The 5x1 DAFNE study protocol: a cluster randomised trial comparing a standard 5 day DAFNE course delivered over 1 week against DAFNE training delivered over 1 day a week for 5 consecutive weeks

BMC Endocrine Disorders

Simon Heller³  Simon Dixon²  Mike Campbell²  Celia Emery⁴  David Rankin¹  Julia Lawton¹  Jackie Elliott³ 

[1] Centre for Population Health Sciences, The University of Edinburgh, Medical School, Teviot Place, Edinburgh, EH8 9AG, UK;School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK;Academic Unit of Diabetes, Endocrinology & Metabolism, Department of Human Metabolism, The University of Sheffield, The Medical School, Beech Hill Road, Sheffield, S10 2RX, UK;DAFNE NIHR Project Office, 11 Broomfield Rd, Sheffield, S10 2SE, UK

关键词: Training programs;    Teaching;    Education;    Type 1 diabetes;   

Others  :  1086088
DOI  :  10.1186/1472-6823-12-28

 received in 2012-05-25, accepted in 2012-10-29,  发布年份 2012

【 摘 要 】

Background

Structured education programmes are now established as an essential component to assist effective self-management of diabetes. In the case of Type 1 diabetes, the Dose Adjustment For Normal Eating (DAFNE) programme improves both glycaemic control and quality of life. Traditionally delivered over five consecutive days, this format has been cited as a barrier to participation by some patients, such as those who work full-time. Some centres in the UK have organised structured education programmes to be delivered one day a week over several consecutive weeks. This type of format may add benefit by allowing more time in which to practice skills between sessions, but may suffer as a result of weaker peer support being generated compared to that formed over five consecutive days.

Methods/design

We aim to compare DAFNE delivered over five consecutive days (1 week course) with DAFNE delivered one day a week over five weeks (5 week course) in a randomised controlled trial. A total of 213 patients were randomised to attend either a 1 week or a 5 week course delivered in seven participating centres. Study outcomes (measured at baseline, 6 and 12 months post-course) include HbA_1c, weight, self-reported rates of severe hypoglycaemia, psychosocial measures of quality of life, and cost-effectiveness. Generalisability was optimised by recruiting patients from DAFNE waiting lists at each centre, and by mailing eligible patients from hospital clinic lists. The inclusion and exclusion criteria were identical to those used to recruit to a standard DAFNE course (e.g., HbA_1c <12%, with no lower limit). Qualitative interviews were undertaken with a sub-sample of n=30 patients and their course educators (n=11) to help understand and interpret differences and similarities in outcomes between thetwo arms, and to identify logistical problems and unanticipated issues arising from the adaptation and delivery ofa 5 week course.

Discussion

This trial has been designed to test the hypothesis that the benefits of delivering a structured education programme over 5 weeks are comparable to those observed after a 1 week course. The results of the trial and the qualitative sub-study will both inform the design and delivery of future DAFNE courses, and the development of structured education programmes in other fields of medicine.

