- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00599378
Implementation Intentions to Promote Colon Cancer Screening in Rural Primary Care Practice
6. september 2013 opdateret af: Kimberly Engelman, PhD
To assess the efficacy of a novel prompting intervention based on the concept of "implementation intentions.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Although colorectal cancer (CRC) is preventable and curable if detected early, a large portion of the population is not current with screening recommendations.
Many unscreened individuals 50 years of age and older do not receive health care system prompts to promote adherence to test preparation or completion.
This study will assess the efficacy of a novel prompting intervention based on the concept of "implementation intentions".
The intervention will be delivered through a partnership between patients, rural primary care physicians, and trained CRC information specialists (CRC-IS) and will focus on the 'recalcitrant' primary care population.
A randomized design will test a comparison condition of a "no-partnership" system with generic information versus a "partnership" intervention system that specifically addresses each participants' CRC screening "implementation intentions" (the "when," "where" and "how" screening details).
The study will be conducted with 600 patients eligible for CRC screening and recruited while presenting for care in a set of Research Network affiliated primary care clinics, or patient contact information gathered from in-house chart reviews.
All participants who are not up-to-date on CRC screening, or not at high risk for CRC, will receive a baseline tablet PC-administered CRC assessment, or a letter of invitation from their PC physician to go online to the Healthy Living Kansas patient portal to complete the assessment.
Completion of CRC screening at 60 days post index visit will be assessed through follow-up phone calls.
Those not completing CRC screening after taking the assessment,(i.e., recalcitrant participants) then will be randomized to either C (comparison group-"no-partnership") or CPI2 (active intervention-CRC-IS/ physician/patient partnership and implementation intentions-based communication concepts).
Physicians will receive informational fax sheets summarizing all participant phone calls.
A 120-day post randomization follow-up telephone call will assess the effects of implementation intentions communications and perceived CRC screening barriers encountered.
The primary outcome will be CRC screening adherence at 120 days.
Secondary outcomes will assess 120-day perceived barriers and advancement in screening decisional stage.
This intervention will provide information on the utility of embedding an "implementation intentions" based behavioral intervention for promoting CRC screening among initially non-adherent primary care patients.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
373
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Kansas
-
Kansas City, Kansas, Forenede Stater, 66160
- University of Kansas Medical Center
-
-
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
50 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 50 years of age or older
- at average risk for colorectal cancer
- not up to date with colorectal cancer screening
Exclusion Criteria:
- Younger than 50 years of age
- at high risk for colorectal cancer
- up to date with colorectal cancer screening
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: 1
Implementation Intentions-based telephone counseling.
Partnership intervention between rural Primary Care Physicians, their patients, and CRC Information Specialists using an implementation intentions based approach.
|
Implementation Intentions-based telephone counseling
|
|
Ingen indgriben: 2
Healthy Living information on Physical Activity and Nutrition
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Follow up survey to assess participant compliance with CRC screening. For those non compliant participants, randomized to either Control group or CPI2 group - active intervention with implementation intentions-based communication concepts
Tidsramme: 60 days
|
60 days
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
120 day followup survey to assess perceived barriers and screening decisional stage
Tidsramme: 120 Days
|
120 Days
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Kimberly K. Engelman, PhD, University of Kansas Medical Center
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. september 2007
Primær færdiggørelse (Faktiske)
1. december 2011
Studieafslutning (Faktiske)
1. juni 2012
Datoer for studieregistrering
Først indsendt
31. december 2007
Først indsendt, der opfyldte QC-kriterier
10. januar 2008
Først opslået (Skøn)
23. januar 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
10. september 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. september 2013
Sidst verificeret
1. september 2013
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 11018
- 1R01CA121016-01A2 (U.S. NIH-bevilling/kontrakt)
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 .
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