- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00955370
The Experience of Uncertainty in Parents of Children With an Undiagnosed Medical Condition
30. června 2017 aktualizováno: National Human Genome Research Institute (NHGRI)
Background:
- Rare and undiagnosed conditions are often chronic and disabling, with symptoms affecting different organ systems at various levels of severity. Perhaps the most challenging feature of an undiagnosed medical condition that has lasted 2 or more years is its characteristic uncertainty. In the absence of a diagnosis, health care professionals can provide only limited treatment and prognostic information.
- In the case of a child with an undiagnosed condition, the uncertainty that accompanies what is often a chronic, debilitating medical condition and an undefined prognosis may have physical, psychological, social, and spiritual implications for the entire family. Research suggests that parents of a child with an undiagnosed medical condition may be at significantly increased risk of anxiety, depression, poor health, and overall lower quality of life.
- It is not well understood how individuals cope with and adapt to chronic uncertainty, and the factors that influence this process. To design future interventions, descriptive studies are needed to reveal predictors that can be manipulated to improve outcomes.
Objectives:
- To examine whether perceptions of uncertainty, and perceived personal control, are associated with coping and adaptation.
- To examine how the length of time elapsed since child was identified as sick and perceptions of uncertainty affect coping and adaptation.
- To assess how perceptions of uncertainty, time elapsed since child became sick, optimism, and perceived personal control affect coping and adaptation.
Eligibility:
- Parents (older than 18 years of age) of children who have an undiagnosed medical condition.
- Participants must have a working e-mail address or fixed postal address.
Design:
- Parents will be recruited from Web-based support networks for parents of undiagnosed children through Web site postings, electronic mailing lists, and printed newsletter postings.
- Participants will be asked to complete a questionnaire about their experiences in living with a child who has an undiagnosed but chronic medical condition. The main outcome variable is adaptation to living with one's child's undiagnosed medical condition.
- Participants have the option to complete an online or paper version of the questionnaire. The questionnaire should take between 20 and 30 minutes to complete.
- No medical treatments are specifically offered as a part of this study.
Přehled studie
Postavení
Dokončeno
Podmínky
Detailní popis
This study aims to understand the impact on parents of having a child with an undiagnosed medical condition and the factors that contribute to their adaptation.
Rare and undiagnosed conditions are often chronic and disabling, with symptoms affecting different organ systems at various levels of severity.
Perhaps the most challenging feature of an undiagnosed medical condition that has lasted two or more years, however, is its characteristic uncertainty.
In the absence of a diagnosis, health care professionals can provide only limited treatment and prognostic information.
It is not well understood how individuals cope with and adapt to chronic uncertainty, and the factors that influence this process.
To design future interventions, descriptive studies are needed to reveal predictors that can be manipulated to improve outcomes.
In this study, Lazarus and Folkman's Transactional Model of Stress and Coping provides a framework to examine coping and adaptation in the parents of children who have had a chronic, undiagnosed medical condition for two or more years.
A cross-sectional research design using a mixed methods survey will be used to examine the relationships among appraisals (perceptions of uncertainty and perceived personal control), time elapsed since parents first realized their child was sick, coping and adaptation.
Parents will be recruited from web-based support networks for parents of undiagnosed children via website postings, email listservs and printed newsletter postings.
Participants will have the option to complete an online or paper version of the questionnaire.
The main outcome variable is adaptation to living with one's child's undiagnosed medical condition.
Typ studie
Pozorovací
Zápis (Očekávaný)
500
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Maryland
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Bethesda, Maryland, Spojené státy, 20892
- National Human Genome Research Institute (NHGRI), 9000 Rockville Pike
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 100 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
- INCLUSION CRITERIA:
- Men and women 18 years or older
- Biological or adoptive parent
- At least one child of participants has a medical problem or problems that have remained undiagnosed for > 2 years
- The child with an undiagnosed medical problem must reside with the parent
- Read and write in English
EXCLUSION CRITERIA:
-One parent/household may participate
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- Guillem P, Cans C, Robert-Gnansia E, Ayme S, Jouk PS. Rare diseases in disabled children: an epidemiological survey. Arch Dis Child. 2008 Feb;93(2):115-8. doi: 10.1136/adc.2006.104455. Epub 2007 Oct 17.
- Lenhard W, Breitenbach E, Ebert H, Schindelhauer-Deutscher HJ, Henn W. Psychological benefit of diagnostic certainty for mothers of children with disabilities: lessons from Down syndrome. Am J Med Genet A. 2005 Mar 1;133A(2):170-5. doi: 10.1002/ajmg.a.30571.
- Rosenthal ET, Biesecker LG, Biesecker BB. Parental attitudes toward a diagnosis in children with unidentified multiple congenital anomaly syndromes. Am J Med Genet. 2001 Oct 1;103(2):106-14. doi: 10.1002/ajmg.1527.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
4. srpna 2009
Dokončení studie
10. dubna 2012
Termíny zápisu do studia
První předloženo
7. srpna 2009
První předloženo, které splnilo kritéria kontroly kvality
7. srpna 2009
První zveřejněno (Odhad)
10. srpna 2009
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
2. července 2017
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
30. června 2017
Naposledy ověřeno
10. dubna 2012
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 999909206
- 09-HG-N206
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .