scholarly journals Improving Self-Care in Patients With Coexisting Type 2 Diabetes and Hypertension by Technological Surrogate Nursing: Randomized Controlled Trial

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 ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Type 2 Diabetes ◽  
Chronic Disease ◽  
Care Management ◽  
Controlled Trial ◽  
Intervention Group ◽  
Self Care ◽  
Control Group ◽  
Randomized Controlled

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

scholarly journals Influence of education training in patients with type 2 diabetes in the improvement of lifestyle and biochemical characteristics: a randomized controlled trial

2019 ◽  
Vol 6 (4) ◽  
pp. 293-299
Author(s):  
Alida Ramaj ◽  
Fatjona Kamberi
Keyword(s):  
Blood Pressure ◽  
Type 2 Diabetes ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
The Mean ◽  
Education Training

Abstract Objective The objective of this randomized controlled trial study was to evaluate the education training in relation to lifestyle improvement in patients with type 2 diabetes through its influence in the levels of glycated hemoglobin (HbA1c), blood pressure, triglyceride, cholesterol levels, and body mass index (BMI). Methods The study included patients with type 2 diabetes randomly selected from 20 residential areas in Tirana, Albania where family physicians provide services. The sample size in total was 200 patients in both groups (control and intervention). The education training (four sessions) was conducted by trained nursing staff for 6 months. Patients were screened for the biochemical profile before and after the intervention. To compare the groups with respect to the interest outcomes, the t-test was used. The value of P < 0.05 was considered significant. Results There were 104 male patients and 96 female patients. The mean age was 54.9 ± 8.7. No significant differences were found between the study groups in relation to clinical and biochemical data before the education sessions. After the intervention, in the intervention group, the mean level of HbA1c was significantly lower than the value in the control group (6.2% vs 6.8%, P = 0.001) as well as for the mean values of BMI. The mean reduction (more than 15%) in HbA1c after the intervention was 43% in the intervention group and 2% in the control group (OR = 36.9, P < 0.05). Differences in BMI, HbA1c, triglycerides, and cholesterol were more significantly visible in the intervention group. However, the difference in systolic and diastolic blood pressure values was almost the same (P > 0.05). Conclusions The results of this study further support that the approach for education of patients with type 2 diabetes on changing lifestyle benefit the patient in controlling diabetes. It is believed that the establishment of diabetes education classes in health centers is an important investment in improving the management of type 2 diabetes.

scholarly journals Influence of physical activity on periodontal health in patients with type 2 diabetes mellitus. A blinded, randomized, controlled trial

2021 ◽  
Author(s):  
K. Wernicke ◽  
J. Grischke ◽  
M. Stiesch ◽  
S. Zeissler ◽  
K. Krüger ◽  
...  
Keyword(s):  
Physical Activity ◽  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Periodontal Health ◽  
Randomized Controlled ◽  
Hba1c Levels

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.

scholarly journals Effects of Face-to-Face and Telephone-Based Family-Oriented Education on Self-Care Behavior and Patient Outcomes in Type 2 Diabetes: A Randomized Controlled Trial

2017 ◽  
Vol 2017 ◽  
pp. 1-10 ◽  
Author(s):  
Masumeh Hemmati Maslakpak ◽  
Somaieh Razmara ◽  
Zahra Niazkhani
Keyword(s):  
Type 2 Diabetes ◽  
Patient Outcomes ◽  
Controlled Trial ◽  
Self Care ◽  
Control Group ◽  
Face To Face ◽  
Randomized Controlled ◽  
Education Group ◽  
Care Behavior

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.

scholarly journals A Highly Tailored Text and Voice Messaging Intervention to Improve Medication Adherence in Patients With Either or Both Hypertension and Type 2 Diabetes in a UK Primary Care Setting: Feasibility Randomized Controlled Trial of Clinical Effectiveness

10.2196/16629 ◽  
2020 ◽  
Vol 22 (5) ◽  
pp. e16629 ◽  
Author(s):  
Aikaterini Kassavou ◽  
Venus Mirzaei ◽  
James Brimicombe ◽  
Simon Edwards ◽  
Efthalia Massou ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Primary Care ◽  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Clinical Effectiveness ◽  
Control Group ◽  
Randomized Controlled

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.

scholarly journals Effectiveness of a clinic-based randomized controlled intervention for type 2 diabetes management: an innovative model of intensified diabetes management in Mainland China (C-IDM study)

2020 ◽  
Vol 8 (1) ◽  
pp. e001030 ◽  
Author(s):  
Qinglin Lou ◽  
Qing Ye ◽  
Haidi Wu ◽  
Zhiyong Wang ◽  
Robert S Ware ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Large Scale ◽  
Diabetes Management ◽  
Controlled Trial ◽  
Intervention Group ◽  
Mainland China ◽  
Outcome Variable ◽  
Control Group ◽  
Randomized Controlled

ObjectivesHighly efficient diabetes management programs are needed for tackling diabetes in China. This study aimed to assess the effectiveness of a clinic-based intensified diabetes management model (C-IDM) in Mainland China.Research design and methodsA 2-year clinic-based randomized controlled trial was conducted among patients with type 2 diabetes in Nanjing, China. The C-IDM intervention components comprised four domains (disease targeting management, express referral channel, expert visit, patients’ self-management) and an integrated running system (disease control centers, general hospitals and local clinics). Control group participants received their usual care, while intervention participants received both the C-IDM package and the usual services. The primary outcome variable was change of hemoglobin A1c (HbA1c). Mixed-effects models were used to compute effect estimates and 95% CI with consideration of both individual and cluster-level confounders.ResultsOverall, 1095 of 1143 participants were assessed at study completion. The mean change in HbA1c was significantly greater in the intervention group than in the control group (mean difference (MD)=−0.57, 95% CI −0.79 to –0.36). Similar results were observed for change in body mass index (MD=−0.29, 95% CI −0.49 to –0.10). Participants in the intervention group were more likely to achieve normal HbA1c and body weight compared with their counterparts in control group after adjusting for potentially confounding variables (adjusted OR=1.94, 95% CI 1.35 to 2.81 and 1.79, 95% CI 1.13 to 2.85, respectively).ConclusionsThe C-IDM model is feasible and effective in large-scale management of patients with type 2 diabetes in China. It has public health implications for tackling the burden of diabetes in China.Trial registration numberChiCTR-IOR-15006019.

scholarly journals A Highly Tailored Text and Voice Messaging Intervention to Improve Medication Adherence in Patients With Either or Both Hypertension and Type 2 Diabetes in a UK Primary Care Setting: Feasibility Randomized Controlled Trial of Clinical Effectiveness (Preprint)

2019 ◽  
Author(s):  
Aikaterini Kassavou ◽  
Venus Mirzaei ◽  
James Brimicombe ◽  
Simon Edwards ◽  
Efthalia Massou ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Primary Care ◽  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Clinical Effectiveness ◽  
Control Group ◽  
Randomized Controlled

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.

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
Keyword(s):  
Type 2 Diabetes ◽  
Family Medicine ◽  
Mobile Applications ◽  
Mobile Application ◽  
Controlled Trial ◽  
Self Care ◽  
The Self ◽  
Control Group ◽  
The Impact

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

Increasing Medical Adherence in Elderly With Type 2 Diabetes Mellitus: A Systematic Review

2018 ◽  
Vol 39 (2) ◽  
pp. 109-117
Author(s):  
Seyed Mohammad Mehdi Hazavehei ◽  
Sahar Khoshravesh ◽  
Zahra Taheri-Kharameh
Keyword(s):  
Systematic Review ◽  
Type 2 Diabetes ◽  
Educational Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
The Elderly ◽  
Risk Of Bias ◽  
Control Group ◽  
Medical Adherence

Background One of the most common problems that the elderly with chronic diseases, especially diabetes, faces is lack or poor medical adherence. The aim of this study was to determine the effect of interventions in increasing medical adherence in the elderly with type 2 diabetes. Methods The databases of Cochrane, Embase, PubMed, Scopus, Science Direct, and web of science were searched until April 2017 free from time and language limitation. In review, only randomized controlled trial (RCT) design studies were investigated. The studies of interest were evaluated from three perspectives: educational intervention with or without theories/models of health education and promotion, educational intervention (individual or group education), and noneducational intervention to increase medical adherence. The qualification of RCTs was evaluated through Cochrane Collaboration Risk of Bias Tool. Results Finally, five studies were considered in this systematic review. Educational interventions were used in all of the studies, and in three of these studies, noneducational interventions such as support group, psychiatric consultation, and phone consultation were implemented along with educational intervention. In all studies, medical adherence in the intervention group increased when compared with the control group or basic conditions ( p < .05). All RCTs had high risk of bias. Conclusion This review provides evidence which must be considered in the elderly with diabetes a combination of the educational and noneducational methods to increase medical adherence. It is necessary to conduct studies with higher quality to assess the efficacy of interventions.

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