- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00577252
Coping Compliance and Adjustment in Adolescents With Cystic Fibrosis
23. november 2009 opdateret af: Akron Children's Hospital
In this research, we will use established surveys to look at the relationship between various styles of coping with a disease, religious coping styles, treatment compliance, locus of control, broad measures of mental health and adjustment, and basic health data (e.g., PFTs, recent hospitalizations or antibiotics within the past year, lung microbiology, CFTR mutations, and co-morbid conditions such as diabetes, depression, and liver disease).
While the research is correlational, it should suggest relationships (both positive and negative) between various coping styles and desired outcomes (compliance and well-being).
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
OVERVIEW: We anticipate that the data we collect will help us better understand some of the factors associated with improved coping, treatment compliance, and emotional adjustment, which, in turn, may suggest possible interventions to improve compliance, emotional adjustment, and general physical health. Specific hypotheses include the following:
- Subjects who score high on measures of positive coping will have greater levels of treatment compliance and psychological well-being.
- Subjects who score high on measures of negative coping will have lower levels of treatment compliance and psychological well-being.
- Subjects who score high on measures of positive religious coping will have greater levels of treatment compliance and psychological well being.
- Subjects who score high on measures of negative religious coping will have lower levels of treatment compliance and psychological well-being.
- Subjects who score high on measures of internal locus of control will have higher levels of treatment compliance and psychological well-being compared to subjects who score low on measures of internal locus of control.
- Subjects who score high on measures of treatment compliance will have higher levels of physical health.
- We do not anticipate a positive correlation between positive coping mechanisms and general physical health; however, subjects who score high on measures of negative coping may have lower levels of general physical health (e.g., lower PFTs, increased rates and lengths of hospitalizations) probably due to third variables (e.g., if someone uses denial as a coping mechanism, it may lead to poor treatment compliance, which may lead to declines in physical health).
- Anecdotal evidence suggests that parental education may be positively correlated with treatment compliance, but this has not been evaluated. Likewise, anecdotal evidence suggest that marital status may be correlated with treatment compliance (probably because of third variables, e.g., if, as much research suggests, divorce is related to lower SES and fewer social supports, these factors may in turn interfere with treatment compliance). Two questions on the demographic sheet will allow us to explore whether or not this may be worth exploring further.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
40
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Ohio
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Akron, Ohio, Forenede Stater, 44308
- Akron Children's Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
13 år til 19 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Adolescents age 13-19 with CF at a single CF center.
Beskrivelse
Inclusion Criteria:
- cystic fibrosis age 13-19 yrs
Exclusion Criteria:
- acutely ill
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Tværsnit
Kohorter og interventioner
Gruppe / kohorte |
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1
Adolescents with CF.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Multiple measures of coping strategies in adolescents with cystic fibrosis.
Tidsramme: Single visit
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Single visit
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Coping startegies will be correlated with measures of clinical illness.
Tidsramme: Single visit
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Single visit
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Nathan C Kraynack, MD, Akron Children's Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2007
Studieafslutning (Faktiske)
1. april 2008
Datoer for studieregistrering
Først indsendt
18. december 2007
Først indsendt, der opfyldte QC-kriterier
19. december 2007
Først opslået (Skøn)
20. december 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
24. november 2009
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. november 2009
Sidst verificeret
1. november 2009
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- COPING1424
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Cystisk fibrose
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M.D. Anderson Cancer CenterRekrutteringFibrose | Lymfødem | Fibrosis syndrom | Hoved & amp; HalskræftForenede Stater
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National Cancer Centre, SingaporeMerck Sharp & Dohme LLC; National Cancer Center, JapanIkke rekrutterer endnuTilbagevendende adenoid cystisk karcinom | Papillært skjoldbruskkirtelcarcinom | Adenoid Cystic Carcinoma MetastatiskSingapore, Japan, Malaysia, Sydkorea