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BMC Public Health
Published in: BMC Public Health 1/2010

Open Access 01-12-2010 | Study protocol

Randomised controlled trial of an automated, interactive telephone intervention to improve type 2 diabetes self-management (Telephone-Linked Care Diabetes Project): study protocol

Authors: Dominique Bird, Brian Oldenburg, Mandy Cassimatis, Anthony Russell, Susan Ash, Mary D Courtney, Paul A Scuffham, Ian Stewart, Richard Wootton, Robert H Friedman

Published in: BMC Public Health | Issue 1/2010

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Abstract

Background

An estimated 285 million people worldwide have diabetes and its prevalence is predicted to increase to 439 million by 2030. For the year 2010, it is estimated that 3.96 million excess deaths in the age group 20-79 years are attributable to diabetes around the world. Self-management is recognised as an integral part of diabetes care. This paper describes the protocol of a randomised controlled trial of an automated interactive telephone system aiming to improve the uptake and maintenance of essential diabetes self-management behaviours.

Methods/Design

A total of 340 individuals with type 2 diabetes will be randomised, either to the routine care arm, or to the intervention arm in which participants receive the Telephone-Linked Care (TLC) Diabetes program in addition to their routine care. The intervention requires the participants to telephone the TLC Diabetes phone system weekly for 6 months. They receive the study handbook and a glucose meter linked to a data uploading device. The TLC system consists of a computer with software designed to provide monitoring, tailored feedback and education on key aspects of diabetes self-management, based on answers voiced or entered during the current or previous conversations. Data collection is conducted at baseline (Time 1), 6-month follow-up (Time 2), and 12-month follow-up (Time 3). The primary outcomes are glycaemic control (HbA1c) and quality of life (Short Form-36 Health Survey version 2). Secondary outcomes include anthropometric measures, blood pressure, blood lipid profile, psychosocial measures as well as measures of diet, physical activity, blood glucose monitoring, foot care and medication taking. Information on utilisation of healthcare services including hospital admissions, medication use and costs is collected. An economic evaluation is also planned.

Discussion

Outcomes will provide evidence concerning the efficacy of a telephone-linked care intervention for self-management of diabetes. Furthermore, the study will provide insight into the potential for more widespread uptake of automated telehealth interventions, globally.

Trial Registration Number

ACTRN12607000594426
Literature
1.
Shaw JE, Sicree RA, Zimmet PZ: Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Research and Clinical Practice. 2010, 87 (1): 4-14. 10.1016/j.diabres.2009.10.007.CrossRefPubMed
2.
International Diabetes Federation: IDF Diabetes Atlas. 2009, Brussels, Belgium: International Diabetes Federation, 4
3.
UK Prospective Diabetes Study (UKPDS) Group: Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). The Lancet. 1998, 352 (9131): 837-853. 10.1016/S0140-6736(98)07019-6.CrossRef
4.
Selvin E, Marinopoulos S, Berkenblit G, Rami T, Brancati FL, Powe NR, Golden SH: Meta-Analysis: Glycosylated Hemoglobin and Cardiovascular Disease in Diabetes Mellitus. Annals of Internal Medicine. 2004, 141 (6): 421-431.CrossRefPubMed
5.
6.
Norris SL, Engelgau MM, Narayan KMV: Effectiveness of self-management training in type 2 diabetes: a systematic review of randomized controlled trials. Diabetes Care. 2001, 24 (3): 561-587. 10.2337/diacare.24.3.561.CrossRefPubMed
7.
Norris SL, Lau J, Smith SJ, Schmid CH, Engelgau MM: Self-management education for adults with type 2 diabetes: a meta-analysis of the effect on glycemic control. Diabetes Care. 2002, 25 (7): 1159-1171. 10.2337/diacare.25.7.1159.CrossRefPubMed
8.
Fisher EB, Brownson CA, O'Toole ML, Anwuri VV: Ongoing follow-up and support for chronic disease self-mangement in the Robert Wood Johnson Foundation Diabetes Initiative. The Diabetes Educator. 2007, 33 (Supplement 6): 201S-207S. 10.1177/0145721707304189.CrossRefPubMed
9.
Murray E, Burns J, See Tai S, Lai R, Nazareth I: Interactive Health Communication Applications for people with chronic disease. Cochrane Database of Systematic Reviews. 2005, 4
10.
Balas EA, Krishna S, Kretschmer RA, Cheek TR, Lobach DF, Boren SA: Computerized knowledge management in diabetes care. Medical care. 2004, 42 (6): 610-621. 10.1097/01.mlr.0000128008.12117.f8.CrossRefPubMed
11.
Jackson CL, Bolen S, Brancati FL, Batts-Turner ML, Gary TL: A systematic review of interactive computer-assisted technology in diabetes care. Interactive information technology in diabetes care. Journal of General Internal Medicine. 2006, 21 (2): 105-110.PubMedPubMedCentral
12.
Krishna S, Balas EA, Boren SA, Maglaveras N: Patient acceptance of educational voice messages: a review of controlled clinical studies. Methods of Information in Medicine. 2002, 41 (5): 360-369.PubMed
13.
Delichatsios HK, Friedman RH, Glanz K, Tennstedt S, Smigelski C, Pinto BM, Kelley H, Gillman MW: Randomized trial of a "talking computer" to improve adults' eating habits. American Journal Of Health Promotion. 2001, 15 (4): 215-224.CrossRefPubMed
14.
Farzanfar R, Frishkopf S, Migneault J, Friedman R: Telephone-linked care for physical activity: A qualitative evaluation of the use patterns of an information technology program for patients. Journal of Biomedical Informatics. 2005, 38 (3): 220-228. 10.1016/j.jbi.2004.11.011.CrossRefPubMed
15.
Glanz K, Shigaki D, Farzanfar R, Pinto B, Kaplan B, Friedman RH: Participant reactions to a computerized telephone system for nutrition and exercise counseling. Patient Education and Counseling. 2003, 49 (2): 157-163. 10.1016/S0738-3991(02)00076-9.CrossRefPubMed
16.
Jarvis KL, Friedman RH, Heeren T, Cullinane PM: Older women and physical activity: using the telephone to walk. Women's Health Issues. 1997, 7 (1): 24-29. 10.1016/S1049-3867(96)00050-3.CrossRefPubMed
17.
Pinto BM, Friedman R, Marcus BH, Kelley H, Tennstedt S, Gillman MW: Effects of a computer-based, telephone-counseling system on physical activity. American Journal of Preventive Medicine. 2002, 23 (2): 113-120. 10.1016/S0749-3797(02)00441-5.CrossRefPubMed
18.
Toobert DJ, Glasgow RE, Strycker LA, Barrera M, Radcliffe JL, Wander RC, Bagdade JD: Biologic and quality-of-life outcomes from the Mediterranean Lifestyle Program: a randomized clinical trial. Diabetes Care. 2003, 26 (8): 2288-2293. 10.2337/diacare.26.8.2288.CrossRefPubMed
19.
Jenkinson C, Stewart-Brown S, Petersen S, Paice C: Assessment of the SF-36 version 2 in the United Kingdom. Journal of Epidemiology and Community Health. 1999, 53 (1): 46-50. 10.1136/jech.53.1.46.CrossRefPubMedPubMedCentral
20.
Bird D, Oldenburg B, Wootton R, Friedman R: Development and evaluation of an automated telephone system for diabetes self-management [abstract]. Annals of Behavioral Medicine. 2008, 35 (Supplement): S013-
21.
Oldenburg B, Bird D, Friedman RH: Adaptation of an automated telephone system to promote physical activity in Australia [abstract]. Annals of Behavioral Medicine. 2005, 29 (Supplement): S083-
22.
Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P: Extending the CONSORT Statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Annals of Internal Medicine. 2008, 148 (4): 295-309.CrossRefPubMed
23.
24.
Ware JE, Kosinski M, Dewey J: How to score version 2 of the SF-36 Health Survey. 2000, Lincoln, RI: QualityMetric Incorporated
25.
Ware JE, Sherbourne CD: The MOS 36-item short-form health survey (SF-36): I. Conceptual framework and item selection. Medical Care. 1992, 30 (6): 473-483. 10.1097/00005650-199206000-00002.CrossRefPubMed
26.
Zigmond AS, Snaith RP: The Hospital Anxiety and Depression Scale. Acta Psychiatry Scandinavia. 1983, 67 (6): 361-370. 10.1111/j.1600-0447.1983.tb09716.x.CrossRef
27.
Mitchell PH, Powell L, Blumenthal J, Norten J, Ironson G, Pitula CR, Froelicher ES, Czajkowski S, Youngblood M, Huber M, et al: A short social support measure for patients recovering from myocardial infarction: the ENRICHD Social Support Inventory. Journal Of Cardiopulmonary Rehabilitation. 2003, 23 (6): 398-403. 10.1097/00008483-200311000-00001.CrossRefPubMed
28.
Schwarzer R, Renner B: Social-cognitive predictors of health behavior: action self-efficacy and coping self-efficacy. Health Psychology. 2000, 19 (5): 487-495. 10.1037/0278-6133.19.5.487.CrossRefPubMed
29.
Australian Institute of Health & Welfare: The Active Australia Survey: A guide and manual for implementation, analysis and reporting Canberra. 2003
30.
Hodge A, Patterson AJ, Brown WJ, Ireland P, Giles G: The Anti Cancer Council of Victoria FFQ: relative validity of nutrient intakes compared with weighed food records in young to middle-aged women in a study of iron supplementation. Australian and New Zealand Journal of Public Health. 2000, 24 (6): 576-583. 10.1111/j.1467-842X.2000.tb00520.x.CrossRefPubMed
31.
Toobert DJ, Hampson SH, Glasgow RE: The Summary of Diabetes Self-Care Activities measure: Results from 7 studies and a revised scale. Diabetes Care. 2000, 23 (7): 943-950. 10.2337/diacare.23.7.943.CrossRefPubMed
32.
Brazier J, Roberts J, Deveril M: The estimation of a preference-based measure of health from the SF-36. Journal of Health Economics. 2002, 21 (2): 271-292. 10.1016/S0167-6296(01)00130-8.CrossRefPubMed
33.
Doubilet P, Begg CB, Weinstein MC, Braun P, McNeil BJ: Probablistic sensitivity analysis using Monte Carlo simulations: a practical approach. Medical Decision Making. 1985, 5 (2): 157-177. 10.1177/0272989X8500500205.CrossRefPubMed
Metadata
Title
Randomised controlled trial of an automated, interactive telephone intervention to improve type 2 diabetes self-management (Telephone-Linked Care Diabetes Project): study protocol
Authors
Dominique Bird
Brian Oldenburg
Mandy Cassimatis
Anthony Russell
Susan Ash
Mary D Courtney
Paul A Scuffham
Ian Stewart
Richard Wootton
Robert H Friedman
Publication date
01-12-2010
Publisher
BioMed Central
Published in
BMC Public Health / Issue 1/2010
Electronic ISSN: 1471-2458
DOI
https://doi.org/10.1186/1471-2458-10-599

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