Barriers encountered during enrollment in an internet-mediated randomized controlled trial
<p>Abstract</p> <p>Background</p> <p>Online technology is a promising resource for conducting clinical research. While the internet may improve a study's reach, as well as the efficiency of data collection, it may also introduce a number of challenges for participa...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
BMC
2009-08-01
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| Series: | Trials |
| Online Access: | http://www.trialsjournal.com/content/10/1/76 |
| _version_ | 1818443985749803008 |
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| author | Culver Silas A Hess Michael L Janney Adrienne W Buis Lorraine R Richardson Caroline R |
| author_facet | Culver Silas A Hess Michael L Janney Adrienne W Buis Lorraine R Richardson Caroline R |
| author_sort | Culver Silas A |
| collection | DOAJ |
| description | <p>Abstract</p> <p>Background</p> <p>Online technology is a promising resource for conducting clinical research. While the internet may improve a study's reach, as well as the efficiency of data collection, it may also introduce a number of challenges for participants and investigators. The objective of this research was to determine the challenges that potential participants faced during the enrollment phase of a randomized controlled intervention trial of Stepping Up to Health, an internet-mediated walking program that utilized a multi-step online enrollment process.</p> <p>Methods</p> <p>We conducted a quantitative content analysis of 623 help tickets logged in a participant management database during the enrollment phase of a clinical trial investigating the effect of an automated internet-mediated walking intervention. Qualitative coding was performed by two trained coders, and 10% of the sample was coded by both coders to determine inter-coder reliability. Quantitative analyses included standard descriptive statistics on ticket characteristics and theme frequency, and a Poisson regression analysis identified characteristics of potential participants who reported more frequent problems during enrollment.</p> <p>Results</p> <p>In total, 880 potential participants visited the study website and 80% completed the enrollment screening. Of the potential participants who visited the study website, 38% had help tickets logged in the participant management database. The total number of help tickets associated with individual potential participants ranged from 0 to 7 (M = .71). Overall, 46% of help tickets were initiated by email and 54% were initiated by phone. The most common help ticket theme was issues related to the study process (48%). The next most prominent theme was discussion related to obtaining medical clearance (34%), followed by issues related to pedometers and uploading (31%). Older individuals, women, and those with lower self-rated internet ability were more likely to report problems during the enrollment process.</p> <p>Conclusion</p> <p>Prospective participants in an online clinical trial encountered a number of barriers to enrollment that led them to request help from study staff. Questions about the complex enrollment process itself were common. In a complex multi-step enrollment process, providing personalized feedback to potential participants indicating their status within the enrollment process may be beneficial.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov NCT00729040</p> |
| first_indexed | 2024-12-14T19:08:45Z |
| format | Article |
| id | doaj.art-271af0d8f015429cbc1a530d40e613d4 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-14T19:08:45Z |
| publishDate | 2009-08-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-271af0d8f015429cbc1a530d40e613d42022-12-21T22:50:46ZengBMCTrials1745-62152009-08-011017610.1186/1745-6215-10-76Barriers encountered during enrollment in an internet-mediated randomized controlled trialCulver Silas AHess Michael LJanney Adrienne WBuis Lorraine RRichardson Caroline R<p>Abstract</p> <p>Background</p> <p>Online technology is a promising resource for conducting clinical research. While the internet may improve a study's reach, as well as the efficiency of data collection, it may also introduce a number of challenges for participants and investigators. The objective of this research was to determine the challenges that potential participants faced during the enrollment phase of a randomized controlled intervention trial of Stepping Up to Health, an internet-mediated walking program that utilized a multi-step online enrollment process.</p> <p>Methods</p> <p>We conducted a quantitative content analysis of 623 help tickets logged in a participant management database during the enrollment phase of a clinical trial investigating the effect of an automated internet-mediated walking intervention. Qualitative coding was performed by two trained coders, and 10% of the sample was coded by both coders to determine inter-coder reliability. Quantitative analyses included standard descriptive statistics on ticket characteristics and theme frequency, and a Poisson regression analysis identified characteristics of potential participants who reported more frequent problems during enrollment.</p> <p>Results</p> <p>In total, 880 potential participants visited the study website and 80% completed the enrollment screening. Of the potential participants who visited the study website, 38% had help tickets logged in the participant management database. The total number of help tickets associated with individual potential participants ranged from 0 to 7 (M = .71). Overall, 46% of help tickets were initiated by email and 54% were initiated by phone. The most common help ticket theme was issues related to the study process (48%). The next most prominent theme was discussion related to obtaining medical clearance (34%), followed by issues related to pedometers and uploading (31%). Older individuals, women, and those with lower self-rated internet ability were more likely to report problems during the enrollment process.</p> <p>Conclusion</p> <p>Prospective participants in an online clinical trial encountered a number of barriers to enrollment that led them to request help from study staff. Questions about the complex enrollment process itself were common. In a complex multi-step enrollment process, providing personalized feedback to potential participants indicating their status within the enrollment process may be beneficial.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov NCT00729040</p>http://www.trialsjournal.com/content/10/1/76 |
| spellingShingle | Culver Silas A Hess Michael L Janney Adrienne W Buis Lorraine R Richardson Caroline R Barriers encountered during enrollment in an internet-mediated randomized controlled trial Trials |
| title | Barriers encountered during enrollment in an internet-mediated randomized controlled trial |
| title_full | Barriers encountered during enrollment in an internet-mediated randomized controlled trial |
| title_fullStr | Barriers encountered during enrollment in an internet-mediated randomized controlled trial |
| title_full_unstemmed | Barriers encountered during enrollment in an internet-mediated randomized controlled trial |
| title_short | Barriers encountered during enrollment in an internet-mediated randomized controlled trial |
| title_sort | barriers encountered during enrollment in an internet mediated randomized controlled trial |
| url | http://www.trialsjournal.com/content/10/1/76 |
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