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Sun Protection of Kidney Transplant Recipients

21. april 2015 opdateret af: June Robinson, Northwestern University

Internet-Based Sun Protection Program for Kidney Transplantation Recipients

This study is being done to evaluate the effectiveness of a Sun Protection Strategies internet-based program for kidney transplant recipients. Since the medication taken to preserve the kidney transplant puts kidney transplant recipients at increased risk of developing a sunburn as well a skin cancer, the program will help people learn how to practice effective sun protection for their condition.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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:

  1. 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.
  2. To pilot test the internet-based sun protection brochure with English speaking KTRs representing 3 ethnic groups: White, Black and Hispanic.
  3. To explore understanding of the importance of sun protection and the KTRs' confidence in their being able to practice sun protection.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

335

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern Memorial Faculty Foundation

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

18 år til 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Sun Protection Education
Distribution of the internet-based sun protection educational program.
Adfærdsmæssigt: Internet-based sun protection education
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.
Ingen indgriben: Control
Distribution of general skin care information.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Use of sun protection
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Level of sun burn or skin irritation from the sun
Tidsramme: 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
Tidsramme: 6 weeks
Skin pigment as measured by reflectance spectrophotometry, ranging from limited [225 area-under-the-curve (AUIC)] to dense (75 AUIC).
6 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Northwestern University

Efterforskere

  • Ledende efterforsker: June K. Robinson, M.D., Northwestern University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. november 2013

Primær færdiggørelse (Faktiske)

1. marts 2015

Studieafslutning (Faktiske)

1. marts 2015

Datoer for studieregistrering

Først indsendt

13. juli 2012

Først indsendt, der opfyldte QC-kriterier

17. juli 2012

Først opslået (Skøn)

20. juli 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

23. april 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. april 2015

Sidst verificeret

1. april 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • STU00058220

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 Internet-based sun protection education

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Tanzania

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner