- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00248846
A Randomized Trial: Changing Behavior in Post-Angioplasty Patients
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Among coronary artery disease patients who have just had either angioplasty or stents, the objective of this randomized trial is to evaluate whether a novel behavioral intervention that employs induced positive affect and self-affirmation is more effective than an intervention without positive affect in increasing the maintenance of newly initiated physical activity post-procedure.
Secondary objectives:
- To determine whether more patients who receive the positive affect and self-affirmation intervention initiate more multiple behavior changes (e.g., changes in more health behaviors directed to their risk-factor profile) than those in the control group at one year.
- To determine whether the positive affect and self-affirmation intervention increases physical activity among patients who have depressive symptoms.
- To determine whether patients who are successful in increasing physical activity are more successful at changing other health behaviors.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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New York
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New York, New York, États-Unis, 10021
- The New York Presbyterian Hospital-Weill Medical Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- All patients undergoing coronary artery catheterization who are found to have at least single vessel stenosis and who have had revascularization with angioplasty or coronary artery stenting will be eligible for enrollment.
- Patients must be able to provide informed consent within the one week after the procedure.
Exclusion Criteria:
- Patients who are unable to walk several blocks regardless of the reason will be excluded from all the trials (e.g., arthritis, stroke, claudication).
- Enrollment in other trials designed to modify post-procedure behaviors.
- Patients who refuse to participate will be excluded.
- If at any time prior to enrollment in the study, the patient's cardiologist determines that the patient should not participate in this study, the patient will not be enrolled in the trial.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Aucune intervention: Control Group
This group received follow-up every 2-months for one year.
Follow-up included questions about their heart disease progression and how well they had been able to engage in their doctor approved physical activity goal.
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Expérimental: Intervention Group
This group received follow-up every 2-months for one year.
Follow-up included questions about their heart disease progression and how well they had been able to engage in their doctor approved physical activity goal, which was the same as the control arm.
Additionally, subjects in this arm were encouraged to use positive affect and self-affirmation techniques to motivate an increased level of participation in their physical activity goal.
These subjects also received small token gifts to remind them of their study participation.
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During the physical activity goal setting process, subjects were randomly assigned to either the control or the intervention group.
The intervention included receiving an additional educational workbook about using positive affect and self affirmation, as well as participating in using positive affect and self-affirmation to motivate behavior change, which in this case was to increase their physical activity level.
Patient also received small token gifts to remind them of their participation in the study and to induce positive affect.
The control group also set a physical activity goal and received the same follow-up, but did not participate in the positive affect and self-affirmation portion.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Within patient change in the Paffenbarger Exercise and Physical Activity Index
Délai: basline, at 2-month intervals(2, 4, 6, 8, 10-months) and closeout
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basline, at 2-month intervals(2, 4, 6, 8, 10-months) and closeout
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Collaborateurs et enquêteurs
Publications et liens utiles
Publications générales
- Peterson JC, Allegrante JP, Pirraglia PA, Robbins L, Lane KP, Boschert KA, Charlson ME. Living with heart disease after angioplasty: A qualitative study of patients who have been successful or unsuccessful in multiple behavior change. Heart Lung. 2010 Mar-Apr;39(2):105-15. doi: 10.1016/j.hrtlng.2009.06.017. Epub 2009 Aug 25.
- Charlson ME, Boutin-Foster C, Mancuso CA, Peterson JC, Ogedegbe G, Briggs WM, Robbins L, Isen AM, Allegrante JP; Translational Behavioral Science Research Consortium. Randomized controlled trials of positive affect and self-affirmation to facilitate healthy behaviors in patients with cardiopulmonary diseases: rationale, trial design, and methods. Contemp Clin Trials. 2007 Nov;28(6):748-62. doi: 10.1016/j.cct.2007.03.002. Epub 2007 Mar 12.
- Peterson JC, Charlson ME, Hoffman Z, Wells MT, Wong SC, Hollenberg JP, Jobe JB, Boschert KA, Isen AM, Allegrante JP. A randomized controlled trial of positive-affect induction to promote physical activity after percutaneous coronary intervention. Arch Intern Med. 2012 Feb 27;172(4):329-36. doi: 10.1001/archinternmed.2011.1311. Epub 2012 Jan 23.
- Peterson JC, Charlson ME, Wells MT, Altemus M. Depression, coronary artery disease, and physical activity: how much exercise is enough? Clin Ther. 2014 Nov 1;36(11):1518-30. doi: 10.1016/j.clinthera.2014.10.003. Epub 2014 Nov 14.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- N01-HC-25196 (0203-694)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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