Feasibility of the Web-Based IDEAL CGM Training and Follow-Up Support Intervention: A Randomized Controlled Pilot Study (Preprint)

Physicians’ Choice in Using Internet and Fax for Patient Recruitment and Follow-up in a Randomized Controlled Trial

Methods of Information in Medicine ◽

10.1055/s-0038-1633867 ◽

2004 ◽

Vol 43 (03) ◽

pp. 268-272 ◽

Cited By ~ 5

Author(s):

S. Morita ◽

T. Fukui ◽

J. Sakamoto ◽

M. Rahman

Keyword(s):

Randomized Controlled Trial ◽

Odds Ratio ◽

Controlled Trial ◽

Data Entry ◽

Regression Analyses ◽

Multivariate Logistic Regression ◽

Web Based ◽

Randomized Controlled ◽

The Web

Summary Objective: To examine the physicians’ preference between Web and fax-based remote data entry (RDE) system for an ongoing randomized controlled trial (RCT) in Japan. Methods: We conducted a survey among all the collaborating physicians (n = 512) of the CASE-J (Candesartan Antihypertensive Survival Evaluation in Japan) trial, who have been recruiting patients and sending follow-up data using the Web or a fax-based RDE system. The survey instrument assessed physicians’ choice between Web and fax-based RDE systems, their practice pattern, and attitudes towards these two modalities. Results: A total of 448 (87.5%) responses were received. The proportions of physicians who used Web, fax, and the combination of these two were 45.9%, 33.3% and 20.8%, respectively. Multivariate logistic regression analyses revealed that physicians 55 years or younger [odds ratio (OR) = 1.9, 95% confidence interval (CI) = 1.1-3.3] and regular users of computers (OR = 4.2, 95% CI = 2.1-8.2) were more likely to use the Web-based RDE system. Conclusions: This information would be useful in designing an RCT with a Web-based RDE system in Japan and abroad.

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Feasibility of the Web-Based IDEAL CGM Training and Follow-Up Support Intervention: A Randomized Controlled Pilot Study (Preprint)

10.2196/preprints.15410 ◽

2019 ◽

Author(s):

Madison Brick Smith ◽

Anastasia Albanese-O'Neill ◽

Yingwei Yao ◽

Diana J. Wilkie ◽

Michael J. Haller ◽

...

Keyword(s):

Pilot Study ◽

Glycemic Control ◽

Standard Care ◽

Cognitive Theory ◽

Healthcare Team ◽

Post Intervention ◽

Web Based ◽

The Web ◽

The Ideal

BACKGROUND Proper training and follow-up for patients new to continuous glucose monitor (CGM) use are required to maintain adherence and achieve diabetes-related outcomes. However, CGM training is hampered by a lack of evidence-based standards and poor reimbursement. We hypothesized that web-based CGM training and education would be effective and could be provided with minimal burden to the healthcare team. OBJECTIVE To perform a pilot feasibility study testing a theory-driven, web-based intervention designed to provide extended training and follow-up support to adolescents and young adults newly implementing CGM, and to describe CGM adherence, glycemic control and CGM-specific psychosocial measures pre- and post-intervention. METHODS The “Intervention Designed to Educate and improve Adherence through Learning to use CGM”, (IDEAL CGM) web-based training intervention was based on supporting literature and theoretical concepts adapted from the Health Belief Model and Social Cognitive Theory. Patients new to CGM aged 15-24 with type 1 diabetes for more than 6 months were recruited from within a public university’s endocrinology clinics. Participants were randomized to enhanced standard care or enhanced standard care plus the IDEAL CGM intervention using a 1:3 randomization scheme. HbA1c and psychosocial measures were assessed at baseline and 3 months after start of the intervention. RESULTS 10 eligible subjects were approached for recruitment and eight were randomized. Within the IDEAL CGM group 4 of the 6 participants received exposure to the web-based training. Half of the participants completed at least 5 of the 7 modules, however dosage of the intervention and level of engagement varied widely among participants. This study provided proof of concept for use of a web-based intervention to deliver follow-up CGM training and support. However, revisions to the intervention are needed in order to improve engagement and determine feasibility. CONCLUSIONS This pilot study underscores the importance of continued research efforts to optimimize the use of web-based intervention tools for their potential to improve adherence, glycemic control and the psychosocial impact of the use of diabetes technologies without adding significant burden to the healthcare team. Enhancements should be made to the intervention to increase engagement, maximize responsiveness, and ensure attainment of the skills necessary to achieve consistent use and improvements in glycemic control prior to the design of a larger well-powered clinical trial to establish feasibility. CLINICALTRIAL ClinicalTrials.gov NCT03367351, https://clinicaltrials.gov/ct2/show/NCT03367351.

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Effectiveness of a Web-Based Menu-Planning Intervention to Improve Childcare Service Compliance With Dietary Guidelines: Randomized Controlled Trial

Journal of Medical Internet Research ◽

10.2196/13401 ◽

2020 ◽

Vol 22 (2) ◽

pp. e13401 ◽

Cited By ~ 5

Author(s):

Alice Grady ◽

Luke Wolfenden ◽

John Wiggers ◽

Chris Rissel ◽

Meghan Finch ◽

...

Keyword(s):

Controlled Trial ◽

Dietary Guidelines ◽

Food Groups ◽

Web Based ◽

Randomized Controlled ◽

Menu Planning ◽

The Mean ◽

The Web ◽

Planning Intervention

Background Foods provided in childcare services are not consistent with dietary guideline recommendations. Web-based systems offer unique opportunities to support the implementation of such guidelines. Objective This study aimed to assess the effectiveness of a Web-based menu planning intervention in increasing the mean number of food groups on childcare service menus that comply with dietary guidelines. Secondary aims were to assess the impact of the intervention on the proportion of service menus compliant with recommendations for (1) all food groups; (2) individual food groups; and (3) mean servings of individual food groups. Childcare service use and acceptability of the Web-based program were also assessed. Methods A single-blind, parallel-group randomized controlled trial was undertaken with 54 childcare services in New South Wales, Australia. Services were randomized to a 12-month intervention or usual care control. Intervention services received access to a Web-based menu planning program linked to their usual childcare management software system. Childcare service compliance with dietary guidelines and servings of food groups were assessed at baseline, 3-month follow-up, and 12-month follow-up. Results No significant differences in the mean number of food groups compliant with dietary guidelines and the proportion of service menus compliant with recommendations for all food groups, or for individual food groups, were found at 3- or 12-month follow-up between the intervention and control groups. Intervention service menus provided significantly more servings of fruit (P<.001), vegetables (P=.03), dairy (P=.03), and meat (P=.003), and reduced their servings of discretionary foods (P=.02) compared with control group at 3 months. This difference was maintained for fruit (P=.03) and discretionary foods (P=.003) at 12 months. Intervention childcare service staff logged into the Web-based program an average of 40.4 (SD 31.8) times and rated the program as highly acceptable. Conclusions Although improvements in childcare service overall menu and individual food group compliance with dietary guidelines were not statistically significant, findings indicate that a Web-based menu planning intervention can improve the servings for some healthy food groups and reduce the provision of discretionary foods. Future research exploring the effectiveness of differing strategies in improving the implementation of dietary guidelines in childcare services is warranted. Trial Registration Australian New Zealand Clinical Trial Registry (ANZCTR): 16000974404; http://www.anzctr.org.au/ACTRN12616000974404.aspx

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Improving the Course of Depressive Symptoms After Inpatient Psychotherapy Using Adjunct Web-Based Self-Help: Follow-Up Results of a Randomized Controlled Trial

Journal of Medical Internet Research ◽

10.2196/13655 ◽

2019 ◽

Vol 21 (10) ◽

pp. e13655 ◽

Cited By ~ 5

Author(s):

Rüdiger Zwerenz ◽

Carlotta Baumgarten ◽

Jan Becker ◽

Ana Tibubos ◽

Martin Siepmann ◽

...

