scholarly journals A Smartphone App to Improve Medication Adherence in Patients With Type 2 Diabetes in Asia: Feasibility Randomized Controlled Trial

10.2196/14914 ◽  
2019 ◽  
Vol 7 (9) ◽  
pp. e14914 ◽  
Author(s):  
Zhilian Huang ◽  
Eberta Tan ◽  
Elaine Lum ◽  
Peter Sloot ◽  
Bernhard Otto Boehm ◽  
...  

Background The efficacy of smartphone apps for improving medication adherence in type 2 diabetes is not well studied in Asian populations. Objective This study aimed to determine the feasibility, acceptability, and clinical outcomes of using a smartphone app to improve medication adherence in a multiethnic Asian population with type 2 diabetes. Methods We block randomized 51 nonadherent and digitally literate patients with type 2 diabetes between the ages of 21 and 75 years into two treatment arms (control: usual care; intervention: usual care+Medisafe app) and followed them up for 12 weeks. Recruitment occurred at a public tertiary diabetes specialist outpatient center in Singapore. The intervention group received email reminders to complete online surveys monthly, while the control group only received an email reminder(s) at the end of the study. Barriers to medication adherence and self-appraisal of diabetes were assessed using the Adherence Starts with Knowledge-12 (ASK-12) and Appraisal of Diabetes Scale (ADS) questionnaires at baseline and poststudy in both groups. Perception toward medication adherence and app usage, attitude, and satisfaction were assessed in the intervention group during and after the follow-up period. Sociodemographic data were collected at baseline. Clinical data (ie, hemoglobin A1c, body mass index, low-density lipoprotein, high-density lipoprotein, and total cholesterol levels) were extracted from patients’ electronic medical records. Results A total of 51 (intervention group: 25 [49%]; control group: 26 [51%]) participants were randomized, of which 41 (intervention group: 22 [88.0%]; control group: 19 [73.1%]) completed the poststudy survey. The baseline-adjusted poststudy ASK-12 score was significantly lower in the intervention group than in the control group (mean difference: 4.7, P=.01). No changes were observed in the clinical outcomes. The average 12-week medication adherence rate of participants tracked by the app was between 38.3% and 100% in the intervention group. The majority (>80%) of the participants agreed that the app was easy to use and made them more adherent to their medication. Conclusions Our feasibility study showed that among medication-nonadherent patients with type 2 diabetes, a smartphone app intervention was acceptable, improved awareness of medication adherence, and reduced self-reported barriers to medication adherence, but did not improve clinical outcomes in a developed Asian setting.

2019 ◽  
Vol 7 (1) ◽  
pp. e000981 ◽  
Author(s):  
Anne Meike Boels ◽  
Rimke C Vos ◽  
Lioe-Ting Dijkhorst-Oei ◽  
Guy E H M Rutten

ObjectiveTo investigate the effect of diabetes self-management education and support via a smartphone app in individuals with type 2 diabetes on insulin therapy.Research design and methodsOpen two-arm multicenter parallel randomized controlled superiority trial. The intervention group (n=115) received theory and evidence-based self-management education and support via a smartphone app (optionally two or six times per week, once daily at different times). The control group (n=115) received care as usual. Primary outcome: HbA1c at 6 months. Other outcomes included HbA1c ≤53 mmol/mol (≤7%) without any hypoglycemic event, body mass index, glycemic variability, dietary habits and quality of life. We performed multiple imputation and regression models adjusted for baseline value, age, sex, diabetes duration and insulin dose.ResultsSixty-six general practices and five hospital outpatient clinics recruited 230 participants. Baseline HbA1c was comparable between groups (8.1% and 8.3%, respectively). At 6 months, the HbA1c was 63.8 mmol/mol (8.0%) in the intervention vs 66.2 mmol/mol (8.2%) in the control group; adjusted difference −0.93 mmol/mol (−0.08%), 95% CI −4.02 to 2.17 mmol/mol (−0.37% to 0.20%), p=0.557. The odds for achieving an HbA1c level ≤7% without any hypoglycemic event was lower in the intervention group: OR 0.87, 95% CI 0.33 to 2.35. There was no effect on secondary outcomes. No adverse events were reported.ConclusionsThis smartphone app providing diabetes self-management education and support had small and clinically not relevant effects. Apps should be more personalized and target individuals who think the app will be useful for them.Trial registration numberNTR5515.


