Controlled Education of patients after Stroke (CEOPS)- nurse-led multimodal and long-term interventional program involving a patient's caregiver to optimize secondary prevention of stroke: study protocol for a randomized controlled trial

Anne-Marie Mendyk, Alain Duhamel, Yannick Bejot, Didier Leys, Laurent Derex, Olivier Dereeper, Olivier Detante, Pierre-Yves Garcia, Olivier Godefroy, Francisco Macian Montoro, Jean-Philippe Neau, Sébastien Richard, Thierry Rosolacci, Igor Sibon, Denis Sablot, Serge Timsit, Mathieu Zuber, Charlotte Cordonnier, Régis Bordet, on the behalf of Strokavenir network, S Canaple, A Arnoux, M Barbey, C Lamy, S Blin, L Lilan, N Heyvang, F Leroux, N Gouvenec, F Couadou, B Lemaire, E Manier, C Perez, J C Seghezzi, H Soret, M Giroud, N Mielle, M Bodenant, D Deplanque, N Dequatre, H Hénon, F Lebeau, Christine Peré, B Pommet, J Teypaz, N Desfarges, A Setnikar, O Deporter, S Monvoisin, S Godaux, A Chatelain, B Touati, A Bonnetain, E Gimenez, J Joule, M Karl, S Mesnildrey, A Lahanque, Anne-Marie Mendyk, Alain Duhamel, Yannick Bejot, Didier Leys, Laurent Derex, Olivier Dereeper, Olivier Detante, Pierre-Yves Garcia, Olivier Godefroy, Francisco Macian Montoro, Jean-Philippe Neau, Sébastien Richard, Thierry Rosolacci, Igor Sibon, Denis Sablot, Serge Timsit, Mathieu Zuber, Charlotte Cordonnier, Régis Bordet, on the behalf of Strokavenir network, S Canaple, A Arnoux, M Barbey, C Lamy, S Blin, L Lilan, N Heyvang, F Leroux, N Gouvenec, F Couadou, B Lemaire, E Manier, C Perez, J C Seghezzi, H Soret, M Giroud, N Mielle, M Bodenant, D Deplanque, N Dequatre, H Hénon, F Lebeau, Christine Peré, B Pommet, J Teypaz, N Desfarges, A Setnikar, O Deporter, S Monvoisin, S Godaux, A Chatelain, B Touati, A Bonnetain, E Gimenez, J Joule, M Karl, S Mesnildrey, A Lahanque

Abstract

Background: Setting up a follow-up secondary prevention program after stroke is difficult due to motor and cognitive impairment, but necessary to prevent recurrence and improve patients' quality of life. To involve a referent nurse and a caregiver from the patient's social circle in nurse-led multimodal and long-term management of risk factors after stroke could be an advantage due to their easier access to the patient and family. The aim of this study is to compare the benefit of optimized follow up by nursing personnel from the vascular neurology department including therapeutic follow up, and an interventional program directed to the patient and a caregiving member of their social circle, as compared with typical follow up in order to develop a specific follow-up program of secondary prevention of stroke.

Methods/design: The design is a randomized, controlled, clinical trial conducted in the French Stroke Unit of the Strokavenir network. In total, 410 patients will be recruited and randomized in optimized follow up or usual follow up for 2 years. In both group, patients will be seen by a neurologist at 6, 12 and 24 months. The optimized follow up will include follow up by a nurse from the vascular neurology department, including therapeutic follow up, and a training program on secondary prevention directed to the patient and a caregiving member of their social circle. After discharge, a monthly telephone interview, in the first year and every 3 months in the second year, will be performed by the nurse. At 6, 12 and 24 month, the nurse will give the patient and caregiver another training session. Usual follow up is only done by the patient's general practitioner, after classical information on secondary prevention of risk factors during hospitalization. The primary outcome measure is blood pressure measured after the first year of follow up. Blood pressure will be measured by nursing personnel who do not know the group into which the patient has been randomized. Secondary endpoints are associated mortality, morbidity, recurrence, drug side-effects and medico-economic analysis.

Discussion: The result of this trial is expected to provide the benefit of a nurse-led optimized multimodal and long-term interventional program for management of risk factors after stroke, personalizing the role of the nurse and including the patient's caregiver.

Trial registration: ClinicalTrials.gov, NCT 02132364. Registered on 7 May 2014. EUDRACT, A 00473-40.

Trial registration: ClinicalTrials.gov NCT02132364.

Keywords: Family caregiver; Multimodal intervention; Nurse; Secondary prevention; Stroke.

Conflict of interest statement

Ethics approval and consent to participate

The protocol has been approved by CPP Nord-Ouest IV on 2012 (A00473 40) with 11 approved modifications (in particular for recruitment of new centers). The last version of the protocol was approved on 23 may 2017. All patients and caregivers have to give their consent before inclusion.

Consent for publication

The authors have been informed of the publication and gave their consent.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study design. GP, general practitioner; M6, M12, M24, month 6, month 12, month 24
Fig. 2
Fig. 2
Schedule of enrollment, interventions, and assessments

References

    1. Donnan GA, Fisher M, Macleod M, Davis SM. Stroke. Lancet. 2008;371:1612–1623. doi: 10.1016/S0140-6736(08)60694-7.
    1. Leys D, Béjot Y, Debette S, Giroud M. Burden of stroke in France. Int J Stroke. 2008;3:117–119. doi: 10.1111/j.1747-4949.2008.00188.x.
    1. Furie KL, Kasner SE, Adams RJ, Albers GW, Bush RL, Fagan SC, Halperin JL, Johnston SC, Katzan I, Kernan WN, Mitchell PH, Ovbiagele B, Palesch YY, Sacco RL, Schwamm LH, Wassertheil-Smoller S, Turan TN, Wentworth D, on behalf of the American Heart Association Stroke Council, Council on Cardiovascular Nursing, Council on Clinical Cardiology, and Interdisciplinary Council on Quality of Care and Outcomes Research Guidelines for the prevention of stroke in patients with stroke or transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2011;42:227–276. doi: 10.1161/STR.0b013e3181f7d043.
    1. Brainin M, Matz K, Nemec M, Teuschl Y, Dachenhausen A, Asenbaum-Nan S, Bancher C, Kepplinger B, Oberndorfer S, Pinter M, Schnider P, Tuomilehto J, ASPIS Study Group Prevention of poststroke cognitive decline: ASPIS–a multicenter, randomized, observer-blind, parallel group clinical trial to evaluate multiple lifestyle interventions–study design and baseline characteristics. Int J Stroke. 2015;10(4):627–635. doi: 10.1111/ijs.12188.
    1. Eckel RH, Jakicic JM, Ard JD, de Jesus JM, Houston Miller N, Hubbard VS, Lee IM, Lichtenstein AH, Loria CM, Millen BE, Nonas CA, Sacks FM, Smith SC, Jr, Svetkey LP, Wadden TA, Yanovski SZ, Kendall KA, Morgan LC, Trisolini MG, Velasco G, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC, Jr, Tomaselli GF, American College of Cardiology/American Heart Association Task Force on Practice Guidelines 2013 AHA/ACC guideline on lifestyle management to reduce cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014;129(25 Suppl 2):S76–S99. doi: 10.1161/01.cir.0000437740.48606.d1.
    1. Cameron JI, O’Connell C, Foley N, Salter K, Booth R, Boyle R, Cheung D, Cooper N, Corriveau H, Dowlatshahi D, Dulude A, Flaherty P, Glasser E, Gubitz G, Hebert D, Holzmann J, Hurteau P, Lamy E, LeClaire S, McMillan T, Murray J, Scarfone D, Smith EE, Shum V, Taylor K, Taylor T, Yanchula C, Teasell R, Lindsay P, Heart and Stroke Foundation Canadian Stroke Best Practice Committees Canadian Stroke Best Practice Recommendations: Managing transitions of care following Stroke, Guidelines Update 2016. Int J Stroke. 2016;11:807–822. doi: 10.1177/1747493016660102.
    1. Jamison J, Graffy J, Mullis R, Mant J, Sutton S. Barriers to medication adherence for the secondary prevention of stroke: a qualitative interview study in primary care. Br J Gen Pract. 2016;66:e568–e576. doi: 10.3399/bjgp16X685609.
    1. Ostwald SK, Davis S, Hersch G, Kelley C, Godwin KM. Evidence-based educational guidelines for stroke survivors after discharge home. J Neurosci Nurs. 2008;40:173–179. doi: 10.1097/01376517-200806000-00008.
    1. Jönsson AC, Höglund P, Brizzi M, Pessah-Rasmussen H. Secondary prevention and health promotion after stroke: can it be enhanced? J Stroke Cerebrovasc Dis. 2014;23:2287–2295. doi: 10.1016/j.jstrokecerebrovasdis.2014.04.021.
    1. Hornnes N, Larsen K, Boysen G. Blood pressure 1 year after stroke: the need to optimize secondary prevention. J Stroke Cerebrovasc Dis. 2011;20:16–23. doi: 10.1016/j.jstrokecerebrovasdis.2009.10.002.
    1. Rahiman A, Saver JL, Porter V, Buxton W, McNair N, Razinia T, Ovbiagele B. In-hospital initiation of secondary prevention is associated with improved vascular outcomes at 3 months. J Stroke Cerebrovasc Dis. 2008;17:5–8. doi: 10.1016/j.jstrokecerebrovasdis.2007.09.004.
    1. Touzé E, Coste J, Voicu M, Kansao J, Masmoudi R, Doumenc B, Durieux P, Mas JL. Importance of in-hospital initiation of therapies and therapeutic inertia in secondary stroke prevention: implementation of prevention after a cerebrovascular event (IMPACT) study. Stroke. 2008;39:1834–1843. doi: 10.1161/STROKEAHA.107.503094.
    1. Sullivan KA, Katajamaki A. Stroke education: retention effects in those at low- and high-risk of stroke. Patient Educ Couns. 2009;74:205–212. doi: 10.1016/j.pec.2008.08.024.
    1. Lager KE, Mistri AK, Khunti K, Haunton VJ, Sett AK, Wilson AD. Interventions for improving modifiable risk factor control in the secondary prevention of stroke. Cochrane Database Syst Rev. 2014;5:CD009103.
    1. Lawrence M, Pringle J, Kerr S, Booth J, Govan L, Roberts NJ. Multimodal secondary prevention behavioral interventions for TIA and stroke: a systematic review and meta-analysis. PLoS One. 2015;10:e0120902. doi: 10.1371/journal.pone.0120902.
    1. De Simoni A, Hardeman W, Mant J, Farmer AJ, Kinmonth AL. Trials to improve blood pressure through adherence to antihypertensives in stroke/TIA: systematic review and meta-analysis. J Am Heart Assoc. 2013;2:e000251. doi: 10.1161/JAHA.113.000251.
    1. McAlister FA, Grover S, Padwal RS, Youngson E, Fradette M, Thompson A, Buck B, Dean N, Tsuyuki RT, Shuaib A, Majumdar SR. Case management reduces global vascular risk after stroke: secondary results from the the preventing recurrent vascular events and neurological worsening through intensive organized case-management randomized controlled trial. Am Heart J. 2014;168:924–930. doi: 10.1016/j.ahj.2014.08.001.
    1. Bushnell C, Arnan M, Han S. A new model for secondary prevention of stroke: transition coaching for stroke. Front Neurol. 2014;5:219. doi: 10.3389/fneur.2014.00219.
    1. Larson J, Franzen-Dahlin A, Billing E, Arbin M, Murray V, Wredling R. The impact of nurse-led support and education programme for spouses of stroke patients: a randomized controlled trial. J Clin Nurs. 2005;14:995–1003. doi: 10.1111/j.1365-2702.2005.01206.x.
    1. Franzen-Dahlin A, Larson J, Murray V, Wredling R, Billing E. A randomized controlled trial evaluating the effect of a support and education programme for spouses of people affected by stroke. Clin Rehabil. 2008;22:722–730. doi: 10.1177/0269215508090161.
    1. Pfeiffer K, Beische D, Hautzinger M, Berry JW, Wengert J, Hoffrichter R, Becker C, van Schayck R, Elliott TR. Telephone-based problem-solving intervention for family caregivers of stroke survivors: a randomized controlled trial. J Consult Clin Psychol. 2014;82:628–643. doi: 10.1037/a0036987.
    1. Legg LA, Quinn TJ, Mahmood F, Weir CJ, Tierney J, Stott DJ, Smith LN, Langhorne P. Non-pharmacological interventions for caregivers of stroke survivors. Cochrane Database Syst Rev. 2011;5:CD008179.
    1. Ferguson C, Inglis SC, Newton PJ, Middleton S, Macdonald PS, Davidson PM. The caregiver role in thromboprophylaxis management in atrial fibrillation: a literature review. Eur J Cardiovasc Nurs. 2015;14:98–107. doi: 10.1177/1474515114547647.
    1. Malfitano J, Turner BS, Piper E, Burlingame PA, D’Angelo E. Improving stroke education performance measures scores: the impact of a stroke nurse coordinator. J Neurosci Nurs. 2013;45:332–337. doi: 10.1097/JNN.0b013e3182a3ce63.
    1. Perry L, Hamilton S, Williams J, Jones S. Nursing interventions for improving nutritional status and outcomes of stroke patients: descriptive reviews of processes and outcomes. Worldviews Evid-Based Nurs. 2013;10:17–40. doi: 10.1111/j.1741-6787.2012.00255.x.
    1. Tonstad S, Alm CS, Sandvik E. Effect of nurse counselling on metabolic risk factors in patients with mild hypertension: a randomised controlled trial. Eur J Cardiovasc Nurs. 2007;6:160–164. doi: 10.1016/j.ejcnurse.2006.07.003.
    1. Green T, Haley E, Eliasziw M, Hoyte K. Education in stroke prevention: efficacy of an educational counselling intervention to increase knowledge in stroke survivors. Can J Neurosci Nurs. 2007;29(2):13–20.
    1. Irewall AL, Ögren J, Bergström L, Laurell K, Söderström L, Mooe T. Nurse-led, telephone-based, secondary preventive follow-up after stroke or transient ischemic attack improves blood pressure and LDL cholesterol: results from the first 12 months of the randomized, controlled NAILED stroke risk factor trial. PLoS One. 2015;10:e0139997. doi: 10.1371/journal.pone.0139997.
    1. Fukuoka Y, Hosomi N, Hyakuta T, Omori T, Ito Y, Uemura J, Kimura K, Matsumoto M, Moriyama M, DMP Stroke Trial Investigators Baseline feature of a randomized trial assessing the effects of disease management programs for the prevention of recurrent ischemic stroke. J Stroke Cerebrovasc Dis. 2015;24:610–617. doi: 10.1016/j.jstrokecerebrovasdis.2014.10.007.
    1. Joubert J, Davis SM, Hankey GJ, Levi C, Olver J, Gonzales G, Donnan GA. ICARUSS, the Integrated Care for the Reduction of Secondary Stroke trial: rationale and design of a randomized controlled trial of a multimodal intervention to prevent recurrent stroke in patients with a recent cerebrovascular event, ACTRN = 12611000264987. Int J Stroke. 2015;10:773–777. doi: 10.1111/ijs.12510.
    1. Johnson C, Lane H, Barber PA, Charleston A. Medication compliance in ischaemic stroke patients. Intern Med J. 2012;42:e47–e52. doi: 10.1111/j.1445-5994.2010.02209.x.
    1. Moll van Charante EP, Richard E, Eurelings LS, van Dalen JW, Ligthart SA, van Bussel EF, Hoevenaar-Blom MP, Vermeulen M, van Gool WA. Effectiveness of a 6-year multidomain vascular care intervention to prevent dementia (preDIVA): a cluster-randomised controlled trial. Lancet. 2016;388:797–805. doi: 10.1016/S0140-6736(16)30950-3.

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