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 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.

Effect of web-based time-use intervention on occupational balance during the Covid-19 pandemic

2021 ◽  
pp. 000841742199496
Author(s):  
Serkan Pekçetin ◽  
Ayla Günal
Keyword(s):  
University Students ◽  
Time Use ◽  
Time Management ◽  
Intervention Group ◽  
Control Group ◽  
Single Session ◽  
Post Intervention ◽  
Web Based ◽  
Management Intervention ◽  
Management Interventions

Background. Restrictions implemented to control the spread of the Covid-19 pandemic may lead to disruptions in occupational balance among university students. Purpose. The aim of this study was to evaluate the effectiveness of a web-based time-use intervention on the occupational balance of university students. Method. A total of 60 participants were randomly assigned to the intervention and control groups. The intervention group received eight sessions of web-based time management intervention, while the control group received a single-session web-based time management intervention. Pre-and post-intervention occupational balance of the participants was evaluated with Occupational Balance Questionnaire (OBQ). Findings. The eight-session intervention was more effective than the single-session intervention in improving OBQ total scores and all individual OBQ item scores except for “Having sufficient things to do during a regular week.” Implications. Occupational therapists can implement web-based time management interventions to promote the occupational balance of university students during the Covid-19 pandemic.

scholarly journals Effect of Chamomile Extract on Prevention of Peristomal Skin Complications

2021 ◽  
Vol 9 (4) ◽  
Author(s):  
Abbas Abedi ◽  
Mansour Dianati ◽  
Hamidreza Gilasi
Keyword(s):  
Health Care Professionals ◽  
Color Change ◽  
Intervention Group ◽  
Health Clinic ◽  
Control Group ◽  
Control Groups ◽  
Study Results ◽  
Peristomal Skin ◽  
Educational Degree ◽  
And Control

Objectives: The purpose of the present study was to determine the effect of chamomile extract on the prevention of peristomal skin complications. Methods: This single-blinded, placebo-controlled, randomized clinical trial was conducted on 80 ostomy patients who were referred to Koroush Health Clinic, Isfahan, Iran. For the participants in the intervention group, chamomile extract was applied topically on the peristomal skin. For the participants in the control group, distilled water was applied as a placebo. The intervention group participants’ peristomal skin was examined using the ostomy skin tool (OST) once a week for four consecutive weeks. The peristomal skin in the control group was assessed at the beginning and the end of the study. Results: The intervention and control groups were not significantly different in terms of gender, marital status, educational degree, ostomy type, chemotherapy history, and radiotherapy history. The scores of the OST indicated that after the intervention, the scores of skin complications (color change, secretion, and wound) around the stoma were significantly higher in the control group than in the intervention group (P < 0.05). Conclusions: Our findings showed that chamomile extract was effective in preventing peristomal skin complications and related side effects. The results of the present study can be used by health care professionals to manage peristomal skin complications.

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.

scholarly journals Healthy eating and lifestyle in pregnancy (HELP): a cluster randomised trial to evaluate the effectiveness of a weight management intervention for pregnant women with obesity on weight at 12 months postpartum

2021 ◽  
Author(s):  
Sharon A. Simpson ◽  
Elinor Coulman ◽  
Dunla Gallagher ◽  
Karen Jewell ◽  
David Cohen ◽  
...  
Keyword(s):  
Weight Management ◽  
Healthy Eating ◽  
Primary Outcome ◽  
Intervention Group ◽  
Control Group ◽  
Risky Drinking ◽  
Management Intervention ◽  
Cluster Randomised ◽  
Secondary Outcomes ◽  
Weight Management Intervention