10.2196/16629 ◽  
2020 ◽  
Vol 22 (5) ◽  
pp. e16629 ◽  
Author(s):  
Aikaterini Kassavou ◽  
Venus Mirzaei ◽  
James Brimicombe ◽  
Simon Edwards ◽  
Efthalia Massou ◽  
...  

Background The efficacy of a highly tailored digital intervention to support medication adherence and feasibility to support clinical effectiveness as an adjunct to the primary care setting has not been evaluated. Objective This trial aimed to assess the behavioral efficacy of a highly tailored digital intervention to support medication adherence and to evaluate the feasibility of its clinical effectiveness, in patients with either or both hypertension and type 2 diabetes. We also examined quality of life and mechanisms of behavior change. Intervention fidelity, engagement, and satisfaction were also explored. Methods This was a multicenter, individually randomized controlled trial of 2 parallel groups: an intervention group that received a highly tailored text message and interactive voice response intervention for 12 weeks, and a control group that received usual care. Medication adherence was measured using self-reports and assessor-blinded practice records of a repeat prescription. Systolic blood pressure and glucose levels were assessed by nurses blinded to group allocation during practice visits at 3 months follow-up. Questionnaires obtained data to assess intervention mechanisms of action and satisfaction and digital log files captured data to evaluate fidelity and engagement. Results A total of 135 nonadherent patients (62/135, 46% female; 122/135, 90.3%; aged above 50 years) were randomly allocated in the intervention (n=79) or in the control group (n=56); of whom 13% (18/135) were lost at follow-up. Medication adherence was significantly improved in the intervention group compared with the control group (t116=2.27; P=.02, 2-tailed). Systolic blood pressure was 0.6 mmHg (95% CI −7.423 to 6.301), and hemoglobin A1c was 4.5 mmol/mol (95% CI −13.099 to 4.710) lower in the intervention group compared with the control group. Changes in intentional nonadherence and nonintentional nonadherence explained the improvements in medication adherence in the intervention group (beta=.074, SE=0.464; P=.04), but not in the control group (beta=.00, SE 1.35; P=.37). The intervention had 100% fidelity, a median of 12 days of engagement, and 76% overall satisfaction. Conclusions Our trial is the first that has been conducted in the United Kingdom and showed that among nonadherent patients with either or both hypertension and type 2 diabetes, a highly tailored digital intervention was effective at improving treatment adherence and feasible to obtain clinically meaningful outcomes. Changes in intentional and nonintentional nonadherence predicted the improvements in medication adherence. The intervention had high fidelity, engagement, and satisfaction. Future research using a rigorous design is needed to evaluate the clinical effectiveness and cost-effectiveness of the intervention in primary care. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN) 10668149; http://www.controlled-trials.com/ISRCTN10668149.


2020 ◽  
Vol 11 ◽  
pp. 215013272096508
Author(s):  
Pratibha Nair ◽  
Kok Wai Kee ◽  
Choon Siong Mah ◽  
Eng Sing Lee

Background: There is limited understanding on the impact of the multidose medication packaging service (MDMPS). Objectives: The main objective of this study was to evaluate changes in medication adherence in patients using MDMPS compared to patients receiving standard medication packaging (control group). The other objectives were to determine the association between medication adherence and clinical outcomes, and to assess patients’/caregivers’ perceptions toward MDMPS. Methods: A retrospective cohort study was conducted among primary care patients in Singapore enrolled into MDMPS between 2012 and 2017. Eligible patients were taking at least five chronic medications, diagnosed with Hypertension, Hyperlipidemia and/or Type 2 Diabetes, with prescription records for at least six months before and after the index period. They were matched to control patients based on the type of comorbidities and medication adherence status. Medication Possession Ratio (MPR), glycated hemoglobin (HbA1c), blood pressure and low-density lipoprotein-cholesterol (LDL-C) of both groups were compared between baseline and at least six months post-index period. Interviewer-administered questionnaires were also conducted for MDMPS patients. Results: The MPR of MDMPS patients (n = 100) increased by 0.37% ( P < .001) compared to the control group (n = 100). MDMPS patients with diabetes had reduced HbA1c by 0.1% after six months ( P = .022) but was not significant after 12 months. No significant changes were seen in blood pressure and LDL-C between both groups. At least 50% of patients were highly satisfied with MDMPS. Conclusion: MDMPS can improve medication adherence. Further studies are needed to understand its clinical impact.


2019 ◽  
Author(s):  
Aikaterini Kassavou ◽  
Venus Mirzaei ◽  
James Brimicombe ◽  
Simon Edwards ◽  
Efthalia Massou ◽  
...  

BACKGROUND The efficacy of a highly tailored digital intervention to support medication adherence and feasibility to support clinical effectiveness as an adjunct to the primary care setting has not been evaluated. OBJECTIVE This trial aimed to assess the behavioral efficacy of a highly tailored digital intervention to support medication adherence and to evaluate the feasibility of its clinical effectiveness, in patients with either or both hypertension and type 2 diabetes. We also examined quality of life and mechanisms of behavior change. Intervention fidelity, engagement, and satisfaction were also explored. METHODS This was a multicenter, individually randomized controlled trial of 2 parallel groups: an intervention group that received a highly tailored text message and interactive voice response intervention for 12 weeks, and a control group that received usual care. Medication adherence was measured using self-reports and assessor-blinded practice records of a repeat prescription. Systolic blood pressure and glucose levels were assessed by nurses blinded to group allocation during practice visits at 3 months follow-up. Questionnaires obtained data to assess intervention mechanisms of action and satisfaction and digital log files captured data to evaluate fidelity and engagement. RESULTS A total of 135 nonadherent patients (62/135, 46% female; 122/135, 90.3%; aged above 50 years) were randomly allocated in the intervention (n=79) or in the control group (n=56); of whom 13% (18/135) were lost at follow-up. Medication adherence was significantly improved in the intervention group compared with the control group (<i>t</i><sub>116</sub>=2.27; <i>P</i>=.02, 2-tailed). Systolic blood pressure was 0.6 mmHg (95% CI −7.423 to 6.301), and hemoglobin A<sub>1c</sub> was 4.5 mmol/mol (95% CI −13.099 to 4.710) lower in the intervention group compared with the control group. Changes in intentional nonadherence and nonintentional nonadherence explained the improvements in medication adherence in the intervention group (beta=.074, SE=0.464; <i>P</i>=.04), but not in the control group (beta=.00, SE 1.35; <i>P</i>=.37). The intervention had 100% fidelity, a median of 12 days of engagement, and 76% overall satisfaction. CONCLUSIONS Our trial is the first that has been conducted in the United Kingdom and showed that among nonadherent patients with either or both hypertension and type 2 diabetes, a highly tailored digital intervention was effective at improving treatment adherence and feasible to obtain clinically meaningful outcomes. Changes in intentional and nonintentional nonadherence predicted the improvements in medication adherence. The intervention had high fidelity, engagement, and satisfaction. Future research using a rigorous design is needed to evaluate the clinical effectiveness and cost-effectiveness of the intervention in primary care. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN) 10668149; http://www.controlled-trials.com/ISRCTN10668149.


