Chronic hand eczema--self-management and prognosis: a study protocol for a randomised clinical trial

Annette Mollerup, Niels Kren Veien, Jeanne Duus Johansen, Annette Mollerup, Niels Kren Veien, Jeanne Duus Johansen

Abstract

Background: Hand eczema has a one-year prevalence of approximately 10 % in the general Danish population. Often the disease becomes chronic with numerous implications for the individual's daily life, occupation and quality of life. However, no guidelines of self-management recommendations beyond the acute stage are given. Self-management of the disease is pivotal and involves self-monitoring of the condition, medication adherence, and preventive behaviour. Interventions best to support the individual in this ongoing process need to be developed.

Methods/design: This paper describes the design of a randomised clinical trial to test a newly developed intervention of individual counselling versus conventional information. 300 patients consecutively referred to dermatologic treatment at two different settings are individually randomised to either the intervention programme, named 'The Healthy Skin Clinic' or to the control group. Block-wise randomisation according to setting and gender is carried out.The intervention offers a tool for self-monitoring; basic and specific individual counselling; the possibility of asynchronous communication with the intervention team; and an electronic patient dialogue forum. Primary outcome variable is objective assessment of the hand eczema severity performed at baseline prior to randomisation, and repeated at six months follow-up. Secondary outcome variables are dermatology related life quality and perceived global burden of disease.

Discussion: The trial aims at evaluating a newly developed guidance programme which is expected to support self-management of patients referred to dermatology treatment due to chronic hand eczema. The design of the protocol is pragmatic with blinding of neither participants nor the investigator. Thus, in the interpretation of the results, the investigator takes into account effects that may be attributed to actors of the interventions rather than the intervention per se as well of potential observer bias. Inclusion criterions are wide in order to increase transferability of the results.

Trial registration: The trial is registered in ClinicalTrials.Gov with registration number NCT01482663.

Figures

Figure 1
Figure 1
Trial flow chart.
Figure 2
Figure 2
Graphical depictions of interventions in the CHE-trial. Components are regarded either as objects (represented by squares) or as activities (represented by circles) [30].

