Dataset Information

A Web-Based Computer-Tailored Program to Improve Treatment Adherence in Patients With Type 2 Diabetes: Randomized Controlled Trial.

ABSTRACT:

Background

Adherence to core type 2 diabetes mellitus (T2DM) treatment behaviors is suboptimal, and nonadherence is generally not limited to one treatment behavior. The internet holds promise for programs that aim to improve adherence. We developed a computer-tailored eHealth program for patients with T2DM to improve their treatment adherence, that is, adherence to both a healthy lifestyle and medical behaviors.

Objective

The objective of this study is to examine the effectiveness of the eHealth program in a randomized controlled trial.

Methods

Patients with T2DM were recruited by their health professionals and randomized into either the intervention group, that is, access to the eHealth program for 6 months, or a waiting-list control group. In total, 478 participants completed the baseline questionnaire, of which 234 gained access to the eHealth program. Of the 478 participants, 323 were male and 155 were female, the mean age was 60 years, and the participants had unfavorable BMI and HbA_1c levels on average. Outcome data were collected through web-based assessments on physical activity (PA) levels, caloric intake from unhealthy snacks, and adherence to oral hypoglycemic agents (OHAs) and insulin therapy. Changes to separate behaviors were standardized and summed into a composite change score representing changes in the overall treatment adherence. Further standardization of this composite change score yielded the primary outcome, which can be interpreted as Cohen d (effect size). Standardized change scores observed in separate behaviors acted as secondary outcomes. Mixed linear regression analyses were conducted to examine the effectiveness of the intervention on overall and separate treatment behavior adherence, accommodating relevant covariates and patient nesting.

Results

After the 6-month follow-up assessment, 47.4% (111/234) of participants in the intervention group and 72.5% (177/244) of participants in the control group were retained. The overall treatment adherence improved significantly in the intervention group compared with the control group, reflected by a small effect size (d=0.27; 95% CI 0.032 to 0.509; P=.03). When considering changes in separate treatment behaviors, a significant decrease was observed only in caloric intake from unhealthy snacks in comparison with the control group (d=0.36; 95% CI 0.136 to 0.584; P=.002). For adherence to PA (d=-0.14; 95% CI -0.388 to 0.109; P=.27), OHAs (d=0.27; 95% CI -0.027 to 0.457; P=.08), and insulin therapy (d=0.35; 95% CI -0.066 to 0.773; P=.10), no significant changes were observed. These results from the unadjusted analyses were comparable with the results of the adjusted analyses, the per-protocol analyses, and the sensitivity analyses.

Conclusions

Our multibehavior program significantly improved the overall treatment adherence compared with the control group. To further enhance the impact of the intervention in the personal, societal, and economic areas, a wide-scale implementation of our eHealth intervention is suggested.

Trial registration

Netherlands Trial Register NL664; https://www.trialregister.nl/trial/6664.

SUBMITTER: Vluggen S

PROVIDER: S-EPMC7943340 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Publications

A Web-Based Computer-Tailored Program to Improve Treatment Adherence in Patients With Type 2 Diabetes: Randomized Controlled Trial.

Vluggen Stan S Candel Math M Hoving Ciska C Schaper Nicolaas C NC de Vries Hein H

Journal of medical Internet research 20210223 2

<h4>Background</h4>Adherence to core type 2 diabetes mellitus (T2DM) treatment behaviors is suboptimal, and nonadherence is generally not limited to one treatment behavior. The internet holds promise for programs that aim to improve adherence. We developed a computer-tailored eHealth program for patients with T2DM to improve their treatment adherence, that is, adherence to both a healthy lifestyle and medical behaviors.<h4>Objective</h4>The objective of this study is to examine the effectiveness ...[more]

PMID: 33620321

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Project description:BACKGROUND:Improving practice nurses' (PN) adherence to smoking cessation counseling guidelines will benefit the quality of smoking cessation care and will potentially lead to higher smoking abstinence rates. However, support programs to aid PNs in improving their guideline uptake and adherence do not exist yet. OBJECTIVE:The aim of this study was to assess the effects of a novel computer-tailored electronic learning (e-learning) program on PNs' smoking cessation guideline adherence. METHODS:A Web-based randomized controlled trial (RCT) was conducted in which an intervention group (N=147) with full access to the e-learning program for 6 months was compared with a control group (N=122) without access. Data collection was fully automated at baseline and 6-month follow-up via online questionnaires, assessing PNs' demographics, work-related factors, potential behavioral predictors based on the I-Change model, and guideline adherence. PNs also completed counseling checklists to retrieve self-reported counseling activities for each consultation with a smoker (N=1175). To assess the program's effectiveness in improving PNs' guideline adherence (ie, overall adherence and adherence to individual counseling guideline steps), mixed linear and logistic regression analyses were conducted, thus accommodating for the smokers being nested within PNs. Potential effect moderation by work-related factors and behavioral predictors was also examined. RESULTS:After 6 months, 121 PNs in the intervention group (82.3%, 121/147) and 103 in the control group (84.4%, 103/122) completed the follow-up questionnaire. Mixed linear regression analysis revealed that counseling experience moderated the program's effect on PNs' overall guideline adherence (beta=.589; 95% CI 0.111-1.068; PHolm-Bonferroni =.048), indicating a positive program effect on adherence for PNs with a more than average level of counseling experience. Mixed logistic regression analyses regarding adherence to individual guideline steps revealed a trend toward moderating effects of baseline levels of behavioral predictors and counseling experience. More specifically, for PNs with less favorable scores on behavioral predictors (eg, low baseline self-efficacy) and high levels of counseling experience, the program significantly increased adherence. CONCLUSIONS:Results from our RCT showed that among PNs with more than average counseling experience, the e-learning program resulted in significantly better smoking cessation guideline adherence. Experienced PNs might have been better able to translate the content of our e-learning program into practically applicable counseling strategies compared with less experienced colleagues. Less favorable baseline levels of behavioral predictors among PNs possibly contributed to this effect, as there was more room for improvement by consulting the tailored content of the e-learning program. To further substantiate the effectiveness of e-learning programs on guideline adherence by health care professionals (HCPs), it is important to assess how to support a wider range of HCPs. TRIAL REGISTRATION:Netherlands Trial Register NTR4436; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4436 (Archived by WebCite at http://www.webcitation.org/6zJQuSRq0).

Project description:Effective interventions to influence workplace sitting are needed, as office-based workers demonstrate high levels of continued sitting, and sitting too much is associated with adverse health effects. Therefore, we developed a theory-driven, Web-based, interactive, computer-tailored intervention aimed at reducing and interrupting sitting at work.The objective of our study was to investigate the effects of this intervention on objectively measured sitting time, standing time, and breaks from sitting, as well as self-reported context-specific sitting among Flemish employees in a field-based approach.Employees (n=213) participated in a 3-group randomized controlled trial that assessed outcomes at baseline, 1-month follow-up, and 3-month follow-up through self-reports. A subsample (n=122) were willing to wear an activity monitor (activPAL) from Monday to Friday. The tailored group received an automated Web-based, computer-tailored intervention including personalized feedback and tips on how to reduce or interrupt workplace sitting. The generic group received an automated Web-based generic advice with tips. The control group was a wait-list control condition, initially receiving no intervention. Intervention effects were tested with repeated-measures multivariate analysis of variance.The tailored intervention was successful in decreasing self-reported total workday sitting (time × group: P<.001), sitting at work (time × group: P<.001), and leisure time sitting (time × group: P=.03), and in increasing objectively measured breaks at work (time × group: P=.07); this was not the case in the other conditions. The changes in self-reported total nonworkday sitting, sitting during transport, television viewing, and personal computer use, objectively measured total sitting time, and sitting and standing time at work did not differ between conditions.Our results point out the significance of computer tailoring for sedentary behavior and its potential use in public health promotion, as the effects of the tailored condition were superior to the generic and control conditions.Clinicaltrials.gov NCT02672215; http://clinicaltrials.gov/ct2/show/NCT02672215 (Archived by WebCite at http://www.webcitation.org/6glPFBLWv).

Project description:BackgroundComputer-tailored physical activity (PA) interventions delivered through the Internet represent a promising and appealing method to promote PA at a population level. However, personalized advice is mostly provided based on subjectively measured PA, which is not very accurate and might result in the delivery of advice that is not credible or effective. Therefore, an innovative computer-tailored PA advice was developed, based on objectively pedometer-measured PA.ObjectiveThe study aim was to evaluate the effectiveness of a computer-tailored, pedometer-based PA intervention in working adults.MethodsParticipants (≥18 years) were recruited between May and December 2012 from eight Flemish workplaces. These workplaces were allocated randomly to an intervention or control group. Intervention group participants (n=137) received (1) a booklet with information on how to increase their steps, (2) a non-blinded pedometer, and (3) an Internet link to request computer-tailored step advice. Control group participants (n=137) did not receive any of the intervention components. Self-reported and pedometer-based PA were assessed at baseline (T0), and 1 month (T1) and 3 months (T2) months post baseline. Repeated measures analyses of covariance were used to examine intervention effects for both the total sample and the at-risk sample (ie, adults not reaching 10,000 steps a day at baseline).ResultsThe recruitment process resulted in 274 respondents (response rate of 15.1%) who agreed to participate, of whom 190 (69.3%) belonged to the at-risk sample. Between T0 and T1 (1-month post baseline), significant intervention effects were found for participants' daily step counts in both the total sample (P=.004) and the at-risk sample (P=.001). In the at-risk sample, the intervention effects showed a daily step count increase of 1056 steps in the intervention group, compared to a decrease of 258 steps in the control group. Comparison of participants' self-reported PA revealed a significant intervention effect for time spent walking in the at-risk sample (P=.02). Intervention effects were still significant 3 months post baseline for participants' daily step counts in both the total sample (P=.03) and the at-risk sample (P=.02); however, self-reported PA differences were no longer significant.ConclusionsA computer-tailored, pedometer-based PA intervention was effective in increasing both pedometer-based and self-reported PA levels, mainly in the at-risk participants. However, more effort should be devoted to recruit and retain participants in order to improve the public health impact of the intervention.Trial registrationClinicalTrials.gov: NCT02080585; https://clinicaltrials.gov/ct2/show/NCT02080585 (Archived by WebCite at http://www.webcitation.org/6VvQnRQSy).

