title: 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.
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.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT01315756; http://clinicaltrials.gov/ct2/show/NCT01315756 (Archived by WebCite at http://www.webcitation/6BTyuRMpH).
authors: Department of Nursing, Faculty of Health Sciences, Oslo and Akershus University College of Applied Sciences, Oslo, Norway. Lis.Ribu@hioa.no.
authors: Lis
authors: L
authors: Ribu
authors: Heidi
authors: H
authors: Holmen
authors: Astrid
authors: A
authors: Torbjørnsen
authors: Astrid Klopstad
authors: AK
authors: Wahl
authors: Astrid
authors: A
authors: Grøttland
authors: Milada Cvancarova
authors: MC
authors: Småstuen
authors: Elisabeth
authors: E
authors: Elind
authors: Trine Strand
authors: TS
authors: Bergmo
authors: Elin
authors: E
authors: Breivik
authors: Eirik
authors: E
authors: Arsand
keywords: acceptability; complex intervention; empowerment; health counseling; health-related quality of life; lifestyle intervention; mHealth; mixed methods; motivation; self-management; telemedicine; type 2 diabetes
references: Diabetes Care. 2013 Jan;36 Suppl 1:S100-8
references: 23264420
references: Res Nurs Health. 2000 Jun;23(3):246-55
references: 10871540
references: Nurs Clin North Am. 2011 Sep;46(3):255-70, v
references: 21791261
references: J Med Internet Res. 2010 Jun 16;12(2):e21
references: 20554500
references: Depress Anxiety. 2010 Apr;27(4):323-6
references: 20376836
references: BMC Health Serv Res. 2011 Aug 05;11:184
references: 21819569
references: Clin Pract Epidemiol Ment Health. 2011 Mar 04;7:44-50
references: 21559233
references: Fam Pract. 2009 Oct;26(5):391-7
references: 19549623
references: Int J Med Inform. 2010 Nov;79(11):736-71
references: 20884286
references: J Med Internet Res. 2007 Dec 14;9(5):e37
references: 18093904
references: Am J Prev Med. 2002 May;22(4 Suppl):39-66
references: 11985934
references: Int J Technol Assess Health Care. 2012 Jan;28(1):44-51
references: 22617736
references: Diabetes Care. 1993 Feb;16(2):509-18
references: 8432226
references: BMC Health Serv Res. 2010 Feb 09;10:36
references: 20144218
references: Eval Health Prof. 2005 Dec;28(4):464-78
references: 16272426
references: Age Ageing. 2009 Mar;38(2):219-25
references: 19171951
references: Tidsskr Nor Laegeforen. 2004 Jun 3;124(11):1511-4
references: 15195154
references: Diabetes Care. 2002 Jul;25(7):1159-71
references: 12087014
references: BMJ. 2008 Sep 29;337:a1655
references: 18824488
references: Diabetes Care. 2011 Jan;34(1):2-7
references: 21193619
references: Patient Educ Couns. 2007 May;66(2):192-201
references: 17320338
references: Lancet. 1998 Sep 12;352(9131):837-53
references: 9742976
references: Diabetes Educ. 2002 Jan-Feb;28(1):99-105
references: 11852748
references: Diabetes Care. 2010 Feb;33(2):264-9
references: 19933989
references: Diabetes Care. 2003 May;26(5):1641-2
references: 12716841
references: Diabetes Spectr. 2010 Jan 21;23(1):15-18
references: 22485068
references: J Med Internet Res. 2011 Sep 22;13(3):e65
references: 21979293
references: Diabet Med. 2005 Oct;22(10):1372-8
references: 16176199
references: J Consult Clin Psychol. 1983 Jun;51(3):390-5
references: 6863699
references: Diabetes Care. 2011 Jun;34(6):1249-57
references: 21617109
references: J Diabetes Sci Technol. 2010 Mar 01;4(2):328-36
references: 20307393
references: QJM. 2000 Jun;93(6):369-74
references: 10873187
references: BMC Public Health. 2010 Apr 23;10:204
references: 20416042
references: Diabetes Care. 2005 Jun;28(6):1510-7
references: 15920083
references: Diabetes Care. 2009 Jan;32(1):81-3
references: 18852338
references: Diabetes Care. 2001 Jan;24(1):124-30
references: 11194217
references: Diabetes Care. 2008 May;31(5):1046-50
references: 18445728
references: Lancet. 1996 Apr 20;347(9008):1118-9
references: 8602090
references: Diabetes Obes Metab. 2009 Oct;11(10):913-30
references: 19531058
references: Ann Intern Med. 2008 Nov 18;149(10):708-19
references: 19017589
references: Qual Life Res. 2013 Sep;22(7):1805-16
references: 23111571
references: Scand J Soc Med. 1998 Dec;26(4):250-8
references: 9868748
references: N Engl J Med. 2001 May 3;344(18):1343-50
references: 11333990
references: Diabet Med. 2009 Apr;26(4):425-36
references: 19388974
references: Med Care. 1992 Jun;30(6):473-83
references: 1593914
references: Qual Life Res. 2013 Sep;22(7):1655-64
references: 23161330
references: J Am Med Inform Assoc. 2002 Jan-Feb;9(1):49-62
references: 11751803
references: N Engl J Med. 2013 Apr 25;368(17):1613-24
references: 23614587
references: Diabet Med. 2009 Apr;26(4):315-27
references: 19388959
references: Diabetes Care. 2007 Oct;30(10):2433-40
references: 17666457
references: Am Psychol. 1992 Sep;47(9):1102-14
references: 1329589
references: Diabetes Care. 2003 May;26(5):1468-74
references: 12716806
references: Diabetes Care. 2000 Jun;23(6):739-43
references: 10840988
references: J Health Econ. 2002 Mar;21(2):271-92
references: 11939242
references: J Telemed Telecare. 2007;13(2):62-8
references: 17359568
references: Diabetes Res Clin Pract. 2010 Jan;87(1):4-14
references: 19896746
references: Diabetes Res Clin Pract. 2008 May;80(2):314-20
references: 18279994
references: Eur J Cancer Prev. 2006 Feb;15(1):10-9
references: 16374224
references: Diabetes Care. 2010 Mar;33(3):478-84
references: 20009091
references: BMC Health Serv Res. 2012 Jul 26;12:220
references: 22834978
references: J Pharmacol Pharmacother. 2010 Jul;1(2):100-7
references: 21350618
references: BMJ. 2012 Jun 21;344:e3874
references: 22723612
references: JAMA. 2013 Feb 27;309(8):814-22
references: 23443445
references: BMC Health Serv Res. 2011 May 27;11:131
references: 21619596
references: Tidsskr Nor Laegeforen. 2008 Nov 20;128(22):2570-4
references: 19023353