References

    1. Thyssen JP, Johansen JD, Linneberg A, Menne T. The epidemiology of hand eczema in the general population–prevalence and main findings. Contact Dermatitis. 2010;62:75–87. doi: 10.1111/j.1600-0536.2009.01669.x.
    1. Hald M, Berg ND, Elberling J, Johansen JD. Medical consultations in relation to severity of hand eczema in the general population. Br J Dermatol. 2008;158:773–777. doi: 10.1111/j.1365-2133.2007.08431.x.
    1. Veien NK, Hattel T, Laurberg G. Hand eczema: causes, course, and prognosis I. Contact Dermatitis. 2008;58:330–334. doi: 10.1111/j.1600-0536.2008.01345.x.
    1. Menne T, Johansen JD, Sommerlund M, Veien NK. Hand eczema guidelines based on the Danish guidelines for the diagnosis and treatment of hand eczema. Contact Dermatitis. 2011;65:3–12. doi: 10.1111/j.1600-0536.2011.01915.x.
    1. Meding B, Wrangsjo K, Jarvholm B. Fifteen-year follow-up of hand eczema: persistence and consequences. Br J Dermatol. 2005;152:975–980. doi: 10.1111/j.1365-2133.2005.06494.x.
    1. Cvetkovski RS, Zachariae R, Jensen H, Olsen J, Johansen JD, Agner T. Quality of life and depression in a population of occupational hand eczema patients. Contact Dermatitis. 2006;54:106–111. doi: 10.1111/j.0105-1873.2006.00783.x.
    1. Diepgen TL, Elsner P, Schliemann S, Fartasch M, Kollner A, Skudlik C, John SM, Worm M. Guideline on the management of hand eczema ICD-10 Code: L20. L23. L24. L25. L30. J Dtsch Dermatol Ges. 2009;7(Suppl 3):S1–16.
    1. Holness DL, Nethercott JR. Is a worker's understanding of their diagnosis an important determinant of outcome in occupational contact dermatitis? Contact Dermatitis. 1991;25(5):296–301. doi: 10.1111/j.1600-0536.1991.tb01877.x.
    1. Diepgen TL, Agner T, Aberer W, Berth-Jones J, Cambazard F, Elsner P, McFadden J, Coenraads PJ. Management of chronic hand eczema. Contact Dermatitis. 2007;57:203–210. doi: 10.1111/j.1600-0536.2007.01179.x.
    1. Agner T, Held E. Skin protection programmes. Contact Dermatitis. 2002;47(5):253–256. doi: 10.1034/j.1600-0536.2002.470501.x.
    1. Serup J, Lindblad AK, Maroti M, Kjellgren KI, Niklasson E, Ring L, Ahlner J. et follow or not to follow dermatological treatment–a review of the literature. Acta Derm Venereol. 2006;86:193–197. doi: 10.2340/00015555-0073.
    1. Storm A, Andersen SE, Benfeldt E, Serup J. One in 3 prescriptions are never redeemed: primary nonadherence in an outpatient clinic. J Am Acad Dermatol. 2008;59(1):27–33. doi: 10.1016/j.jaad.2008.03.045.
    1. Hodari KT, Nanton JR, Carroll CL, Feldman SR, Balkrishnan R. Adherence in dermatology: a review of the last 20 years. J Dermatolog Treat. 2006;17(3):136–142. doi: 10.1080/09546630600688515.
    1. Haynes RB, Ackloo E, Sahota N, McDonald HP, Yao X. Interventions for enhancing medication adherence. Cochrane Database Syst Rev. 2008. p. CD000011.
    1. Sabaté E, World Health Organization. Adherence to long-term therapies, evidence for action. Geneva: WHO; 2003. Ref Type: Report. Available at .
    1. Bauer A, Schmitt J, Bennett C, Coenraads PJ, Elsner P, English J, Williams HC. Interventions for preventing occupational irritant hand dermatitis. Cochrane Database Syst Rev. 2010. p. CD004414.
    1. Winker R, Salameh B, Stolkovich S, Nikl M, Barth A, Ponocny E, Drexler H, Tappeiner G G. Effectiveness of skin protection creams in the prevention of occupational dermatitis: results of a randomized, controlled trial. Int Arch Occup Environ Health. 2009;82:653–662. doi: 10.1007/s00420-008-0377-2.
    1. Dulon M, Pohrt U, Skudlik C, Nienhaus A. Prevention of occupational skin disease: a workplace intervention study in geriatric nurses. Br J Dermatol. 2009;161:337–344. doi: 10.1111/j.1365-2133.2009.09226.x.
    1. Held E, Wolff C, Gyntelberg F, Agner T. Prevention of work-related skin problems in student auxiliary nurses: an intervention study. Contact Dermatitis. 2001;44:297–303. doi: 10.1034/j.1600-0536.2001.440509.x.
    1. Flyvholm MA, Mygind K, Sell L, Jensen A, Jepsen KF. A randomised controlled intervention study on prevention of work related skin problems among gut cleaners in swine slaughterhouses. Occup Environ Med. 2005;62:642–649. doi: 10.1136/oem.2004.016576.
    1. Sell L, Flyvholm MA, Lindhard G, Mygind K. Implementation of an occupational skin disease prevention programme in Danish cheese dairies. Contact Dermatitis. 2005;53:155–161. doi: 10.1111/j.0105-1873.2005.00674.x.
    1. Matterne U, Diepgen TL, Weisshaar E. Effects of a health-educational and psychological intervention on socio-cognitive determinants of skin protection behaviour in individuals with occupational dermatoses. Int Arch Occup Environ Health. 2010;83:183–189. doi: 10.1007/s00420-009-0448-z.
    1. Relton C, Torgerson D, O'Cathain A, Nicholl J. Rethinking pragmatic randomised controlled trials: introducing the "cohort multiple randomised controlled trial" design. BMJ. 2010;340:c1066. doi: 10.1136/bmj.c1066.
    1. Dean K. Self-care components of lifestyles: the importance of gender, attitudes and the social situation. Soc Sci Med. 1989;29:137–152. doi: 10.1016/0277-9536(89)90162-7.
    1. Nyberg F, Osika I, Evengard B. "The Laundry Bag Project"–unequal distribution of dermatological healthcare resources for male and female psoriatic patients in Sweden. Int J Dermatol. 2008;47:144–149. doi: 10.1111/j.1365-4632.2008.03485.x.
