Recruitment and enrollment of participants in an online diabetes self-management intervention in a virtual environment

Vorderstrasse, Allison; Reagan, Louise; Melkus, Gail D’Eramo; Nowlin, Sarah; Birdsall, Stacia B.; Burd, Andrew; Cho, Yoon Hee; Jang, Myoungock; Johnson, Constance

doi:10.1016/j.cct.2021.106399

Cited by 3 publications

(1 citation statement)

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“…To the best of our knowledge, this is the first study to specifically examine the rate of opt-out across four different modes of opt-out. Commonly, studies using opt-out recruitment strategies include only one mode of opt-out, for example, via the post26 59 or telephone 60. The most frequent mode of opt-out in the ENGAGE feasibility trial was paper via the post (47.6 %), followed by telephone (32.3%), with findings similar to a quantitative telephone survey with military veterans examining rural and urban differences in attitudes towards mental healthcare and influence on mental health service use, whereby opt-out via the post was more frequent (75%) than opt-out via the telephone (25%) 50.…”

Section: Discussionmentioning

confidence: 99%

Opt-out rates and reasons for non-participation in a single-arm feasibility trial (ENGAGE) of a guided internet-administered CBT-based intervention for parents of children treated for cancer: a nested cross-sectional survey

et al. 2022

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ObjectivesDifficulties with recruitment into clinical trials are common. An opt-out recruitment strategy, whereby potential participants can decline further contact about a study (opt-out), and non-responders are contacted, may facilitate participation. Primary objectives examined opt-out and consent rates, mode and time point of opt-out, and sociodemographic characteristics of those who opted out versus those who chose to participate in a single-arm feasibility trial (ENGAGE) of a guided, internet-administered, cognitive–behavioural therapy-based intervention for parents of children treated for cancer. Secondary objectives examined reasons for non-participation.DesignA cross-sectional survey nested within the ENGAGE feasibility trial.SettingThe intervention was delivered from Uppsala University, with parents located throughout Sweden.ParticipantsPotential participants were recruited 3 months–5 years following their child ending treatment for cancer and were identified via their personal identification number (via the Swedish Childhood Cancer Registry and Swedish Tax Agency) and invited via postal invitation packs and could opt out via post, online, telephone or email. Those who did not opt out or consent, within 4 weeks, received up to five telephone calls and/or one postal reminder.ResultsOf 509 invited, 164 (32.2%) opted out, 78 (47.6%) via post, 53 (32.3%) via telephone, 24 (14.6%) online, and 6 (3.7%) via email, 88 (53.7%) opted out after at least one telephone call and/or postal reminder. There was a trend for parents with lower educational levels to opt out. No need of psychological support, lack of time, and no interest in internet-administered self-help were frequently reported reasons for non-participation.ConclusionsResults emphasise the importance of using different opt-out modes and suggest future research should consider how to widen study participation for parents with lower education levels. Self-identifying a need for psychological support and the acceptability of internet-administered self-help are important factors for participation and should be considered in future research to increase recruitment.Trial registration numberISRCTN57233429.

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Section: Discussionmentioning

confidence: 99%

Opt-out rates and reasons for non-participation in a single-arm feasibility trial (ENGAGE) of a guided internet-administered CBT-based intervention for parents of children treated for cancer: a nested cross-sectional survey

et al. 2022

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Learning in a Virtual Environment to Improve Type 2 Diabetes Outcomes: Randomized Controlled Trial