Project description:BACKGROUND:Intensive lifestyle interventions are effective in reducing the risk of type 2 diabetes, but the implementation of learnings from landmark studies is expensive and time consuming. The availability of digital lifestyle interventions is increasing, but evidence of their effectiveness is limited. OBJECTIVE:This randomized controlled trial (RCT) aimed to test the feasibility of a web-based diabetes prevention program (DPP) with step-dependent feedback messages versus a standard web-based DPP in people with prediabetes. METHODS:We employed a two-arm, parallel, single-blind RCT for people at high risk of developing diabetes. Patients with a hemoglobin A1c (HbA1c) level of 39-47 mmol/mol were recruited from 21 general practices in London. The intervention integrated a smartphone app delivering a web-based DPP course with SMS texts incorporating motivational interviewing techniques and step-dependent feedback messages delivered via a wearable device over 12 months. The control group received the wearable technology and access to the web-based DDP but not the SMS texts. As this was a feasibility study, the primary aim was to estimate potential sample size at different stages of the study, including the size of the target study population and the proportion of participants who consented, were randomized, and completed follow-up. We also measured the main outcomes for a full-scale RCT, namely, change in weight and physical activity at 6- and 12-month follow-ups, and secondary outcomes, including changes in the HbA1c level, blood pressure, waist circumference, waist-to-hip ratio, and lipid levels. RESULTS:We enrolled 200 participants: 98 were randomized to the intervention and 102 were randomized to the control group. The follow-up rate was higher in the control group (87/102, 85.3%) than in the intervention group (69/98, 70%) at 12 months. There was no treatment effect on weight at 6 months (mean difference 0.15; 95% CI -0.93 to 1.23) or 12 months (mean difference 0.07 kg; 95% CI -1.29 to 1.44) or for physical activity levels at 6 months (mean difference -382.90 steps; 95% CI -860.65 to 94.85) or 12 months (mean difference 92.64 steps; 95% CI -380.92 to 566.20). We did not observe a treatment effect on the secondary outcomes measured at the 6-month or 12-month follow-up. For the intervention group, the mean weight was 92.33 (SD 15.67) kg at baseline, 91.34 (SD 16.04) kg at 6 months, and 89.41 (SD 14.93) kg at 12 months. For the control group, the mean weight was 92.59 (SD 17.43) kg at baseline, 91.71 (SD 16.48) kg at 6 months, and 91.10 (SD 15.82) kg at 12 months. In the intervention group, the mean physical activity was 7308.40 (SD 4911.93) steps at baseline, 5008.76 (SD 2733.22) steps at 6 months, and 4814.66 (SD 3419.65) steps at 12 months. In the control group, the mean physical activity was 7599.28 (SD 3881.04) steps at baseline, 6148.83 (SD 3433.77) steps at 6 months, and 5006.30 (SD 3681.1) steps at 12 months. CONCLUSIONS:This study demonstrates that it is feasible to successfully recruit and retain patients in an RCT of a web-based DPP. TRIAL REGISTRATION:ClinicalTrials.gov NCT02919397; http://clinicaltrials.gov/ct2/show/NCT02919397.

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Project description:BackgroundLong-term use of adjuvant endocrine therapy (AET) among women with early-stage, hormone receptor-positive breast cancer significantly reduces the risk of hospitalizations, cancer recurrence, and mortality. AET is associated with adverse symptoms that often result in poor adherence. A web-enabled app offers a novel way to communicate and manage symptoms for women on AET. In a region with significant racial disparities in breast cancer outcomes, our study tests the impact of a web-enabled app that collects and transmits patient-reported symptoms to healthcare teams to facilitate timely and responsive symptom management on medication adherence.MethodsIn this randomized controlled trial, we randomize 300 patients initiating AET to one of three arms: 1) an "App" group (n = 100) that receives weekly reminders to use the THRIVE study app; 2) an "App+Feedback" group (n = 100) that receives weekly reminders and tailored feedback based on their use of the app; or 3) a "Usual Care" group (n = 100) that receives usual care only. Participants are stratified by race: 50% White and 50% Black. The duration of the intervention is six months following enrollment, and outcomes are assessed at 12-months. The primary outcome is adherence, which is captured using an electronic monitoring pillbox. Secondary outcomes include symptom burden, quality of life, self-efficacy for managing symptoms, and healthcare costs. We also evaluate the impact of the intervention on racial disparities in adherence. Data are derived from three sources: electronic health record data to capture treatment changes, healthcare utilization, and health outcomes; self-report survey data related to adherence, symptom burden, and quality of life; and an electronic medication monitoring device that captures adherence.DiscussionA successful web-enabled intervention could be disseminated across systems, conditions, and populations. By evaluating the impact of this intervention on a comprehensive set of measures, including AET adherence, patient outcomes, and costs, our study will provide valuable and actionable results for providers, policy makers, and insurers who strive to achieve the "Triple Aim" - reduce costs while improving health outcomes and the patient care experience.Trial registrationNCT03592771. Prospectively registered on July 19, 2018.

Project description:BACKGROUND:The efficacy of smartphone apps for improving medication adherence in type 2 diabetes is not well studied in Asian populations. OBJECTIVE:This study aimed to determine the feasibility, acceptability, and clinical outcomes of using a smartphone app to improve medication adherence in a multiethnic Asian population with type 2 diabetes. METHODS:We block randomized 51 nonadherent and digitally literate patients with type 2 diabetes between the ages of 21 and 75 years into two treatment arms (control: usual care; intervention: usual care+Medisafe app) and followed them up for 12 weeks. Recruitment occurred at a public tertiary diabetes specialist outpatient center in Singapore. The intervention group received email reminders to complete online surveys monthly, while the control group only received an email reminder(s) at the end of the study. Barriers to medication adherence and self-appraisal of diabetes were assessed using the Adherence Starts with Knowledge-12 (ASK-12) and Appraisal of Diabetes Scale (ADS) questionnaires at baseline and poststudy in both groups. Perception toward medication adherence and app usage, attitude, and satisfaction were assessed in the intervention group during and after the follow-up period. Sociodemographic data were collected at baseline. Clinical data (ie, hemoglobin A1c, body mass index, low-density lipoprotein, high-density lipoprotein, and total cholesterol levels) were extracted from patients' electronic medical records. RESULTS:A total of 51 (intervention group: 25 [49%]; control group: 26 [51%]) participants were randomized, of which 41 (intervention group: 22 [88.0%]; control group: 19 [73.1%]) completed the poststudy survey. The baseline-adjusted poststudy ASK-12 score was significantly lower in the intervention group than in the control group (mean difference: 4.7, P=.01). No changes were observed in the clinical outcomes. The average 12-week medication adherence rate of participants tracked by the app was between 38.3% and 100% in the intervention group. The majority (>80%) of the participants agreed that the app was easy to use and made them more adherent to their medication. CONCLUSIONS:Our feasibility study showed that among medication-nonadherent patients with type 2 diabetes, a smartphone app intervention was acceptable, improved awareness of medication adherence, and reduced self-reported barriers to medication adherence, but did not improve clinical outcomes in a developed Asian setting.

Project description:BACKGROUND:Optimal immunosuppressive medication adherence is essential to graft survival. Transplant-TAVIE is a Web-based tailored intervention developed to promote this adherence. OBJECTIVE:The objective of our study was to evaluate the Transplant-TAVIE intervention's acceptability, feasibility, and preliminary efficacy. METHODS:In a pilot, parallel-group, randomized controlled trial, we randomly assigned a convenience sample of 70 kidney transplant patients on immunosuppressive medication either to an experimental group (Transplant-TAVIE) or to a control group (existing websites). Kidney transplant recipients had to be older than 18 years, be taking immunosuppressant medication, and have access to the internet to participate in this study. Transplant-TAVIE was composed of three interactive Web-based sessions hosted by a virtual nurse. We documented user appreciation of and exposure to the intervention. Furthermore, we assessed medication adherence, medication self-efficacy, intake-related skills, and medication side effects at baseline and 3 and 6 months later. Analyses of variance were used to assess intergroup differences over time. RESULTS:After baseline questionnaire completion, participants were randomly assigned either to Transplant-TAVIE (n=35) or to the websites (n=35) group. All participants had received their kidney graft <1 year to 32 years earlier (mean 6.8 years). Of the experimental group, 54% (19/35) completed the sessions of Transplant-TAVIE. Users found the intervention to be acceptable-33% were extremely satisfied (6/18), 39% were very satisfied (7/18), and 28% were satisfied (5/18). At baseline and over time, both experimental and control groups reported high medication adherence, high medication self-efficacy, and frequent use of skills related to medication intake. No intergroup differences emerged over time. CONCLUSIONS:The results of this study support the feasibility and acceptability of Transplant-TAVIE. It could constitute an accessible adjunct in support of existing specialized services.

Dataset Information

A Web-Based Computer-Tailored Program to Improve Treatment Adherence in Patients With Type 2 Diabetes: Randomized Controlled Trial.

Background

Objective

Methods

Results

Conclusions

Trial registration

Publications

A Web-Based Computer-Tailored Program to Improve Treatment Adherence in Patients With Type 2 Diabetes: Randomized Controlled Trial.

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