- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01844713
Evaluation of Sun Protection Education for Kidney Transplant Recipients
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Cognitive interview about the Sun Protection Strategies workbook will be performed with up to 25 kidney transplant recipients (KTR) who have participated in past surveys. A second phase of the study involves 156 KTRs that will be asked to take part in a randomized controlled trial evaluating the fully developed sun protective strategies workbook.
Kidney transplant recipients (KTRs) are at risk to develop skin cancer. Adequate sun protection after transplantation can reduce the risk of developing skin cancer. In 2006, the National Kidney Foundation (NKF) found that sun protection education delivery and content varied among transplantation centers. Clinicians rarely knew when to initiate education about skin cancer risks and prevention including timing and scope, and rarely demonstrated understanding of the importance of reminders for and repeated education of patients (National Kidney Foundation 2006).
Aims:
- To explore culturally sensitive use of terms describing ethnic cultural perceptions of sun burning, pigment darkening after sun exposure and description of skin color by the amount of photo-protective pigment in the skin.
- To pilot test the sun protection workbook with English speaking KTRs representing the 3 ethnic groups: White, Black and Hispanic.
- To assess the effectiveness of an education intervention encouraging the use of sun protection strategies.
- To explore understanding of the importance of sun protection and the KTRs confidence in their being able to practice sun protection.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Illinois
-
Chicago, Illinois, Forente stater, 60611
- Northwestern Memorial Faculty Foundation
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Subjects with a history of kidney transplantation within the last 2-24 months
- Speaks English
- Can see to read
- Lives in the greater Chicago area and can attend two study visits
- 18-85 years old
Exclusion Criteria:
- Unable to speak English
- Cognitive impairment or neurologic disease
- Dementia or insufficient cognitive skills to follow instructions provided at a sixth grade language level
- Has had a skin cancer
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Experimental: Workbook
Distribution of the sun protection educational workbook
|
Subjects will read a workbook about sun protection
|
|
Ingen inngripen: Control
Distribution of general skin care information
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
use of sun protection
Tidsramme: An average of 1 year
|
Subjects will complete self-report surveys of behavior prior to educational intervention and 6- 8 weeks after the educational intervention
|
An average of 1 year
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: June K. Robinson, M.D., Northwestern University
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- STU00069552
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