scholarly journals An Electronic Medication Module to Improve Health Literacy in Patients With Type 2 Diabetes Mellitus: Pilot Randomized Controlled Trial

10.2196/13746 ◽  
2020 ◽  
Vol 4 (4) ◽  
pp. e13746 ◽  
Author(s):  
Hanna Marita Seidling ◽  
Cornelia Mahler ◽  
Beate Strauß ◽  
Aline Weis ◽  
Marion Stützle ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Health Literacy ◽  
Intervention Group ◽  
Controlled Study ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Null Effect

Background In primary care, patients play a crucial role in managing care processes and handling drug treatment. A decisive factor for success is their health literacy, and several interventions have been introduced to support patients in fulfilling their responsibility. Objective The aim of this study is to assess the influence of such an intervention (ie, a medication module) within a patient-led electronic health record on patients’ health literacy. Methods We conducted a randomized controlled study among community-dwelling patients with type 2 diabetes mellitus. Patients were recruited from primary care practices. After randomization, patients either had access to an internet-based medication module allowing them to store their medication information, look up drug information, and print a medication schedule (intervention group), or they received an information brochure on the importance of medication schedules (control group). After 4-8 weeks, all patients were invited to attend a structured medication review (ie, follow-up visit). Data were collected via questionnaires before the start of the intervention and during the follow-up visit. The main outcome measure was the mean difference in health literacy between baseline and follow-up assessments of patients in the control and intervention groups. Results Of 116 recruited patients, 107 (92.2%) completed the follow-up assessment and were eligible for intention-to-treat analyses. Only 73 patients, of which 29 were in the intervention group, followed the study protocol and were eligible for per-protocol analysis. No differences in overall health literacy were observed in either the intention-to-treat or in the per-protocol cohorts. Reasons for a null effect might be that the cohort was not particularly enriched with participants with low health literacy, thus precluding measurable improvement (ie, ceiling effect). Moreover, the success of implementation was considered poor because both the correct application of the study procedure (ie, randomization according to the protocol and dropout of 29 patients) and the actual interaction with the medication module was modest (ie, dropout of 9 patients). Conclusions The conduct of this randomized controlled study was challenging, leaving it open whether inadequate implementation, too short of a duration, or insufficient efficacy of the intervention, as such, contributed to the null effect of this study. This clearly outlines the value of piloting complex interventions and the accompanying process evaluations.

scholarly journals A Randomized Controlled Trial of an Educational Intervention to Promote Oral and Dental Health of Patients with Type 2 Diabetes Mellitus

2020 ◽  
Author(s):  
Maryam Mallekmahmoodi ◽  
Mohsen Shamsi ◽  
Nasrin Roozbahani ◽  
Rahmatollah Moradzadeh
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Randomized Controlled Trial ◽  
Type 2 Diabetes Mellitus ◽  
Dental Hygiene ◽  
Controlled Trial ◽  
Intervention Group ◽  
Randomized Controlled

Abstract Background: Diabetes is the most prevalent disease resulted from metabolic disorders. This study aimed to investigate the effect of training based on health belief model (HBM) on oral hygiene-related behaviors in patients with type 2 diabetes mellitus. Methods: This study was conducted as an educational randomized controlled trial (single blind) on 120 patients with type 2 diabetes referring to a diabetes clinic selected through systematic sampling, who were assigned to two groups of control (N=60) and intervention (N=60). The data collection tool was a valid and reliable questionnaire based on HBM which was completed by both groups before the intervention. Then, the intervention group received 4 sessions of educational program based on HBM in one month, and the same questionnaire was completed again after 3 months and the data were analyzed through SPSS version 20 software with inferential statistics, t-test, paired t-tests, Chi square, Mann-Whitney test, and Wilcoxon test analysis. Results: Three months after the intervention, awareness of the patients and perceived susceptibility, benefits, self-efficacy, internal cue to action, and performance in oral and dental hygiene-related behaviors had a significant increase in the intervention group (p<0.05). So that the performance of oral and dental hygiene in the intervention group increased from 2.16 ± 0.71 to 3.25 ± 0.49 (p=0.001) after the education. Conclusion: Our results suggest that training patients with diabetes based on HBM as well as through active follow-up can enhance their skills in oral and dental hygiene-related behaviors. Controlling, monitoring and follow-up during the program are also recommended.

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 Sodium-glucose cotransporter 2 inhibitors and fracture risk in patients with type 2 diabetes mellitus: a meta-analysis of randomized controlled trials

2020 ◽  
Vol 11 ◽  
pp. 204062232096159
Author(s):  
Yake Lou ◽  
Ying Yu ◽  
Junchao Duan ◽  
Sining Bi ◽  
Khaing Nyein Chan Swe ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Subgroup Analysis ◽  
Controlled Trials ◽  
Risk Of Fracture ◽  
Randomized Controlled ◽  
Increased Risk

Background: Patients with type 2 diabetes mellitus (T2DM) have an increased risk of fracture compared with those without T2DM. Some oral glucose-lowering agents may increase the incidence of fracture. Whether sodium-glucose co-transporter 2 inhibitors (SGLT2is) are associated with increased risk of fracture remains unclear. Methods: We retrieved articles from PubMed, Embase, Cochrane Library database, and other sources up to 24 October 2019. We included randomized controlled trials (RCTs) that reported fractures and analyzed the fracture incidence of SGLT2i, canagliflozin, dapagliflozin, and empagliflozin. Subgroup analysis was also performed based on baseline characteristics. Results: A total of 78 RCTs with 85,122 patients were included in our analysis. The overall SGLT2i fracture incidence was 2.56% versus 2.77% in the control group [odds ratio (OR), 1.03; 95% confidence interval (CI) (0.95, 1.12); p = 0.49]. Compared with the control treatment, treatment with canagliflozin led to a higher rate of fractures [OR, 1.17; 95% CI (1.00, 1.37); p = 0.05], but no significant difference was observed when compared with dapagliflozin [OR, 1.02; 95% CI (0.90, 1.15); p = 0.79] or empagliflozin [OR, 0.89; 95% CI (0.73, 1.10); p = 0.30]. Subgroup analysis showed that, in a follow-up of less than 52 weeks, SGLT2i decreased the incidence of fracture by 29% [OR, 0.71; 95% CI (0.55, 0.93); p = 0.01], but this benefit was lost when the follow-up extended to more than 52 weeks [OR, 1.08; 95% CI (0.98, 1.18); p = 0.12]. Conclusion: Canagliflozin seems to increase the risk of fracture, while other SGLT2is do not result in a higher incidence of fracture.

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