TELEmedicine for Patients with Inflammatory Bowel Disease (TELE-IBD): Design and implementation of randomized clinical trial

Contemporary Clinical Trials

Volumn 42, Issue , 2015, Pages 132-144

  Cross, Raymond K ^a   Jambaulikar, Guruprasad ^a   Langenberg, Patricia ^a   Tracy, J Kathleen ^a   Collins, Joseph F ^a,b   Katz, Jonathan ^c   Regueiro, Miguel ^d   Schwartz, David A ^e   Quinn, Charlene C ^a  

^a UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

^b VA Cooperative Studies Coordinating Center   (United States)

^c CircleLink Health   (United States)

^d UNIVERSITY OF PITTSBURGH   (United States)

^e VANDERBILT UNIVERSITY   (United States)

Author keywords

Clinical trials; Comparative effectiveness; Crohn's disease; Inflammatory bowel diseases; Telemedicine; Ulcerative colitis

Indexed keywords

ADULT; ARTICLE; CROHN DISEASE; DISEASE ACTIVITY; HEALTH CARE ACCESS; HEALTH CARE UTILIZATION; HUMAN; INFLAMMATORY BOWEL DISEASE; MAJOR CLINICAL STUDY; MOBILE PHONE; OUTCOME ASSESSMENT; PATIENT MONITORING; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); SELF CONCEPT; SYMPTOMATOLOGY; TELEMEDICINE; ULCERATIVE COLITIS; CHRONIC DISEASE; CLINICAL TRIAL; CONTROLLED STUDY; HEALTH SERVICE; INFLAMMATORY BOWEL DISEASES; MULTICENTER STUDY; ORGANIZATION AND MANAGEMENT; PATIENT CARE PLANNING; PATIENT DROPOUTS; PATIENT EDUCATION; PATIENT SATISFACTION; PROCEDURES; RANDOMIZED CONTROLLED TRIAL; REMINDER SYSTEM; UTILIZATION;

CELL PHONES; CHRONIC DISEASE; HEALTH SERVICES; HUMANS; INFLAMMATORY BOWEL DISEASES; PATIENT CARE PLANNING; PATIENT DROPOUTS; PATIENT EDUCATION AS TOPIC; PATIENT SATISFACTION; QUALITY OF LIFE; REMINDER SYSTEMS; TELEMEDICINE;

EID: 84927136333     PISSN: 15517144     EISSN: 15592030     Source Type: Journal    
DOI: 10.1016/j.cct.2015.03.006     Document Type: Article

References (59)

1. Loftus E.V. Clinical epidemiology of inflammatory bowel disease: incidence, prevalence, and environmental influences. Gastroenterology 2004, 126(6):1504-1517.
2. Sands B.E. From symptom to diagnosis: clinical distinctions among various forms of intestinal inflammation. Gastroenterology 2004, 126(6):1518-1532.
3. Bernklev T., Jahnsen J., Lygren I., Henriksen M., Vatn M., Moum B. Health-related quality of life in patients with inflammatory bowel disease measured with the Short Form-36: psychometric assessments and a comparison with general population norms. Inflamm Bowel Dis 2005, 11(10):909-918.
4. Gibson T.B., Ng E., Ozminkowski R.J., Wang S., Burton W.N., Goetzel R.Z., et al. The direct and indirect cost burden of Crohn's disease and ulcerative colitis. J Occup Environ Med 2008, 50(11):1261-1272.
5. Longobardi T., Jacobs P., Bernstein C.N. Work losses related to inflammatory bowel disease in the United States: results from the National Health Interview Survey. Am J Gastroenterol 2003, 98(5):1064-1072.
6. Kappelman MD1, Rifas-Shiman S.L., Porter C.Q., Ollendorf D.A., Sandler R.S., Galanko J.A., Finkelstein J.A. Direct health care costs of Crohn's disease and ulcerative colitis in US children and adults. Gastroenterology Dec 2008, 135(6):1907-1913. [Epub 2008 Sep 17]. 10.1053/j.gastro.2008.09.012.
7. Colombel J.F., Sandborn W.J., Reinisch W., Mantzaris G.J., Kornbluth A., Rachmilewitz D., et al. Infliximab, azathioprine, or combination therapy for Crohn's disease. N Engl J Med 2010, 362(15):1383-1395.
8. Kane S., Huo D., Aikens J., Hanauer S. Medication nonadherence and the outcomes of patients with quiescent ulcerative colitis. Am J Med 2003, 114(1):39-43.
9. Sewitch M.J., Abrahamowicz M., Barkun A., Bitton A., Wild G.E., Cohen A., et al. Patient nonadherence to medication in inflammatory bowel disease. Am J Gastroenterol 2003, 98(7):1535-1544.
10. Cross R.K., Wilson K.T., Binion D.G. Polypharmacy and Crohn's disease. Aliment Pharmacol Ther 2005, 21(10):1211-1216.
11. Cross R.K., Lapshin O., Finkelstein J. Patient subjective assessment of drug side effects in inflammatory bowel disease. J Clin Gastroenterol 2008, 42(3):244-251.
12. Quan H., Present J.W., Sutherland L.R. Evaluation of educational programs in inflammatory bowel disease. Inflamm Bowel Dis 2003, 9(6):356-362.
13. Krier M., Kaltenbach T., McQuaid K., Soetikno R. Potential use of telemedicine to provide outpatient care for inflammatory bowel disease. Am J Gastroenterol Dec 2011, 106(12):2063-2067. 10.1038/ajg.2011.329.
14. Robinson A., Thompson D.G., Wilkin D., Roberts C. Guided self-management and patient-directed follow-up of ulcerative colitis: a randomised trial. Lancet 2001, 358(9286):976-981.
15. Elkjaer M., Shuhaibar M., Burisch J., Bailey Y., Scherfig H., Laugesen B., et al. E-health empowers patients with ulcerative colitis: a randomised controlled trial of the web-guided 'constant-care' approach. Gut 2010, 59(12):1652-1661.
16. Ramos-Rivers C., Regueiro M., Vargas E.J., Szigethy E., Schoen R.E., Dunn M., et al. Association between telephone activity and features of patients with inflammatory bowel disease. Clin Gastroenterol Hepatol 2014, 12(6):986-994. 6.
17. Kennedy A.P., Nelson E., Reeves D., Richardson G., Roberts C., Robinson A., et al. A randomised controlled trial to assess the effectiveness and cost of a patient orientated self management approach to chronic inflammatory bowel disease. Gut 2004, 53(11):1639-1645.
18. Cross R.K., Arora M., Finkelstein J. Acceptance of telemanagement is high in patients with inflammatory bowel disease. J Clin Gastroenterol 2006, 40(3):200-208.
19. Cross R.K., Finkelstein J. Feasibility and acceptance of a home telemanagement system in patients with inflammatory bowel disease: a 6-month pilot study. Dig Dis Sci 2007, 52(2):357-364.
