The Impact of Mobile Health use on the Self-Care of Patients with Type 2 Diabetes: A Protocol for a Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Lucija Gosak ◽  
Majda Pajnkihar ◽  
Gregor Štiglic

BACKGROUND Chronic diseases are an important public health issue worldwide and affect an individual's quality of life. Due to the alarming rise in type 2 diabetes, healthcare, which was previously largely focused primarily on diagnosis and treatment of the disease, is increasingly focused on prevention and self-care. Patients who adhere to a constant and strict treatment regimen (physical activity, diet, medication) and regularly monitor their health, maintain self-care and health, prevent exacerbation of the disease and prevent complications of diabetes (retinopathy, diabetic feet). Many innovative devices that have become increasingly present in patient health care in recent years, such as mobile applications, are available to patients to maintain consistency in monitoring their health status. Mobile applications make it easier for individuals to monitor their self-care, monitor illness, and make it easier to follow instructions regarding disease control. OBJECTIVE The study aim is to determine the impact of mobile application use on self-care in patients with type 2 diabetes. The aim of the study is also to evaluate and test the usefulness of the forDiabetes application as a tool to improve the self-care of individuals with type 2 diabetes. METHODS We will perform a double-blind randomized controlled trial. The study will include individuals over the age of 18 who have been diagnosed and have regulated type 2 diabetes, who have already received oral treatment and are being treated in family medicine practice. Also, individuals included in the study should not have any acute complications due to the consequences of type 2 diabetes. During the study, they should be able to use an Android or iOS mobile phone and a blood glucose meter. With the help of simple randomization, individuals will be divided into an intervention and a control group. Individuals in the intervention group will use the forDiabetes mobile app to monitor their self-care for type 2 diabetes. Individuals in the control group will not receive a special intervention. Data will be collected using the “Self-care of Diabetes Inventory” questionnaire and a “Brief Illness Perception Questionnaire”. Blood sugar, blood pressure, HbA1c, and weight measurements will be monitored using the calibrated instruments during the study by the nurses employed in family medicine practice. Data will be collected at the beginning of the study and after the patient visit to the family medicine practice. RESULTS The expected results as a result of using the mobile application forDiabetes are the impact on the level of self-care, the impact on the perception of the disease, blood sugar levels, blood pressure, HbA1c, and the measured body weight of the patient. CONCLUSIONS The research contributes to greater visibility and usability of mobile applications for self-care of patients with type 2 diabetes and makes aware of the possible use of innovative methods. CLINICALTRIAL NCT04999189

2017 ◽  
Vol 2017 ◽  
pp. 1-10 ◽  
Author(s):  
Masumeh Hemmati Maslakpak ◽  
Somaieh Razmara ◽  
Zahra Niazkhani

Background. Education of patients and their families is the cornerstone of effective diabetes care. The present study aimed to compare the effects of a face-to-face and telephone-based family-oriented educational program on self-care behavior and patient outcomes in type 2 diabetes patients. Methods. In the present randomized controlled trial, 90 type 2 diabetes patients were randomly divided into three groups of 30 participants: a face-to-face education group, a telephone-based education group, and a control group. The educational program lasted for 3 months. Outcomes evaluated included self-care, fasting blood sugar, hemoglobin A1c, cholesterol, and triglyceride. Results. The overall self-care scores in the intervention groups were significantly higher than that in the control group (P=0.0001). In addition, lipid profiles significantly improved in the interventions compared to the control (P<0.05). Comparing the two interventions showed better results for the face-to-face group regarding dietary adherence and physical activity, but the latter group had comparable results in blood glucose monitoring, foot care, and cholesterol level. Conclusions. This study shows the beneficiary effects of a family-oriented education on self-care and patient outcomes. It also shows the potential value of low-cost telephone technology in delivering effective diabetes care.


