{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Randell RL"],"funding":["NICHD NIH HHS","NIAID NIH HHS","NHLBI NIH HHS","FDA HHS","NIMHD NIH HHS","U.S. Food and Drug Administration","NIAMS NIH HHS","NIGMS NIH HHS"],"pagination":["e000494"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC8108689"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["8(1)"],"pubmed_abstract":["<h4>Introduction</h4>Direct-to-family clinical trials efficiently provide data while reducing the participation burden for children and their families. Although these trials can offer significant advantages over traditional clinical trials, the process of designing and implementing direct-to-family studies is poorly defined, especially in children with rheumatic disease. This paper provides lessons learnt from the design and implementation of a self-controlled, direct-to-family pilot trial aimed to evaluate the effects of a medication management device on adherence to hydroxychloroquine in paediatric SLE.<h4>Methods</h4>Several design features accommodate a direct-to-family approach. Participants meeting eligibility criteria from across the USA were identified a priori through a disease re"],"journal":["Lupus science & medicine"],"pubmed_title":["Delivering clinical trials at home: protocol, design and implementation of a direct-to-family paediatric lupus trial."],"pmcid":["PMC8108689"],"funding_grant_id":["R01 FD006099","HHSN272201500006C","HHSN272201300017C","U19 AR069522","K24 AI143971","U18-FD006298","HHSN275201000003C","K23 AR075874","U24 MD016258","R61 HL147833","R13 HD102136","HHSN275201000003I","U18 FD006298","HHSN272201300017I","R33 HL147833","T32 GM086330"],"pubmed_authors":["Wampler Muskardin T","Sran R","Misajon E","Taneja A","Dover S","Clairman H","Orandi A","Rafko J","Ruth N","McCurdy Stokes P","Dalrymple A","Riordan M","Woolnough L","Zeft R","Nigrovic P","Falcon M","Blakley M","Walker J","Gotschlich E","Ritter M","McCurdy D","Kitcharoensakkul M","Gillispie-Taylor M","Verbsky J","Taber S","Nassi L","Hahn T","Levy D","Lapin B","Pagano E","Weiser P","Dedeoglu F","Gerhold K","Miller M","Yu Q","Manos C","Oberle E","Pfeiffer T","Shelly A","Benham H","Shenoi S","Magni Manzoni S","Pepmueller P","Kienzle B","Henrickson M","Stringer E","Phillippi K","Paller A","Ramirez C","Waite H","White A","Correll C","Morgan Dewitt E","Tory H","Savani S","Chang-Hoftman A","Santiago L","McMullen-Jackson C","Zeft A","Klein K","Zhu A","Hickey K","Puplava B","Drew J","Quinlan-Waters M","Schmeling H","Paredes J","Ramsey S","Hong S","Modica R","Reed A","Seay T","Du Q","Heiart J","Edelheit B","Hance M","Davis T","De Benedetti F","Rothman D","Tse S","Goh I","Davis C","Rodriquez M","Davis A","Nelson B","Griffin T","Onel K","Allenspach E","Sadun R","Neely J","Tapani S","Guittar P","De Guzman M","Gilbert M","Sule S","Wagner J","Binstadt B","Curry M","Sanni A","Fleming C","Baszis K","Klausmeier T","Benseler S","Ponder L","Failing C","Randell RL","Fields K","Olson J","Curington T","Lai J","Shalen J","Sumner J","Kemp A","Johnson N","Hoffart C","Beltz E","Cohen-Wolkowiez M","Zartoshti A","Hiraki L","Dowling J","Griswold J","Weiss J","Chalom E","Martyniuk A","Schanberg L","Janow G","Schollaert-Fitch K","Fritz K","Agbayani R","Brothers M","Driest K","Weiss P","Canna S","Nativ S","McGuire S","Singler L","Lasky A","Merritt A","Syed R","McConnell K","Duarte K","Stevens A","Stevens B","Anderson E","Akoghlanian S","Chundru K","Harris J","Mercado R","Srinivasalu H","Dean J","Volpe N","Cooper J","Yomogida K","Uriguen S","Hillyer S","Laxer R","Pardeo M","Rosenkranz M","Nanda K","Cooper S","Conlon H","Kaufman K","Smitherman E","Ardoin S","Stewart K","Fox M","Newhall L","Bigley T","Bohnsack J","Barillas-Arias L","Insalaco A","McHale I","Fox E","Cassidy E","Nicholas J","Sabbagh S","Cartwright V","Radhakrishna S","Rakestraw A","Kramer S","Confair A","Hager M","Federici S","Stern S","Lingis M","Lo M","Singer N","Van Mater H","Vilar G","Walters H","Vannoy L","Guevara M","Kimura Y","Aiello J","Thomas B","Favier L","Khalsa U","Protopapas S","Waqar L","Nicolai R","Chang J","Mason T","Goldsmith D","Goheer H","Malla B","Mitchell M","Ronis T","Schneider R","Quach J","Schlefman A","Bullock D","Black C","Ling N","Richmond A","Mruk V","Kingsbury D","Imundo L","Wahezi D","Soep J","Szymanski A","Froese S","Hollander M","Hobday P","Cerracchio L","Mellins E","Silverman E","Watson M","Baker E","Lang B","Schmidt K","Co D","Lvovich S","Nahal B","Eckert M","Schulert G","Wise A","Mohan S","Sletten J","Mendoza E","Tesher M","Freeman M","Grom A","Maller J","Valcarcel T","Spence S","Harel L","Kompelien B","Yee M","Pratt S","Nasah N","Toib D","HuiYuen J","Alpizar M","Vehe R","Donaldson B","Becker M","Mannion M","Giverc E","Ede K","Beukelman T","Ramsay E","Schikler K","Saad N","Son M","Sivaraman V","Shivers C","Remmel K","Smith C","Smith A","Vora S","Smith J","Natter M","Justiniano A","Rabinovich C","Lovell D","Cooper A","Oliver M","Pan N","Cunningham A","Ferrucho R","Stapp H","Parsons A","Gracia C","Ringold S","Varghese C","Wright T","James K","Scalzi L","Meidan E","Williams C","Taylor J","Ferguson I","Spiegel L","McAllister L","Patel J","Huber A","Woo J","McCormick E","Toruner C","Osei-Onomah S","Reyes A","Syverson G","Rojas K","Dickson T","Lin C","with the CARRA Registry investigators","Raisian J","Hersh A","Hartigan E","Stevenson R","George N","Feldman B","Spitznagle J","Twilt M","Zhao Y","Dingle J","Armendariz S","Guzman M","Lentini L","Terry M","Vazzana K","Shergill K","Buckley M","Moussa T","Stoll M","Fadrhonc S","Huggins J","Lapidus S","Obispo B","Riebschleger M","Ferguson P","Harry O","Michalowski L","Shirley J","Sundel R","Milojevic D","Miettunen P","Latham D","Hsu J","Kremer C","Muscal E","Luca N","Hornik CP","Balevic SJ","Basiaga M","Hay A","Lieberman S","Rubinstein T","Hill P","Fogel L","Hiskey M","Brunner H","Dvergsten J","Hammelev E","Tate L","Ting T","Fair D","Chira P","Boneparth A","Rothermel H","Fitzgerald M","Bracaglia C","Rodela E","Sutter M","Abel N","Kracker J","Gottlieb B","Grevich S","Nocton J","Panupattanapong S","Li S","Dorsey E","Jones J","Alejandro C","Jones K","Bowman S","Tambralli A","Fuhlbrigge R","Jones S","Mirizio E","Hausmann J","Lerman M","Barbar-Smiley F","Carper P","Jackson A","Halyabar O","Marques L","Flynn O","Costanzo D","Vasquez N","Fennell J","Huttenlocher A","Jackson S","Amarilyo G","Godiwala C","Franco L","Waterfield M","Moore K","Pooni R","Moss C","Zhang Y","Dempsey V","O'Neil K","Watts A","Reid H","Bukulmez H","Lim L","Yeung R","De Ranieri D","Jared S","Tiffany K","Balevic S","Pires Marafon D","O'Brien B","Sacco E","Hanson A","Madison C","Toth M","Okeke O","Connor R","Riskalla M","O'Brien T","Taxter A","Nadler R","Stokes J","Ballinger S","Hayward K","McCarthy K","Klein-Gitelman M","Cannon L","DeSantis E","Madison J","Murphy A","Bell-Brunson H","Henderson L","Zic C","Finkel T","Tal R","Tanner T","Lee P","Repp A","Kessler E","Moorthy L","Velez J","Inman C","Veiga K","Oz R","Lawson E","Edens C","Huntington J","Ferreira B","Gotte A","Justice C","Pentakota K","Holland M","Tipp A","Adams A","Kim S","Adams M","Yen E","Sandborg C","Ballenger L","Corvalan R","Hekl K","Jung L","Lee T","Tarvin S","Wershba E","Brown A","Horwitz M","Gerstbacher D","Scharnhorst S","Wu E","Brooks E","Stingl C","Nolan B","Ervin B","Seper C","Schanberg LE","Chauhan V","Ibarra M","Elder M","von Scheven E","Haro S","Mathus S","Lowman D","Malloy M","Roth-Wojcicki E","Bernal W","Prahalad S","Eberhard A","Abulaban K","Ambler W","Duverger E","Cron R","Rouster-Stevens K","Steigerwald K","Boland J","Graham T","Wagner-Weiner L","Karan N","Balboni I","Rosolowski B","Sarkissian A","Yalcindag A","Zapata R","Balmuri N","Hung C","Durkee D","Cameron B","Chinn T","McMonagle A","Torok K","Kosikowski A","Thatayatikom A","Curiel-Duran L","Joshi S","Ng L","Alperin R","Randell R","Sterba Rakovchik Y","Tarshish G","Delnay N","Orlando M","Edgerly Y","Sheets R","Rivas-Chacon R","Jaquith J","Schmitt E","Tubwell V","Morgan S","Robinson A","Kovalick L","Fuller J","Lam J","Shishov M"],"additional_accession":[]},"is_claimable":false,"name":"Delivering clinical trials at home: protocol, design and implementation of a direct-to-family paediatric lupus trial.","description":"<h4>Introduction</h4>Direct-to-family clinical trials efficiently provide data while reducing the participation burden for children and their families. Although these trials can offer significant advantages over traditional clinical trials, the process of designing and implementing direct-to-family studies is poorly defined, especially in children with rheumatic disease. This paper provides lessons learnt from the design and implementation of a self-controlled, direct-to-family pilot trial aimed to evaluate the effects of a medication management device on adherence to hydroxychloroquine in paediatric SLE.<h4>Methods</h4>Several design features accommodate a direct-to-family approach. Participants meeting eligibility criteria from across the USA were identified a priori through a disease re","dates":{"release":"2021-01-01T00:00:00Z","publication":"2021 May","modification":"2026-06-11T06:22:57.507Z","creation":"2022-02-10T11:43:58.798Z"},"accession":"S-EPMC8108689","cross_references":{"pubmed":["33963084"],"doi":["10.1136/lupus-2021-000494"]}}