Keyword(s):

Depressive Symptoms ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Inpatient Psychotherapy ◽

Web Based ◽

Randomized Controlled ◽

Self Help ◽

The Web

Background We recently showed in a randomized controlled trial that Web-based self-help as an adjunct improved the effectiveness of multimodal inpatient psychotherapy for depression. Objective The aims of this study were (1) to determine whether a Web-based self-help adjunctive to multimodal inpatient psychotherapeutic treatment could also improve the course of depressive symptoms and (2) to identify predictors of residual depressive symptoms at follow-up. Methods Overall, 229 patients were randomized either to the Web-based self-help intervention group (Deprexis) or an active control group (Web-based information about depression and depressive symptoms) in addition to multimodal inpatient psychotherapy. Participants in both groups were able to access their respective Web-based programs for 12 weeks, which meant that they typically had access after discharge from the inpatient unit (mean hospitalization duration: 40 days, T1). Follow-up was performed 6 months after study intake (T3). Results At follow-up, participants of the Web-based self-help group had considerably lower symptom load regarding depressive symptoms (d=0.58) and anxiety (d=0.46) as well as a better quality of life (d=0.43) and self-esteem (d=0.31) than participants of the control group. Nearly 3 times as many participants of the intervention group compared with the control group achieved remission in accordance with less deterioration. The number needed to treat based on the Beck Depression Inventory-II (BDI-II) improved over time (T1: 7.84, T2: 7.09, and T3: 5.12). Significant outcome predictors were BDI at discharge and treatment group. Conclusions Web-based self-help as an add-on to multimodal inpatient psychotherapy improved the short-term course of depressive symptoms beyond termination. Residual symptoms at discharge from inpatient treatment and utilization of the Web-based self-help were the major predictors of depressive symptoms at follow-up. Challenges and barriers (eg, costs, therapists’ concerns, or technical barriers) of adding Web-based interventions to inpatient treatment have to be addressed. Trial Registration ClinicalTrials.gov NCT02196896; https://clinicaltrials.gov/ct2/show/NCT02196896.

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Improving the Course of Depressive Symptoms After Inpatient Psychotherapy Using Adjunct Web-Based Self-Help: Follow-Up Results of a Randomized Controlled Trial (Preprint)

10.2196/preprints.13655 ◽

2019 ◽

Author(s):

Rüdiger Zwerenz ◽

Carlotta Baumgarten ◽

Jan Becker ◽

Ana Tibubos ◽

Martin Siepmann ◽

...

Keyword(s):

Depressive Symptoms ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Inpatient Psychotherapy ◽

Web Based ◽

Randomized Controlled ◽

Self Help ◽

The Web

BACKGROUND We recently showed in a randomized controlled trial that Web-based self-help as an adjunct improved the effectiveness of multimodal inpatient psychotherapy for depression. OBJECTIVE The aims of this study were (1) to determine whether a Web-based self-help adjunctive to multimodal inpatient psychotherapeutic treatment could also improve the course of depressive symptoms and (2) to identify predictors of residual depressive symptoms at follow-up. METHODS Overall, 229 patients were randomized either to the Web-based self-help intervention group (Deprexis) or an active control group (Web-based information about depression and depressive symptoms) in addition to multimodal inpatient psychotherapy. Participants in both groups were able to access their respective Web-based programs for 12 weeks, which meant that they typically had access after discharge from the inpatient unit (mean hospitalization duration: 40 days, T1). Follow-up was performed 6 months after study intake (T3). RESULTS At follow-up, participants of the Web-based self-help group had considerably lower symptom load regarding depressive symptoms (<italic>d</italic>=0.58) and anxiety (<italic>d</italic>=0.46) as well as a better quality of life (<italic>d</italic>=0.43) and self-esteem (<italic>d</italic>=0.31) than participants of the control group. Nearly 3 times as many participants of the intervention group compared with the control group achieved remission in accordance with less deterioration. The number needed to treat based on the Beck Depression Inventory-II (BDI-II) improved over time (T1: 7.84, T2: 7.09, and T3: 5.12). Significant outcome predictors were BDI at discharge and treatment group. CONCLUSIONS Web-based self-help as an add-on to multimodal inpatient psychotherapy improved the short-term course of depressive symptoms beyond termination. Residual symptoms at discharge from inpatient treatment and utilization of the Web-based self-help were the major predictors of depressive symptoms at follow-up. Challenges and barriers (eg, costs, therapists’ concerns, or technical barriers) of adding Web-based interventions to inpatient treatment have to be addressed. CLINICALTRIAL ClinicalTrials.gov NCT02196896; https://clinicaltrials.gov/ct2/show/NCT02196896.

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Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial

Trials ◽

10.1186/s13063-021-05333-2 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Lena Violetta Krämer ◽

Nadine Eschrig ◽

Lena Keinhorst ◽

Luisa Schöchlin ◽

Lisa Stephan ◽

...

Keyword(s):

Physical Activity ◽

Randomized Controlled Trial ◽

Mixed Model ◽

Controlled Trial ◽

Control Group ◽

Web Based ◽

Intention To Treat ◽

Randomized Controlled ◽

Link Type

Abstract Background Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectiveness of web-based interventions in university students is low. Our study aims at investigating a web-based intervention for students. The intervention is based on the Health Action Process Approach (HAPA), which discriminates between processes of intention formation (motivational processes) and processes of intention implementation (volitional processes). Primary outcome is change in physical activity; secondary outcomes are motivational and volitional variables as proposed by the HAPA as well as quality of life and depressive symptoms. Methods A two-armed randomized controlled trial (RCT) of parallel design is conducted. Participants are recruited via the internet platform StudiCare (www.studicare.com). After the baseline assessment (t1), participants are randomized to either intervention group (immediate access to web-based intervention) or control group (access only after follow-up assessment). Four weeks later, post-assessment (t2) is performed in both groups followed by a follow-up assessment (t3) 3 months later. Assessments take place online. Main outcome analyses will follow an intention-to-treat principle by including all randomized participants into the analyses. Outcomes will be analysed using a linear mixed model, assuming data are missing at random. The mixed model will include group, time, and the interaction of group and time as fixed effects and participant and university as random effect. Discussion This study is a high-quality RCT with three assessment points and intention-to-treat analysis meeting the state-of-the-art of effectiveness studies. Recruitment covers almost 20 universities in three countries, leading to high external validity. The results of this study will be of great relevance for student health campaigns, as they reflect the effectiveness of self-help interventions for young adults with regard to behaviour change as well as motivational and volitional determinants. From a lifespan perspective, it is important to help students find their way into regular physical activity. Trial registration The German clinical trials register (DRKS) DRKS00016889. Registered on 28 February 2019

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A Suite of Mobile Conversational Agents for Daily Stress Management (Popbots): Mixed Methods Exploratory Study (Preprint)

10.2196/preprints.25294 ◽

2020 ◽

Author(s):

Matthew Louis Mauriello ◽

Nantanick Tantivasadakarn ◽

Marco Antonio Mora-Mendoza ◽

Emmanuel Thierry Lincoln ◽

Grace Hon ◽

...

Keyword(s):