2021 ◽  
Author(s):  
Abhijeet Prasad Sinha ◽  
Manmohan Singhal ◽  
Mansi Gupta ◽  
Ashish Joshi

BACKGROUND Diabetes represents an important public health challenge in India and Globally. It affects quality of life and is one of the leading causes of death and disability. The burden on global health is huge and about 463 million adults are currently living with diabetes. 77 million people in India in the age group of 20-79 years are affected by this pandemic and total cost to health expenditure is 8 billion US dollars, therefore huge burden, and great economic cost on Public health. The self-management of diabetes, the research priorities include exploring the concept of diabetes self-management and major research questions would comprise of asking what affects self-management in persons with diabetes and how do m-health application and interventions can impact on the self-management behaviors in development, utility of the m-health app in self-management of person with diabetes. Therefore, this project research is of great significance and would bring an integrative approach on self-care management OBJECTIVE To design, develop and evaluate the impact of m-health enabled nutrition informatics intervention for home based self-management of type 2 diabetes in an Indian setting. METHODS A mixed research study will be conducted between January 2022 and January 2023. A sample of approximately 250 individuals will be recruited and enrolled using a nonprobability complete enumeration sampling method from selected urban settings of Delhi inclusion and exclusion criteria with age20-79 years male and female with Type 2 diabetes and have access to Smart phone Data will be collected using which questionnaires. The collected data will be used to assess use and utility of mobile health application developed. The knowledge, attitudes, practices, and beliefs regarding Diabetes self-care management. Lastly, the study questionnaire system usability survey(SUS) will be used to assess the usability of mobile applications on selfcare management of Diabetes RESULTS A pilot of 250 individuals has been conducted to pretest the DBMS questionnaire. The data collection will be initiated from January 2022, and the initial results are planned for publication by October 2022.Descriptive analysis of the gathered data will be performed using SPSS V11, and reporting of the results will be done at 95% CIs and P=.0.05. CONCLUSIONS The findings of the study would inform the elements essential for the development of m-health intervention to improve self-care management of diabetes at home settings. The usefulness and acceptance of the proposed intervention will be conducted. CLINICALTRIAL DITU/UREC/2021/07/10


2021 ◽  
Vol 11 (2) ◽  
pp. 177-186
Author(s):  
Made Rini Damayanti ◽  
Gusti Ayu Ary Antari ◽  
Ni Luh Putu Nopriani

Background: Diabetes mellitus is a chronic disease that may pose serious complications if poorly managed. The application of mobile technology (m-health) ranging from simple to more complex programs in diabetes management has the potential to foster patients’ active involvement in their care. However, the evidence of m-health effectiveness on the self-management of type-2 diabetes patients in low- and middle-income countries is still mixed.Purpose: To evaluate the effect of a ten-week short message system (SMS)-based intervention (Tweek SMSDM) on self-management of type-2 diabetes patients.Methods: A quasi-experimental study was performed in two groups. The intervention group (n=30) received additional daily automated messages to enhance their diabetic self-care practice, while the control group (n=30) continued to follow the standard program only. Pre- and post-intervention data were measured in both groups using the Indonesian version of the Summary of Diabetes Self-Care Activities (SDSCA) questionnaire. T-test, Mann-Whitney, Wilcoxon Signed-Ranks, McNemar and Fisher exact tests were carried out to analyze the data.Results: After ten weeks, the intervention group showed significant mean changes in the domains of general diet (0.42±1.08; p=0.034), specific diet (1.75±1.42; p=0.0001), exercise (1.02±1.85; p=0.005), blood-glucose testing (0.53±1.67; p=0.009), and foot care (4.75±2.51; p=0.001) before and after the intervention, while the control group did not. This study also found significant differences in the mean scores for each domain of the SDSCA between the intervention and the control groups (p<0.05).Conclusion: The Tweek SMSDM program can improve the self-management of type-2 diabetes patients and positively affect each domain in the SDSCA. The findings of this study recommend that nurses integrate the program into patient treatment regimes in primary healthcare centers; therefore, patients and their significant others can play more proactive roles in their diabetic care.


2020 ◽  
Vol 8 (B) ◽  
pp. 161-167
Author(s):  
Manizheh Zakizad Abkenar ◽  
Fazlollah Ghofranipour ◽  
Zahra Kashi ◽  
Ali Montazeri