    1. Edwards P. Questionnaires in clinical trials: guidelines for optimal design and administration. Trials. 2010;11:2. doi: 10.1186/1745-6215-11-2.
    1. Lindberg M. Compliance - Om afvigelser mellem lægers ordinationer og patienternes faktiske medicinering [Compliance – on discrepancies between physicians’ prescriptions and patients’ actual medication] Copenhagen: Institut for Rationel Farmakoterapi; 2006. Ref Type: Report. Available at .
    1. Sørensen J, Gut R, Freil M. Kroniske syges oplevelser i mødet med sundhedsvæsenet [Chronic patients’ experiences in encounters with health care] Copenhagen: Enheden for Brugerundersøgelser: Region Hovedstaden; 2007. Ref Type: Report. Available at .
    1. Willemann M, Hanak ML. Egenomsorg - et særligt perspektiv på forebyggelse og sundhedsfremme.[Self-care – a special perspective on prevention and health promotion] Copenhagen: National Board of Health; 2006. Ref Type: Report. Available at .
    1. Perera R, Heneghan C, Yudkin P. Graphical method for depicting randomised trials of complex interventions. BMJ. 2007;334:127–129. doi: 10.1136/bmj.39045.396817.68.
    1. Held E, Skoet R, Johansen JD, Agner T. The hand eczema severity index (HECSI): a scoring system for clinical assessment of hand eczema. A study of inter- and intraobserver reliability. Br J Dermatol. 2005;152:302–307. doi: 10.1111/j.1365-2133.2004.06305.x.
    1. Basra MK, Fenech R, Gatt RM, Salek MS, Finlay AY. The Dermatology Life Quality Index 1994–2007: a comprehensive review of validation data and clinical results. Br J Dermatol. 2008;159:997–1035.
    1. Evers AW, Duller P, van de Kerkhof PCM, van der Valk PGM, de Jong EMGJ, Gerritsen MJP, Otero E, Verhoeven EWM, Verhaak CM, Kraaimaat FW. The Impact of Chronic Skin Disease on Daily Life (ISDL): a generic and dermatology-specific health instrument. Br J Dermatol. 2008;158:101–108.
    1. Madsen MH, Højgaard B, Albæk J. Health literacy - Begrebet, konsekvenser og mulige interventioner.[Health literacy – the concept, consequences and possible interventions] Copenhagen: The National Board of Health; 2009. Ref Type: Report. Available at .
    1. Miller MJ, Allison JJ, Schmitt MR, Ray MN, Funkhouser EM, Cobaugh DJ. et al.Using single-item health literacy screening questions to identify patients who read written nonsteroidal anti-inflammatory medicine information provided at pharmacies. J Health Commun. 2010;15:413–427. doi: 10.1080/10810731003753091.
    1. Nutbeam D. Health Promotion Glossary - Moving towards a new public health. Geneva: World Health Organization; 1998. Ref Type: Report.
    1. Powers BJ, Trinh JV, Bosworth HB. Can this patient read and understand written health information? JAMA. 2010;304:76–84. doi: 10.1001/jama.2010.896.
    1. Bandura A. Health promotion by social cognitive means. Health Educ Behav. 2004;31:143–164. doi: 10.1177/1090198104263660.
    1. Mikkelsen EG, Einarsen S. Relationships between exposure to bullying at work and psychological and psychosomatic health complaints: the role of state negative affectivity and generalized self-efficacy. Scand J Psychol. 2002;43:397–405. doi: 10.1111/1467-9450.00307.
    1. Jacobsen R, Moldrup C, Christrup L, Sjogren P, Hansen OB. The Danish version of the medication adherence report scale: preliminary validation in cancer pain patients. Pain Pract. 2009;9:1–7.
    1. Susitaival P, Flyvholm MA, Meding B, Kanerva L, Lindberg M, Svensson A, Olafsson JH. Nordic Occupational Skin Questionnaire (NOSQ-2002): a new tool for surveying occupational skin diseases and exposure. Contact Dermatitis. 2003;49:70–76. doi: 10.1111/j.0105-1873.2003.00159.x.
    1. Kristjansdottir J, Olsson GI, Sundelin C, Naessen T. Could SF-36 be used as a screening instrument for depression in a Swedish youth population? Scand J Caring Sci. 2010;25:262–268.
    1. Storm A, Benfeldt E, Andersen SE, Serup J. A prospective study of patient adherence to topical treatments: 95 % of patients underdose. J Am Acad Dermatol. 2008;59:975–980. doi: 10.1016/j.jaad.2008.07.039.
    1. Hald M, Agner T, Blands J, Veien NK, Laurberg G, Avnstorp C, Menné T, Kaaber K, Kristensen B, Kristensen O, Andersen KE, Paulsen E, Thormann J, Sommerlund M, Nielsen NH, Johansen JD. Clinical severity and prognosis of hand eczema. Br J Dermatol. 2009;160:1229–1236. doi: 10.1111/j.1365-2133.2009.09139.x.
    1. Holman R, Glas CA, de Haan RJ. Power analysis in randomized clinical trials based on item response theory. Control Clin Trials. 2003;24:390–410. doi: 10.1016/S0197-2456(03)00061-8.
    1. Francis JJ, Eccles MP, Johnston M, Walker A, Grimshaw J, Foy R, Kaner EFS, Smith L, Bonetti D. Constructing questionnaires based on the theory of planned behaviour. A manual for health services researchers 2004. 2010. pp. 2–12. Ref Type: Report.
    1. Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008;148:295–309.
    1. Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P. Methods and processes of the CONSORT Group: example of an extension for trials assessing nonpharmacologic treatments. Ann Intern Med. 2008;148:W60–W66.

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