Johnson¹,

Melkus²,

Reagan³

et al. 2023

JMIR Form Res

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Background Given the importance of self-management in type 2 diabetes mellitus (T2DM), a major aspect of health is providing diabetes self-management education and support. Known barriers include access, availability, and the lack of follow through on referral to education programs. Virtual education and support have increased in use over the last few years. Objective The purpose of the Diabetes Learning in a Virtual Environment (LIVE) study was to compare the effects of the LIVE intervention (educational 3D world) to a diabetes self-management education and support control website on diet and physical activity behaviors and behavioral and metabolic outcomes in adults with T2DM over 12 months. Methods The LIVE study was a 52-week multisite randomized controlled trial with longitudinal repeated measures. Participants were randomized to LIVE (n=102) or a control website (n=109). Both contained the same educational materials, but the virtual environment was synchronous and interactive, whereas the control was a flat website. Data were collected at baseline and 3, 6, and 12 months using surveys and clinical, laboratory, and Fitbit measures. Descriptive statistics included baseline characteristics and demographics. The effects of the intervention were initially examined by comparing the means and SDs of the outcomes across the 4 time points between study arms, followed by multilevel modeling on trajectories of the outcomes over the 12 months. Results This trial included 211 participants who consented. The mean age was 58.85 (SD 10.1) years, and a majority were White (127/211, 60.2%), non-Hispanic (198/211, 93.8%), married (107/190, 56.3%), and female (125/211, 59.2%). Mean hemoglobin A1c (HbA1c) level at baseline was 7.64% (SD 1.79%) and mean BMI was 33.51 (SD 7.25). We examined weight loss status versus randomized group, where data with no weight change were eliminated, and the LIVE group experienced significantly more weight loss than the control group (P=.04). There were no significant differences between groups in changes in physical activity and dietary outcomes (all P>.05), but each group showed an increase in physical activity. Both groups experienced a decrease in mean HbA1c level, systolic and diastolic blood pressure, cholesterol, and triglycerides over the course of 12 months of study participation, including those participants whose baseline HbA1c level was 8.6% or higher. Conclusions This study confirmed that there were minor positive changes on glycemic targets in both groups over the 12-month study period; however, the majority of the participants began with optimal HbA1c levels. We did find clinically relevant metabolic changes in those who began with an HbA1c level >8.6% in both groups. This study provided a variety of resources to our participants in both study groups, and we conclude that a toolkit with a variety of services would be helpful to improving self-care in the future for persons with T2DM. Trial Registration ClinicalTrials.gov NCT02040038; https://clinicaltrials.gov/ct2/show/NCT02040038

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Learning in a Virtual Environment to Improve Type 2 Diabetes Outcomes: Randomized Controlled Trial (Preprint)

Johnson¹,

Melkus²,

Reagan³

et al. 2022

Preprint

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BACKGROUND Given the importance of self-management in type 2 diabetes (T2D), a major aspect of health is providing diabetes self-management education and support (DSME/S). There are known barriers including access, availability, and lack of follow through on referral to education programs. Virtual education and support have increased in use, particularly over the last few years. OBJECTIVE The purpose of the Diabetes LIVE (Learning in a Virtual Environment) study was to compare the effects of the LIVE intervention (educational 3D world) on diet and physical activity behaviors, behavioral and metabolic outcomes in adults with T2D over 12 months to an online DSME/S control website. METHODS The LIVE study was a 52-week multi-site randomized controlled trial with longitudinal repeated measures. Participants were randomized to Diabetes LIVE (n =101) or a web control site (n=110). Both contained the same educational materials, but the VE was synchronous and interactive and the other was a flat website. Data were collected at baseline, 3, 6, and 12 months using surveys, clinical, laboratory, and Fitbit measures. Descriptive statistics for baseline characteristics and demographics were used. The effects of the intervention on outcomes were initially examined by comparing the means and standard deviations across the four time points of the outcomes between study arms, followed by multilevel modeling on trajectories of the outcomes over the 12 months. RESULTS 211 participants consented to participate in this trial. The mean age of participants was 58.85 (+10.1) years, and a majority were White (60.2%), non-Hispanic (93.8%), married (56.3%), and female (59.2%). Mean A1c at baseline was 7.64% (+1.79) and the mean BMI was 33.51 (+7.25). We examined weight loss status vs. randomized group, where data with no weight change were eliminated, and we found a statistically significant difference with the LIVE group experiencing more weight loss than the WebControl group (P=.04). There were no statistically significant differences between groups in changes in physical activity and dietary outcomes, but each group showed an increase in physical activity. Both groups experienced a decrease in mean A1c, systolic and diastolic blood pressure, cholesterol, and triglycerides over the course of 12 months of study participation, including those participants whose baseline A1c was 8.6 or higher. CONCLUSIONS This study confirmed that there were minor positive changes on metabolic control in both groups over the 12-month study period, however, the majority of the participants began with good metabolic control. We did find clinically relevant metabolic changes in those who began with an A1c level >8.6% in both groups. This study provided a variety of resources to our participants in both study groups, and we conclude that a toolkit with a variety of services would be helpful to improving self-care in the future for persons with T2D. CLINICALTRIAL Clinical Trials.Gov nCT02040038

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Recruitment and enrollment of participants in an online diabetes self-management intervention in a virtual environment

Cited by 3 publications

References 30 publications

Opt-out rates and reasons for non-participation in a single-arm feasibility trial (ENGAGE) of a guided internet-administered CBT-based intervention for parents of children treated for cancer: a nested cross-sectional survey

Opt-out rates and reasons for non-participation in a single-arm feasibility trial (ENGAGE) of a guided internet-administered CBT-based intervention for parents of children treated for cancer: a nested cross-sectional survey

Learning in a Virtual Environment to Improve Type 2 Diabetes Outcomes: Randomized Controlled Trial

Learning in a Virtual Environment to Improve Type 2 Diabetes Outcomes: Randomized Controlled Trial (Preprint)

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