{"id":51,"date":"2018-11-26T20:32:20","date_gmt":"2018-11-27T01:32:20","guid":{"rendered":"https:\/\/mrctcenter.org\/health-literacy\/?page_id=51"},"modified":"2018-11-26T20:32:20","modified_gmt":"2018-11-27T01:32:20","slug":"on-study","status":"publish","type":"page","link":"https:\/\/mrctcenter.org\/health-literacy\/trial-life-cycle\/overview\/on-study\/","title":{"rendered":"On Study"},"content":{"rendered":"<section class=\"wpb-content-wrapper\"><p>[vc_row][vc_column][vc_empty_space][\/vc_column][\/vc_row][vc_row][vc_column width=&#8221;1\/6&#8243;][vc_single_image image=&#8221;1340&#8243;][\/vc_column][vc_column width=&#8221;5\/6&#8243;][vc_column_text css=&#8221;.vc_custom_1561734090964{padding-top: 20px !important;}&#8221;]<\/p>\n<h1>4. On Study<\/h1>\n<p><strong>Clear information about ongoing research procedures, data collection and reporting<\/strong>[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text]\u201cOn Study<em>\u201d <\/em>is the\u00a0time when\u00a0the participant is enrolled into the specific research study and undergoes the research procedures outlined in the protocol.<\/p>\n<ul>\n<li>At this point the focus of the research team is on quality data collection, compliance with the research procedures and retention of enrolled participants.<\/li>\n<li>Ongoing clear communications about expectations and logistics are important.<\/li>\n<li>It is advised that any materials and scripts used during the ongoing study should go through <a href=\"https:\/\/mrctcenter.org\/health-literacy\/tools\/overview\/usability-testing\/\">usability testing<\/a> with members of the intended audience.<\/li>\n<li>Through a process of ongoing engagement and active listening, researchers should periodically confirm participants understanding of the research and willingness to continue as the study proceeds<\/li>\n<\/ul>\n<p>[\/vc_column_text][vc_row_inner css=&#8221;.vc_custom_1570380812474{padding-top: 10px !important;padding-right: 10px !important;padding-bottom: 10px !important;padding-left: 10px !important;background-color: #99ccff !important;}&#8221;][vc_column_inner][vc_column_text]<strong>Click through the individual tabs to learn more about how your \u201cOn Study\u201d research communications can be improved through plain language, numeracy, clear design and cultural considerations.<\/strong>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row][vc_column][vc_tta_tabs style=&#8221;flat&#8221; shape=&#8221;square&#8221; alignment=&#8221;center&#8221; active_section=&#8221;1&#8243; no_fill_content_area=&#8221;true&#8221;][vc_tta_section title=&#8221;Plain Language&#8221; tab_id=&#8221;1554832212073-afa98397-f7c2&#8243;][vc_row_inner][vc_column_inner][vc_column_text]<\/p>\n<h2>Plain Language<\/h2>\n<p>[\/vc_column_text][vc_column_text]During the &#8220;On Study&#8221; stage the use of plain language\u00a0continues to be important.\u00a0Even though study participants may be more experienced at this stage,\u00a0 plain language\u00a0terminology that was introduced earlier in the clinical trial should still be used to maintain continuity, comprehension of, and trust in the study and research team.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_column_text]Protocol non-adherence, missed visits, and loss-to-follow-up can impact the validity of the research results. Plain language communications to help mitigate these issues include:[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243; css=&#8221;.vc_custom_1570211870125{margin-top: -35px !important;}&#8221;][vc_column_text css=&#8221;.vc_custom_1615582209298{margin-top: 5px !important;margin-right: 5px !important;margin-bottom: 5px !important;margin-left: 5px !important;border-top-width: 1px !important;border-right-width: 1px !important;border-bottom-width: 1px !important;border-left-width: 1px !important;padding-top: 30px !important;padding-right: 30px !important;padding-bottom: 30px !important;padding-left: 30px !important;background-color: #99ccff !important;border-left-style: none !important;border-right-style: none !important;border-top-style: none !important;border-bottom-style: none !important;border-radius: 1px !important;}&#8221;]Once a participant starts their active participation, <a href=\"https:\/\/mrctcenter.org\/health-literacy\/download\/1935\/\" target=\"_blank\" rel=\"noopener noreferrer\">a commitment contract<\/a> can be a helpful way to re-enforce study expectations.[\/vc_column_text][\/vc_column_inner][vc_column_inner][vc_column_text]<\/p>\n<ul>\n<li>reminders about the importance of the study question and the value of the participant\u2019s continued research contributions,<\/li>\n<li>additional explanations about specific study procedures,<\/li>\n<li>in depth inquiries into what might prevent a participant from\u00a0fulfilling the study requirements and discussing\u00a0ways that the clinical research team may be able to help,<\/li>\n<li>expressing gratitude for what participants have provided to date.<\/li>\n<\/ul>\n<p>[\/vc_column_text][vc_btn title=&#8221;FIND OUT MORE ABOUT PLAIN LANGUAGE&#8221; style=&#8221;custom&#8221; custom_background=&#8221;#053a4a&#8221; custom_text=&#8221;#ffffff&#8221; size=&#8221;lg&#8221; align=&#8221;center&#8221; button_block=&#8221;true&#8221; link=&#8221;url:https%3A%2F%2Fmrctcenter.org%2Fhealth-literacy%2Ftools%2Foverview%2Fplain-language%2F|||&#8221;][\/vc_column_inner][\/vc_row_inner][\/vc_tta_section][vc_tta_section title=&#8221;Numeracy&#8221; tab_id=&#8221;1554832210461-97729afc-4e06&#8243;][vc_row_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_column_text]<\/p>\n<h2>Numeracy<\/h2>\n<p>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][\/vc_column_inner][\/vc_row_inner][vc_column_text]During the &#8220;On Study&#8221; stage it is possible to continue building upon whatever resources were provided during recruitment and consent to\u00a0re-affirm participant understanding of the details of the study. Health literate communications can be used to remind participants of the:<\/p>\n<ul>\n<li>frequency of study visits and procedures,<\/li>\n<li>study medication instructions (including review of tools such as study medication logs and study drug reconciliation procedures),<\/li>\n<li>the nature and probability of risks.<\/li>\n<\/ul>\n<p>[\/vc_column_text][vc_btn title=&#8221;FIND OUT MORE ABOUT NUMERACY&#8221; style=&#8221;custom&#8221; custom_background=&#8221;#053a4a&#8221; custom_text=&#8221;#ffffff&#8221; size=&#8221;lg&#8221; align=&#8221;center&#8221; button_block=&#8221;true&#8221; link=&#8221;url:https%3A%2F%2Fmrctcenter.org%2Fhealth-literacy%2Ftools%2Foverview%2Fnumeracy%2F|||&#8221;][\/vc_tta_section][vc_tta_section title=&#8221;Clear Design&#8221; tab_id=&#8221;1554832209545-625c8093-e71b&#8221;][vc_row_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_column_text]<\/p>\n<h2>Clear Design<\/h2>\n<p>[\/vc_column_text][vc_column_text]<\/p>\n<p style=\"text-align: left\">During the &#8220;On Study&#8221; stage clear design techniques\u00a0can be applied to\u00a0print materials\u00a0to support a\u00a0participant\u2019s continued engagement in the study.<\/p>\n<p style=\"text-align: left\">All tools and resources\u00a0 (such as health literate study calendars, study medication instructions, and study procedure descriptions), as well as additional materials like a regular study newsletter or results report should be laid-out in ways that are easy to review and understand.<\/p>\n<p>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_single_image image=&#8221;1548&#8243; img_size=&#8221;full&#8221; onclick=&#8221;link_image&#8221;][\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner][vc_btn title=&#8221;FIND OUT MORE ABOUT CLEAR DESIGN&#8221; style=&#8221;custom&#8221; custom_background=&#8221;#053a4a&#8221; custom_text=&#8221;#ffffff&#8221; size=&#8221;lg&#8221; align=&#8221;center&#8221; button_block=&#8221;true&#8221; link=&#8221;url:https%3A%2F%2Fmrctcenter.org%2Fhealth-literacy%2Ftools%2Foverview%2Fvisualization-design%2F|||&#8221;][\/vc_column_inner][\/vc_row_inner][\/vc_tta_section][vc_tta_section title=&#8221;Cultural Considerations&#8221; tab_id=&#8221;1554832208876-f9243cfa-f0c5&#8243;][vc_row_inner][vc_column_inner][vc_column_text]<\/p>\n<h2>Cultural Considerations<\/h2>\n<p>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_column_text]During the &#8220;On Study&#8221; stage the concept of cultural can be addressed through an active inquiry into why participants may wish to continue or to decline ongoing participation in the study.<\/p>\n<ul>\n<li>Additional efforts for more difficult to reach populations may be required, particularly if logistical barriers to participation are identified.<\/li>\n<\/ul>\n<p>[\/vc_column_text][vc_row_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_column_text]<\/p>\n<ul>\n<li>A study satisfaction survey administered when participants have had\u00a0some experience in the study may permit the clinical research team to identify opportunities for improvement and may minimize the risk of participants not completing the study.<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_column_text css=&#8221;.vc_custom_1615581887695{margin-top: 5px !important;margin-right: 5px !important;margin-bottom: 5px !important;margin-left: 5px !important;border-top-width: 1px !important;border-right-width: 1px !important;border-bottom-width: 1px !important;border-left-width: 1px !important;padding-top: 30px !important;padding-right: 30px !important;padding-bottom: 30px !important;padding-left: 30px !important;background-color: #99ccff !important;border-left-style: none !important;border-right-style: none !important;border-top-style: none !important;border-bottom-style: none !important;border-radius: 1px !important;}&#8221;]See what one organization included in their study satisfaction survey for participants <a href=\"https:\/\/mrctcenter.org\/health-literacy\/download\/1931\/\" target=\"_blank\" rel=\"noopener noreferrer\">here<\/a>.[\/vc_column_text][\/vc_column_inner][vc_column_inner][vc_column_text]<\/p>\n<ul>\n<li>Holiday and birthday cards that include a message of appreciation for participants\u2019 contributions can help keep participants interested and feeling that they are valued.<\/li>\n<\/ul>\n<p>[\/vc_column_text][vc_btn title=&#8221;FIND OUT MORE ABOUT CULTURAL CONSIDERATIONS&#8221; style=&#8221;custom&#8221; custom_background=&#8221;#053a4a&#8221; custom_text=&#8221;#ffffff&#8221; size=&#8221;lg&#8221; align=&#8221;center&#8221; button_block=&#8221;true&#8221; link=&#8221;url:https%3A%2F%2Fmrctcenter.org%2Fhealth-literacy%2Ftools%2Foverview%2Fcultural-considerations%2F|||&#8221;][\/vc_column_inner][\/vc_row_inner][\/vc_tta_section][\/vc_tta_tabs][vc_raw_js]JTNDc2NyaXB0JTIwdHlwZSUzRCUyMnRleHQlMkZqYXZhc2NyaXB0JTIyJTNFJTIwalF1ZXJ5JTI4JTIwZnVuY3Rpb24lMjglMjQlMjklMjAlN0IlMEElMEElMjAlMjAlMjQlMjhkb2N1bWVudCUyOS5vbiUyOCUyN3RvdWNoc3RhcnQlMjBjbGljayUyNyUyQyUyMCUyN2xpLnZjX3R0YS10YWIlMjBhJTJDbGkudmNfdHRhLXRhYiUyQy52Y190dGEtcGFuZWwtdGl0bGUlMjclMkMlMjBmdW5jdGlvbiUyOCUyOSU3QiUwQSUyMCUyMCUyMCUyMCUyMCUyNCUyOCUyN2h0bWwlMkMlMjBib2R5JTI3JTI5LnN0b3AlMjglMjklM0IlMEElMjAlMjAlN0QlMjklM0IlMEElMEElN0QlMjklM0IlMjAlM0MlMkZzY3JpcHQlM0U=[\/vc_raw_js][\/vc_column][\/vc_row][vc_row][vc_column][vc_separator color=&#8221;mulled_wine&#8221;][vc_empty_space][vc_column_text]<\/p>\n<p style=\"text-align: center\"><em>Scroll through the life-cycle:<\/em><\/p>\n<p style=\"text-align: center\"><a href=\"https:\/\/mrctcenter.org\/health-literacy\/trial-life-cycle\/overview\/discovery\/\">Discovery<\/a>\u00a0&gt;\u00a0<a href=\"https:\/\/mrctcenter.org\/health-literacy\/trial-life-cycle\/overview\/recruitment\/\">Recruitment<\/a>\u00a0&gt;\u00a0<a href=\"https:\/\/mrctcenter.org\/health-literacy\/trial-life-cycle\/overview\/consent\/\">Consent<\/a>\u00a0&gt;\u00a0<a href=\"https:\/\/mrctcenter.org\/health-literacy\/trial-life-cycle\/overview\/on-study\/\">On Study<\/a> &gt; <a href=\"https:\/\/mrctcenter.org\/health-literacy\/trial-life-cycle\/overview\/end-of-study\/\">End of Study<\/a><\/p>\n<p>[\/vc_column_text][\/vc_column][\/vc_row]<\/p>\n<\/section>","protected":false},"excerpt":{"rendered":"<p>[vc_row][vc_column][vc_empty_space][\/vc_column][\/vc_row][vc_row][vc_column width=&#8221;1\/6&#8243;][vc_single_image image=&#8221;1340&#8243;][\/vc_column][vc_column width=&#8221;5\/6&#8243;][vc_column_text css=&#8221;.vc_custom_1561734090964{padding-top: 20px !important;}&#8221;] 4. On Study Clear information about ongoing research procedures, data collection and reporting[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text]\u201cOn Study\u201d is the\u00a0time when\u00a0the participant is enrolled into the specific research study and undergoes the research procedures outlined in the protocol. At this point the focus of the research team is on quality data collection, [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":0,"parent":43,"menu_order":5,"comment_status":"closed","ping_status":"closed","template":"template-sub.php","meta":{"footnotes":""},"class_list":["post-51","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.0 (Yoast SEO v25.0) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>On Study - Health Literacy in Clinical Research<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/mrctcenter.org\/health-literacy\/trial-life-cycle\/overview\/on-study\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"On Study\" \/>\n<meta property=\"og:description\" content=\"[vc_row][vc_column][vc_empty_space][\/vc_column][\/vc_row][vc_row][vc_column width=&#8221;1\/6&#8243;][vc_single_image image=&#8221;1340&#8243;][\/vc_column][vc_column width=&#8221;5\/6&#8243;][vc_column_text css=&#8221;.vc_custom_1561734090964{padding-top: 20px !important;}&#8221;] 4. On Study Clear information about ongoing research procedures, data collection and reporting[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text]\u201cOn Study\u201d is the\u00a0time when\u00a0the participant is enrolled into the specific research study and undergoes the research procedures outlined in the protocol. 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