Dataset Information

Effectiveness of a web-based screening and brief intervention with weekly text-message-initiated individualised prompts for reducing risky alcohol use among teenagers: study protocol of a randomised controlled trial within the ProHEAD consortium.

ABSTRACT:

Background

Early and excessive alcohol use is a significant threat to healthy development. Evidence supports the effectiveness of electronic alcohol interventions for young drinkers. However, effects are typically small and studies targeting under 18-year-olds are scarce. This trial is the first to evaluate the effectiveness of a single-session, brief, motivational, web-based intervention (ProWISE) plus weekly text-message-initiated individualised prompts (TIPs) in reducing alcohol consumption and alcohol-related harm among children and adolescents aged ??12?years. TIPs are designed to decrease risky alcohol use by reaching youth in the contexts of their everyday lives and by providing individualised feedback on drinking intentions, actual drinking and succession in achieving personal goals for low-risk drinking or abstinence.

Methods/design

The trial is part of the multicentre consortium ProHEAD testing e-interventions for mental health problems in children and adolescents. Participants in grades 6-13 aged ??12?years will be recruited in schools which participate in ProHEAD (target N =?15,000). Main criterion for inclusion in the ProWISE-TIP trial is a positive screening for at-risk alcohol use in the CRAFFT-d questionnaire (target n =?1076). In a multicentre, four-arm, randomised controlled design the following groups will be compared: (A) web-based intervention plus TIPs for 12?weeks; (B) web-based intervention plus text-message-initiated assessment of alcohol consumption for 12?weeks; (C) web-based intervention only; and (D) alcohol-related psychoeducation. TIPs will be delivered shortly before and after high-risk situations for excessive alcohol use and will be tailored to age, gender, drinking motives and alcohol consumption. Study participants will be followed up at three, six and nine?months in the ProWISE-TIP trial and at one and two?years in the ProHEAD consortium. Primary outcome is alcohol use in the past 30?days at nine?months after enrolment. Secondary outcomes are alcohol-related problems, co-occurring substance use, health service utilisation, mental health problems and quality of life.

Discussion

Trial results will generate important evidence on how to enhance effectiveness of single-session, web-based alcohol interventions for youth. The ProWISE-TIP intervention, if effective, can be used as a stand-alone alcohol intervention or as an add-on to school-based or community-based alcohol prevention programs.

Trial registration

German Clinical Trials Register, DRKS00014606 Registered on 20 April 2018.

SUBMITTER: Diestelkamp S

PROVIDER: S-EPMC6341631 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effectiveness of a web-based screening and brief intervention with weekly text-message-initiated individualised prompts for reducing risky alcohol use among teenagers: study protocol of a randomised controlled trial within the ProHEAD consortium.

Diestelkamp Silke S Wartberg Lutz L Kaess Michael M Bauer Stephanie S Rummel-Kluge Christine C Becker Katja K Eschenbeck Heike H Salize Hans-Joachim HJ Moessner Markus M Baldus Christiane C Arnaud Nicolas N Thomasius Rainer R

Trials 20190122 1

<h4>Background</h4>Early and excessive alcohol use is a significant threat to healthy development. Evidence supports the effectiveness of electronic alcohol interventions for young drinkers. However, effects are typically small and studies targeting under 18-year-olds are scarce. This trial is the first to evaluate the effectiveness of a single-session, brief, motivational, web-based intervention (ProWISE) plus weekly text-message-initiated individualised prompts (TIPs) in reducing alcohol consu ...[more]

PMID: 30670102

Similar Datasets

Project description:BackgroundUse of a person's name in a text message has been shown to be effective in instigating behaviour change. We evaluated the effectiveness of a personalised text message (including the recipient's name) versus a standardised text message for prompting a response from trial participants to complete and return postal follow-up questionnaires.MethodsUsing a randomised study within a trial (SWAT) embedded within the host GRASP (Getting it Right: Addressing Shoulder Pain) trial, participants who provided a mobile telephone number were randomised (1:1) by a central computer system to receive either (1) a personalised text message which included their name or (2) a standard text message. Text messages were sent by the trial office on the same day as the 6-month GRASP follow-up questionnaire. The primary outcome was questionnaire response rate, defined as the proportion of 6-month GRASP follow-up questionnaires returned by participants. Secondary outcomes included time to response, the proportion of participants sent a reminder follow-up questionnaire, and cost.ResultsBetween March 2017 and May 2019 (recruitment period for GRASP trial), 618 participants were randomised to a personalised (n = 309) or standard (n = 309) text message and all were included in the analysis. The overall questionnaire response rate was 87% (n = 537/618); 90% (n = 277/309) of participants responded in the personalised text message group compared to 84% (n = 260/309) in the standard text message group (relative risk (RR) 1.07; 95% CI 1.00 to 1.13). Participants randomised to receive the personalised text message were more likely to return their initial postal questionnaire than those who received the standard text message (n = 185/309; 60% vs. n = 160/309; 52%) (RR 1.16; 95% CI 1.00 to 1.33); this represents an absolute percentage difference between intervention groups of 8%. Post hoc subgroup analysis showed that males under 65 years were the group most likely to return their initial questionnaire if they received a personalised text message.ConclusionOverall, participants who received a personalised text message were more likely to return their questionnaire than those who received the standard text message.Trial registrationGRASP Trial ISRCTN16539266 ; SWAT Repository ID 35.

Project description:BackgroundEngagement with digital health interventions (DHIs) may be regarded as a prerequisite for the intervention to achieve positive health or behavior change outcomes. One method employed to promote engagement is the use of prompts such as emails and text messages. However, little is known about the characteristics of prompts that promote engagement. This study explored the association between the content and delivery mode of prompts and the users' engagement with HeLP-Diabetes (Healthy Living for People with type 2 Diabetes), a DHI that aimed to promote self-management in adults with type 2 diabetes.ObjectiveThe objective of this study was to identify the characteristics of prompts, specifically the content and delivery mode, which were associated with increased engagement.MethodsThis was a mixed-methods study. Email and text message prompts were sent to the registered users of HeLP-Diabetes. Use of the intervention was recorded and examined to identify which email and text message prompts were associated with subsequent visits to the DHI. Characteristics of prompts that were identified as particularly effective or ineffective were explored through think-aloud interviews with the participants.ResultsOf a total of 39 email prompts, 49% (19/39) prompts showed a significant association with subsequent visits to the DHI. However, none of the text message prompts were associated with subsequent visits to the DHI. Furthermore, think-aloud interviews were carried out with 6 experienced participants with type 2 diabetes. The findings suggest that these participants preferred email prompts that were clear, relatively short, and empowering; used nondirective advice; included health professional references; were visually appealing; and contained news and updates.ConclusionsThe findings of this study contribute to the existing evidence supporting the role of email prompts in promoting and maintaining engagement with DHIs. This study described the content of prompts that may be engaging. However, the results should be interpreted with caution, as prompts may be context-specific interventions and the results may not be generalizable across other DHIs or other types of interventions targeting self-management of type 2 diabetes.

Project description:Interventions to improve adherence to treatment for latent tuberculosis infection (LTBI) are necessary to improve treatment completion rates and optimise tuberculosis (TB) control efforts. The high prevalence of cell phone use presents opportunities to develop innovative ways to engage patients in care. A randomised controlled trial (RCT), WelTel Kenya1, demonstrated that weekly text messages improved antiretroviral adherence and clinical outcomes among patients initiating HIV treatment. The aim of this study is to determine whether the WelTel intervention can improve treatment completion among patients with LTBI and to evaluate the intervention's cost-effectiveness.This open, two-site, parallel RCT (WelTel LTBI) will be conducted at TB clinics in Vancouver and New Westminster, British Columbia, Canada. Over 2 years, we aim to recruit 350 individuals initiating a 9-month isoniazid regimen. Participants will be randomly allocated to an intervention or control (standard care) arm in a 1:1 ratio. Intervention arm participants will receive a weekly text-message 'check-in' to which they will be asked to respond within 48 h. A TB clinician will follow-up instances of non-response and problems that are identified. Participants will be followed until treatment completion (up to 12 months) or discontinuation. The primary outcome is self-reported treatment completion (taking ?80% of doses within 12 months). Secondary outcomes include daily adherence (percentage of days participants used medication as prescribed) and time to treatment completion. Patient satisfaction with the intervention will be evaluated, and the intervention's cost-effectiveness will be analysed through decision-analytic modelling.Ethical approval has been obtained from the University of British Columbia. This trial will test the efficacy and cost-effectiveness of the WelTel intervention to improve treatment completion among patients with LTBI. Trial results and economic evaluation will help inform policy and practice on the use of WelTel in this population.ClinicalTrials.gov NCT01549457.

Project description:Background: Research outcome data is commonly collected using postal questionnaires; however, poor response can introduce bias and reduce statistical power. Text messaging is simple, cost-effective, and can be customised to the individual. Personalised, reminder text messages may improve response rates. Methods: A two-arm, parallel group 'Study within a Trial' (SWAT) was embedded within the Occupational Therapist Intervention Study (OTIS), a randomised controlled trial of a home assessment for falls prevention in older people. OTIS participants who provided a mobile phone number were randomly allocated (1:1) to receive either a personalised text message (Title, Surname, plus York Trials Unit (YTU) text) or the standard YTU text alone, prior to receiving their four-month post-randomisation follow-up postal questionnaire. The primary outcome measure was the proportion of participants who returned the questionnaire. Secondary outcomes were: time to response, completeness of response, requirement of a reminder letter, and cost-effectiveness. Binary data were compared using logistic regression and time to response by Cox proportional hazards regression. Results: A total of 403 participants were randomised: 201 to the personalised text and 202 to the standard text. Of the 283 participants included in the final analysis, 278 (98.2%) returned their questionnaire; 136 (97.8%) for the personalised text versus 142 (98.6%) for the standard text (adjusted odds ratio 0.64, 95% CI 0.10 to 3.88, p=0.63). The median time to response was nine days in both groups. In total, 271 (97.5%) participants returned a complete questionnaire; 133 (97.8%) in the personalised text versus 138 (97.2%) for the standard text. In total, 21 reminder letters were sent. The additional cost of personalised text messages was £0.04 per participant retained. Conclusions: Personalised texts were not superior to standard texts in any outcome assessed in our study. Further SWATs are needed to perform a meta-analysis and obtain more evidence. Registration: ISRCTN22202133; SWAT 35.

Project description:INTRODUCTION:The feasibility and accuracy of text messaging to monitor events after influenza vaccination throughout pregnancy and the neonatal period has not been studied, but may be important for seasonal and pandemic influenza vaccines and future maternal vaccines. METHODS:This prospective observational study was conducted during 2013-2014 and analyzed in 2015-2016. Enrolled pregnant women receiving inactivated influenza vaccination at a gestational age <20 weeks were sent text messages intermittently through participant-reported pregnancy end to request fever, health events, and neonatal outcomes. Text message response rates, Day 0-2 fever (?100.4°F), health events, and birth/neonatal outcomes were assessed. RESULTS:Most (80.2%, n=166) eligible women enrolled. Median gestational age was 8.9 (SD=3.9) weeks at vaccination. Response rates remained high (80.0%-95.2%). Only one Day 0-2 fever was reported. Women reported via text both pregnancy- and non-pregnancy-specific health events, not all associated with medical visits. Most pregnancy-specific events in the electronic medical record (EMR) were reported via text message. Of all enrollees, 84.9% completed the study (131 reported live birth, ten reported pregnancy loss). Two losses reported via text were not medically attended; there was one additional EMR-identified loss. Gestational age and weight at birth were similar between text message-reported and EMR-abstracted data and 95% CIs were overlapping for proportions of prematurity, low birth weight, small for gestational age, and major birth defects, as identified by text message-reported versus EMR-abstracted plus text message-reported versus EMR-abstracted data only. CONCLUSIONS:This study demonstrated the feasibility of text messaging for influenza vaccine safety surveillance sustained throughout pregnancy. In these women receiving inactivated influenza vaccination during pregnancy, post-vaccination fever was infrequent and a typical pattern of maternal and neonatal health outcomes was observed.

