{"id":43,"date":"2018-11-26T20:31:20","date_gmt":"2018-11-27T01:31:20","guid":{"rendered":"https:\/\/mrctcenter.org\/health-literacy\/?page_id=43"},"modified":"2018-11-26T20:31:20","modified_gmt":"2018-11-27T01:31:20","slug":"overview","status":"publish","type":"page","link":"https:\/\/mrctcenter.org\/health-literacy\/trial-life-cycle\/overview\/","title":{"rendered":"Overview"},"content":{"rendered":"<section class=\"wpb-content-wrapper\"><p>[vc_row][vc_column][vc_column_text]<\/p>\n<h1>Health literacy can support the participant through their clinical trial journey.<\/h1>\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_separator color=&#8221;mulled_wine&#8221; border_width=&#8221;2&#8243;][\/vc_column][\/vc_row][vc_row css=&#8221;.vc_custom_1569974174622{padding-left: -50px !important;}&#8221;][vc_column width=&#8221;1\/5&#8243;][vc_single_image image=&#8221;203&#8243; onclick=&#8221;custom_link&#8221; css_animation=&#8221;none&#8221; link=&#8221;https:\/\/mrctcenter.org\/health-literacy\/trail-life-cycle\/discovery\/&#8221; css=&#8221;.vc_custom_1570378279505{padding-bottom: -50px !important;}&#8221;][vc_column_text css_animation=&#8221;none&#8221; css=&#8221;.vc_custom_1570379496571{margin-top: -5px !important;}&#8221;]<\/p>\n<h3 style=\"text-align: left\"><\/h3>\n<h3 style=\"text-align: left\"><a href=\"https:\/\/mrctcenter.org\/health-literacy\/trial-life-cycle\/overview\/discovery\/\">1. DISCOVERY<\/a><\/h3>\n<p>Public awareness of, education about, and access to clinical research[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/5&#8243; css=&#8221;.vc_custom_1570377791304{margin-right: 40px !important;margin-left: -10px !important;}&#8221;][vc_single_image image=&#8221;206&#8243; onclick=&#8221;custom_link&#8221; css_animation=&#8221;none&#8221; link=&#8221;https:\/\/mrctcenter.org\/health-literacy\/trail-life-cycle\/recruitment\/&#8221; css=&#8221;.vc_custom_1570377882062{padding-left: 20px !important;}&#8221;][vc_column_text css_animation=&#8221;none&#8221; css=&#8221;.vc_custom_1570379511907{margin-right: -10px !important;}&#8221;]<\/p>\n<h3 style=\"text-align: left\"><\/h3>\n<h3 style=\"text-align: left\"><a href=\"https:\/\/mrctcenter.org\/health-literacy\/trial-life-cycle\/overview\/recruitment\/\">2. RECRUITMENT<\/a><\/h3>\n<p>Targeted, relevant, written and verbal invitations to join research[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/5&#8243; css=&#8221;.vc_custom_1570377647122{margin-left: 10px !important;}&#8221;][vc_single_image image=&#8221;202&#8243; onclick=&#8221;custom_link&#8221; link=&#8221;https:\/\/mrctcenter.org\/health-literacy\/trail-life-cycle\/consent\/&#8221;][vc_column_text css=&#8221;.vc_custom_1570379597321{margin-top: -5px !important;}&#8221;]<\/p>\n<h3 style=\"text-align: left\"><\/h3>\n<h3 style=\"text-align: left\"><a href=\"https:\/\/mrctcenter.org\/health-literacy\/trial-life-cycle\/overview\/consent\/\">3. CONSENT<\/a><\/h3>\n<p>Clear written and verbal conversations about informed consent to research participation[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/5&#8243;][vc_single_image image=&#8221;1340&#8243; onclick=&#8221;custom_link&#8221; link=&#8221;https:\/\/mrctcenter.org\/health-literacy\/trail-life-cycle\/on-study\/&#8221;][vc_column_text css=&#8221;.vc_custom_1570379615847{margin-top: -5px !important;padding-right: -25px !important;}&#8221;]<\/p>\n<h3 style=\"text-align: left\"><\/h3>\n<h3 style=\"text-align: left\"><a href=\"https:\/\/mrctcenter.org\/health-literacy\/trial-life-cycle\/overview\/on-study\/\">4. ON STUDY<\/a><\/h3>\n<p>Clear information about ongoing research procedures, data collection and reporting[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/5&#8243;][vc_single_image image=&#8221;204&#8243; onclick=&#8221;custom_link&#8221; link=&#8221;https:\/\/mrctcenter.org\/health-literacy\/trail-life-cycle\/end-of-study\/&#8221;][vc_column_text css=&#8221;.vc_custom_1570379623074{margin-top: -5px !important;margin-right: -30px !important;}&#8221;]<\/p>\n<h3 style=\"text-align: left\"><\/h3>\n<h3 style=\"text-align: left\"><a href=\"https:\/\/mrctcenter.org\/health-literacy\/trial-life-cycle\/overview\/end-of-study\/\">5. END OF STUDY<\/a><\/h3>\n<p>Plain language summaries, results reports, and research publications[\/vc_column_text][\/vc_column][vc_column][vc_row_inner][vc_column_inner][vc_separator color=&#8221;mulled_wine&#8221; border_width=&#8221;2&#8243;][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row][vc_column][vc_empty_space][vc_column_text css=&#8221;.vc_custom_1570377935418{margin-bottom: 0px !important;padding-bottom: 20px !important;}&#8221;]<\/p>\n<h2><strong>There are opportunities to integrate health literacy practices and principles at every point along this journey.<\/strong><\/h2>\n<p>A person\u2019s journey through a clinical trial generally consists of five categories:[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_row_inner css=&#8221;.vc_custom_1567895214253{margin-top: 0px !important;margin-bottom: 0px !important;padding-top: 0px !important;padding-bottom: 20px !important;}&#8221;][vc_column_inner width=&#8221;1\/2&#8243;][vc_column_text css=&#8221;.vc_custom_1570153122996{margin-bottom: 0px !important;padding-bottom: 0px !important;}&#8221;]1) <a href=\"https:\/\/mrctcenter.org\/health-literacy\/trial-life-cycle\/overview\/discovery\/\"><em>Discovery<\/em><\/a> \u2013 when they learn about research<\/p>\n<p>2) <a href=\"https:\/\/mrctcenter.org\/health-literacy\/trial-life-cycle\/overview\/recruitment\/\"><em>Recruitment<\/em><\/a>\u00a0&#8211; when they are asked to join a specific study<\/p>\n<p>3) <a href=\"https:\/\/mrctcenter.org\/health-literacy\/trial-life-cycle\/overview\/consent\/\"><em>Consent<\/em><\/a>\u00a0&#8211; when they are guided through a consent process to decide whether the study is right for them<\/p>\n<p>4) <a href=\"https:\/\/mrctcenter.org\/health-literacy\/trial-life-cycle\/overview\/on-study\/\"><em>On-Study<\/em><\/a> &#8211; when they begin their study visits and go through study procedures as participants<\/p>\n<p>5) <a href=\"https:\/\/mrctcenter.org\/health-literacy\/trial-life-cycle\/overview\/end-of-study\/\"><em>End of Study<\/em><\/a> &#8211; when they reach the end of their time in the research study[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243; css=&#8221;.vc_custom_1571595949324{margin-top: -25px !important;}&#8221;][vc_single_image image=&#8221;1747&#8243; img_size=&#8221;full&#8221; css=&#8221;.vc_custom_1571595926124{padding-top: 24px !important;}&#8221;][\/vc_column_inner][\/vc_row_inner][vc_column_text css=&#8221;.vc_custom_1570492971385{margin-top: 0px !important;padding-top: 0px !important;}&#8221;]<strong>Communicate with potential and enrolled participants throughout the clinical trial life cycle in ways that are designed to be understood:<\/strong><\/p>\n<ul>\n<li>Choose words to describe research information so the intended audience understands as quickly, easily and completely as possible (known as <a href=\"https:\/\/mrctcenter.org\/health-literacy\/tools\/overview\/plain-language\/\">plain language<\/a>)<\/li>\n<li>Address numbers and math concepts (known as <a href=\"https:\/\/mrctcenter.org\/health-literacy\/tools\/overview\/numeracy\/\">numeracy<\/a>) through clear methods that include not only statistics and probabilities, but also calendar\/scheduling information, volumes and doses, and timing\/frequency.<\/li>\n<li>Apply\u00a0<a href=\"https:\/\/mrctcenter.org\/health-literacy\/tools\/overview\/visualization-design\/\">imaging and clear design<\/a> techniques to clinical research content<\/li>\n<li>Use<a href=\"https:\/\/mrctcenter.org\/health-literacy\/tools\/overview\/interactive-techniques\/\">\u00a0interactive techniques<\/a>\u00a0like teach-back and paraphrasing whenever possible to reaffirm clinical research concepts via verbal and in-person encounters.<\/li>\n<li>Take an approach to communication that demonstrates <a href=\"https:\/\/mrctcenter.org\/health-literacy\/tools\/overview\/cultural-considerations\/\">cultural considerations<\/a>, respect, and a partnership with the potential participant and their community.<\/li>\n<li>Perform\u00a0<a href=\"https:\/\/mrctcenter.org\/health-literacy\/tools\/overview\/usability-testing\/\">usability testing<\/a> to assess whether the planned communication achieves its intended goal.<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column width=&#8221;1\/2&#8243;][vc_column_text]<strong>Everyone can use health literacy to communicate\u00a0<\/strong><\/p>\n<p>These techniques work best when adopted by everyone who creates materials for a research study or interacts with participants, including but not limited to:<\/p>\n<ul>\n<li>Investigators and study teams<\/li>\n<li>Sponsors and funders<\/li>\n<li>Institutional Review Boards<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/2&#8243;][vc_column_text css=&#8221;.vc_custom_1570153448212{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: 20px !important;padding-right: 20px !important;padding-bottom: 20px !important;padding-left: 20px !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;]Regulations around the world support clear communication about research:<\/p>\n<ul>\n<li>United States: comprehensive, concise, clear, relevant and understandable consents (45 C.F.R. \u00a7 46.101 et. seq.)<\/li>\n<li>European Union : understandable clinical trial results summaries (EU Clinical Trials Regulation (No 536\/2014), Article 29 and 37(4))<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][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> &gt; <a href=\"https:\/\/mrctcenter.org\/health-literacy\/trial-life-cycle\/overview\/recruitment\/\">Recruitment<\/a>\u00a0&gt; <a href=\"https:\/\/mrctcenter.org\/health-literacy\/trial-life-cycle\/overview\/consent\/\">Consent<\/a> &gt; <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_column_text] Health literacy can support the participant through their clinical trial journey. 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