BACKGROUND: Dyslipidemia is one of the main risk factors of cardiovascular disease in people with diabetes. The principle of diabetes prevention and control is based on patient self-care and education. The Islamic self-care nutrition method is a common and successful way to modify behavior in Islamic ethics and mysticism. AIM: The study aimed to determine the effect of the Islamic self-care nutrition method on the lipid profile of patients with type 2 diabetes. MATERIALS AND METHODS: The present clinical trial was conducted in 2014 on 98 middle-aged patients with type 2 diabetes referred to the Diabetes Center of the Mazandaran University of Medical Sciences, Sari, Iran, who were randomly allocated into two groups of experimental and control. Lipid indices were measured before intervention, and the same education about diabetic healthy diet was provided in both groups. In addition, in the experimental group, Islamic teachings and the Islamic self-care method of nutrition were taught with the intention of pleasing God. Data were analyzed with SPSS 22 software using independent and paired t-test, Chi-square, Fisher’s exact, and analysis of covariance (ANCOVA). RESULTS: After adjusting for the effect of confounding variables with ANCOVA, significant improvement was observed in triglycerides and low-density lipoprotein indices in the experimental group after intervention compared to the control group. Two-proportion z-test results showed a significant increase in the use of lipid-lowering drugs in the control group compared with the experimental group after intervention. CONCLUSION: The Islamic self-care nutrition method could be used to control chronic diseases such as type 2 diabetes affected by behavioral factors.


10.2196/16769 ◽  
2020 ◽  
Vol 22 (3) ◽  
pp. e16769 ◽  
Author(s):  
Calvin Kalun Or ◽  
Kaifeng Liu ◽  
Mike K P So ◽  
Bernard Cheung ◽  
Loretta Y C Yam ◽  
...  

Background Technological surrogate nursing (TSN) derives from the idea that nurse-caregiver substitutes can be created by technology to support chronic disease self-care. Objective This paper begins by arguing that TSN is a useful and viable approach to chronic disease self-care. The analysis then focuses on the empirical research question of testing and demonstrating the effectiveness and safety of prototype TSN supplied to patients with the typical complex chronic disease of coexisting type 2 diabetes and hypertension. At the policy level, it is shown that the data allow for a calibration of TSN technology augmentation, which can be readily applied to health care management. Methods A 24-week, parallel-group, randomized controlled trial (RCT) was designed and implemented among diabetic and hypertensive outpatients in two Hong Kong public hospitals. Participants were randomly assigned to an intervention group, supplied with a tablet-based TSN app prototype, or to a conventional self-managing control group. Primary indices—hemoglobin A1c, systolic blood pressure, and diastolic blood pressure—and secondary indices were measured at baseline and at 8, 12, 16, and 24 weeks after initiation, after which the data were applied to test TSN effectiveness and safety. Results A total of 299 participating patients were randomized to the intervention group (n=151) or the control group (n=148). Statistically significant outcomes that directly indicated TSN effectiveness in terms of hemoglobin 1c were found in both groups but not with regard to systolic and diastolic blood pressure. These findings also offered indirect empirical support for TSN safety. Statistically significant comparative changes in these primary indices were not observed between the groups but were suggestive of an operational calibration of TSN technology augmentation. Statistically significant changes in secondary indices were obtained in one or both groups, but not between the groups. Conclusions The RCT’s strong behavioral basis, as well as the importance of safety and effectiveness when complex chronic illness is proximately self-managed by layperson patients, prompted the formulation of the empirical joint hypothesis that TSN would improve patient self-care while satisfying the condition of patient self-safety. Statistical and decision analysis applied to the experimental outcomes offered support for this hypothesis. Policy relevance of the research is demonstrated by the derivation of a data-grounded operational calibration of TSN technology augmentation with ready application to health care management. Trial Registration ClinicalTrials.gov NCT02799953; https://clinicaltrials.gov/ct2/show/NCT02799953


2020 ◽  
Author(s):  
Michael P. Dorsch ◽  
Karen B. Farris ◽  
Brigid E. Rowell ◽  
Scott L. Hummel ◽  
Todd M. Koelling

BACKGROUND Successful management of heart failure (HF) involves guideline based medical therapy as well as self-care behavior. As a result, the management of HF is moving toward a proactive real-time technological model of assisting patients with monitoring and self-management. OBJECTIVE Evaluate the effectiveness of a mobile application intervention that enhances self-monitoring on health-related quality of life, self-management, and reduces HF readmissions. METHODS A single-center randomized controlled trial was performed. Patients greater than 45 years of age and admitted for acute decompensated HF or recently discharged in the past 4 weeks were included. The intervention group used a mobile application (App). The intervention prompted daily self-monitoring and promoted self-management. The control group (No App) received usual care. The primary outcome was the change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) from baseline to 6 and 12 weeks. Secondary outcomes were the Self-Care Heart Failure Index (SCHFI) questionnaire and recurrent HF admissions. RESULTS Eighty-three patients were enrolled and completed all baseline assessments. Baseline characteristics were similar between groups with the exception of HF etiology. The App group had a reduced MLHFQ at 6 weeks (37.5 ± 3.5 vs. 48.2 ± 3.7, P=0.039) but not at 12 weeks (44.2 ± 4 vs. 45.9 ± 4, P=0.778) compared to No App. There was no effect of the App on the SCHFI at 6 or 12 weeks. The time to first HF admission was not statistically different between the App versus No App groups (HR 0.89, 95% CI 0.39-2.02, P=0.781) over 12 weeks. CONCLUSIONS The mobile application intervention improved MLHFQ at 6 weeks, but did not sustain its effects at 12 weeks. No effect was seen on HF self-care. Further research is needed to enhance engagement in the application for a longer period of time and to determine if the application can reduce HF admissions in a larger study. CLINICALTRIAL NCT03149510


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.


Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
David Cherney ◽  
Mark Cooper ◽  
Ilkka Tikkanen ◽  
Susanne Crowe ◽  
Odd Erik Johansen ◽  
...  

The sodium glucose cotransporter 2 inhibitor empagliflozin (EMPA) reduces HbA1c, weight and blood pressure (BP) in patients with type 2 diabetes (T2D). While glucose lowering with EMPA is dependent on renal function, the impact of chronic kidney disease (CKD) on BP reduction with EMPA is less well understood. Our aim was to determine if impaired renal function attenuates antihypertensive effects of EMPA. A Phase III randomized placebo (PBO)-controlled trial (EMPA-REG BP™) investigated the efficacy and safety of EMPA in patients with T2D and hypertension (defined as mean seated office systolic BP [SBP] 130-159 mmHg and diastolic BP [DBP] 80-99 mmHg at screening). Patients (mean [SD] age 60.2 [9.0] years, HbA1c 7.90 [0.74] %, 24-hour SBP 131.4 [12.3] and 24-hour DBP 75.0 [7.8] mmHg) received EMPA 10 mg (n=276), EMPA 25 mg (n=276) or PBO (n=271) once daily for 12 weeks. We assessed changes from baseline in mean ambulatory 24-hour SBP and HbA1c in subgroups by baseline eGFR (MDRD equation), adjusting for differences in baseline mean 24-hour SBP (for SBP analyses only), HbA1c, region, number of antihypertensive medications, treatment, eGFR and treatment by eGFR interaction between groups. In patients with normal renal function, or stage 2 or 3 CKD, EMPA significantly reduced HbA1c and mean 24-hour SBP vs PBO (Table). As expected, PBO-corrected HbA1c reductions with EMPA appeared to decrease with decreasing eGFR (Table). In contrast, PBO-corrected reductions in mean 24-hour SBP with EMPA mostly appeared to increase with decreasing eGFR (Table). Unlike HbA1c, mean 24-hour SBP reductions with EMPA in patients with T2D and hypertension appear to be greater in patients with lower eGFR, indicating that SBP modulation with EMPA may involve pathways other than urinary glucose excretion such as diuretic effects, weight loss, improved glycemic control, reduced arterial stiffness or direct vascular effects.


2021 ◽  
Author(s):  
◽  
Julio Cesar Loya

Limited information is available regarding culturally-tailored physical activity (PA) interventions for Hispanic adults with type 2 diabetes mellitus (T2DM). A community-partnered approach was used to examine a novel culturally-tailored PA intervention using a pre-post, no control group design. The intervention consisted of six weekly 45-minute sessions for participants to engage in PA led by the researcher. A total of 21 individuals participated in the study. The typical participant was a 53-year-old female (90 percent) Hispanic adult living with T2DM with low acculturation. On average, before the intervention, the participants walked 10,285 (sd 14,779) steps per week with 43.4 (sd 68.1) minutes of PA per week. Despite implementation during the COVID-19 pandemic, the intervention was feasible and acceptable, and 19 (90.5 percent) participants attended all intervention sessions. There were significant increases in steps per week (p=0.007; d=1.03) and minutes of PA per week (p=0.000; d=1.62). Findings suggest that Salud Paso por Paso has promise as a strategy to enhance PA behaviors in the priority population. A randomized, controlled trial with a larger study sample is warranted to examine efficacy and impact on the diabetes health outcomes of Hispanic adults with T2DM.


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