- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00714935
Shared Decision-making: Effects on Cardiac Risk Factor Modification Behavior
Effects of a Decision Aid for Patients With Coronary Artery Disease on Cardiac Risk Factor Modification Behavior and Health Outcomes
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Oslo, Norge
- Oslo University Hospital, Rikshospitalet,
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Oslo, Norge
- Rikshospitalet HF University Hospital, Cardiac Outpatient Clinic
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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:
- Age 18 and older
- Scheduled for an angiogram
- Able to read, write, and speak Norwegian
- Live within approximately 100 km of Oslo
- Have a telephone
Exclusion Criteria:
- Cognitive impairment
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Ingen indgriben: 1
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Eksperimentel: 3
Decision Counseling Program(DCP) combined with Coronary Artery Disease Decision Aid (CAD-DA) described in Arm 2
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An individual decisional counseling program (DCP) to help them comprehend the information, adjust this information to their personal illness history and elicit their preferences for cardiac risk fctor modification behavior in light of this personalized information
Coronary Artery Disease Decision Aid (CAD-DA) presented as a booklet called: "Making Choices: Life Changes to Lower Your Risk of Heart Disease and Stroke" The CAD-DA is developed by the Ottawa Health Research Institute and Division of Clinical Epidemiology at Montreal General Hospital, in CAD patients facing the decision of making lifestyle changes to lower their cardiac risk factors and provides patients with information about what they can you do to prevent the disease from progressing. |
Eksperimentel: 2
Behavioral: Coronary Artery Disease Decision Aid (CAD-DA) presented as a booklet called: "Making Choices: Life Changes to Lower Your Risk of Heart Disease and Stroke" The CAD-DA is developed by the Ottawa Health Research Institute and Division of Clinical Epidemiology at Montreal General Hospital, in CAD patients facing the decision of making lifestyle changes to lower their cardiac risk factors and provides patients with information about what they can you do to prevent the disease from progressing. |
Coronary Artery Disease Decision Aid (CAD-DA) presented as a booklet called: "Making Choices: Life Changes to Lower Your Risk of Heart Disease and Stroke" The CAD-DA is developed by the Ottawa Health Research Institute and Division of Clinical Epidemiology at Montreal General Hospital, in CAD patients facing the decision of making lifestyle changes to lower their cardiac risk factors and provides patients with information about what they can you do to prevent the disease from progressing. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Health Related Quality of Life
Tidsramme: Repeated measures prior to patients angiogram and 2, 4, and 6 months after angiogram
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Repeated measures prior to patients angiogram and 2, 4, and 6 months after angiogram
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Health outcomes (angina symptoms, body weight, cholesterol level, blood pressure, health service use)
Tidsramme: Repeated measures prior to patients angiogram and 2, 4, and 6 months after angiogram
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Repeated measures prior to patients angiogram and 2, 4, and 6 months after angiogram
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Intermediate outcome: adherence to cardiac risk factor modification behavior
Tidsramme: Repeated measure 2, 4, and 6 months after angiogram
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Repeated measure 2, 4, and 6 months after angiogram
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Mediating variables: knowledge, decisional conflict, intention to adhere to cardiac risk factor modification behavior, perceived susceptibility and severity of CAD progression, and benefits and barriers of cardiac risk factor modification behavior
Tidsramme: Prior to patients angiogram, and 2 months following angiogram
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Prior to patients angiogram, and 2 months following angiogram
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Cornelia M Ruland, PhD, Oslo University Hospital
Publikationer og nyttige links
Generelle publikationer
- Wensaas L. Effects of a decision aid with and without additional decisional counseling for patients being examined for coronary artery disease on cardiac risk reduction behavior and health outcomes : A randomized controlled trial. Doctoral thesis. University of Oslo, 2012
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- S-07207a
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