- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Oslo, Norge
- Oslo University Hospital, Rikshospitalet,
-
Oslo, Norge
- Rikshospitalet HF University Hospital, Cardiac Outpatient Clinic
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Inget ingripande: 1
|
|
Experimentell: 3
Decision Counseling Program(DCP) combined with Coronary Artery Disease Decision Aid (CAD-DA) described in Arm 2
|
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. |
Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Health Related Quality of Life
Tidsram: Repeated measures prior to patients angiogram and 2, 4, and 6 months after angiogram
|
Repeated measures prior to patients angiogram and 2, 4, and 6 months after angiogram
|
Health outcomes (angina symptoms, body weight, cholesterol level, blood pressure, health service use)
Tidsram: Repeated measures prior to patients angiogram and 2, 4, and 6 months after angiogram
|
Repeated measures prior to patients angiogram and 2, 4, and 6 months after angiogram
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Intermediate outcome: adherence to cardiac risk factor modification behavior
Tidsram: Repeated measure 2, 4, and 6 months after angiogram
|
Repeated measure 2, 4, and 6 months after angiogram
|
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
Tidsram: Prior to patients angiogram, and 2 months following angiogram
|
Prior to patients angiogram, and 2 months following angiogram
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Cornelia M Ruland, PhD, Oslo University Hospital
Publikationer och användbara länkar
Allmänna 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
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- S-07207a
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