20. Cross R.K., Cheevers N., Finkelstein J. Home telemanagement for patients with ulcerative colitis (UC HAT). Dig Dis Sci 2009, 54(11):2463-2472.
21. Cross R.K., Cheevers N., Rustgi A., Langenberg P., Finkelstein J. Randomized, controlled trial of home telemanagement in patients with ulcerative colitis (UC HAT). Inflamm Bowel Dis 2012, 18(6):1018-1025.
22. Lennard-Jones J.E. Classification of inflammatory bowel disease. Scand J Gastroenterol Suppl 1989, 170:2-6. [discussion 16-9].
23. Harvey R.F., Bradshaw J.M. A simple index of Crohn's-disease activity. Lancet 1980, 1(8167):514.
24. Best W.R. Predicting the Crohn's disease activity index from the Harvey-Bradshaw Index. Inflamm Bowel Dis 2006, 12(4):304-310.
25. Walmsley R.S., Ayres R.C., Pounder R.E., Allan R.N. A simple clinical colitis activity index. Gut 1998, 43(1):29-32.
26. Higgins P.D., Schwartz M., Mapili J., Krokos I., Leung J., Zimmermann E.M. Patient defined dichotomous end points for remission and clinical improvement in ulcerative colitis. Gut 2005, 54(6):782-788.
27. Best W.R., Becktel J.M., Singleton J.W. Rederived values of the eight coefficients of the Crohn's Disease Activity Index (CDAI). Gastroenterology 1979, 77(4 Pt 2):843-846.
28. Higgins P.D., Schwartz M., Mapili J., Zimmermann E.M. Is endoscopy necessary for the measurement of disease activity in ulcerative colitis?. Am J Gastroenterol 2005, 100(2):355-361.
29. D'Haens G.R., Panaccione R., Higgins P.D., Vermeire S., Gassull M., Chowers Y., et al. The London position statement of the world congress of gastroenterology on biological therapy for IBD with the European Crohn's and colitis organization: when to start, when to stop, which drug to choose, and how to predict response?. Am J Gastroenterol 2011, 106(2):199-212. quiz 3.
30. Kornbluth A., Sachar D.B. Practice Parameters Committee of the American College of G. Ulcerative colitis practice guidelines in adults: American College Of Gastroenterology, Practice Parameters Committee. Am J Gastroenterol 2010, 105(3):501-523. [quiz 24].
31. Lichtenstein G.R., Abreu M.T., Cohen R., Tremaine W. American Gastroenterological Association Institute technical review on corticosteroids, immunomodulators, and infliximab in inflammatory bowel disease. Gastroenterology 2006, 130(3):940-987.
32. Best W.R., Becktel J.M., Singleton J.W., Kern F. Development of a Crohn's disease activity index. National Cooperative Crohn's Disease Study. Gastroenterology 1976, 70(3):439-444.
33. Satsangi J., Sutherland L.R. Inflammatory bowel diseases 2003, Churchill Livingstone.
34. Seo M., Okada M., Yao T., Ueki M., Arima S., Okumura M. An index of disease activity in patients with ulcerative colitis. Am J Gastroenterol 1992, 87(8):971-976.
35. Seo M., Okada M., Yao T., Okabe N., Maeda K., Oh K. Evaluation of disease activity in patients with moderately active ulcerative colitis: comparisons between a new activity index and Truelove and Witts' classification. Am J Gastroenterol 1995, 90(10):1759-1763.
36. Boirivant M., Leoni M., Tariciotti D., Fais S., Squarcia O., Pallone F. The clinical significance of serum C reactive protein levels in Crohn's disease. Results of a prospective longitudinal study. J Clin Gastroenterol 1988, 10(4):401-405.
37. Brignola C., Campieri M., Bazzocchi G., Farruggia P., Tragnone A., Lanfranchi G.A. A laboratory index for predicting relapse in asymptomatic patients with Crohn's disease. Gastroenterology 1986, 91(6):1490-1494.
38. Andre C., Descos L., Landais P., Fermanian J. Assessment of appropriate laboratory measurements to supplement the Crohn's disease activity index. Gut 1981, 22(7):571-574.
39. Cooke W.T., Prior P. Determining disease activity in inflammatory bowel disease. J Clin Gastroenterol 1984, 6(1):17-25.
40. Guyatt G., Mitchell A., Irvine E.J., Singer J., Williams N., Goodacre R., et al. A new measure of health status for clinical trials in inflammatory bowel disease. Gastroenterology 1989, 96(3):804-810.