Project description:BACKGROUND:Ensuring treatment adherence is important for the internal validity of clinical trials. In intervention studies where touch points decrease over time, there is even more of an adherence challenge. Trials with multiple cohorts offer an opportunity to innovate on ways to increase treatment adherence without compromising the integrity of the study design, and previous cohorts can serve as historical controls. Electronically delivered nudges offer low-cost opportunities to increase treatment adherence. OBJECTIVE:This study aimed to evaluate the effectiveness of electronic messages (e-messages) on treatment adherence to the last cohort of a parent weight loss intervention during the second half of a year-long trial, when intervention checkpoint frequency decreases. Treatment adherence is measured by intervention class attendance and adherence to the intervention diet. METHODS:All participants in the last cohort (cohort 5, n=128) of a large randomized weight loss study were offered an e-message intervention to improve participant adherence during the last 6 months of a 1-year weight loss program. Overall, 3 to 4 electronic weekly messages asked participants about intervention diet adherence. A propensity score model was estimated using 97 participants who opted to receive e-messages and 31 who declined in cohort 5 and used to pair match cohort 5 e-message participants to a historical control group from cohorts 1 to 4. Moreover, 88 participants had complete data, yielding 176 participants in the final analyses. After matching, intervention and matched control groups were compared on (1) proportion of class attendance between the 6 and 12 month study endpoints, (2) diet adherence, as measured by total carbohydrate grams for low-carbohydrate (LC) and total fat grams for low-fat (LF) diets at 12 months, and (3) weight change from 6 to 12 months. The dose-response relationship between the proportion of text messages responded to and the 3 outcomes was also investigated. RESULTS:Compared with matched controls, receiving e-messages had no effect on (1) treatment adherence; class attendance after 6 months +4.6% (95% CI -4.43 to 13.68, P=.31), (2) adherence; LC -2.5 g carbohydrate, 95% CI -29.9 to 24.8, P=.85; LF +6.2 g fat, 95% CI -4.1 to 17.0, P=.26); or on (3) the secondary outcome of weight change in the last 6 months; +0.3 kg (95% CI -1.0 to 1.5, P=.68). There was a positive significant response correlation between the percentage of messages to which participants responded and class attendance (r=.45, P<.001). CONCLUSIONS:Although this e-message intervention did not improve treatment adherence, future studies can learn from this pilot and may incorporate more variety in the prompts and more interaction to promote more effective user engagement. Uniquely, this study demonstrated the potential for innovating within a multicohort trial using propensity score-matched historical control subjects. TRIAL REGISTRATION:ClinicalTrials.gov NCT01826591; https://clinicaltrials.gov/ct2/show/NCT01826591. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):RR2-10.1016/j.cct.2016.12.021.

Dataset Information

Effectiveness of a web-based screening and brief intervention with weekly text-message-initiated individualised prompts for reducing risky alcohol use among teenagers: study protocol of a randomised controlled trial within the ProHEAD consortium.

Background

Methods/design

Discussion

Trial registration

Publications

Effectiveness of a web-based screening and brief intervention with weekly text-message-initiated individualised prompts for reducing risky alcohol use among teenagers: study protocol of a randomised controlled trial within the ProHEAD consortium.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets