scholarly journals Benefit of Digital Tools Used for Integrated Personalized Diabetes Management: Results From the PDM-ProValue Study Program

2019 ◽  
Vol 14 (2) ◽  
pp. 240-249
Author(s):  
Lutz Heinemann ◽  
Wendelin Schramm ◽  
Helena Koenig ◽  
Annette Moritz ◽  
Iris Vesper ◽  
...  
Keyword(s):  
Health Care Professionals ◽  
Diabetes Management ◽  
Intervention Group ◽  
Digital Tools ◽  
Clinical Inertia ◽  
Control Group ◽  
Traffic Light ◽  
Study Program ◽  
Therapeutic Concept ◽  
Cluster Randomized

Background: Integrated personalized diabetes management (iPDM) is a digitally supported therapeutic concept to improve patient-physician interaction to overcome the aspects of clinical inertia. Integrated personalized diabetes management can support decision making and improve therapeutic outcomes of suboptimally controlled persons with insulin-treated type 2 diabetes (T2D). In this paper, we report the results of an analysis of the PDM-ProValue study program on the effectiveness and perceived benefit of this approach, with a focus on how physicians used and assessed the digital tools provided for the iPDM process. Materials and Methods: The study program included two 12-month, prospective, controlled, cluster-randomized multicenter trials. A total of 101 practices participated with 907 patients. Practices were cluster-randomized to an intervention group and a control group. Digital tools for data visualization and analysis applied were used. HCP were asked to assess the use, relevance, and usefulness of the tools. Results: A clear preference was stated for the visual overview over more statistically complex analyses. A total of 83% of the participants rated a high relevance of the “daily profile,” 81% of the “total profile,” and 68% the “risk illustrated by traffic light symbols” for the therapy decision. The overall iPDM process was very favorably rated with respect to structuredness and potential for personalized treatment and well accepted among health care professionals (HCP). Conclusions: Embedding digital tools in a structured process (iPDM) were proved to provide a benefit for insulin-treated T2D patients and their physicians. These results offer insight for further development and improvement of the tools and add information on how to overcome clinical inertia.

scholarly journals Effect of a Mobile Phone–Based Glucose-Monitoring and Feedback System for Type 2 Diabetes Management in Multiple Primary Care Clinic Settings: Cluster Randomized Controlled Trial

10.2196/16266 ◽  
2020 ◽  
Vol 8 (2) ◽  
pp. e16266 ◽  
Author(s):  
Yeoree Yang ◽  
Eun Young Lee ◽  
Hun-Sung Kim ◽  
Seung-Hwan Lee ◽  
Kun-Ho Yoon ◽  
...  
Keyword(s):  
Primary Care ◽  
Mobile Phone ◽  
Diabetes Management ◽  
Primary Care Clinic ◽  
Intervention Group ◽  
Glucose Monitoring ◽  
Feedback System ◽  
Control Group ◽  
Care Clinic ◽  
Cluster Randomized

Background Recent evidence of the effectiveness of mobile phone–based diabetes management systems is generally based on studies conducted in tertiary hospitals or professional diabetes clinics. Objective This study aimed to evaluate the clinical efficacy and applicability of a mobile phone–based glucose-monitoring and feedback system for the management of type 2 diabetes mellitus (T2DM) in multiple primary care clinic settings. Methods In this multicenter, cluster-randomized controlled, open trial, 13 primary care clinics in Seoul and other large cities in South Korea were voluntarily recruited. Overall, 150 (9 clinics) and 97 (4 clinics) participants with T2DM were assigned to the intervention and control groups, respectively (2:1 allocation). Every month, participants in both groups attended face-to-face physicians’ consultation for the management of diabetes in the clinic. For the intervention group, participants were required to upload their daily self-monitoring of blood glucose (SMBG) results using the mobile phone app in addition to outpatient care for 3 months. The results were automatically transmitted to the main server. Physicians had to check their patients’ SMBG results through an administrator’s website and send a short feedback message at least once a week. At baseline and 3 months, both groups had anthropometry and blood tests, including hemoglobin A1c (HbA1c), and responded to questionnaires about treatment satisfaction and compliance. Results At 3 months, participants in the intervention group showed significantly more improvement in HbA1c (adjusted mean difference to control −0.30%, 95% CI −0.50 to −0.11; P=.003) and fasting plasma glucose (−17.29 mg/dL, 95% CI −29.33 to −5.26; P=.005) than those in the control group. In addition, there was significantly more reduction in blood pressure, and the score regarding treatment satisfaction and motivation for medication adherence increased more in the intervention group than in the control group. In the subgroup analyses, the effect on glycemic control was more significant among younger patients and higher baseline HbA1c levels. Conclusions The mobile phone–based glucose-monitoring and feedback system was effective in glycemic control when applied in primary care clinic settings. This system could be utilized effectively with diverse institutions and patients. Trial Registration Clinical Research Information Service (CRIS) https://tinyurl.com/tgqawbz

scholarly journals Diabetes management intervention studies: lessons learned from two studies

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Bettina Petersen ◽  
Iris Vesper ◽  
Bernhild Pachwald ◽  
Nicole Dagenbach ◽  
Sina Buck ◽  
...  
Keyword(s):  
Medical Device ◽  
Health Care Professionals ◽  
Intervention Studies ◽  
Diabetes Management ◽  
Intervention Group ◽  
Control Group ◽  
Main Body ◽  
Management Intervention ◽  
Management Interventions ◽  
Study Results

Abstract Introduction Several clinical studies investigated improvements of patient outcomes due to diabetes management interventions. However, chronic disease management is intricate with complex multifactorial behavior patterns. Such studies thus have to be well designed in order to allocate all observed effects to the defined intervention and to exclude effects of other confounders as well as possible. This article aims to provide challenges in interpreting diabetes management intervention studies and suggests approaches for optimizing study implementation and for avoiding pitfalls based on current experiences. Main body Lessons from the STeP and ProValue studies demonstrated the difficulty in medical device studies that rely on behavioral changes in intervention group patients. To successfully engage patients, priority should be given to health care professionals being engaged, operational support in technical issues being available, and adherence being assessed in detail. Another difficulty is to avoid contamination of the control group with the intervention; therefore, strict allocation concealment should be maintained. However, randomization and blinding are not always possible. A limited effect size due to improvements regarding clinical endpoints in the control group is often caused by the Hawthorne effect. Improvements in the control group can also be caused with increased attention paid to the subjects. In order to reduce improvements in the control group, it is essential to identify the specific reasons and adjust study procedures accordingly. A pilot phase is indispensable for this. Another option is to include a third study arm to control for enhanced standard of care and study effects. Furthermore, retrospective data collection could be a feasible option. Adaptive study designs might reduce the necessity of a separate pilot study and combine the exploratory and confirmatory stages of an investigation in one single study. Conclusion There are several aspects to consider in medical device studies when using interventions that rely on changes in behavior to achieve an effective implementation and significant study results. Improvements in the control group may reduce effect sizes and limit statistical significance; therefore, alternatives to the traditional randomized controlled trials may be considered.

scholarly journals Effect of a Mobile Phone–Based Glucose-Monitoring and Feedback System for Type 2 Diabetes Management in Multiple Primary Care Clinic Settings: Cluster Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Yeoree Yang ◽  
Eun Young Lee ◽  
Hun-Sung Kim ◽  
Seung-Hwan Lee ◽  
Kun-Ho Yoon ◽  
...  
Keyword(s):  
Primary Care ◽  
Mobile Phone ◽  
Diabetes Management ◽  
Primary Care Clinic ◽  
Intervention Group ◽  
Glucose Monitoring ◽  
Feedback System ◽  
Control Group ◽  
Care Clinic ◽  
Cluster Randomized

BACKGROUND Recent evidence of the effectiveness of mobile phone–based diabetes management systems is generally based on studies conducted in tertiary hospitals or professional diabetes clinics. OBJECTIVE This study aimed to evaluate the clinical efficacy and applicability of a mobile phone–based glucose-monitoring and feedback system for the management of type 2 diabetes mellitus (T2DM) in multiple primary care clinic settings. METHODS In this multicenter, cluster-randomized controlled, open trial, 13 primary care clinics in Seoul and other large cities in South Korea were voluntarily recruited. Overall, 150 (9 clinics) and 97 (4 clinics) participants with T2DM were assigned to the intervention and control groups, respectively (2:1 allocation). Every month, participants in both groups attended face-to-face physicians’ consultation for the management of diabetes in the clinic. For the intervention group, participants were required to upload their daily self-monitoring of blood glucose (SMBG) results using the mobile phone app in addition to outpatient care for 3 months. The results were automatically transmitted to the main server. Physicians had to check their patients’ SMBG results through an administrator’s website and send a short feedback message at least once a week. At baseline and 3 months, both groups had anthropometry and blood tests, including hemoglobin A<sub>1c</sub> (HbA<sub>1c</sub>), and responded to questionnaires about treatment satisfaction and compliance. RESULTS At 3 months, participants in the intervention group showed significantly more improvement in HbA<sub>1c</sub> (adjusted mean difference to control −0.30%, 95% CI −0.50 to −0.11; <i>P</i>=.003) and fasting plasma glucose (−17.29 mg/dL, 95% CI −29.33 to −5.26; <i>P</i>=.005) than those in the control group. In addition, there was significantly more reduction in blood pressure, and the score regarding treatment satisfaction and motivation for medication adherence increased more in the intervention group than in the control group. In the subgroup analyses, the effect on glycemic control was more significant among younger patients and higher baseline HbA<sub>1c</sub> levels. CONCLUSIONS The mobile phone–based glucose-monitoring and feedback system was effective in glycemic control when applied in primary care clinic settings. This system could be utilized effectively with diverse institutions and patients. CLINICALTRIAL Clinical Research Information Service (CRIS) https://tinyurl.com/tgqawbz

Effectiveness of an Educational Intervention in Reducing New International Postgraduates’ Acculturative Stress in Malaysian Public Universities: Protocol for a Cluster Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Musheer Abdulwahid Al-Jaberi ◽  
Muhamad Hanafiah Juni ◽  
Hayati Kadir Shahar ◽  
Siti Irma Fadhilah Ismail ◽  
Murad Abdu Saeed ◽  
...  
Keyword(s):  
International Students ◽  
Acculturative Stress ◽  
Educational Program ◽  
Public Universities ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Policy Makers ◽  
Randomized Controlled ◽  
Cluster Randomized

BACKGROUND Universities around the world, including Malaysia, have attracted many international students from different countries. Research has reported that acculturative stress resulting from international students’ attempts to adjust to the cultures of host countries is one of the most challenging issues that affects their lives in general and academic lives in particular. OBJECTIVE This study aims to examine the effectiveness of an educational intervention on acculturative stress among new postgraduate international students joining Malaysian public universities. METHODS A cluster randomized controlled trial design with Malaysian public universities as the unit of randomization will be used in this study. Public universities will be randomized in a 1:1 ratio to be either in the intervention (educational program) or control group (waiting list). Participants in the intervention group will receive 7 sessions in 9 hours delivered by an expert in psychology and the researcher. The control group will receive the intervention once the 3-month follow-up evaluation is completed. RESULTS The data will be analyzed using the generalized estimation equation with a confidence interval value of 95%; significant differences between and within groups are determined as <i>P</i>&lt;.05. The results of the study underlie the effectiveness of educational program in decreasing acculturative stress of new international students and enabling them to cope with a new environment. The results of this study will contribute to previous knowledge of acculturative stress, acculturation, and adjustment of international students. Furthermore, such results are expected to play a role in raising university policy makers’ awareness of their postgraduate international students’ acculturative stress issues and how they can help them avoid such stress and perform well in their academic life. CONCLUSIONS We expect that the intervention group will score significantly lower than the wait-list group on the immediate and 3-month postintervention evaluation of acculturative stress and achieve a higher level of adjustment. Results will have implications for international students, policy makers at universities, the Malaysian Ministry of Higher Education, and future research. CLINICALTRIAL Clinical Trials Registry India CTRI/2018/01/011223; http://ctri.nic.in/Clinicaltrials/showallp.php?mid1= 21978&amp;amp;EncHid=&amp;amp;userName=Muhamad%20Hanafiah%20Juni INTERNATIONAL REGISTERED REPORT PRR1-10.2196/12950

An Internet-based health gateway device for interactive communication and automatic data uploading: Clinical efficacy for type 2 diabetes in a multi-centre trial

2016 ◽  
Vol 23 (6) ◽  
pp. 595-604 ◽  
Author(s):  
Jae Hyoung Cho ◽  
Hun-Sung Kim ◽  
Seung Hyun Yoo ◽  
Chang Hee Jung ◽  
Woo Je Lee ◽  
...  
Keyword(s):  
Adverse Events ◽  
Healthcare System ◽  
Glucose Control ◽  
Large Scale ◽  
Diabetes Management ◽  
Intervention Group ◽  
Diabetes Control ◽  
Control Group ◽  
Anthropometric Parameters ◽  
Automatic Data

Introduction The aim of this study was to improve the quality of diabetes control and evaluate the efficacy of an Internet-based integrated healthcare system for diabetes management and safety. Methods We conducted a large-scale, multi-centre, randomized clinical trial involving 484 patients. Patients in the intervention group ( n = 244) were treated with the Internet-based system for six months, while the control group ( n = 240) received the usual outpatient management over the same period. HbA1c, blood chemistries, anthropometric parameters, and adverse events were assessed at the beginning of the study, after three months, and the end of the study. Results There were no initial significant differences between the groups with respect to demographics and clinical parameters. Upon six-month follow-up, HbA1c levels were significantly decreased from 7.86 ± 0.69% to 7.55 ± 0.86% within the intervention group ( p < 0.001) compared to 7.81 ± 0.66% to 7.70 ± 0.88% within the control group. Postprandial glucose reduction was predominant. A subgroup with baseline HbA1c higher than 8% and good compliance achieved a reduction of HbA1c by 0.8 ± 1.05%. Glucose control and waist circumference reduction were more effective in females and subjects older than 40 years of age. There were no adverse events associated with the intervention. Discussion This e-healthcare system was effective for glucose control and body composition improvement without associated adverse events in a multi-centre trial. This system may be effective in improving diabetes control in the general population.

Effects of Teaching Resourcefulness in Patients with Coronary Heart Disease

2021 ◽  
pp. 019394592110207
Author(s):  
Min Wen ◽  
Yaqin Liang ◽  
Qianqian Shen ◽  
Juping Yu ◽  
Pingping He ◽  
...  
Keyword(s):  
Coronary Heart Disease ◽  
Heart Disease ◽  
Health Education ◽  
Controlled Trial ◽  
Coping Styles ◽  
Intervention Group ◽  
Control Group ◽  
Convenience Sample ◽  
Cluster Randomized ◽  
And Coping

This cluster randomized controlled trial aimed to investigate the effects of an intervention to teach resourcefulness on depression and coping style of patients with coronary heart disease (CHD). A convenience sample of 72 patients in community settings took part. Participants in the intervention group (n = 36) received an 8-week intervention based on the concept of resourcefulness, plus routine health education. Participants in the control group (n = 36) received routine health education only. After the intervention, participants in the intervention group had significantly higher scores on resourcefulness and coping styles, and lower scores on depression than those in the control group (both ps < .001). The findings suggest that a well-developed intervention to teach resourcefulness could help patients with CHD to be more resourceful, improve their level of depression, and choose more effective strategies to cope with stress.

A randomized trial of the effect of peer education on the sexual quality of life in patients with myocardial infarction

2020 ◽  
Vol 17 (3) ◽  
Author(s):  
Ali Abbasi ◽  
Hossein Ebrahimi ◽  
Hossein Bagheri ◽  
Mohammad Hasan Basirinezhad ◽  
Seyedmohammad Mirhosseini ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Myocardial Infarction ◽  
Health Care Professionals ◽  
Peer Education ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Sexual Quality Of Life ◽  
Significant Difference

AbstractBackgroundOne of the factors associated with readmission is inappropriate sexual activity after myocardial infarction (MI). This study aimed to assess the effect of peer education on the sexual quality of life (SQOL) in patients with MI.MethodsIn this randomized controlled clinical trial, 70 patients with MI meeting the inclusion criteria were assigned to experimental or control groups using block randomization. Peer education for the intervention group was provided on the third day after MI. Education sessions lasted from 90 to 120 minutes. Data were collected using demographic, sexual quality of life-female (SQOL-F), and sexual quality of life-male (SQOL-M) questionnaires during the fourth week after MI.ResultsThere was no significant difference between the two groups before the intervention in terms of demographic and SQOL. The mean of SQOL in the peer education group was significantly higher than the control group at the 4-week follow-up.ConclusionsAccording to the results, using peer education is recommended for the sexual health care professionals.

scholarly journals A Cluster Randomized Controlled Trial Feasibility Study of a WhatsApp-Delivered Intervention to Promote Healthy Eating Habits in Male Firefighters

2021 ◽  
Vol 18 (12) ◽  
pp. 6633
Author(s):  
Winnie Wing Man Ng ◽  
Anthony Siu Wo Wong ◽  
Kin Cheung
Keyword(s):  
Randomized Controlled Trial ◽  
Healthy Eating ◽  
Eating Habits ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Healthy Eating Habits ◽  
Cluster Randomized

This cluster randomized controlled trial (CRCT)-designed study aimed to explore the feasibility of a promotion pamphlet and/or WhatsApp as a suitable mode of delivery to promote healthy eating habits with fruit and vegetables (F&V) among firefighters. Convenience and snowball sampling methods were used. Forty-five firefighters from 23 fire stations were recruited and they all received the printed pamphlet, while the intervention group participants (n = 20) received additional teaching material through WhatsApp every two weeks for eight weeks. Feasibility outcomes included retention, practicality, and implementation. The participants reported high levels of satisfaction with the intervention. There were significant improvements in the mean numbers of days consuming F&V (p = 0.002; p = 0.031) in the intervention group, and for fruit consumption (p = 0.033) in the control group between the baseline (T0) and 3 months after completion of intervention (T1). High levels of participants’ satisfaction with the intervention revealed that a full-scale CRCT of the WhatsApp-delivered intervention promoting healthy eating could be feasible, especially as a means of increasing the numbers of days they consumed F&V and the numbers of servings of these consumed per day.

