogle Scholar
Teasdale, G. M., Pettigrew, L. E. L., Wilson, J. T., Murray, G., & Jennett, B. (1998). Analyzing outcome of treatment of severe head injury: A review and update on advancing the use of the Glasgow Outcome Scale. Journal of Neurotrauma, 15, 587597. doi: 10.1089/neu.1998.15.587.CrossRefGoogle ScholarPubMed
Togher, L., Hand, L., & Code, C. (1997). Analysing discourse in the traumatic brain injury population: Telephone interactions with different communication partners. Brain Injury, 11(3), 169189. doi: 10.1080/026990597123629.Google ScholarPubMed
Togher, L., McDonald, S., Tate, R., Power, E., & Rietdijk, R. (2013). Training communication partners of people with severe traumatic brain injury improves everyday conversations: A multicenter single blind clinical trial. Journal of Rehabilitation Medicine, 45(7), 637645. doi: 10.2340/16501977-1173.CrossRefGoogle ScholarPubMed
Togher, L., McDonald, S., Tate, R., Rietdijk, R., & Power, E. (2016). The effectiveness of social communication partner training for adults with severe chronic TBI and their families using a measure of perceived communication ability. NeuroRehabilitation, 38(3), 243255. doi: 10.3233/NRE-151316.CrossRefGoogle ScholarPubMed
Togher, L., Power, E., McDonald, S., Tate, R., & Rietdijk, R. (2009). Training communication partners of people with traumatic brain injury: Reporting the protocol for a clinical trial. Brain Impairment, 10(2), 188204. doi: 10.1375/brim.10.2.188.CrossRefGoogle Scholar
Togher, L., Power, E., Tate, R., McDonald, S., & Rietdijk, R. (2010). Measuring the social interactions of people with traumatic brain injury and their communication partners: The adapted Kagan scales. Aphasiology, 24(6–8), 914927. doi: 10.1080/02687030903422478.CrossRefGoogle Scholar
Togher, L., Wiseman-Hakes, C., Douglas, J., Stergiou-Kita, M., Ponsford, J., Teasell, R., … Panel, I. E. (2014). INCOG recommendations for management of cognition following traumatic brain injury, part IV: Cognitive communication. Journal of Head Trauma Rehabilitation, 29(4), 353368. doi: 10.1097/HTR.0000000000000071.CrossRefGoogle ScholarPubMed
von Steinbuchel, N., Wilson, L., Gibbons, H., Hawthorne, G., Hofer, S., Schmidt, S., … Force, Q. T. (2010). Quality of life after brain injury (QOLIBRI): Scale development and metric properties. Journal of Neurotrauma, 27(7), 11671185. doi: 10.1089/neu.2009.1076.CrossRefGoogle ScholarPubMed
Whiteneck, G., Dijkers, M., Heinemann, A., Bogner, J., Bushnik, T., Cicerone, K., … Malec, J. (2011). Development of the participation assessment with recombined tools-objective for use with individuals with traumatic brain injury. Archives of Physical Medicine and Rehabilitation, 92, 542551. doi: 10.1016/j.apmr.2010.08.002.CrossRefGoogle Scholar
Wiltshire, G. E., & Ehrlich, C. (2014). Is conversation partner training effective in assisting individuals with a traumatic brain injury to display improved communication outcomes. Journal of Social Inclusion, 5(2), 926.CrossRefGoogle Scholar