Abstract Objective To assess whether a weight management intervention for pregnant women with obesity was effective in reducing body mass index (BMI) 12 months after giving birth. Methods Pragmatic, cluster randomised controlled trial (RCT) with embedded cost-effectiveness analysis. 598 women with a BMI of ≥30 kg/m2 (between 12 and 20 weeks gestation) were recruited from 20 secondary care maternity units in England and Wales. BMI at 12 months postpartum was the primary outcome. A range of clinical and behavioural secondary outcomes were examined. Interventions Women attending maternity units randomised to intervention were invited to a weekly weight management group, which combined expertise from a commercial weight loss programme with clinical advice from midwives. Both intervention and control participants received usual care and leaflets on diet and physical activity in pregnancy. Results Mean (SD) BMI at 12 months postpartum was 36.0 kg/m2 (5.2) in the control group, and 37.5 kg/m2 (6.7) in the intervention group. After adjustment for baseline BMI, the intervention effect was −0.02 (95% CI −0.04 to 0.01). The intervention group had an improved healthy eating score (3.08, 95% CI 0.16 to 6.00, p < 0.04), improved fibre score (3.22, 1.07 to 5.37, p < 0.01) and lower levels of risky drinking at 12 months postpartum compared to the control group (OR 0.45, 0.27 to 0.74, p < 0.002). The net incremental monetary benefit was not statistically significantly different between arms, although the probability of the intervention being cost-effective was above 60%, at policy-relevant thresholds. Conclusions There was no significant difference between groups on the primary outcome of BMI at 12 months. Analyses of secondary outcomes indicated improved healthy eating and lower levels of risky drinking. Trial registration: Current Controlled Trials ISRCTN25260464.

scholarly journals 83 A Medication Self-Management Intervention to Improve Medication Adherence For Older People with Multimorbidity: A Pilot Study

2021 ◽  
Vol 50 (Supplement_1) ◽  
pp. i12-i42
Author(s):  
C Yang ◽  
Z Hui ◽  
S Zhu ◽  
X Wang ◽  
G Tang ◽  
...  
Keyword(s):  
Medication Adherence ◽  
Pilot Study ◽  
Older People ◽  
Intervention Group ◽  
Self Management ◽  
Control Group ◽  
Medication Knowledge ◽  
Management Intervention ◽  
Patient Reported

Abstract Introduction Medication self-management support has been recognised as an essential element in primary health care to promote medication adherence and health outcomes for older people with chronic conditions. A patient-centred intervention empowering patients and supporting medication self-management activities could benefit older people. This pilot study tested a newly developed medication self-management intervention for improving medication adherence among older people with multimorbidity. Method This was a two-arm randomised controlled trial. Older people with multimorbidity were recruited from a community healthcare centre in Changsha, China. Participants were randomly allocated to either a control group receiving usual care (n = 14), or to an intervention group receiving three face-to-face medication self-management sessions and two follow-up phone calls over six weeks, targeting behavioural determinants of adherence from the Information-Motivation-Behavioural skills model (n = 14). Feasibility was assessed through recruitment and retention rates, outcome measures collection, and intervention implementation. Follow-up data were measured at six weeks after baseline using patient-reported outcomes including medication adherence, medication self-management capabilities, treatment experiences, and quality of life. Preliminary effectiveness of the intervention was explored using generalised estimating equations. Results Of the 72 approached participants, 28 (38.89%) were eligible for study participation. In the intervention group, 13 participants (92.86%) completed follow-up and 10 (71.42%) completed all intervention sessions. Ten participants (71.42%) in the control group completed follow-up. The intervention was found to be acceptable by participants and the intervention nurse. Comparing with the control group, participants in the intervention group showed significant improvements in medication adherence (β = 0.26, 95%CI 0.12, 0.40, P &lt; 0.001), medication knowledge (β = 4.43, 95%CI 1.11, 7.75, P = 0.009), and perceived necessity of medications (β = −2.84, 95%CI -5.67, −0.01, P = 0.049) at follow-up. Conclusions The nurse-led medication self-management intervention is feasible and acceptable among older people with multimorbidity. Preliminary results showed that the intervention may improve patients’ medication knowledge and beliefs and thus lead to improved adherence.

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.

Effect of health education on awareness and practices of breast self-examination among females attending a charitable hospital at North Karachi

2021 ◽  
Vol 71 (9) ◽  
Author(s):  
Zohra Jabeen ◽  
Nighat Shah ◽  
Zaeema Ahmer ◽  
Sulhera Khan ◽  
Amir Hussain Khan ◽  
...  
Keyword(s):  
Health Education ◽  
Intervention Group ◽  
Positive Association ◽  
Control Group ◽  
Low Resource ◽  
Resource Setting ◽  
Low Resource Setting ◽  
Study Results ◽  
Quasi Experimental ◽  
And Performance