2020 ◽  
Vol 8 (1) ◽  
pp. 69
Author(s):  
Kartika Yuliani ◽  
Nyoman Kertia ◽  
Lily Arsanti Lestari

Background : As one of important markers of cardiovascular complication in patients with type 2 diabetes mellitus, low density lipoprotein (LDL) shall be maintained to be in normal range. Based on previous research, consumption of probiotic yogurt contains Lactobacillus acidophilus and Bifidobacterium animalis subsp. Lactis is presumed can improve LDL in patients with type 2 diabetes mellitus but the scientific evidence is still few.Objectives: To investigate the effect of probiotic yogurt on LDL in patients with type 2 diabetes.Methods: This study was double blinded randomized controlled trial which was conducted on 32 patientss with type 2 diabetes mellitus. Subjects were divided randomly into 2 groups and given 4 weeks intervention. Subjects in control group were given conventional yogurt while subjects in intervention group were given probiotic yogurt contains L. acidophilus LA5 and B. animalis subsp. Lactis Bb12. Food intake data was collected 4 times using 24-hour recall method during intervention period. LDL of subjects was measured before and after intervention.Results: There was no significant difference between LDL before and after intervention in control group (128 – 148.5 mg/dL) and intervention group (130 – 120.5 mg/dL). Meanwhile, LDL after intervention in control group and intervention group were significantly different (p<0.05). LDL between energy and macronutrients intake categories were not significantly different.Conclusion: Probiotic yogurt has a better LDL reduction effect in patients with type 2 diabetes mellitus than conventional yogurt, although the reduction is not significant.


Author(s):  
Nidaul Hasanah ◽  
Zullies Ikawati ◽  
Zainol Akbar Zainal

Introduction: Smartphone-based education has been proven to indirectly improve clinical outcomes of type-2 diabetes mellitus patients via practical disease management. “Teman Diabetes” is a new smartphone application that helps diabetics better manage their diabetes, and allows collaboration between diabetics, their inner circle, and medical professionals. However, there is still limited evidence about the effectiveness of “Teman Diabetes” on clinical outcomes of diabetic patients, especially type-2 diabetes mellitus. The objective of this research is to determine the positive effect of smartphone application-based education “Teman Diabetes” on the clinical outcomes of type-2 diabetes mellitus patients. The clinical outcomes measured were HbA1c and fasting plasma glucose levels. Method: Using a quasi-experimental design, a total of 83 participants were selected by consecutive sampling. Patients in the intervention group (n = 44) received "Teman Diabetes" when they assigned the informed consent form. Furthermore, they received a WhatsApp message containing a different link from the "Artikel" feature on the Teman Diabetes every week from the research team, from the second week to twelfth week. The control group (n = 39) only received standard therapy without any additional interventions. Patients in both groups were followed before and after 3 months (HbA1c and fasting plasma glucose levels). The statistical test used in this study is Mann-Whitney test for hypotheses and comparison of mean changes between groups; Wilcoxon test for comparison of mean changes between treatments; and analysis of covariance (ANCOVA) test for the effect of confounding variables. Results: After 3 months, the mean HbA1c reduction was greater in the intervention group by -0.7 ± 0.9% (P<0.001) than in the control group by -0.1 ± 1.1% (P=0.17). Also, the mean fasting plasma glucose reduction was greater in the intervention group by -25.0 ± 71.4mg/dl (P=.02) instead of in the control group by 7.6 ± 72.4mg/dl (P=0.78). It is concluded that smartphone application-based education “Teman Diabetes” give a significant positive effect on clinical outcomes among type-2 diabetes mellitus patients. The main features that contributed to the clinical outcome of this study were "Artikel", "Forum", and "Edukasi" feature.


Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Fatemeh Haidari ◽  
Mehrnoosh Zakerkish ◽  
Fatemeh Borazjani ◽  
Kambiz Ahmadi Angali ◽  
Golnaz Amoochi Foroushani

