- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01646099
Sun Protection of Kidney Transplant Recipients
Internet-Based Sun Protection Program for Kidney Transplantation Recipients
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
Cognitive interviews about an internet-based sun protection strategies program will be performed with up to 45 kidney transplant recipients (KTRs) who have participated in past surveys. A second group of 150 KTRs will be asked to evaluate the internet-based module for the effectiveness of information. A third group of 12 KTRs will be asked to evaluate the internet-based module for usability. A fourth group of 160 KTRs will be asked to take part in a randomized controlled trial evaluating the fully developed internet-based sun protection strategies program.
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) The NKF supported standard, formal, well timed skin cancer prevention information and sending reminders to KTRs at the beginning of summer.
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 photoprotective pigment in the skin.
- To pilot test the internet-based sun protection brochure with English speaking KTRs representing 3 ethnic groups: White, Black and Hispanic.
- To explore understanding of the importance of sun protection and the KTRs' confidence in their being able to practice sun protection.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Illinois
-
Chicago, Illinois, Stati Uniti, 60611
- Northwestern Memorial Faculty Foundation
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Subjects with a history of kidney transplantation within the last 5 years
- Speaks English
- Can see to read
- Lives in the greater Chicago area and can attend a cognitive interview session
- 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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Sun Protection Education
Distribution of the internet-based sun protection educational program.
|
Prior to summer, KTRs who agree to participate will receive a text message with their access code to the Internet intervention to access from their homes on a personal device.
After online completion of baseline assessments, participants will be randomized to receive the intervention or general skin care information (control).
Following the initial use, the participants may revisit the Internet intervention on a personal device or at the doctor's office on a tablet PC.
Over the next 6 weeks, sun protection text reminders will be sent to intervention KTRs' cell phones and they will respond that they read the message.
Control participants will receive text messages about general skin care.
|
Nessun intervento: Control
Distribution of general skin care information.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Use of sun protection
Lasso di tempo: 6 weeks
|
Use of sun protection will be measured using 10 questions about what a person regularly does in summer during a warm sunny day and during a cloudy day regarding: 1) use of sunscreen; 2) wearing hat; 3) shirt with sleeves; 4) sunglasses; and 5) staying in the shade.
The scores for these questions will be summed to derive a dichotomous measure of sun protection use (1= use of sun protection often or always; 0 otherwise).
|
6 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Level of sun burn or skin irritation from the sun
Lasso di tempo: 6 weeks
|
Three telephone interviews will be done on Mondays after at least 2 holiday weekends in which the weather is reported as sunny or partly sunny by the national weather service (Memorial Day, 4th of July and Labor Day) as well as one sunny non-holiday weekend.
The KTR will be asked if they experienced a sunburn or skin irritation.
The response will be dichotomous (yes/no).
|
6 weeks
|
Forearm skin pigment
Lasso di tempo: 6 weeks
|
Skin pigment as measured by reflectance spectrophotometry, ranging from limited [225 area-under-the-curve (AUIC)] to dense (75 AUIC).
|
6 weeks
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: June K. Robinson, M.D., Northwestern University
Pubblicazioni e link utili
Pubblicazioni generali
- Robinson JK, Friedewald JJ, Desai A, Gordon EJ. Response Across the Health-Literacy Spectrum of Kidney Transplant Recipients to a Sun-Protection Education Program Delivered on Tablet Computers: Randomized Controlled Trial. JMIR Cancer. 2015 Aug 18;1(2):e8. doi: 10.2196/cancer.4787.
- Robinson JK, Guevara Y, Gaber R, Clayman ML, Kwasny MJ, Friedewald JJ, Gordon EJ. Efficacy of a sun protection workbook for kidney transplant recipients: a randomized controlled trial of a culturally sensitive educational intervention. Am J Transplant. 2014 Dec;14(12):2821-9. doi: 10.1111/ajt.12932. Epub 2014 Nov 13.
- Guevara Y, Gaber R, Clayman ML, Gordon EJ, Friedewald J, Robinson JK. Sun protection education for diverse audiences: need for skin cancer pictures. J Cancer Educ. 2015 Mar;30(1):187-9. doi: 10.1007/s13187-014-0661-7.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- STU00058220
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Internet-based sun protection education
-
Scripps Whittier Diabetes InstituteReclutamentoDiabete di tipo 2Stati Uniti
-
Hacettepe UniversityCompletatoDiabete di tipo 2Tacchino