Stress Management ◽

Design Guidelines ◽

Coping Resources ◽

Rank Test ◽

Depression Symptoms ◽

Conversational Agents ◽

Daily Stress ◽

Web Based ◽

The Web

BACKGROUND Approximately 60%-80% of the primary care visits have a psychological stress component, but only 3% of patients receive stress management advice during these visits. Given recent advances in natural language processing, there is renewed interest in mental health chatbots. Conversational agents that can understand a user’s problems and deliver advice that mitigates the effects of daily stress could be an effective public health tool. However, such systems are complex to build and costly to develop. OBJECTIVE To address these challenges, our aim is to develop and evaluate a fully automated mobile suite of shallow chatbots—we call them Popbots—that may serve as a new species of chatbots and further complement human assistance in an ecosystem of stress management support. METHODS After conducting an exploratory Wizard of Oz study (N=14) to evaluate the feasibility of a suite of multiple chatbots, we conducted a web-based study (N=47) to evaluate the implementation of our prototype. Each participant was randomly assigned to a different chatbot designed on the basis of a proven cognitive or behavioral intervention method. To measure the effectiveness of the chatbots, the participants’ stress levels were determined using self-reported psychometric evaluations (eg, web-based daily surveys and Patient Health Questionnaire-4). The participants in these studies were recruited through email and enrolled on the web, and some of them participated in follow-up interviews that were conducted in person or on the web (as necessary). RESULTS Of the 47 participants, 31 (66%) completed the main study. The findings suggest that the users viewed the conversations with our chatbots as helpful or at least neutral and came away with increasingly positive sentiment toward the use of chatbots for proactive stress management. Moreover, those users who used the system more often (ie, they had more than or equal to the median number of conversations) noted a decrease in depression symptoms compared with those who used the system less often based on a Wilcoxon signed-rank test (W=91.50; Z=−2.54; <i>P</i>=.01; <i>r</i>=0.47). The follow-up interviews with a subset of the participants indicated that half of the common daily stressors could be discussed with chatbots, potentially reducing the burden on human coping resources. CONCLUSIONS Our work suggests that suites of shallow chatbots may offer benefits for both users and designers. As a result, this study’s contributions include the design and evaluation of a novel suite of shallow chatbots for daily stress management, a summary of benefits and challenges associated with random delivery of multiple conversational interventions, and design guidelines and directions for future research into similar systems, including authoring chatbot systems and artificial intelligence–enabled recommendation algorithms.

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Lessons learnt during the implementation of a web-based triage tool for Dutch intensive care follow-up clinics

BMJ Open ◽

10.1136/bmjopen-2017-021249 ◽

2018 ◽

Vol 8 (9) ◽

pp. e021249 ◽

Cited By ~ 2

Author(s):

Ilse van Beusekom ◽

Ferishta Bakhshi-Raiez ◽

Nicolette F de Keizer ◽

Dave A Dongelmans ◽

Marike van der Schaaf

Keyword(s):

Intensive Care ◽

Health Professionals ◽

Web Based ◽

Quality Registry ◽

Email Address ◽

National Quality ◽

The Web ◽

Screening Software ◽

National Quality Registry

ObjectivesScreening for symptoms of postintensive care syndrome is based on a long list of questionnaires, filled out by the intensive care unit (ICU) survivor and manually reviewed by the health professional. This is an inefficient and time-consuming process. The aim of this study was to evaluate the feasibility of a web-based triage tool and to compare the outcomes from web-based questionnaires to those from paper-based questionnaires.DesignA mixed-methods study.SettingNine Dutch ICU follow-up clinics.Participants221 ICU survivors and 14 health professionals.InterventionsA web-based triage tool was implemented by nine ICU follow-up clinics. End users, that is, health professionals were interviewed in order to evaluate the feasibility of the triage tool. ICU survivors were invited to fill out web-based questionnaires 3 months after hospital discharge.Primary outcomesOutcomes of the questionnaires were merged with clinical data from a national quality registry to assess the differences in outcomes between paper-based and web-based questionnaires.Results221 ICU survivors received an invitation to fill out questionnaires, 93 (42.1%) survivors did not respond to the invitation. Respondents to the web-based questionnaires (n=54) were significantly younger and had a significantly longer ICU stay than those who preferred the paper-based questionnaires (n=74). The prevalence of mental, physical and nutritional problems was high, although comparable between the groups. Health professionals’ interviews revealed that the software was complex to use (n=8) and although emailing survivors is very convenient, not all survivors have an email address (n=7).ConclusionsWeb-based screening software has major benefits compared with paper-based screening. However, implementation has shown to be rather difficult and there are important barriers to consider. Although different in age, the health status is comparable between the users of the web-based questionnaire and paper-based questionnaire.

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A Storytelling Intervention in a Mobile, Web-Based Platform: A Pilot Randomized Controlled Trial to Evaluate the Preliminary Effectiveness to Promote Human Papillomavirus Vaccination in Korean American College Women

Health Education & Behavior ◽

10.1177/1090198119894589 ◽

2020 ◽

Vol 47 (2) ◽

pp. 258-263

Author(s):

Minjin Kim ◽

Haeok Lee ◽

Peter Kiang ◽

Teri Aronowitz ◽

Lisa Kennedy Sheldon ◽

...

Keyword(s):

Hpv Vaccine ◽

Comparison Group ◽

Controlled Trial ◽

Korean American ◽

Web Based ◽

Mobile Web ◽

Randomized Controlled ◽

Experimental Group ◽

Pilot Randomized Controlled Trial

Korean American women have substantially greater incidence rates of cervical cancer and the lowest rates of cervical cancer screening in the United States. However, there has been minimal research to promote human papillomavirus (HPV) vaccination among this population. A pilot randomized controlled trial was conducted to evaluate preliminary effectiveness of a storytelling video intervention using mobile, Web-based technology. One hundred and four Korean American college women were randomized to the experimental group (storytelling video) or the comparison group (information-based written material). The effects of the intervention were assessed immediately postintervention and at the 2-month follow-up. Both groups improved in knowledge of and attitude toward the HPV vaccine at the postintervention. At the 2-month follow-up, the experimental group was twice as likely to receive the HPV vaccine compared to the comparison group. This preliminary evidence supports the use of a storytelling video intervention and shows substantial promise for further development and testing in larger scale studies.

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Pilot Randomized Controlled Trial of Web-Delivered Acceptance and Commitment Therapy Versus Smokefree.gov for Smokers With Bipolar Disorder

Nicotine & Tobacco Research ◽

10.1093/ntr/ntz242 ◽

2019 ◽

Vol 22 (9) ◽

pp. 1543-1552 ◽

Cited By ~ 1

Author(s):

Jaimee L Heffner ◽

Megan M Kelly ◽

Jeanette Waxmonsky ◽

Kristin Mattocks ◽

Edit Serfozo ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Trial Design ◽

Nicotine Patch ◽

Controlled Trial ◽

Web Based ◽

Randomized Controlled ◽

Acceptance And Commitment ◽

End Of Treatment ◽

Pilot Randomized Controlled Trial

Abstract Introduction Smokers with bipolar disorder (BD) are less successful at quitting than the general population. In this study, we evaluated in a pilot randomized controlled trial a novel, targeted, web-based intervention for smokers with BD based on acceptance and commitment therapy (ACT) and designed for reach and disseminability. Aims and Methods Daily smokers (n = 51) with bipolar I or II disorder were recruited from four US sites and randomly assigned to one of two web-based smoking cessation interventions—ACT-based WebQuit Plus (n = 25) or Smokefree.gov (n = 26) over a 10-week treatment period. All participants received nicotine patch for 8 weeks. Key outcomes were trial design feasibility, intervention acceptability, and cessation at end of treatment and 1-month follow-up. Results We screened 119 to enroll 51 participants (target sample size = 60) over 24 months. The most common reason for ineligibility was the inability to attend study appointments. Retention was 73% at end of treatment and 80% at follow-up, with no differences by arm. The mean number of logins was twice as high for WebQuit Plus (10.3 vs. 5.3). The usefulness of program skills was rated higher for WebQuit Plus (75% vs. 29%). Biochemically confirmed, 7-day abstinence at end of treatment was 12% in WebQuit Plus versus 8% in Smokefree.gov (odds ratio = 1.46, 95% confidence interval = 0.21 to 9.97). At follow-up, abstinence rates were 8% in both arms. Conclusions Trial design produced favorable retention rates, although alternative recruitment methods will be needed for a larger trial. At end of treatment, acceptability and estimated effect size of WebQuit Plus relative to Smokefree.gov were promising and support continued program refinement and evaluation. Implications In this first randomized controlled trial of a targeted intervention for smokers with BD, we found that the ACT-based WebQuit Plus intervention, delivered in combination with the nicotine patch, had promising acceptability and cessation outcomes relative to Smokefree.gov. The observed signals for acceptability and cessation suggest that the WebQuit Plus program should be refined based on participant feedback and evaluated in a larger trial. Feasibility findings from this study also provide direction for refining trial procedures to enhance the recruitment of smokers with BD.

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