Abstract Background The objective of this study was to investigate the effects of Anethum graveolens (dill) powder supplementation on glycemic control, lipid profile, some antioxidants and inflammatory markers, and gastrointestinal symptoms in patients with type 2 diabetes. Materials and methods In this study, 42 patients with type 2 diabetes were randomly allocated to intervention and control groups and received either 3 g/day dill powder or placebo (3 capsules/day, 1 g each). Fasting blood sugar, insulin, homeostatic model assessment of insulin resistance, lipid profile, high-sensitivity C-reactive protein, total antioxidant capacity, malondialdehyde and gastrointestinal symptoms were measured in all of the subjects at baseline and postintervention. Results The dill powder supplementation significantly decreased the mean serum levels of insulin, homeostatic model assessment of insulin resistance, low-density lipoprotein cholesterol, total cholesterol and malondialdehyde in the intervention group in comparison with the baseline measurements (P < 0.05). Furthermore, the mean serum levels of high-density lipoprotein and total antioxidant capacity were significantly increased in the intervention group in comparison with the baseline measurement (P < 0.05). Colonic motility disorder was the only gastrointestinal symptom whose frequency was significantly reduced by supplementation (P = 0.01). The mean changes in insulin, low-density lipoprotein cholesterol, total cholesterol and malondialdehyde were significantly lower in the intervention group than in the control group (P < 0.05). In addition, the mean changes in high-density lipoprotein were significantly higher in the intervention group than in the control group (P < 0.05). Conclusion Dill powder supplementation can be effective in controlling the glycemic, lipid, stress oxidative and gastrointestinal symptoms in patients with type 2 diabetes. Trial registration Iran Clinical Trials Registry: IRCT20120704010181N12. Registered on 12 May 2018.


2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Anja Wollny ◽  
Christin Löffler ◽  
Eva Drewelow ◽  
Attila Altiner ◽  
Christian Helbig ◽  
...  

Abstract Background We investigate whether an educational intervention of GPs increases patient-centeredness and perceived shared decision making in the treatment of patients with poorly controlled type 2 diabetes mellitus? Methods We performed a cluster-randomized controlled trial in German primary care. Patients with type 2 diabetes mellitus defined as HbA1c levels ≥ 8.0% (64 mmol/mol) at the time of recruitment (n = 833) from general practitioners (n = 108) were included. Outcome measures included subjective shared decision making (SDM-Q-9; scale from 0 to 45 (high)) and patient-centeredness (PACIC-D; scale from 1 to 5 (high)) as secondary outcomes. Data collection was performed before intervention (baseline, T0), at 6 months (T1), at 12 months (T2), at 18 months (T3), and at 24 months (T4) after baseline. Results Subjective shared decision making decreased in both groups during the course of the study (intervention group: -3.17 between T0 and T4 (95% CI: -4.66, -1.69; p < 0.0001) control group: -2.80 (95% CI: -4.30, -1.30; p = 0.0003)). There were no significant differences between the two groups (-0.37; 95% CI: -2.20, 1.45; p = 0.6847). The intervention's impact on patient-centeredness was minor. Values increased in both groups, but the increase was not statistically significant, nor was the difference between the groups. Conclusions The intervention did not increase patient perceived subjective shared decision making and patient-centeredness in the intervention group as compared to the control group. Effects in both groups might be partially attributed to the Hawthorne-effect. Future trials should focus on patient-based intervention elements to investigate effects on shared decision making and patient-centeredness. Trial registration The trial was registered on March 10th, 2011 at ISRCTN registry under the reference ISRCTN70713571.


Author(s):  
K. Wernicke ◽  
J. Grischke ◽  
M. Stiesch ◽  
S. Zeissler ◽  
K. Krüger ◽  
...  

Abstract Objectives The aim was to investigate the effect of physical activity on periodontal health and HbA1c levels in patients with type 2 diabetes mellitus (T2DM) over a period of 6 months. Materials and methods Thirty-seven patients with non-insulin-dependent T2DM were included in the study. The intervention group (n=20) performed physical activity over a period of 6 months. The control group (n=17) did not receive any intervention. Baseline and final examinations included dental parameters and concentrations of glycosylated hemoglobin (HbA1c) and high-sensitivity C-reactive protein (hsCRP). Results Physical activity showed a positive effect on periodontal health. Both the BOP (p= 0.005) and the severity of periodontitis (p= 0.001) were significantly reduced in the intervention group compared to the control group. Furthermore, HbA1c levels were reduced (p= 0.010) significantly in the intervention group while hsCRP levels significantly increased in the control group (p= 0.04). Conclusions Within the limitations of this randomized, controlled trial, physical activity over a period of 6 months is a health-promoting measure for patients with T2DM and improves both periodontal health and HbA1c concentrations.


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