Low-intensity self-management intervention for persons with type 2 diabetes using a mobile phone-based diabetes diary, with and without health counseling and motivational interviewing: Protocol for a randomized controlled trial

JMIR Research Protocols

Volumn 2, Issue 2, 2013, Pages

  Ribu, Lis ^a   Holmen, Heidi ^a   Torbjørnsen, Astrid ^a   Wahl, Astrid Klopstad ^b   Grøttland, Astrid ^c   Småstuen, Milada Cvancarova ^a,b   Elind, Elisabeth ^a   Bergmo, Trine Strand ^c   Breivik, Elin ^c   Årsand, Eirik ^c  

^a OSLO METROPOLITAN UNIVERSITY   (Norway)

^b UNIVERSITY OF OSLO   (Norway)

^c UNIVERSITY HOSPITAL OF NORTH NORWAY   (Norway)

Author keywords

Acceptability; Complex intervention; Empowerment; Health counseling; Health related quality of life; Lifestyle intervention; MHealth; Mixed methods; Motivation; Self management; Telemedicine; Type 2 diabetes

Indexed keywords

EID: 85099718772     PISSN: None     EISSN: 19290748     Source Type: Journal    
DOI: 10.2196/resprot.2768     Document Type: Article

References (80)

1. Shaw JE, Sicree RA, Zimmet PZ. Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Res Clin Pract 2010 Jan; 87(1):4-14. [doi: 10.1016/j.diabres.2009.10.007] [Medline: 19896746]
2. Stene LC, Midthjell K, Jenum AK, Skeie S, Birkeland KI, Lund E, et al. [Prevalence of diabetes mellitus in Norway]. Tidsskr Nor Laegeforen 2004 Jun 3; 124(11):1511-1514 [FREE Full text] [Medline: 15195154]
3. Hu FB. Globalization of diabetes: The role of diet, lifestyle, and genes. Diabetes Care 2011 Jun; 34(6):1249-1257 [FREE Full text] [doi: 10.2337/dc11-0442] [Medline: 21617109]
4. Ali MK, Bullard KM, Saaddine JB, Cowie CC, Imperatore G, Gregg EW. Achievement of goals in U.S. diabetes care, 1999-2010. N Engl J Med 2013 Apr 25; 368(17):1613-1624. [doi: 10.1056/NEJMsa1213829] [Medline: 23614587]
5. Claudi T, Ingskog W, Cooper JG, Jenum AK, Hausken MF. [Quality of diabetes care in Norwegian general practice]. Tidsskr Nor Laegeforen 2008 Nov 20; 128(22):2570-2574 [FREE Full text] [Medline: 19023353]
6. 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). Lancet 1998 Sep 12; 352(9131):837-853. [Medline: 9742976]
7. Norwegian Ministry of HealthCare Services. Report No. 47 (2008-2009) to the storting. The coordination reform. Proper treatment - at the right place and right time. Oslo, Norway; 2009. URL: http://www.regjeringen.no/upload/HOD/Dokumenter%20INFO/Samhandling%20engelsk_PDFS.pdf [accessed 2013-08-14] [WebCite Cache ID 6IsMLGoTp]
8. Directorate for Health and Social Affairs. National Guidelines. Diabetes. Prevention, Diagnosis and Treatment. Oslo, Norway: Directorate for Health and Social Affairs; 2009. URL: http://helsedirektoratet.no/publikasjoner/nasjonal-faglig-retningslinje-diabetes/Publikasjoner/Nasjonal-faglig-retningslinje-Diabetes-fullversjon.pdf [accessed 2013-08-20] [WebCite Cache ID 6J0qoEoT0]
9. Jenssen TG, Tonstad S, Claudi T, Midthjell K, Cooper J. The gap between guidelines and practice in the treatment of type 2 diabetes: A nationwide survey in Norway. Diabetes Res Clin Pract 2008 May; 80(2):314-320. [doi: 10.1016/j.diabres.2007.12.025] [Medline: 18279994]
10. Cooper JG, Claudi T, Jenum AK, Thue G, Hausken MF, Ingskog W, et al. Quality of care for patients with type 2 diabetes in primary care in Norway is improving: Results of cross-sectional surveys of 33 general practices in 1995 and 2005. Diabetes Care 2009 Jan; 32(1):81-83 [FREE Full text] [doi: 10.2337/dc08-0605] [Medline: 18852338]
11. Norris SL, Nichols PJ, Caspersen CJ, Glasgow RE, Engelgau MM, Jack L, et al. Increasing diabetes self-management education in community settings. A systematic review. Am J Prev Med 2002 May; 22(suppl 4):39-66. [Medline: 11985934]
12. Tuomilehto J, Lindström J, Eriksson JG, Valle TT, Hämäläinen H, Ilanne-Parikka P, Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med 2001 May 3; 344(18):1343-1350. [doi: 10.1056/NEJM200105033441801] [Medline: 11333990]
13. Haas L, Maryniuk M, Beck J, Cox CE, Duker P, Edwards L, 2012 Standards Revision Task Force. National standards for diabetes self-management education and support. Diabetes Care 2013 Jan; 36(suppl 1):S100-S108. [doi: 10.2337/dc13-S100] [Medline: 23264420]
14. Osborne RH, Batterham R, Livingston J. The evaluation of chronic disease self-management support across settings: The international experience of the health education impact questionnaire quality monitoring system. Nurs Clin North Am 2011 Sep; 46(3):255-70, v. [doi: 10.1016/j.cnur.2011.05.010] [Medline: 21791261]
15. 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 Jul; 25(7):1159-1171. [Medline: 12087014]
16. Ismail K, Thomas SM, Maissi E, Chalder T, Schmidt U, Bartlett J, et al. Motivational enhancement therapy with and without cognitive behavior therapy to treat type 1 diabetes: A randomized trial. Ann Intern Med 2008 Nov 18; 149(10):708-719. [Medline: 19017589]
17. Peyrot M, Rubin RR. Behavioral and psychosocial interventions in diabetes: A conceptual review. Diabetes Care 2007 Oct; 30(10):2433-2440. [doi: 10.2337/dc07-1222] [Medline: 17666457]
18. Katon W. Depression and diabetes: Unhealthy bedfellows. Depress Anxiety 2010 Apr; 27(4):323-326. [doi: 10.1002/da.20683] [Medline: 20376836]
19. de Groot M, Kushnick M, Doyle T, Merrill J, McGlynn M, Shubrook J, et al. Depression among adults with diabetes: Prevalence, impact, and treatment options. Diabetes Spectr 2010 Jan 21; 23(1):15-18 [FREE Full text] [doi: 10.2337/diaspect.23.1.15] [Medline: 22485068]
20. Lin EH, Rutter CM, Katon W, Heckbert SR, Ciechanowski P, Oliver MM, et al. Depression and advanced complications of diabetes: A prospective cohort study. Diabetes Care 2010 Feb; 33(2):264-269 [FREE Full text] [doi: 10.2337/dc09-1068] [Medline: 19933989]
21. May CR, Finch TL, Cornford J, Exley C, Gately C, Kirk S, et al. Integrating telecare for chronic disease management in the community: what needs to be done? BMC Health Serv Res 2011; 11:131 [FREE Full text] [doi: 10.1186/1472-6963-11-131] [Medline: 21619596]
22. Castelnuovo G, Manzoni GM, Cuzziol P, Cesa GL, Corti S, Tuzzi C, et al. TECNOB Study: Ad interim results of a randomized controlled trial of a multidisciplinary telecare intervention for obese patients with type-2 diabetes. Clin Pract Epidemiol Ment Health 2011; 7:44-50 [FREE Full text] [doi: 10.2174/1745017901107010044] [Medline: 21559233]
23. Castelnuovo G, Manzoni GM, Cuzziol P, Cesa GL, Tuzzi C, Villa V, et al. TECNOB: Study design of a randomized controlled trial of a multidisciplinary telecare intervention for obese patients with type-2 diabetes. BMC Public Health 2010; 10:204 [FREE Full text] [doi: 10.1186/1471-2458-10-204] [Medline: 20416042]
24. Verhoeven F, van Gemert-Pijnen L, Dijkstra K, Nijland N, Seydel E, Steehouder M. The contribution of teleconsultation and videoconferencing to diabetes care: A systematic literature review. J Med Internet Res 2007; 9(5):e37 [FREE Full text] [doi: 10.2196/jmir.9.5.e37] [Medline: 18093904]
25. Steventon A, Bardsley M, Billings J, Dixon J, Doll H, Hirani S, Whole System Demonstrator Evaluation Team. Effect of telehealth on use of secondary care and mortality: Findings from the Whole System Demonstrator cluster randomised trial. BMJ 2012 Jun 21; 344:e3874 [FREE Full text] [Medline: 22723612]
26. Trief PM, Teresi JA, Eimicke JP, Shea S, Weinstock RS. Improvement in diabetes self-efficacy and glycaemic control using telemedicine in a sample of older, ethnically diverse individuals who have diabetes: The IDEATel project. Age Ageing 2009 Mar; 38(2):219-225 [FREE Full text] [doi: 10.1093/ageing/afn299] [Medline: 19171951]
27. Welschen LM, Bloemendal E, Nijpels G, Dekker JM, Heine RJ, Stalman WA, et al. Self-monitoring of blood glucose in patients with type 2 diabetes who are not using insulin: A systematic review. Diabetes Care 2005 Jun; 28(6):1510-1517. [Medline: 15920083]
28. Paré G, Moqadem K, Pineau G, St-Hilaire C. Clinical effects of home telemonitoring in the context of diabetes, asthma, heart failure and hypertension: A systematic review. J Med Internet Res 2010; 12(2):e21 [FREE Full text] [doi: 10.2196/jmir.1357] [Medline: 20554500]
29. Polisena J, Tran K, Cimon K, Hutton B, McGill S, Palmer K. Home telehealth for diabetes management: A systematic review and meta-analysis. Diabetes Obes Metab 2009 Oct; 11(10):913-930. [doi: 10.1111/j.1463-1326.2009.01057.x] [Medline: 19531058]
30. García-Lizana F, Sarría-Santamera A. New technologies for chronic disease management and control: A systematic review. J Telemed Telecare 2007; 13(2):62-68. [doi: 10.1258/135763307780096140] [Medline: 17359568]
31. Chumbler NR, Neugaard B, Kobb R, Ryan P, Qin H, Joo Y. Evaluation of a care coordination/home-telehealth program for veterans with diabetes: Health services utilization and health-related quality of life. Eval Health Prof 2005 Dec; 28(4):464-478. [doi: 10.1177/0163278705281079] [Medline: 16272426]
32. Field MJ. Telemedicine. A Guide to Assessing Telecommunications in Health Care. Washington, DC: National Academy Press; 1996.
33. Chomutare T, Fernandez-Luque L, Arsand E, Hartvigsen G. Features of mobile diabetes applications: Review of the literature and analysis of current applications compared against evidence-based guidelines. J Med Internet Res 2011; 13(3):e65 [FREE Full text] [doi: 10.2196/jmir.1874] [Medline: 21979293]
34. Farmer A, Gibson OJ, Tarassenko L, Neil A. A systematic review of telemedicine interventions to support blood glucose self-monitoring in diabetes. Diabet Med 2005 Oct; 22(10):1372-1378. [doi: 10.1111/j.1464-5491.2005.01627.x] [Medline: 16176199]
35. Ekeland AG, Bowes A, Flottorp S. Effectiveness of telemedicine: A systematic review of reviews. Int J Med Inform 2010 Nov; 79(11):736-771. [doi: 10.1016/j.ijmedinf.2010.08.006] [Medline: 20884286]
36. Shea S, Starren J, Weinstock RS, Knudson PE, Teresi J, Holmes D, et al. Columbia University's Informatics for Diabetes Education and Telemedicine (IDEATel) Project: Rationale and design. J Am Med Inform Assoc 2002; 9(1):49-62 [FREE Full text] [Medline: 11751803]
37. Stone RA, Rao RH, Sevick MA, Cheng C, Hough LJ, Macpherson DS, et al. Active care management supported by home telemonitoring in veterans with type 2 diabetes: The DiaTel randomized controlled trial. Diabetes Care 2010 Mar; 33(3):478-484 [FREE Full text] [doi: 10.2337/dc09-1012] [Medline: 20009091]
38. Nolte S, Elsworth GR, Newman S, Osborne RH. Measurement issues in the evaluation of chronic disease self-management programs. Qual Life Res 2012 Nov 18. [doi: 10.1007/s11136-012-0317-1] [Medline: 23161330]
39. Kidholm K, Ekeland AG, Jensen LK, Rasmussen J, Pedersen CD, Bowes A, et al. A model for assessment of telemedicine applications: MAST. Int J Technol Assess Health Care 2012 Jan; 28(1):44-51. [doi: 10.1017/S0266462311000638] [Medline: 22617736]
40. World Health Organization. Preparing a Health Care Workforce for the 21st Century: The Challenge of Chronic Conditions. Geneva, Switzerland: World Health Organization; 2005. URL: http://www.who.int/chp/knowledge/publications/workforce_report.pdf [accessed 2013-08-20] [WebCite Cache ID 6J0rXzh4z]
41. Richards D, Chellingsworth M, Hope R, Turpin T, Whyte M. Reach Out: National Programme Supervisor Materials to Support the Delivery of Training for Psychological Wellbeing Practitioners Delivering Low Intensity Interventions. London: Rethink; 2010. URL: http://www.babcp.com/files/Accreditation/PWP/IAPT-PWP-Supervision-Manual-Reach-Out.pdf [accessed 2013-08-20] [WebCite Cache ID 6J0reHkuh]
42. Richards D, Whyte M. Reach Out: National Programme Educator Materials to Support the Delivery of Training for Psychological Wellbeing Practitioners Delivering Low Intensity Interventions. London: Rethink; 2009. URL: http://www. iapt.nhs.uk/silo/files/reach-out-educator-manual.pdf [accessed 2013-08-20] [WebCite Cache ID 6J0rlyCV0]
43. Rollnick S, Miller WR, Butler CC. Motivational Interviewing in Health Care: Helping Patients Change Behavior (Applications of Motivational Interviewing). New York, NY: The Guilford Press; 2008.
44. Prochaska JO, DiClemente CC, Norcross JC. In search of how people change. Applications to addictive behaviors. Am Psychol 1992 Sep; 47(9):1102-1114. [Medline: 1329589]
45. Prochaska JO, DiClemente CC. Stages and processes of self-change of smoking: Toward an integrative model of change. J Consult Clin Psychol 1983 Jun; 51(3):390-395. [Medline: 6863699]
46. Vallis M, Ruggiero L, Greene G, Jones H, Zinman B, Rossi S, et al. Stages of change for healthy eating in diabetes: Relation to demographic, eating-related, health care utilization, and psychosocial factors. Diabetes Care 2003 May; 26(5):1468-1474. [Medline: 12716806]
47. Walker EA, Shmukler C, Ullman R, Blanco E, Scollan-Koliopoulus M, Cohen HW. Results of a successful telephonic intervention to improve diabetes control in urban adults: A randomized trial. Diabetes Care 2011 Jan; 34(1):2-7 [FREE Full text] [doi: 10.2337/dc10-1005] [Medline: 21193619]
48. Glasgow RE, Peeples M, Skovlund SE. Where is the patient in diabetes performance measures? The case for including patient-centered and self-management measures. Diabetes Care 2008 May; 31(5):1046-1050 [FREE Full text] [doi: 10.2337/dc07-1845] [Medline: 18445728]
49. Sandelowski M. Combining qualitative and quantitative sampling, data collection, and analysis techniques in mixed-method studies. Res Nurs Health 2000 Jun; 23(3):246-255. [Medline: 10871540]