A Randomized Study to Assess the Impact of Pharmacist Counseling of Employer-Based Health Plan Beneficiaries With Diabetes

2011 ◽  
Vol 25 (2) ◽  
pp. 169-179 ◽  
Author(s):  
Dale F. Kraemer ◽  
Wayne A. Kradjan ◽  
Theresa M. Bianco ◽  
Judi A. Low
Keyword(s):  
Diabetes Management ◽  
Statistical Significance ◽  
Glycosylated Hemoglobin ◽  
Randomized Study ◽  
Intervention Group ◽  
Control Group ◽  
Counseling Intervention ◽  
Care Plans ◽  
Pharmacist Counseling ◽  
The Impact

Objective: To assess the impact of pharmacist counseling on empowering people with diabetes to better self-care. Introduction: Community-based pharmacists can play a key role in educating and empowering people in such programs. Methods: A randomized trial compared the effects of pharmacist counseling (intervention group) with printed materials (control group) in diabetic beneficiaries of several employer-based health care plans. All participants also received waiver of out-of-pocket expenses for diabetic-related medications and supplies. Clinical, humanistic, and claim outcomes were evaluated at baseline and at 1 year follow-up. Results: Sixty-seven beneficiaries participated in this study. The 0.50% decrease from baseline in glycosylated hemoglobin (A1c) was statistically significant ( P = .0008) in the intervention group and the difference between the groups approached statistical significance ( P = .076). Beneficiaries in both groups had greater claim costs for diabetic-related medications and supplies during the study year. Both groups also improved in ability to manage their diabetes with the counseling group showing a significantly better understanding of diabetes ( P = .0024). Conclusion: There was a trend toward improvement in A1c in patients counseled by pharmacist with an increased utilization of diabetes-related medications and supplies. Counseling also improved diabetes knowledge and empowered patients to better diabetes management.

scholarly journals Scaled-Up Nutrition Education on Pulse-Cereal Complementary Food Practice in Ethiopia: A Cluster-Randomized Trial

2020 ◽  
Author(s):  
Getenesh Berhanu Teshome ◽  
Susan J. Whiting ◽  
Timothy J. Green ◽  
Demelash Mulualem ◽  
Carol J. Henry
Keyword(s):  
Nutritional Status ◽  
Nutrition Education ◽  
Weight Status ◽  
Dietary Diversity ◽  
Randomized Study ◽  
Intervention Group ◽  
Complementary Food ◽  
Southern Ethiopia ◽  
Control Group ◽  
Cluster Randomized

Abstract Background Improving children's weight status through nutrition education (NE) for mothers about using pulses in complementary feeding has been demonstrated in pilot studies, but no effect on stunting was reported. The aim of the study was to evaluate the effectiveness of a 9-month pulse-nutrition education program on mothers' knowledge, attitude, and practices (KAP) towards pulses, as well as its impact on children's dietary diversity, and nutritional status. The NE was delivered by Health Extension Workers (HEWs). Methods A cluster randomized study was employed for the community-based interventional study. Twelve randomly selected villages in Sidama Zone, Southern Ethiopia were included in the study. A total of 772 mother-child pairs involved in the study; where 386 mother-child pairs in the intervention group received additional messages about pulse-cereal complementary food, and 386 pairs (the control) received only routine health education for 9 months. A survey on mothers’ KAP and anthropometric measurements of the children were taken at baseline, midline, and endline. Results At baseline and endline, maternal KAP and the dietary diversity score of the children (mean age at endline 18.8 ± 2.9 mo) were assessed. Results : Intervention mothers’ KAP improved ( p <0.001) at midline and endline compared to that of the control group, as did frequency of pulse consumption and DDS among children. At 9 months, the prevalence of stunting, wasting, and underweight was significantly reduced in the intervention group compared to the control group ( p =0.001). Conclusions NE delivered by HEWs improved KAP of mothers regarding pulse consumption and dietary diversity of children led to improved nutritional status of the children. Training HEWs on the use of pulses for CF may be an effective way to improve the health of children in Ethiopian communities.

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