scholarly journals Dose-Response Relationship of a Web-Based Tailored Intervention Promoting Human Papillomavirus Vaccination: Process Evaluation of a Randomized Controlled Trial

10.2196/14822 ◽  
2020 ◽  
Vol 22 (7) ◽  
pp. e14822
Author(s):  
Mirjam Pot ◽  
Theo GWM Paulussen ◽  
Robert AC Ruiter ◽  
Liesbeth Mollema ◽  
Miranda Hofstra ◽  
...  
Keyword(s):  
Dose Response ◽  
Controlled Trial ◽  
Hpv Vaccination ◽  
Decisional Conflict ◽  
Tailored Intervention ◽  
Web Based ◽  
Vaccination Uptake ◽  
Website Use ◽  
The Web ◽  
Program Acceptability

Background In the Netherlands, human papillomavirus (HPV) vaccination uptake remains low. To improve informed decision making (IDM) and HPV vaccination acceptability, we systematically developed an interactive, web-based tailored intervention to which mothers of Dutch girls were invited to participate. Objective The aim of this study was to provide insight into the intervention’s working mechanisms by evaluating (1) program use, (2) program acceptability, and (3) the relationship of program use with program acceptability and intervention effects (ie, dose-response relationship). Methods Only mothers from the intervention arm of a randomized controlled trial that assessed the effectiveness of the web-based, tailored intervention were included in this study. They were invited to visit the website of the web-based intervention between baseline (January 2015, just before access to the intervention) and follow up (March 2015, prior to the first HPV vaccination). Indicators for program use were time of website use (ie, duration of intervention exposure) and completeness (ie, proportion of all available web pages visited). HPV vaccination uptake registered by Praeventis was used as the primary outcome. Secondary outcomes were IDM, decisional conflict, and social-psychological determinants of HPV vaccination uptake. Results Among the 3995 invited mothers, 2509 (62.80%) logged on to the website, 2239 of whom (89.24%) visited at least one page of the intervention components. On average, mothers spent 21.39 minutes (SD 12.41) on the website and completed 50.04% (SD 26.18%) of the website components. Participants rated the website 7.64 (SD 1.39) on a 10-point scale. Program acceptability was significantly associated with completeness (β=4.36, P<.001), but not with time of website use (β=–.07, P=.77). Intention-to-treat analysis (N=3995) showed a significant positive effect of completeness on all outcome measures (all P<.003; Bonferroni-corrected α=.05/15 factors), including on HPV vaccination uptake. Time of website use had a significant positive effect on all outcomes (all P<.003), except for uptake (P=.20), risk perception when not vaccinated (P=.14), subjective norms (P=.03), and habit (P=.01). Conclusions Program use and acceptability of the intervention were adequate. Completeness was positively associated with acceptability. Furthermore, positive effects (ie, dose-response effects) were found for completeness and time of website use on the mothers’ IDM, decisional conflict, and almost all of the social-psychological determinants of HPV vaccination acceptability. In addition, the extent to which mothers completed the intervention had a positive impact on their daughters’ vaccination uptake. This indicates that the web-based, tailored intervention fits well with the mothers’ needs, and that completeness of use is essential for improving HPV vaccination uptake, acceptability, and IDM. Program use should therefore be promoted. Trial Registration Netherlands Trial Register NTR4795; https://www.trialregister.nl/trial/4795

scholarly journals Dose-Response Relationship of a Web-Based Tailored Intervention Promoting Human Papillomavirus Vaccination: Process Evaluation of a Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Mirjam Pot ◽  
Theo G W M Paulussen ◽  
Robert A C Ruiter ◽  
Liesbeth Mollema ◽  
Miranda Hofstra ◽  
...  
Keyword(s):  
Dose Response ◽  
Controlled Trial ◽  
Hpv Vaccination ◽  
Decisional Conflict ◽  
Tailored Intervention ◽  
Web Based ◽  
Vaccination Uptake ◽  
Website Use ◽  
The Web ◽  
Program Acceptability

BACKGROUND In the Netherlands, human papillomavirus (HPV) vaccination uptake remains low. To improve informed decision making (IDM) and HPV vaccination acceptability, we systematically developed an interactive, web-based tailored intervention to which mothers of Dutch girls were invited to participate. OBJECTIVE The aim of this study was to provide insight into the intervention’s working mechanisms by evaluating (1) program use, (2) program acceptability, and (3) the relationship of program use with program acceptability and intervention effects (ie, dose-response relationship). METHODS Only mothers from the intervention arm of a randomized controlled trial that assessed the effectiveness of the web-based, tailored intervention were included in this study. They were invited to visit the website of the web-based intervention between baseline (January 2015, just before access to the intervention) and follow up (March 2015, prior to the first HPV vaccination). Indicators for program use were time of website use (ie, duration of intervention exposure) and completeness (ie, proportion of all available web pages visited). HPV vaccination uptake registered by Praeventis was used as the primary outcome. Secondary outcomes were IDM, decisional conflict, and social-psychological determinants of HPV vaccination uptake. RESULTS Among the 3995 invited mothers, 2509 (62.80%) logged on to the website, 2239 of whom (89.24%) visited at least one page of the intervention components. On average, mothers spent 21.39 minutes (SD 12.41) on the website and completed 50.04% (SD 26.18%) of the website components. Participants rated the website 7.64 (SD 1.39) on a 10-point scale. Program acceptability was significantly associated with completeness (β=4.36, <i>P</i>&lt;.001), but not with time of website use (β=–.07, <i>P</i>=.77). Intention-to-treat analysis (N=3995) showed a significant positive effect of completeness on all outcome measures (all <i>P</i>&lt;.003; Bonferroni-corrected α=.05/15 factors), including on HPV vaccination uptake. Time of website use had a significant positive effect on all outcomes (all <i>P</i>&lt;.003), except for uptake (<i>P</i>=.20), risk perception when not vaccinated (<i>P</i>=.14), subjective norms (<i>P</i>=.03), and habit (<i>P</i>=.01). CONCLUSIONS Program use and acceptability of the intervention were adequate. Completeness was positively associated with acceptability. Furthermore, positive effects (ie, dose-response effects) were found for completeness and time of website use on the mothers’ IDM, decisional conflict, and almost all of the social-psychological determinants of HPV vaccination acceptability. In addition, the extent to which mothers completed the intervention had a positive impact on their daughters’ vaccination uptake. This indicates that the web-based, tailored intervention fits well with the mothers’ needs, and that completeness of use is essential for improving HPV vaccination uptake, acceptability, and IDM. Program use should therefore be promoted. CLINICALTRIAL Netherlands Trial Register NTR4795; https://www.trialregister.nl/trial/4795

scholarly journals Effectiveness of a Web-Based Tailored Intervention With Virtual Assistants Promoting the Acceptability of HPV Vaccination Among Mothers of Invited Girls: Randomized Controlled Trial

2017 ◽  
Vol 19 (9) ◽  
pp. e312 ◽  
Author(s):  
Mirjam Pot ◽  
Theo GWM Paulussen ◽  
Robert AC Ruiter ◽  
Iris Eekhout ◽  
Hester E de Melker ◽  
...  
Keyword(s):  
Decision Making ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Hpv Vaccination ◽  
Decisional Conflict ◽  
Future Research ◽  
Tailored Intervention ◽  
Web Based ◽  
Vaccination Uptake ◽  
Randomized Controlled

