- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04424758
Testing Video Information About Mammography Screening
Testing Video Information About Mammography Screening in a Randomized Design
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This study will be conducted as a single site parallel-arm, 1:1 randomized controlled trial (RCT) through a web-based quantitative survey uploaded in online forums. Participants will be randomized to either the intervention group (video information about mammography screening followed by a survey about mammography screening) or the control group (video information about energy systems followed by the same survey). The survey computer programme will randomly assign each respondent to either the intervention arm or the control arm in the beginning of the survey.
The allocation will be concealed from the researchers. The survey computer programme will deliver the intervention right after randomization. Participants will be aware of the allocation. However, they do not know about the study design. Data analysts will be kept blinded to the allocation.
Choice, knowledge and opinions related to mammography screening will be compared between the control group and the intervention group at one timepoint.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Capital
-
Copenhagen, Capital, Danmark, 1014
- Rekruttering
- University of Copenhagen, Section of General Practice
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Kontakt:
- Manja D Jensen, MD
- Telefonnummer: 0045-35333123
- E-mail: madj@sund.ku.dk
-
Kontakt:
- John Brodersen, MD, phd
- E-mail: jobr@sund.ku.dk
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Participants eligible for the study includes all men and women age 18-75.
Exclusion Criteria:
- None
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Intervention group
Receives information about mammography screening through a video.
The video was developed with the goal of informing about mammography screening in a societal perspective using best available evidence.
|
A video informing about mammography screening
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|
Placebo komparator: Control group
Receives information about energy systems through a video.
The video does not contain any information related to mammography screening.
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A video informing about smart energy systems
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Choice: proportion of participants in favor of mammography screening
Tidsramme: One month
|
The primary outcome in the study is choice.
A possible effect of the intervention on choice will be examined by comparing the proportion of participants in favor of screening (on the individual level and societal level respectively) between the intervention arm and the control arm.
One question addressing the societal choice and one question addressing the individual choice is included in our questionnaire.
|
One month
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Response duration: time
Tidsramme: One month
|
Response duration is registered for all participants in the online survey.
Mean response duration will be calculated in both the intervention arm and control arm.
|
One month
|
|
Acceptability of the video: percentage of participants finding the video to be neutral, in favor of or against mammography screening.
Tidsramme: One month
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Percentages of the participants finding the video to be neutral, in favor of or against mammography screening will be calculated in the intervention arm.
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One month
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Manja Jensen, MD, Section of General Practice, University of Copenhagen
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2204MDJ
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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