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

Lis Ribu, Heidi Holmen, Astrid Torbjørnsen, Astrid Klopstad Wahl, Astrid Grøttland, Milada Cvancarova Småstuen, Elisabeth Elind, Trine Strand Bergmo, Elin Breivik, Eirik Arsand, Lis Ribu, Heidi Holmen, Astrid Torbjørnsen, Astrid Klopstad Wahl, Astrid Grøttland, Milada Cvancarova Småstuen, Elisabeth Elind, Trine Strand Bergmo, Elin Breivik, Eirik Arsand

Abstract

Background: The present study protocol is designed to cover the Norwegian part of the European Union Collaborative Project-REgioNs of Europe WorkINg together for HEALTH (RENEWING HEALTH). Self-management support is an important element of care for persons with type 2 diabetes (T2D) for achieving metabolic control and positive lifestyle changes. Telemedicine (TM) with or without health counseling may become an important technological aid for self-management and may provide a user-centered model of care. In spite of many earlier studies on TM, there remains a lack of consensus in research findings about the effect of TM interventions.

Objective: The aim of RENEWING HEALTH is to validate and evaluate innovative TM tools on a large scale through a common evaluation, making it easier for decision makers to choose the most efficient and cost-effective technological interventions. The Norwegian pilot study evaluates whether the introduction of a mobile phone with a diabetes diary application together with health counseling intervention produces benefits in terms of the desired outcomes, as reflected in the hemoglobin A1c level, health-related quality of life, behavior change, and cost-effectiveness.

Methods: The present study has a mixed-method design comprising a three-armed prospective randomized controlled trial and qualitative interviews with study data collected at three time points: baseline, after 4 months, and after 1 year. The patients' registrations on the application are recorded continuously and are sent securely to a server.

Results: The inclusion of patients started in March 2011, and 100% of the planned sample size is included (N=151). Of all the participants, 26/151 patients (17.2%) are lost to follow-up by now, and 11/151 patients (7.3%) are still in the trial. Results of the study protocol will be presented in 2014.

Conclusions: The key goals of this trial are to investigate the effect of an electronic diabetes diary app with and without health counseling, and to determine whether health counseling is important to the continued use of the application and the patients' health competence and acceptability. Research within this area is needed because few studies have investigated the effectiveness of apps used in long-term interventions with this degree of self-management.

Trial registration: Clinicaltrials.gov NCT01315756; https://ichgcp.net/clinical-trials-registry/NCT01315756 (Archived by WebCite at http://www.webcitation/6BTyuRMpH).

Keywords: acceptability; complex intervention; empowerment; health counseling; health-related quality of life; lifestyle intervention; mHealth; mixed methods; motivation; self-management; telemedicine; type 2 diabetes.

Conflict of interest statement

Conflicts of Interest: None declared.

Figures

Figure 1
Figure 1
Design of the randomized controlled trial.
Figure 2
Figure 2
Pilot drawings.

References

    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.
    1. Stene LC, Midthjell K, Jenum AK, Skeie S, Birkeland KI, Lund E, Joner G, Tell GS, Schirmer H. [Prevalence of diabetes mellitus in Norway] Tidsskr Nor Laegeforen. 2004 Jun 3;124(11):1511–4.
    1. Hu FB. Globalization of diabetes: the role of diet, lifestyle, and genes. Diabetes Care. 2011 Jun;34(6):1249–57. doi: 10.2337/dc11-0442.
    1. 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):1613–24. doi: 10.1056/NEJMsa1213829.
    1. 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):2570–4.
    1. 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):837–53.
    1. 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. [2013-08-14]. .
    1. Directorate for Health and Social Affairs . National Guidelines. Diabetes. Prevention, Diagnosis and Treatment. Oslo, Norway: Directorate for Health and Social Affairs; 2009. [2013-08-20]. .
    1. 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):314–20. doi: 10.1016/j.diabres.2007.12.025.
    1. Cooper JG, Claudi T, Jenum AK, Thue G, Hausken MF, Ingskog W, Sandberg S. 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):81–3. doi: 10.2337/dc08-0605.
    1. Norris SL, Nichols PJ, Caspersen CJ, Glasgow RE, Engelgau MM, Jack L, Snyder SR, Carande-Kulis VG, Isham G, Garfield S, Briss P, McCulloch D. Increasing diabetes self-management education in community settings. A systematic review. Am J Prev Med. 2002 May;22(suppl 4):39–66.
    1. Tuomilehto J, Lindström J, Eriksson JG, Valle TT, Hämäläinen H, Ilanne-Parikka P, Keinänen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M, 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):1343–50. doi: 10.1056/NEJM200105033441801.
    1. Haas L, Maryniuk M, Beck J, Cox CE, Duker P, Edwards L, Fisher EB, Hanson L, Kent D, Kolb L, McLaughlin S, Orzeck E, Piette JD, Rhinehart AS, Rothman R, Sklaroff S, Tomky D, Youssef G, 2012 Standards Revision Task Force National standards for diabetes self-management education and support. Diabetes Care. 2013 Jan;36(suppl 1):S100–8. doi: 10.2337/dc13-S100.
    1. 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.
    1. 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):1159–71.
    1. Ismail K, Thomas SM, Maissi E, Chalder T, Schmidt U, Bartlett J, Patel A, Dickens CM, Creed F, Treasure J. 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):708–19.
    1. Peyrot M, Rubin RR. Behavioral and psychosocial interventions in diabetes: a conceptual review. Diabetes Care. 2007 Oct;30(10):2433–40. doi: 10.2337/dc07-1222.
    1. Katon W. Depression and diabetes: unhealthy bedfellows. Depress Anxiety. 2010 Apr;27(4):323–6. doi: 10.1002/da.20683.
    1. de Groot M, Kushnick M, Doyle T, Merrill J, McGlynn M, Shubrook J, Schwartz F. Depression among adults with diabetes: prevalence, impact, and treatment options. Diabetes Spectr. 2010 Jan 21;23(1):15–18. doi: 10.2337/diaspect.23.1.15.
    1. Lin EH, Rutter CM, Katon W, Heckbert SR, Ciechanowski P, Oliver MM, Ludman EJ, Young BA, Williams LH, McCulloch DK, Von Korff M. Depression and advanced complications of diabetes: a prospective cohort study. Diabetes Care. 2010 Feb;33(2):264–9. doi: 10.2337/dc09-1068.
    1. May CR, Finch TL, Cornford J, Exley C, Gately C, Kirk S, Jenkings KN, Osbourne J, Robinson AL, Rogers A, Wilson R, Mair FS. Integrating telecare for chronic disease management in the community: what needs to be done? BMC Health Serv Res. 2011;11:131. doi: 10.1186/1472-6963-11-131.
    1. Castelnuovo G, Manzoni GM, Cuzziol P, Cesa GL, Corti S, Tuzzi C, Villa V, Liuzzi A, Petroni ML, Molinari E. 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. doi: 10.2174/1745017901107010044.
    1. Castelnuovo G, Manzoni GM, Cuzziol P, Cesa GL, Tuzzi C, Villa V, Liuzzi A, Petroni ML, Molinari E. 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. doi: 10.1186/1471-2458-10-204.
    1. 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. doi: 10.2196/jmir.9.5.e37.
    1. Steventon A, Bardsley M, Billings J, Dixon J, Doll H, Hirani S, Cartwright M, Rixon L, Knapp M, Henderson C, Rogers A, Fitzpatrick R, Hendy J, Newman 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.
    1. 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):219–25. doi: 10.1093/ageing/afn299.
    1. Welschen LM, Bloemendal E, Nijpels G, Dekker JM, Heine RJ, Stalman WA, Bouter LM. 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):1510–7.
    1. 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. doi: 10.2196/jmir.1357.
    1. 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):913–30. doi: 10.1111/j.1463-1326.2009.01057.x.
    1. García-Lizana F, Sarría-Santamera A. New technologies for chronic disease management and control: a systematic review. J Telemed Telecare. 2007;13(2):62–8. doi: 10.1258/135763307780096140.
    1. 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):464–78. doi: 10.1177/0163278705281079.
    1. Field MJ. Telemedicine. A Guide to Assessing Telecommunications in Health Care. Washington, DC: National Academy Press; 1996.
    1. 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. doi: 10.2196/jmir.1874.
    1. 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):1372–8. doi: 10.1111/j.1464-5491.2005.01627.x.
    1. Ekeland AG, Bowes A, Flottorp S. Effectiveness of telemedicine: a systematic review of reviews. Int J Med Inform. 2010 Nov;79(11):736–71. doi: 10.1016/j.ijmedinf.2010.08.006.
    1. Shea S, Starren J, Weinstock RS, Knudson PE, Teresi J, Holmes D, Palmas W, Field L, Goland R, Tuck C, Hripcsak G, Capps L, Liss D. Columbia University's Informatics for Diabetes Education and Telemedicine (IDEATel) Project: rationale and design. J Am Med Inform Assoc. 2002;9(1):49–62.
    1. Stone RA, Rao RH, Sevick MA, Cheng C, Hough LJ, Macpherson DS, Franko CM, Anglin RA, Obrosky DS, Derubertis FR. Active care management supported by home telemonitoring in veterans with type 2 diabetes: the DiaTel randomized controlled trial. Diabetes Care. 2010 Mar;33(3):478–84. doi: 10.2337/dc09-1012.
    1. 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.
    1. Kidholm K, Ekeland AG, Jensen LK, Rasmussen J, Pedersen CD, Bowes A, Flottorp SA, Bech M. A model for assessment of telemedicine applications: MAST. Int J Technol Assess Health Care. 2012 Jan;28(1):44–51. doi: 10.1017/S0266462311000638.
    1. World Health Organization . Preparing a Health Care Workforce for the 21st Century: The Challenge of Chronic Conditions. Geneva, Switzerland: World Health Organization; 2005. [2013-08-20]. .
    1. 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. [2013-08-20]. .
    1. 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. [2013-08-20]. .
    1. 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.
    1. Prochaska JO, DiClemente CC, Norcross JC. In search of how people change. Applications to addictive behaviors. Am Psychol. 1992 Sep;47(9):1102–14.
    1. 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):390–5.
    1. Vallis M, Ruggiero L, Greene G, Jones H, Zinman B, Rossi S, Edwards L, Rossi JS, Prochaska JO. 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):1468–74.
    1. 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. doi: 10.2337/dc10-1005.
    1. 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):1046–50. doi: 10.2337/dc07-1845.
    1. Sandelowski M. Combining qualitative and quantitative sampling, data collection, and analysis techniques in mixed-method studies. Res Nurs Health. 2000 Jun;23(3):246–55.
    1. 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.
    1. 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):328–36.
    1. 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.
    1. 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):814–22. doi: 10.1001/jama.2013.879.
    1. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. J Pharmacol Pharmacother. 2010 Jul;1(2):100–7. doi: 10.4103/0976-500X.72352.
    1. NTNU The HUNT study - a longitudinal population health Study in Norway. Nord-Trøndelag Health Study .
    1. McNamara R, Robling M, Hood K, Bennert K, Channon S, Cohen D, Crowne E, Hambly H, Hawthorne K, Longo M, Lowes L, Playle R, Rollnick S, Gregory JW. 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. doi: 10.1186/1472-6963-10-36.
    1. Wallace TM, Matthews DR. Poor glycaemic control in type 2 diabetes: a conspiracy of disease, suboptimal therapy and attitude. QJM. 2000 Jun;93(6):369–74.
    1. 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):250–8.
    1. 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):473–83.
    1. 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):315–27. doi: 10.1111/j.1464-5491.2009.02682.x.
    1. 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.
    1. 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.
    1. Anderson RM, Fitzgerald JT, Gruppen LD, Funnell MM, Oh MS. The Diabetes Empowerment Scale-Short Form (DES-SF) Diabetes Care. 2003 May;26(5):1641–2.
    1. Anderson RM, Funnell MM, Fitzgerald JT, Marrero DG. The Diabetes Empowerment Scale: a measure of psychosocial self-efficacy. Diabetes Care. 2000 Jun;23(6):739–43.
    1. 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):425–36. doi: 10.1111/j.1464-5491.2009.02697.x.
    1. 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.
    1. 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):10–9.
    1. 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. pp. 189–94.
    1. Bower P, Cartwright M, Hirani SP, Barlow J, Hendy J, Knapp M, Henderson C, Rogers A, Sanders C, Bardsley M, Steventon A, Fitzpatrick R, Doll H, Newman S. 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. doi: 10.1186/1472-6963-11-184.
    1. Strauss AL, Corbin JM. Basics of Qualitative Research: Techniques and Procedures for Developing Grounded Theory. Thousand Oaks, CA: Sage Publications; 1998.
    1. 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):271–92.
    1. Drummond MF, McGuire A. Economic Evaluation in Health Care: Merging Theory with Practice. Oxford: Oxford University Press; 2001.
    1. Bradley C. Designing medical and educational intervention studies. A review of some alternatives to conventional randomized controlled trials. Diabetes Care. 1993 Feb;16(2):509–18.
    1. Bradley C. Patients' preferences and randomised trials. Lancet. 1996 Apr 20;347(9008):1118–9.
    1. Harwell TS, Dettori N, McDowall JM, Quesenberry K, Priest L, Butcher MK, Flook BN, Helgerson SD, Gohdes D. Do persons with diabetes know their (A1C) number? Diabetes Educ. 2002 Feb;28(1):99–105.
    1. 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.
    1. Polit DF, Beck CT. Nursing Research: Generating and Assessing Evidence for Nursing Practice. 8th edition. Philadelphia, PA: Lippincott Williams & Wilkins; 2008.
    1. Glasgow RE, Hiss RG, Anderson RM, Friedman NM, Hayward RA, Marrero DG, Taylor CB, Vinicor F. 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):124–30.
    1. Bower P, Wallace P, Ward E, Graffy J, Miller J, Delaney B, Kinmonth AL. Improving recruitment to health research in primary care. Fam Pract. 2009 Oct;26(5):391–7. doi: 10.1093/fampra/cmp037.
    1. Sanders C, Rogers A, Bowen R, Bower P, Hirani S, Cartwright M, Fitzpatrick R, Knapp M, Barlow J, Hendy J, Chrysanthaki T, Bardsley M, Newman SP. 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. doi: 10.1186/1472-6963-12-220.

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