Abstract Objective: The objective of this study was to compare the effectiveness of health education as an intervention to promote BSE among intervention and non-intervention group presenting in a low resource setting at North Karachi Methodology: This Quasi-experimental study was conducted from January-August 2018 in a charitable hospital in Karachi after taking ethical approval by the Institutional Review Board of Jinnah Sindh Medical University and relevant approvals from the hospital authorities. This study recruited 172 eligible women by dividing them into intervention (n=86) and control (n=86) groups from a low resource setting in Karachi. Demographic variables were collected through pretested questionnaire by interview. Intervention group then received health education regarding carcinoma of breast, importance of BSE and monthly motivation to perform BSE through cell phone. The questionnaire was again filled after 6 months of intervention. Control group was also given health education sessions upon completion of study. Results: Results revealed that both groups were similar initially. After 6 months females in intervention group showed significant (p=<0.001) improvement in knowledge and performance of BSE from 44.2% to 88.4% but there was no change in control group. Being in intervention group (RR=2.714, 95% CI= 1.760 - 4.186, p=0.001) and education (RR=0.573, 95% CI= 0.361 - 0.910, p=0.018) showed positive association with BSE performance. Upon adjusting with age, marital status, family history and education, intervention group (RR=2.570, 95% CI= 1.654 - 3.992, p= 0.001) remained significant while education (RR=1.466, 95% CI =0.910 - 2.363, p=0.116) became insignificant. Continuous...

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 Topic-specific Infobuttons Reduce Search Time but their Clinical Impact is Unclear

2009 ◽  
Vol 4 (2) ◽  
pp. 161 ◽  
Author(s):  
Shandra Protzko
Keyword(s):  
Success Rate ◽  
Information Seeking ◽  
Clinical Decision Making ◽  
Intervention Group ◽  
Search Time ◽  
Clinical Impact ◽  
Control Group ◽  
Specific Content ◽  
Study Results ◽  
Intermountain Healthcare

A Review of: Del Fiol, Guilherme, Peter J. Haug, James J. Cimino, Scott P. Narus, Chuck Norlin, and Joyce A. Mitchell. ‚Effectiveness of Topic-specific Infobuttons: A Randomized Controlled Trial.‛ Journal of the American Medical Information Association 15.6 (2008): 752-9. Objective – To assess whether infobutton links that direct users to specific content topics (‚topic links‛) are more effective in answering clinical questions than links that direct users to general overview content (‚nonspecific links‛). Design – Randomized control trial. Setting – Intermountain Healthcare, an integrated system of 21 hospitals and over 120 outpatient clinics located in Utah and southeastern Idaho. Subjects – Ninety clinicians and 3,729 infobutton sessions. Methods – To ensure comparable group composition, subjects were paired and randomly allocated to the study groups. Clinicians in the intervention group had access to topic links, while those in the control group had access to nonspecific links. All subjects at Intermountain Healthcare use a Web-based electronic medical record system (EMR) called HELP2 Clinical Desktop with integrated infobutton links. An Infobutton Manager application defines the content topics and resources; in this case, Micromedex® (Thomson Healthcare, Englewood, CO) provided access to the topic links. The medication order entry module, the most popular of the outpatient modules, was selected to test the two configurations of infobuttons. A focus group of seven HELP2 users aided the researchers in determining the most salient topics to be displayed as a part of the intervention group's user-interface. The study measured infobutton session duration, or time spent seeking information, the number of infobutton sessions conducted, and the outcome and impact of the information seeking. A post-session questionnaire displayed randomly in 30% of sessions measured outcome and impact. The study was conducted between May and November, 2007. This project was funded in part by the National Library of Medicine. Main Results – Subjects in the intervention group spent 17.4% less time seeking information than those in the control group (35.5 seconds vs. 43 seconds, p = 0.008). The intervention group used infobuttons 20.5% more often (22 sessions vs. 17.5 sessions, p = 0.21) than those in the control group, a difference that was not statistically significant. Twenty-five subjects answered the post-session survey at least once for a total of 115 (9.9%) responses out of 1,161 possible sessions. The information seeking success rate was equally high in both groups (87.2% intervention vs. 89.4% control, p = .099). Subjects reported high positive clinical impact (i.e., decision enhancement or learning) in 62% of successful sessions. Subjects conveyed a moderate or high level of frustration in 80% of responses associated with unsuccessful sessions. Conclusion – Topic links provide a slight advantage in the clinical decision-making process by reducing the amount of time spent searching. But while the session length difference between the control and intervention groups is statistically significant, it is less clear whether the difference is clinically meaningful. As previous studies have indicated, infobuttons are able to answer clinical medication questions with a high success rate. It is unclear whether topic links have a clinically significant impact, or rather, whether they are more effective than nonspecific links. The authors believe that the study results ‚should generalize to high-frequency, medication-related infobutton users in other institutions‛ (758).

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