50. Årsand E. The Few Touch Digital Diabetes Diary. User-Involved Design of Mobile Self-Help Tools for People with Diabetes. Tromsø: Department of Computer Science, University of Tromsø; 2009.
51. Årsand E, Tatara N, Østengen G, Hartvigsen G. Mobile phone-based self-management tools for type 2 diabetes: The few touch application. J Diabetes Sci Technol 2010 Mar; 4(2):328-336 [FREE Full text] [Medline: 20307393]
52. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M, Medical Research Council Guidance. Developing and evaluating complex interventions: The new Medical Research Council guidance. BMJ 2008; 337:a1655 [FREE Full text] [Medline: 18824488]
53. Calvert M, Blazeby J, Altman DG, Revicki DA, Moher D, Brundage MD, CONSORT PRO Group. Reporting of patient-reported outcomes in randomized trials: The CONSORT PRO extension. JAMA 2013 Feb 27; 309(8):814-822. [doi: 10.1001/jama.2013.879] [Medline: 23443445]
54. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. J Pharmacol Pharmacother 2010 Jul; 1(2):100-107 [FREE Full text] [doi: 10.4103/0976-500X.72352] [Medline: 21350618]
55. NTNU. The HUNT study - a longitudinal population health Study in Norway. Nord-Trøndelag Health StudyURL: http://www.ntnu.edu/hunt[WebCite Cache ID 6J41HGbwi]
56. McNamara R, Robling M, Hood K, Bennert K, Channon S, Cohen D, et al. Development and Evaluation of a Psychosocial Intervention for Children and Teenagers Experiencing Diabetes (DEPICTED): A protocol for a cluster randomised controlled trial of the effectiveness of a communication skills training programme for healthcare professionals working with young people with type 1 diabetes. BMC Health Serv Res 2010; 10:36 [FREE Full text] [doi: 10.1186/1472-6963-10-36] [Medline: 20144218]
57. Wallace TM, Matthews DR. Poor glycaemic control in type 2 diabetes: A conspiracy of disease, suboptimal therapy and attitude. QJM 2000 Jun; 93(6):369-374 [FREE Full text] [Medline: 10873187]
58. Loge JH, Kaasa S. Short Form 36 (SF-36) health survey: normative data from the general Norwegian population. Scand J Soc Med 1998 Dec; 26(4):250-258. [Medline: 9868748]
59. Ware JE, Sherbourne CD. The MOS 36-Item Short-Form Health Survey (SF-36). I. Conceptual framework and item selection. Med Care 1992 Jun; 30(6):473-483. [Medline: 1593914]
60. Speight J, Reaney MD, Barnard KD. Not all roads lead to Rome - a review of quality of life measurement in adults with diabetes. Diabet Med 2009 Apr; 26(4):315-327. [doi: 10.1111/j.1464-5491.2009.02682.x] [Medline: 19388959]
61. Radloff L. The CES-D Scale: A Self-Report Depression Scale for research in the general population. Appl Psychol Meas 1977 Jun 01; 1(3):385-401. [doi: 10.1177/014662167700100306]
62. Osborne RH, Elsworth GR, Whitfield K. The Health Education Impact Questionnaire (heiQ): An outcomes and evaluation measure for patient education and self-management interventions for people with chronic conditions. Patient Educ Couns 2007 May; 66(2):192-201. [doi: 10.1016/j.pec.2006.12.002] [Medline: 17320338]
63. Anderson RM, Fitzgerald JT, Gruppen LD, Funnell MM, Oh MS. The Diabetes Empowerment Scale-Short Form (DES-SF). Diabetes Care 2003 May; 26(5):1641-1642. [Medline: 12716841]
64. Anderson RM, Funnell MM, Fitzgerald JT, Marrero DG. The Diabetes Empowerment Scale: A measure of psychosocial self-efficacy. Diabetes Care 2000 Jun; 23(6):739-743 [FREE Full text] [Medline: 10840988]