41. Hlavaty T., Persoons P., Vermeire S., Ferrante M., Pierik M., Van Assche G., et al. Evaluation of short-term responsiveness and cutoff values of inflammatory bowel disease questionnaire in Crohn's disease. Inflamm Bowel Dis 2006, 12(3):199-204.
42. Irvine E.J., Feagan B., Rochon J., Archambault A., Fedorak R.N., Groll A., et al. Quality of life: a valid and reliable measure of therapeutic efficacy in the treatment of inflammatory bowel disease. Canadian Crohn's Relapse Prevention Trial Study Group. Gastroenterology 1994, 106(2):287-296.
43. Powell-Tuck J., Bown R.L., Lennard-Jones J.E. A comparison of oral prednisolone given as single or multiple daily doses for active proctocolitis. Scand J Gastroenterol 1978, 13(7):833-837.
44. Ware J.E., Sherbourne C.D. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992, 30(6):473-483.
45. Eaden J.A., Abrams K., Mayberry J.F. The Crohn's and Colitis knowledge score: a test for measuring patient knowledge in inflammatory bowel disease. Am J Gastroenterol 1999, 94(12):3560-3566.
46. Lepore S., Helgeson V.S. Social constraints, intrusive thoughts and mental health after prostate cancer. J Soc Clin Psychol 1998, 17(1):89-106.
47. Faust A.H., Halpern L.F., Danoff-Burg S., Cross R.K. Psychosocial factors contributing to inflammatory bowel disease activity and health-related quality of life. Gastroenterol Hepatol (N Y) 2012, 8(3):173-181.
48. Schwarzer R., Jerusalem M. Generalized self-efficacy scale, causal and control beliefs. Measures in health psychology: a user's portfolio 1995, NFER-NELSON, Windsor, England. M. Johnston, S. Wright, J. Weinman (Eds.).
49. Luszczynska A., Scholz U., Schwarzer R. The general self-efficacy scale: multicultural validation studies. J Psychol 2005, 139(5):439-457.
50. Rotter J.B. Generalized expectancies for internal versus external control of reinforcement. Psychol Monogr 1966, 80(1):1-28.
51. Kohli S., Batra P., Aggarwal H.K. Anxiety, locus of control, and coping strategies among end-stage renal disease patients undergoing maintenance hemodialysis. Indian J Nephrol 2011, 21(3):177-181.
52. Bunch J.M., Schneider H.G. Smoking-specific locus of control. Psychol Rep 1991, 69(3 Pt 2):1075-1081.
53. McCreary C., Turner J. Locus of control, repression-sensitization, and psychological disorder in chronic pain patients. J Clin Psychol 1984, 40(4):897-901.
54. Irvine E.J., Zhou Q., Thompson A.K. The Short Inflammatory Bowel Disease Questionnaire: a quality of life instrument for community physicians managing inflammatory bowel disease. CCRPT Investigators. Canadian Crohn's Relapse Prevention Trial. Am J Gastroenterol 1996, 91(8):1571-1578.
55. Pedersen N., Thielsen P., Martinsen L., Bennedsen M., Haaber A., Langholz E., et al. eHealth: individualization of mesalazine treatment through a self-managed web-based solution in mild-to-moderate ulcerative colitis. Inflamm Bowel Dis 2014, 20(12):2276-2285.
56. Modigliani R., Mary J.Y., Simon J.F., Cortot A., Soule J.C., Gendre J.P., et al. Clinical, biological, and endoscopic picture of attacks of Crohn's disease. Evolution on prednisolone. Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives. Gastroenterology 1990, 98(4):811-818.
57. Sipponen T., Savilahti E., Kolho K.L., Nuutinen H., Turunen U., Farkkila M. Crohn's disease activity assessed by fecal calprotectin and lactoferrin: correlation with Crohn's disease activity index and endoscopic findings. Inflamm Bowel Dis 2008, 14(1):40-46.
58. Quinn C.C., Clough S.S., Minor J.M., Lender D., Okafor M.C., Gruber-Baldini A. WellDoc mobile diabetes management randomized controlled trial: change in clinical and behavioral outcomes and patient and physician satisfaction. Diabetes Technol Ther 2008, 10(3):160-168.
59. Wireless quick facts: December 2006 2009, CTIA-The Wireless Association, Washington DC.