Background In 2010, the human papillomavirus (HPV) vaccination was introduced in the Dutch National Immunization Program for 12-year-old girls, aiming to reduce the incidence of cervical cancer in women. HPV vaccination uptake turned out to be lower than expected: 61% versus 70%, respectively. Mothers were shown to play the most important role in the immunization decision about this vaccination. They had also expressed their need for interactive personal information about the HPV vaccination over and above the existing universal general information. To improve the effectiveness of the existing education about the HPV vaccination, we systematically developed a Web-based tailored intervention with virtual assistants providing mothers of girls to be invited with tailored feedback on their decision making about the HPV vaccination. Objective The aim of this study was to evaluate the effectiveness of the Web-based tailored intervention for promoting HPV vaccination acceptance by means of a randomized controlled trial (RCT). Methods Mothers were recruited via the Dutch vaccination register (Praeventis) (n=36,000) and three Web-based panels (n=2483). Those who gave informed consent (N=8062) were randomly assigned to the control (n=4067) or intervention condition (n=3995). HPV vaccination uptake, as registered by Praeventis once the HPV vaccination round was completed, was used as the primary outcome. Secondary outcomes were differential scores across conditions between baseline (before the provided access to the new tailored intervention) and follow-up (just before the first vaccination) regarding the mothers’ degree of informed decision making (IDM), decisional conflict, and critical determinants of HPV vaccination uptake among which are intention, attitude, risk perception, and outcome beliefs. Results Intention-to-treat analysis (N=8062) showed a significant positive effect of the intervention on IDM, decisional conflict, and nearly all determinants of HPV vaccination uptake (P<.001). No effect was found on uptake (P=.60). This may be attributed to the overall high uptake rates in both conditions. Mothers evaluated the intervention as highly positive, including the website as well as the virtual assistants that were used to deliver the tailored feedback. Conclusions This computer-tailored intervention has the potential to improve HPV vaccination acceptability and IDM and to decrease decisional conflict among mothers of invited girls. Implications for future research are discussed. Trial Registration Trialregister.nl NTR4935; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4935 (Archived by WebCite at http://www.webcitation.org/6srT7l9EM)

scholarly journals A Web-Based Human Papillomavirus Vaccination Intervention for Young Gay, Bisexual, and Other Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial

10.2196/16294 ◽  
2020 ◽  
Vol 9 (2) ◽  
pp. e16294 ◽  
Author(s):  
Paul L Reiter ◽  
Amy L Gower ◽  
Dale E Kiss ◽  
Molly A Malone ◽  
Mira L Katz ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Hpv Vaccine ◽  
Controlled Trial ◽  
Hpv Vaccination ◽  
Hpv Infection ◽  
Text Messages ◽  
Web Based ◽  
Randomized Controlled ◽  
Sex With Men ◽  
The Web

Background Gay, bisexual, and other men who have sex with men experience several disparities related to human papillomavirus (HPV) infection, including high incidence rates of anal cancer. Although the HPV vaccine is currently recommended for young adults, HPV vaccine coverage is modest among young gay, bisexual, and other men who have sex with men (YGBMSM). Objective We describe the design and methods for a randomized controlled trial (RCT) to rigorously evaluate Outsmart HPV, a population-targeted, individually tailored, Web-based HPV vaccination intervention for YGBMSM. The RCT is designed to determine the efficacy of the intervention, the mechanism by which the intervention has an effect (ie, mediation), and whether efficacy varies by participant characteristics (ie, moderation). Methods Outsmart HPV was previously developed and pilot-tested. This study is a 3-arm prospective RCT that will enroll a projected 1995 YGBMSM who are aged 18 to 25 years, live in the United States, and have not received any doses of the HPV vaccine. Participants will be recruited by means of paid advertisements on social media sites and randomized to receive (1) standard information on the Web about HPV vaccine (control group), (2) Outsmart HPV content on the Web with monthly unidirectional vaccination reminders sent via text messages, or (3) Outsmart HPV content on the Web with monthly interactive vaccination reminders sent via text messages. Participants will complete Web-based surveys at 4 time points during the study: baseline, immediately after engaging with Web-based content, 3 months after randomization, and 9 months after randomization. Primary outcomes will include both HPV vaccine initiation (ie, receipt of 1 or more doses of the HPV vaccine) and completion (receipt of all 3 doses recommended for this age range). We will examine constructs from the intervention’s theoretical framework as potential mediators and demographic and health-related characteristics as potential moderators of intervention effects. Results The institutional review board at The Ohio State University has approved the study. Materials have been developed and finalized for all study groups. Recruitment for the RCT began in fall 2019. Conclusions If shown to be efficacious, Outsmart HPV has the potential to fill an important gap by promoting HPV vaccination among a population at increased risk of HPV infection and HPV-related disease. Trial Registration ClinicalTrials.gov NCT04032106; http://clinicaltrials.gov/show/NCT04032106 International Registered Report Identifier (IRRID) PRR1-10.2196/16294

scholarly journals Assessing Preference Shift and Effects on Patient Knowledge and Decisional Conflict: Cross-Sectional Study of an Interactive Prostate-Specific Antigen Test Patient Decision Aid (Preprint)

2018 ◽  
Author(s):  
Peter Scalia ◽  
Glyn Elwyn ◽  
Jan Kremer ◽  
Marjan Faber ◽  
Marie-Anne Durand
Keyword(s):  
Prostate Specific Antigen ◽  
Decision Aid ◽  
Specific Antigen ◽  
Decisional Conflict ◽  
Patient Decision Aid ◽  
Web Based ◽  
Psa Test ◽  
Psa Testing ◽  
Patient Decision ◽  
The Web

BACKGROUND Randomized trials of Web-based decision aids for prostate-specific antigen (PSA) testing indicate that these interventions improve knowledge and reduce decisional conflict. However, we do not know about these tools’ impact on people who spontaneously use a PSA testing patient decision aid on the internet. OBJECTIVE The objectives of this study were to (1) determine the impact of the Web-based PSA Option Grid patient decision aid on preference shift, knowledge, and decisional conflict; (2) identify which frequently asked questions (FAQs) are associated with preference shift; and (3) explore the possible relationships between these outcomes. METHODS Data were collected between January 1, 2016, and December 30, 2017. Users who accessed the Web-based, interactive PSA Option Grid were provided with 3 options: have a PSA test, no PSA test, or unsure. Users first declared their initial preference and then completed 5 knowledge questions and a 4-item (yes or no) validated decisional conflict scale (Sure of myself, Understand information, Risk-benefit ratio, Encouragement; SURE). Next, users were presented with 10 FAQs and asked to identify their preference for each question based on the information provided. At the end, users declared their final preference and completed the same knowledge and decisional conflict questions. Paired sample t tests were employed to compare before and after knowledge and decisional conflict scores. A multinomial regression analysis was performed to determine which FAQs were associated with a shift in screening preference. RESULTS Of all the people who accessed the PSA Option Grid, 39.8% (186/467) completed the interactive journey and associated surveys. After excluding 22 female users, we analyzed 164 responses. At completion, users shifted their preference to “not having the PSA test” (43/164, 26.2%, vs 117/164, 71.3%; P<.001), had higher levels of knowledge (112/164, 68.3%, vs 146/164, 89.0%; P<.001), and lower decisional conflict (94/164, 57.3%, vs 18/164, 11.0%; P<.001). There were 3 FAQs associated with preference shift: “What does the test involve?” “If my PSA level is high, what are the chances that I have prostate cancer?” and “What are the risks?” We did not find any relationship between knowledge, decisional conflict, and preference shift. CONCLUSIONS Unprompted use of the interactive PSA Option Grid leads to preference shift, increased knowledge, and reduced decisional conflict, which confirms the ability of these tools to influence decision making, even when used outside clinical encounters.

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

2004 ◽  
Vol 43 (03) ◽  
pp. 268-272 ◽  
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.

Short-term effectiveness of a web-based tailored intervention for cancer survivors on quality of life, anxiety, depression, and fatigue: randomized controlled trial

2016 ◽  
Vol 26 (2) ◽  
pp. 222-230 ◽  
Author(s):  
Roy A. Willems ◽  
Catherine A. W. Bolman ◽  
Ilse Mesters ◽  
Iris M. Kanera ◽  
Audrey A. J. M. Beaulen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Cancer Survivors ◽  
Controlled Trial ◽  
Tailored Intervention ◽  
Short Term ◽  
Web Based ◽  
Randomized Controlled ◽  
Anxiety Depression
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