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Kick, K.* ; Assfalg, R. ; Aydin, S.* ; Bechtold-Dalla Pozza, S.* ; Böcker, D.* ; Braig, S.* ; Bunk, M.* ; Dunstheimer, D.* ; Durmashkina, A.* ; Ermer, U.* ; Gavazzeni, A.* ; Gerstl, E.M.* ; Heinrich, M.* ; Herbst, M. ; Kriesen, Y.* ; Kuhnle-Krahl, U.* ; Müller, H.* ; Nellen-Hellmuth, N.* ; Ockert, C.* ; Ramminger, C.* ; Sindichakis, M.* ; Tretter, S.* ; Warncke, K.* ; Achenbach, P. ; Ziegler, A.-G. ; Hoffmann, V.

Recruiting young pre-symptomatic children for a clinical trial in type 1 diabetes: Insights from the Fr1da insulin intervention study.

Contemp. Clin. Trails Comm. 11, 170-173 (2018)
Verlagsversion DOI PMC
Open Access Gold
Creative Commons Lizenzvertrag
Background: Although detection of children at high risk of developing type 1 diabetes and diagnosis of early stages is possible, up to now there exists no approved therapy to delay or prevent type 1 diabetes. Thus it is vital to develop evidence-based interventions. For this a sufficient number of trial participants is crucial but difficult to obtain especially in asymptomatic children. Aim: Identifying family characteristics that lead to or impede trial participation and analyze reasons stated by families for non-participation. Methods: Participants for the Fr1da Insulin Intervention study are recruited from the Fr1da study, a population based screening for early stage type 1 diabetes in Bavaria. Families with eligible children were invited to enroll. We analyzed sex and age of the child, distance of the family to the study center in Munich and the existence of a first degree family member with type 1 as possible influential factors for study participation. We also analyzed reasons stated by families who declined study participation in a phone interview. Results: Of 146 eligible children 77 (53%) were enrolled into the trial. None of the tested family characteristics differed significantly between the enrolling and the families not participating, but in general enrolling families lived closer to the study site than families not participating. This is also reflected in the reasons given by non-participating families. The most frequent reason stated were time restrictions. The second most frequent reason was the venous blood draw. Conclusion: The factors for non-participation identified in this project need be taken into account for the design of future trials in young children to ensure proper recruitment and thus to generate valid results for medical treatment of children. More research on the reason of participation and non-participation in clinical trials is needed.
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Publikationstyp Artikel: Journalartikel
Dokumenttyp Wissenschaftlicher Artikel
Schlagwörter Asymptomatic ; Children ; Infants ; Trial Enrollment ; Trial Recruitment ; Type 1 Diabetes
Sprache englisch
Veröffentlichungsjahr 2018
HGF-Berichtsjahr 2018
ISSN (print) / ISBN 2451-8654
e-ISSN 2451-8654
Zeitschrift Contemporary clinical trials communications
Quellenangaben Band: 11, Heft: , Seiten: 170-173 Artikelnummer: , Supplement: ,
Verlag Elsevier
Verlagsort Amsterdam
Begutachtungsstatus Peer reviewed
Institut(e) Institute of Diabetes Research (IDF)
POF Topic(s) 30201 - Metabolic Health
Forschungsfeld(er) Helmholtz Diabetes Center
PSP-Element(e) G-502100-001
DOI 10.1016/j.conctc.2018.08.004
Scopus ID 85052154200
PubMed ID 30197933
Erfassungsdatum 2018-09-04
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