65. Eigenmann CA, Colagiuri R, Skinner TC, Trevena L. Are current psychometric tools suitable for measuring outcomes of diabetes education? Diabet Med 2009 Apr; 26(4):425-436. [doi: 10.1111/j.1464-5491.2009.02697.x] [Medline: 19388974]
66. Lorentzen C, Ommundsen Y, Holme I. Psychosocial correlates of stages of change in physical activity in an adult community sample. Eur J Sport Sci 2007 Jun; 7(2):93-106. [doi: 10.1080/17461390701456122]
67. Larsen IK, Grotmol T, Almendingen K, Hoff G. Lifestyle characteristics among participants in a Norwegian colorectal cancer screening trial. Eur J Cancer Prev 2006 Feb; 15(1):10-19. [Medline: 16374224]
68. Brooke J. SUS: A "quick and dirty" usability scale. In: Jordan PW, Thomas B, Weerdmeester BA, McClelland AL, editors. Usability Evaluation in Industry. London: Taylor and Francis; 1996:189-194.
69. Bower P, Cartwright M, Hirani SP, Barlow J, Hendy J, Knapp M, et al. A comprehensive evaluation of the impact of telemonitoring in patients with long-term conditions and social care needs: Protocol for the whole systems demonstrator cluster randomised trial. BMC Health Serv Res 2011; 11:184 [FREE Full text] [doi: 10.1186/1472-6963-11-184] [Medline: 21819569]
70. Strauss AL, Corbin JM. Basics of Qualitative Research: Techniques and Procedures for Developing Grounded Theory. Thousand Oaks, CA: Sage Publications; 1998.
71. Brazier J, Roberts J, Deverill M. The estimation of a preference-based measure of health from the SF-36. J Health Econ 2002 Mar; 21(2):271-292. [Medline: 11939242]
72. Drummond MF, McGuire A. Economic Evaluation in Health Care: Merging Theory with Practice. Oxford: Oxford University Press; 2001.
73. Bradley C. Designing medical and educational intervention studies. A review of some alternatives to conventional randomized controlled trials. Diabetes Care 1993 Feb; 16(2):509-518. [Medline: 8432226]
74. Bradley C. Patients' preferences and randomised trials. Lancet 1996 Apr 20; 347(9008):1118-1119. [Medline: 8602090]
75. Harwell TS, Dettori N, McDowall JM, Quesenberry K, Priest L, Butcher MK, et al. Do persons with diabetes know their (A1C) number? Diabetes Educ 2002 Feb; 28(1):99-105. [Medline: 11852748]
76. Nolte S, Osborne RH. A systematic review of outcomes of chronic disease self-management interventions. Qual Life Res 2012 Oct 31. [doi: 10.1007/s11136-012-0302-8] [Medline: 23111571]
77. Polit DF, Beck CT. Nursing Research: Generating and Assessing Evidence for Nursing Practice. 8th edition. Philadelphia, PA: Lippincott Williams & Wilkins; 2008.
78. Glasgow RE, Hiss RG, Anderson RM, Friedman NM, Hayward RA, Marrero DG, et al. Report of the health care delivery work group: Behavioral research related to the establishment of a chronic disease model for diabetes care. Diabetes Care 2001 Jan; 24(1):124-130. [Medline: 11194217]
79. Bower P, Wallace P, Ward E, Graffy J, Miller J, Delaney B, et al. Improving recruitment to health research in primary care. Fam Pract 2009 Oct; 26(5):391-397 [FREE Full text] [doi: 10.1093/fampra/cmp037] [Medline: 19549623]
80. Sanders C, Rogers A, Bowen R, Bower P, Hirani S, Cartwright M, et al. Exploring barriers to participation and adoption of telehealth and telecare within the Whole System Demonstrator trial: A qualitative study. BMC Health Serv Res 2012; 12:220 [FREE Full text] [doi: 10.1186/1472-6963-12-220] [Medline: 22834978]