- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01844713
Evaluation of Sun Protection Education for Kidney Transplant Recipients
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Illinois
-
Chicago, Illinois, Förenta staterna, 60611
- Northwestern Memorial Faculty Foundation
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Experimental: Workbook
Distribution of the sun protection educational workbook
|
Subjects will read a workbook about sun protection
|
|
Inget ingripande: Control
Distribution of general skin care information
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
use of sun protection
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: June K. Robinson, M.D., Northwestern University
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- STU00069552
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .