DIABETES-SELF MANAGEMENT EDUCATION 17 Appendix A Evaluation Table Citation Bell, A. M., Fonda, S. J., Walker, S., Scmidt, V., & Vigersky, R. A. (2012). Mobile phone-based video messages for diabetes selfcare support. Journal of Diabetes Science and Technology, 6(2), 310-319. USA F-Dept Defense Franzetta, D., Willet, K., & Fairchild, R. (2012). A systematic review of smartphone application use for type 2 diabetic patients. Online Journal of Nursing Informatics USA F-Lilly Endowment Fund Conceptual Framework N.S. N.S. Design/Method Sample/Setting Design: RCT Purpose: Determine if daily video messages of tips on diabetes management and life-style support improves glycemic control. n = 65 Design: SR Purpose: Evaluate smartphone technology for management of patients w/ DM2 n = 11 RCT = 7 Descriptive = 4 Inclusion Criteria RCT, DM2, age>18, cell phone intervention, HbA1c Inclusion Criteria 18+years, care from NP at least 6 months, A1C>8% Exclusion Criteria Pregnant, lactating, planning to become pregnant, using glucocorticoids, amphetamines, anabolic or weight reducing agents. Setting 1 HCF Major Variables & Definitions Dependent HbA1c, BP, SMBG data Independent IVG -SP Video C- UT Measurement Baseline, 3, 6, 9, 12 months Data Analysis t-test chi-square using SAS HbA1c BP SMBG data #videos viewed Findings Δ base IVG HbA1c = 1.2%, 1.1%, 1.2%, 1.3% Decision for Use in Practice/Application to Practice Challenge would be to record daily video tips, not likely a sustainable model. Δ base C HbA1c= 0.4%, 1.1%, 1.1%, 0.9% Δ base at 3 months was SS (p=0.02) between the groups for HbA1c favoring IVG Dependent HbA1c Independent Cell phone intervention HbA1c Variable by study 4/6 RCT showed decrease HbA1c Applicable to practice. HbA1c is reduced by using SP. QS showed apps that allow true SM, providers have security concerns. Δ- change, A – Asian, AA- African American, AGR – age range, AR – attrition rate, BP – blood pressure, BMI – body mass index, C – control group, CBSA –computer based software applications CR – Caucasian race, CL – confidence limits, CI – confidence interval, CS – convenience sample CST – chi-squared test, CVD – cardiovascular diseases, DM1 – diabetes mellitus, type 1, DM2 – diabetes mellitus, type 2, DV- dependent variable, ESRD – end stage renal disease, F – funding, FG – female gender, G – gender, HCF – health care facility, HDL –high density lipoprotein, HRQL – health related quality of life, IBDSME – internet based diabetes self management education, IP – inpatient facilities, IV – independent variable, IVG – intervention group, LDL – low density lipoprotein, LRA – linear regression analysis, MA – mean age, MG – male gender, MHI – mean household income, MTA – meta-analysis, N – sample size (people), n – sample size (studies), NA – Native American, OR – other race, UT – usual treatment, RCT – randomized controlled trial, SM – self-management, SMS – short message service, SMSG – short message service texts generalized, SMSS – short message service texts customized, SP –smartphone, SPA – smartphone application, SR – systematic review, SS- statistically significant, SMLA – single multi-level analysis, Trigs – triglycerides, TT – t-test VM – voice message DIABETES-SELF MANAGEMENT EDUCATION Graziano, J. A., & Gross, C. R. (2009). A randomized controlled trial of an automated telephone intervention to improve glycemic control in type 2 diabetes. Advances in Nursing Science Health Belief Model Design: experimental pretest-post-test design, RCT Purpose: Determine impact of daily automated telephone intervention on HbA1c N = 120 IVG= 62 C = 58 Dependent HbA1c HRQL Inclusion Criteria DM2 for >12 months, age>50 years, HbA1c>7.0%, English speaking, access to cell or landline, ability to hear phone commands, responsible for own care, glucose meter w/ 3 month storage, daily SMBG routine Exclusion Criteria Unable to give informed consent or too ill to participate Setting Midwest HCF Independent Usual care Design: 2 group crossover, repeated measures, RCT Purpose: Determine if iPad DSME improves self-efficacy, increases participation in monitoring behaviors, improves HbA1c N= 17 iPad Journal Dependent HbA1c HRQL Self Monitoring Independent IVG -iPad C- Journaling USA F- Nova Nordisk Hunt, C. W., & Sanderson, B. K. (2014). Support for diabetes using technology: A pilot study to improve selfmanagement. Medsurg Nursing USA F- Gatson Grindell EBP research grant SelfDetermination Theory 18 Male = 41.2% Caucasian = 76.5% Inclusion Criteria DM2, age>19 years, read & write English HbA1c HRQL #BGSM 2 sided TT independent sample TT Mann-Whitney U test Study effect 1.0% decrease in both groups HbA1c Pre-recorded VM difficult to sustain for practice, but possible. No significant reduction in HbA1c. Improvement in HRQL. Patients had positive feedback on utilizing the application. Possibly applicable due to positive feedback on utilization. Lack of data makes it challenging to verify if HbA1c is impacted. Used SPSS Pre-recorded voice message daily Baseline, 3 months, 6 months for crossover HbA1c HRQL Descriptive statistics Mixed model analysis of variance HbA1c draw was not done due to site starting glycemic control of patients Δ- change, A – Asian, AA- African American, AGR – age range, AR – attrition rate, BP – blood pressure, BMI – body mass index, C – control group, CBSA –computer based software applications CR – Caucasian race, CL – confidence limits, CI – confidence interval, CS – convenience sample CST – chi-squared test, CVD – cardiovascular diseases, DM1 – diabetes mellitus, type 1, DM2 – diabetes mellitus, type 2, DV- dependent variable, ESRD – end stage renal disease, F – funding, FG – female gender, G – gender, HCF – health care facility, HDL –high density lipoprotein, HRQL – health related quality of life, IBDSME – internet based diabetes self management education, IP – inpatient facilities, IV – independent variable, IVG – intervention group, LDL – low density lipoprotein, LRA – linear regression analysis, MA – mean age, MG – male gender, MHI – mean household income, MTA – meta-analysis, N – sample size (people), n – sample size (studies), NA – Native American, OR – other race, UT – usual treatment, RCT – randomized controlled trial, SM – self-management, SMS – short message service, SMSG – short message service texts generalized, SMSS – short message service texts customized, SP –smartphone, SPA – smartphone application, SR – systematic review, SS- statistically significant, SMLA – single multi-level analysis, Trigs – triglycerides, TT – t-test VM – voice message DIABETES-SELF MANAGEMENT EDUCATION Pal, K., Eastwood, S. V., Michie, S., Farmer, A. J., Barnard, M. L., Peacock, R., ... Murray, E. (2013). Computer-based diabetes selfmanagement interventions for adults with type 2 diabetes mellitus (Cochrane Review) N.S. (likely Lorig’s self-management) Kim, H. S., & Jeong, H. S. (2006). A nurse short message service by cellular phone in type-2 diabetic patients for six months. Journal of Clinical Nursing, 16(6), 1082-1087. N.S. (possibly Health Education) F- Alumni Research Fund, Catholic U or Korea Kirwan, M., Vandelanotte, C., Fenning, A., & Duncan, M. J. (2013). Diabetes self-management smartphone application for Design: SR Purpose Review using computer based interventions for DSME and reduction of HbA1C n = 16 RCT 3578 participants mean age = 46-67 Dependent HbA1C HRQL intervention time = 112 months Inclusion Criteria RCT, age >18, DM2, CBSA Exclusion Criteria CBSA targeting DM1, age<18 Independent CBSA DSME UT CP Design: RCT, control group pre-testpost-test design N=51 IVG = 25 C=26 Dependent HbA1c FPG Independent SMS texting by nurse. UT (office visits) Baseline, 3, 6 month HbA1c & FPG n = 72 IVG = 36 C = 36 Dependent HbA1c HRQL HbA1c at baseline, 3, 6, 9 months Inclusion Criteria DM1>6 months, age 18-65, HbA1c>7.5%, multiple daily Independent SP app –Glucose Buddy HRQL Purpose: To evaluate whether an Internet-based intervention using SMS by a nurse could improve HbA1c in patients with DM2. South Korea N.S. (likely Individual and Family SelfManagement) 19 Design: RCT Purpose: Examine the effectiveness of a freely available SP application combined with Inclusion Criteria Able to self test BG, inject insulin, own a cell phone. Exclusion Criteria Renal insufficiency w/ creatinine >1.5, using insulin pump Setting Endocrinology clinic, remote education, HCF HbA1c HRQL CST 0.2% reduction in HbA1c overall 0.5% reduction in HbA1c in trials utilizing cellular phones CST TT Fisher’s exact tests ANOVA 1.15% decrease in HbA1c in IVG which was SS Linear mixed models analysis 1.1% decrease in HbA1c in IVG Type III Wald test no difference in HRQL LRA Applicable to practice, SP technology shows reduction in HbA1c. Easy to implement. Applicable to practice. Portal that allows texting is in place. no Δ in FPG Applicable to practice. Portal allows texting. May not relate as well to DM2 patients who do not use insulin. Δ- change, A – Asian, AA- African American, AGR – age range, AR – attrition rate, BP – blood pressure, BMI – body mass index, C – control group, CBSA –computer based software applications CR – Caucasian race, CL – confidence limits, CI – confidence interval, CS – convenience sample CST – chi-squared test, CVD – cardiovascular diseases, DM1 – diabetes mellitus, type 1, DM2 – diabetes mellitus, type 2, DV- dependent variable, ESRD – end stage renal disease, F – funding, FG – female gender, G – gender, HCF – health care facility, HDL –high density lipoprotein, HRQL – health related quality of life, IBDSME – internet based diabetes self management education, IP – inpatient facilities, IV – independent variable, IVG – intervention group, LDL – low density lipoprotein, LRA – linear regression analysis, MA – mean age, MG – male gender, MHI – mean household income, MTA – meta-analysis, N – sample size (people), n – sample size (studies), NA – Native American, OR – other race, UT – usual treatment, RCT – randomized controlled trial, SM – self-management, SMS – short message service, SMSG – short message service texts generalized, SMSS – short message service texts customized, SP –smartphone, SPA – smartphone application, SR – systematic review, SS- statistically significant, SMLA – single multi-level analysis, Trigs – triglycerides, TT – t-test VM – voice message DIABETES-SELF MANAGEMENT EDUCATION adults with type 1 diabetes: Randomized controlled trial. Journal of medical Internet research, 15(11), SMS feedback to improve glycemic control in adults with DM1 injections or insulin pump Exclusion Criteria Pregnant or already using a SP app Setting HCF, single clinic, remote education Design RCT Purpose To evaluate the effect of a webbased comprehensive information system consisting of internet and cellular phone use on BG. N= 40 IVG=20 C=20 Design SR Purpose Determine the strength of evidence for the effectiveness of n= 18 RCT 20 New Zealand F-Central Queensland University Noh, J. H., Cho, Y. J., Nam, H. W., Kim, J. H., Kim, D. J., Yoo, H. S., ... Yoo, M. J. (2010). Webbased comprehensive information system for selfmanagement of diabetes mellitus. Diabetes Technology & Therapeutics, 12(5), 333-337. N.S. (possibly chronic care model) Inclusion Criteria Age 18-80, HbA1c 7%-10%, drug naïve or prior drug therapy, stable glycemic control – no Δ in therapy for 3 months, internet access, and cellular phone Exclusion Criteria Severe medical illness- cirrhosis, ESRD, cancer. Dependent HbA1c, BP, FPG, BMI, LDL, HDL, Trigs HbA1c, BMI, BP, FPG, LDL, HDL, Trigs at baseline, 6 months Independent IVG- eMOD system of online education C-diabetes education books Frequency of accessing via internet or SP Dependent HbA1c n=17 HRQL HbA1c, total steps HRQL Student’s TT Pearson’s x2 test Wilcoxon Sign Rank test LRA SS reduction in HbA1c 1.53%, and post prandial of -54.58 all other were not SS Applicable to practice, easy to implement. Patient portal allows texting. SMBG devices demonstrate a decrease in HbA1c in both insulin dependent and noninsulin forms. Applicable to practice, devices show reduction in HbA1c. P=0.05 Republic of Korea F-Korean Diabetes Association Russell-Minda, E., Jutai, J., Speechley, M., Bradley, K., Chudyk, A., & Petrella, R. (2009). Health N.S. (possibly chronic care model) Inclusion Criteria Age > 14 and youth 7-14 years with DM1 or DM2, Independent Variable by study Δ- change, A – Asian, AA- African American, AGR – age range, AR – attrition rate, BP – blood pressure, BMI – body mass index, C – control group, CBSA –computer based software applications CR – Caucasian race, CL – confidence limits, CI – confidence interval, CS – convenience sample CST – chi-squared test, CVD – cardiovascular diseases, DM1 – diabetes mellitus, type 1, DM2 – diabetes mellitus, type 2, DV- dependent variable, ESRD – end stage renal disease, F – funding, FG – female gender, G – gender, HCF – health care facility, HDL –high density lipoprotein, HRQL – health related quality of life, IBDSME – internet based diabetes self management education, IP – inpatient facilities, IV – independent variable, IVG – intervention group, LDL – low density lipoprotein, LRA – linear regression analysis, MA – mean age, MG – male gender, MHI – mean household income, MTA – meta-analysis, N – sample size (people), n – sample size (studies), NA – Native American, OR – other race, UT – usual treatment, RCT – randomized controlled trial, SM – self-management, SMS – short message service, SMSG – short message service texts generalized, SMSS – short message service texts customized, SP –smartphone, SPA – smartphone application, SR – systematic review, SS- statistically significant, SMLA – single multi-level analysis, Trigs – triglycerides, TT – t-test VM – voice message DIABETES-SELF MANAGEMENT EDUCATION technologies for monitoring and managing diabetes: A systematic review. Journal of Diabetes Science and Technology, 3(6), 1460-1471. self-monitoring devices and technologies for individuals with DM1 or DM2. F-Canadian Institute of Health Research interventions w/ selfmonitoring device, clinical outcomes with device, English, 1985-2008, RCT & observational studies Exclusion Criteria N<10, cross-sectional data, primary interventions with medications, studies assessing accuracy of devices, telemedicine applications, CGM devices 21 SMBG n=5 SMS n= 7 Activity n=4 SP app n=2 Mixed results on pedometers for demonstrating a increase in steps, no evidence for improvement in metabolic parameters. SMS/internet interventions showed decrease in HbA1c SP based app may decrease HbA1c. Saffari, M., Ghanizadeh, G., & Koenig, H. G. (2014). Health education via mobile text messaging for glycemic control in adults with type 2 diabetes: A systematic review and metaanalysis. Primary Care Diabetes Health Education Design: SR and metaanalysis Purpose Review all published articles that have reported the effects of health education by text intervention on glycemic control n = 10 RCT Dependent HbA1C N= 960 Inclusion Criteria Educational intervention using SMS, DM2 diagnosis, HbA1c measurement, age<18 years, RCT Exclusion Criteria Other chronic disorders like CVD, pregnant patients Independent SMS texting UT HbA1c CST Data analysis through Comprehensive Meta-analysis Software 50% greater reduction in HbA1c in IVG compared to UT from metaanalysis Applicable to practice, patient portal allows texting, shows reduction in HbA1c. (Korea, Taiwan, USA) F- Baqiyatallh Univeristy of Medical Sciences Δ- change, A – Asian, AA- African American, AGR – age range, AR – attrition rate, BP – blood pressure, BMI – body mass index, C – control group, CBSA –computer based software applications CR – Caucasian race, CL – confidence limits, CI – confidence interval, CS – convenience sample CST – chi-squared test, CVD – cardiovascular diseases, DM1 – diabetes mellitus, type 1, DM2 – diabetes mellitus, type 2, DV- dependent variable, ESRD – end stage renal disease, F – funding, FG – female gender, G – gender, HCF – health care facility, HDL –high density lipoprotein, HRQL – health related quality of life, IBDSME – internet based diabetes self management education, IP – inpatient facilities, IV – independent variable, IVG – intervention group, LDL – low density lipoprotein, LRA – linear regression analysis, MA – mean age, MG – male gender, MHI – mean household income, MTA – meta-analysis, N – sample size (people), n – sample size (studies), NA – Native American, OR – other race, UT – usual treatment, RCT – randomized controlled trial, SM – self-management, SMS – short message service, SMSG – short message service texts generalized, SMSS – short message service texts customized, SP –smartphone, SPA – smartphone application, SR – systematic review, SS- statistically significant, SMLA – single multi-level analysis, Trigs – triglycerides, TT – t-test VM – voice message DIABETES-SELF MANAGEMENT EDUCATION 22 Appendix B Synthesis Table Trial type DM1 % DM2 % HbA1c HRQL SMSG SMSS IBDSME PC VM SPA Bell (2012) RCT 8% 92% ê N Frazetta (2012) SR 0 100% ê N Y Y Y Y Graziano (2009) RCT 0 100% Ø Y Hunt (2014) RCT 0 100% Ø Y Pal (2013) SR 0 100% ê Y Y Y Y Kim (2006) RCT 0 100% ê N Kirwan (2013) RCT 100% 0 ê Y Y Y Noh (2010) RCT Russell (2009) SR ê N ê Y Y Y Y Y Y Y Y Y Y Y Y Y Y Saffari (2014) SR 0 100% ê N DM1 – diabetes mellitus, type 1, DM2 – diabetes mellitus, type 2, HbA1c – glycolated hemoglobin, HRQL – health related quality of life, IBDSME – internet based diabetes self management education, PC –phone call, RCT – randomized controlled trial, SMSG – short message service texts generalized, SMSS – short message service texts customized, SP –smartphone, SPA – smartphone application, SR – systematic review, VM– voice message, Ø – no change, ê- decrease