Recruiting young pre-symptomatic children for a clinical trial in type 1 diabetes: Insights from the Fr1da insulin intervention study
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 t...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2018-09-01
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| Series: | Contemporary Clinical Trials Communications |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865418300589 |
| _version_ | 1819052017167892480 |
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| author | Kerstin Kick Robin Assfalg Susanne Aydin Susanne Bechtold-Dalla Pozza Dominik Böcker Sonja Braig Melanie Bunk Desiree Dunstheimer Alevtina Durmashkina Uwe Ermer Antonia Gavazzeni Eva-Maria Gerstl Melanie Heinrich Melanie Herbst Yvonne Kriesen Ursula Kuhnle-Krahl Herbert Müller Nicole Nellen-Hellmuth Christian Ockert Claudia Ramminger Marina Sindichakis Stefanie Tretter Katharina Warncke Peter Achenbach Anette-G. Ziegler Verena S. Hoffmann |
| author_facet | Kerstin Kick Robin Assfalg Susanne Aydin Susanne Bechtold-Dalla Pozza Dominik Böcker Sonja Braig Melanie Bunk Desiree Dunstheimer Alevtina Durmashkina Uwe Ermer Antonia Gavazzeni Eva-Maria Gerstl Melanie Heinrich Melanie Herbst Yvonne Kriesen Ursula Kuhnle-Krahl Herbert Müller Nicole Nellen-Hellmuth Christian Ockert Claudia Ramminger Marina Sindichakis Stefanie Tretter Katharina Warncke Peter Achenbach Anette-G. Ziegler Verena S. Hoffmann |
| author_sort | Kerstin Kick |
| collection | DOAJ |
| description | 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. Keywords: Type 1 diabetes, Trial recruitment, Trial enrollment, Infants, Children, Asymptomatic |
| first_indexed | 2024-12-21T12:13:08Z |
| format | Article |
| id | doaj.art-7fc20d3f54a14cc3b5f6b96d53725efb |
| institution | Directory Open Access Journal |
| issn | 2451-8654 |
| language | English |
| last_indexed | 2024-12-21T12:13:08Z |
| publishDate | 2018-09-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj.art-7fc20d3f54a14cc3b5f6b96d53725efb2022-12-21T19:04:31ZengElsevierContemporary Clinical Trials Communications2451-86542018-09-0111170173Recruiting young pre-symptomatic children for a clinical trial in type 1 diabetes: Insights from the Fr1da insulin intervention studyKerstin Kick0Robin Assfalg1Susanne Aydin2Susanne Bechtold-Dalla Pozza3Dominik Böcker4Sonja Braig5Melanie Bunk6Desiree Dunstheimer7Alevtina Durmashkina8Uwe Ermer9Antonia Gavazzeni10Eva-Maria Gerstl11Melanie Heinrich12Melanie Herbst13Yvonne Kriesen14Ursula Kuhnle-Krahl15Herbert Müller16Nicole Nellen-Hellmuth17Christian Ockert18Claudia Ramminger19Marina Sindichakis20Stefanie Tretter21Katharina Warncke22Peter Achenbach23Anette-G. Ziegler24Verena S. Hoffmann25Forschergruppe Diabetes, Technical University Munich, at Klinikum rechts der Isar, Munich, GermanyInstitute of Diabetes Research, Helmholtz Zentrum München, German Research Center for Environmental Health, Munich-Neuherberg, GermanyForschergruppe Diabetes, Technical University Munich, at Klinikum rechts der Isar, Munich, GermanyKlinikum der Universität München, Dr. Von Haunersches Kinderspital, Munich, GermanyKlinikum Nuremberg, Nuremberg, GermanyKlinikum Bayreuth, Bayreuth, GermanyForschergruppe Diabetes e.V. at Helmholtz Zentrum München, German Research Center for Environmental Health, Munich-Neuherberg, GermanyKlinikum Augsburg, Augsburg, GermanyForschergruppe Diabetes, Technical University Munich, at Klinikum rechts der Isar, Munich, GermanyKliniken St. Elisabeth, Neuburg/Donau, GermanyKinderarzt Praxis Bogenhausen, Munich, GermanyKlinikum Dritter Orden, Passau, GermanyForschergruppe Diabetes, Technical University Munich, at Klinikum rechts der Isar, Munich, GermanyForschergruppe Diabetes e.V. at Helmholtz Zentrum München, German Research Center for Environmental Health, Munich-Neuherberg, GermanyForschergruppe Diabetes e.V. at Helmholtz Zentrum München, German Research Center for Environmental Health, Munich-Neuherberg, GermanyDiabetes Center Gauting, Gauting, GermanyKlinikum Kempten, Kempten, GermanyFamilienarztpraxis Dr. med. Hans-Jörg Hellmuth & Kollegen, Würzburg, GermanyRoMed Klinikum Rosenheim, Rosenheim, GermanyForschergruppe Diabetes e.V. at Helmholtz Zentrum München, German Research Center for Environmental Health, Munich-Neuherberg, GermanyKlinikum Traunstein, Traunstein, GermanyKlinikum Weiden, Weiden, GermanyForschergruppe Diabetes e.V. at Helmholtz Zentrum München, German Research Center for Environmental Health, Munich-Neuherberg, Germany; Department of Pediatrics, Klinikum rechts der Isar, Technical University Munich, Munich, GermanyForschergruppe Diabetes, Technical University Munich, at Klinikum rechts der Isar, Munich, Germany; Institute of Diabetes Research, Helmholtz Zentrum München, German Research Center for Environmental Health, Munich-Neuherberg, Germany; Forschergruppe Diabetes e.V. at Helmholtz Zentrum München, German Research Center for Environmental Health, Munich-Neuherberg, GermanyForschergruppe Diabetes, Technical University Munich, at Klinikum rechts der Isar, Munich, Germany; Institute of Diabetes Research, Helmholtz Zentrum München, German Research Center for Environmental Health, Munich-Neuherberg, Germany; Forschergruppe Diabetes e.V. at Helmholtz Zentrum München, German Research Center for Environmental Health, Munich-Neuherberg, Germany; Corresponding author. Institute of Diabetes Research, Helmholtz Zentrum München, German Research Center for Environmental Health, Ingolstädter Landstraße 1, 85764 Neuherberg , Germany.Institute of Diabetes Research, Helmholtz Zentrum München, German Research Center for Environmental Health, Munich-Neuherberg, Germany; Corresponding author. Institute of Diabetes Research, Helmholtz Zentrum München, German Research Center for Environmental Health, Ingolstädter Landstraße 1, 85764 Neuherberg , Germany.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. Keywords: Type 1 diabetes, Trial recruitment, Trial enrollment, Infants, Children, Asymptomatichttp://www.sciencedirect.com/science/article/pii/S2451865418300589 |
| spellingShingle | Kerstin Kick Robin Assfalg Susanne Aydin Susanne Bechtold-Dalla Pozza Dominik Böcker Sonja Braig Melanie Bunk Desiree Dunstheimer Alevtina Durmashkina Uwe Ermer Antonia Gavazzeni Eva-Maria Gerstl Melanie Heinrich Melanie Herbst Yvonne Kriesen Ursula Kuhnle-Krahl Herbert Müller Nicole Nellen-Hellmuth Christian Ockert Claudia Ramminger Marina Sindichakis Stefanie Tretter Katharina Warncke Peter Achenbach Anette-G. Ziegler Verena S. Hoffmann Recruiting young pre-symptomatic children for a clinical trial in type 1 diabetes: Insights from the Fr1da insulin intervention study Contemporary Clinical Trials Communications |
| title | Recruiting young pre-symptomatic children for a clinical trial in type 1 diabetes: Insights from the Fr1da insulin intervention study |
| title_full | Recruiting young pre-symptomatic children for a clinical trial in type 1 diabetes: Insights from the Fr1da insulin intervention study |
| title_fullStr | Recruiting young pre-symptomatic children for a clinical trial in type 1 diabetes: Insights from the Fr1da insulin intervention study |
| title_full_unstemmed | Recruiting young pre-symptomatic children for a clinical trial in type 1 diabetes: Insights from the Fr1da insulin intervention study |
| title_short | Recruiting young pre-symptomatic children for a clinical trial in type 1 diabetes: Insights from the Fr1da insulin intervention study |
| title_sort | recruiting young pre symptomatic children for a clinical trial in type 1 diabetes insights from the fr1da insulin intervention study |
| url | http://www.sciencedirect.com/science/article/pii/S2451865418300589 |
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