- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00314197
Improving Health Behaviors Through Telephone Linked Care
Study That Examines Integration of the Telephone Linked Care Behavioral Change (Automated Counseling) System Into Primary Care
The investigators propose to conduct a randomized controlled trial at the patient level of the Telephone Linked Care - Behavioral Change (TLC-BC) system, which is designed to promote smoking cessation, reduce risky drinking, and improve physical activity and diet. They expect to:
- successfully integrate an automated telephone behavior change intervention into primary care practices;
- demonstrate improvement in health behaviors for individuals randomized (assigned by systematic chance) to use the TLC-BC system compared to individuals who receive written health education informational packets; and
- evaluate the direct costs associated with the use and operation of the TLC-BC system.
Project aims and hypotheses follow:
Aim 1: Integrate a proven, totally automated computer telephone intervention, Telephone Linked Care - Behavior Change (TLC-BC), into primary care practices. This will be assessed by the patient and clinician/staff surveys at the end of data collection.
Aim 2: Demonstrate an improvement in health behaviors for individuals randomized to use the TLC-BC system compared to individuals who receive written informational packets.
Aim 3: Evaluate the direct costs associated with the use and operation of the TLC-BC system within the primary care setting.
Hypothesis 1: The Telephone Linked Care - Behavioral Change system will be successfully implemented by patients and practices.
Hypothesis 2: At 6 months a clinically significant improvement in behavioral change rates will be demonstrated for diet, physical activity, and smoking in the intervention group compared to patients in the control group.
Hypothesis 3: At baseline, 3, 6, and 9 months risky drinking will be identified, but there will be no difference in improvement between the study groups.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Kansas
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Leawood, Kansas, États-Unis, 66211-2672
- American Academy of Family Physicians National Research Network
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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:
- 18 years or older
- Capable of giving informed consent
- Reliable access to a phone
- Able to read English
Exclusion Criteria:
- Less than 18 years of age
- Not capable of giving informed consent
- No reliable access to a phone
- Unable to read English (including blindness)
- Too ill to participate
- Not willing to allow the Telephone Linked Care - Behavior Change system to provide health information reports based on responses to physician
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Aucun (étiquette ouverte)
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
At 6 months a clinically significant improvement in behavioral change rates will be demonstrated for diet, physical activity and smoking in the intervention group compared to patients in the control group
Délai: 6 months
|
6 months
|
|
At baseline, 3, 6, and 9 months risky drinking will be identified, but there will be no difference in improvement between the study groups.
Délai: baseline, 3, 6, and 9 months
|
baseline, 3, 6, and 9 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Wilson D Pace, MD, FAAFP, American Academy of Family Physicians National Research Network
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
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 (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 06-005
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