Trial Registration

Clinicaltrials.gov NCT01069393

【 授权许可】

   
2012 Elliott et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Muhlhauser I, Bruckner I, Berger M, Cheţa D, Jörgens V, Ionescu-Tîrgovişte C, Scholz V, Mincu I: Evaluation of an intensified insulin treatment and teaching programme as routine management of type 1 (insulin-dependent) diabetes. The Bucharest-Dusseldorf Study. Diabetologia 1987, 30:681-690.
• [2]DAFNE Study Group: Training in flexible, intensive insulin management to enable dietary freedom in people with type 1 diabetes: dose adjustment for normal eating (DAFNE) randomised controlled trial. Br Med J 2002, 325:746-749.
• [3]Oliver L, Thompson G: The DAFNE Collaborative. Experiences of developing a nationally delivered evidence-based, quality assured programme for people with type 1 diabetes. Practical Diabetes Int 2009, 26:371-377.
• [4]National Institute for Health and Clinical Excellence Quality Standards. http://www.nice.org.uk/guidance/qualitystandards/diabetesinadults/structurededucation.jsp webcite
• [5]Diabetes-education.net. http://www.diabetes-education.net/index.php?link=education&page=centres webcite
• [6]George JT, Valdovinos AP, Russell I, Dromgoole P, Lomax S, Torgerson DJ, Wells T, Thow JC: Clinical effectiveness of a brief educational intervention in Type 1 diabetes: results from the BITES (Brief Intervention in Type 1 diabetes, Education for Self-efficacy) trial. Diabet Med 2008, 25:1447-1453.
• [7]Knott J, Ryder J, Jenkins E, Charman J, Shaban C, Cross C, Weiss M, Cavan D: A 12-year audit of BERTIE: successful outcomes for at least 5 years [abstract]. Diabet Med 2012, 19(S1):21.
• [8]Lawton J, Jenkins N, Darbyshire J, Farmer A, Hollman R, Hallowell N: Challenges of Maintaining Research Protocol Fidelity in a Clinical Care Setting: A qualitative study of the experiences and views of patients and staff participating in a randomised controlled trial. Trials 2011, 12:108. BioMed Central Full Text
• [9]Moher D, Schulz KF, Altman DG: The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials. Ann Intern Med 2001, 134:657-662.
• [10]The Diabetes Control and Complication Trial Research Group: The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993, 329:683-689.
• [11]UK Hypoglycaemia Study Group: Risk of hypoglycaemia in type 1 and 2 diabetes: effects of treatment modalities and their duration. Diabetologia 2007, 50:1140-1147.
• [12]Bott U, Muhlhauser I, Overmann H, Berger M: Validation of a diabetes-specific quality-of-life scale for patients with type 1 diabetes. Diabetes Care 1998, 21(5):757-769.
• [13]Ware JE, Kosinki M, Keller SD: A 12-item Short Form Health Survey – construction of scales and preliminary tests of reliability and validity. Medical Care 1996, 34:220-233.
• [14]Kind P: The EuroQol instrument: an index of health-related quality of life. In Quality of Life and Pharmacoeconomics in Clinical Trials. Edited by Spilker B. Philadelphia: Lippincott-Raven; 1996.
• [15]Zigmond AS, Snaith RP: The hospital anxiety and depression scale. Acta Psychiatr Scand 1983, 67(6):361-370.
• [16]Welch GW, Jacobson AM, Polonsky WH: The problem areas in diabetes scale. An evaluation of its clinical utility. Diabetes Care 1997, 20:760-766.
• [17]Van Der Ven NC, Weinger K, Yi J, Pouwer F, Ader H, Van Der Ploeg HM, Snoek FJ: The confidence in diabetes self-care scale: psychometric properties of a new measure of diabetes-specific self-efficacy in Dutch and US patients with type 1 diabetes. Diabetes Care 2003, 26:713-718.
• [18]Hampson SE, Glasgow RE, Toobert DJ: Personal models of diabetes and their relations to self-care activities. Health Psychol 1990, 9:632-646.
• [19]Hampson SE, Glasgow RE, Foster LS: Personal models of diabetes among older adults: relationship to self-management and other variables. Diabetes Educ 1995, 21(4):300-307.
• [20]Glasgow RE, Hampson SE, Strycker LA, Ruggiero L: Personal-model beliefs and social-environmental barriers related to diabetes self-management. Diabetes Care 1997, 20:556-561.
• [21]Weinger K, Butler HA, Welch GW, La Greca AM: Measuring diabetes self-care: a psychometric analysis of the Self-Care Inventory-Revised with adults. Diabetes Care 2005, 28:1346-1352.
• [22]Cox DJ, Irvine A, Gonder-Frederick L, Nowacek G, Butterfield J: Fear of hypoglycaemia: quantification, validation, and utilization. Diabetes Care 1987, 10(5):617-621.
• [23]Taylor EP, Crawford JR, Gold AW, Strachen MWJ: Design and development of a scale measuring fear of complications in type 1 diabetes. Diabetes Metab Res Rev 2005, 21:262-269.
• [24]Sarason IG, Levine HM, Basham RB, Sarason BR: Assessing social support: The Social Support Questionnaire. J Pers Soc Psychol 1983, 44:127-139.
• [25]Sarason IG, Sarason BR, Shearin EN, Pierce GR: A brief measure of social support: practical and theoretical implications. J Pers Soc Psychol 1987, 4:497-510.
• [26]Weinman J, Wright S, Johnston M: Social support measures in health psychology, a user’s portfolio. Windsor: NFER-NELSON Publishing Company; 1995:7-8.
• [27]International Wellbeing Group: Personal Wellbeing Index. 4th edition. Melbourne: Australian Centre on Quality of Life, Deakin University; 2006.
• [28]Fitzgerald JL, Funnell MM, Hess GE, Barr PA, Anderson RM, Hiss RG, Davis WK: The reliability and validity if a brief diabetes knowledge test. Diabetes Care 1998, 21:706-710.
• [29]Osborne RH, Elsworth GR, Whitfield K: The health education impact questionnaire (heiQ): an outcomes and evaluation measure for patient education and self-management intervention for people with chronic conditions. Patient education and counselling 2007, 66:192-201.
• [30]Lawton J, Rankin D: How do structured education programmes work? An ethnographic investigation for the dose adjustment for normal eating (DAFNE) programme for tpe 1 diabetes patients in the UK. Social Sci Med 2010, 71:486-493.
• [31]Lawton J, Rankin D, Cooke D, Clarke M, Elliott J, Heller S for the UK NIHR DAFNE Study Group: Dose adjustment for normal eating: a qualitative longitudinal exploration of the food and eating practices of type 1 diabetes patients converted to flexible intensive insulin therapy in the UK. Diabetes Res Clin Pract 2011, 91:87-93.
• [32]Rankin D, Cooke DD, Clark M, Heller S, Elliott J, Lawton J, NIHR DAFNE Study Group: How and why do patients with type 1 diabetes sustain their use of flexible intensive insulin therapy? A qualitative longitudinal investigation of patients’ self-management practices following attendance at a Dose Adjustment For Normal Eating DAFNE) course. Diabet Med 2011, 28:532-538.
• [33]Rankin D, Heller S, Lawton J: Understanding information and education gaps among people with type 1 diabetes: a qualitative investigation. Patient Educ Couns 2011, 83:87-91.
• [34]Rankin D, Cooke DD, Heller S, Elliott J, Amiel S, Lawton J: Experiences of using blood glucose targets when following an intensive insulin regimen: a qualitative longitudinal investigation involving patients with type 1 diabetes. Diabet Medin press
• [35]NICE: Guidance on the use of patient-education models for diabetes. 2003.
• [36]Lawton J, Peel E, Parry O, Araoz G, Douglas M: Lay perceptions of type 2 diabetes in Scotland: bringing health services back in. Soc Sci Med 2005, 60:1423-1435.
• [37]Lawton J, Parry O, Peel E, Douglas M: Diabetes service provision: a qualitative study of newly diagnosed Type 2 diabetes patients' experiences and views. Diabet Med 2005, 22:1246-51.
• [38]Glaser BG, Strauss AL: The discovery of grounded theory: strategies for qualitative research. Chicago: Aldine; 1967.
• [39]Strauss A, Corbin J: Basics of qualitative research: grounded theory procedures and techniques. London: Sage; 1990.