- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01595269
The Clinical and Economic Impacts of e-Heath on Diabetes (eHealthDM)
8 mai 2012 mis à jour par: Dr. Danièle Pacaud
This project addresses the following Null Hypotheses:
- There will be no difference will be found in the use of the search engine and the information accessed among the three education modes.
- There will be no difference in education mode's effect on metabolic control, self-care management practices, and medical resource utilization.
- There will be no difference in the economic impact on the health care system based on differing education modes.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
In addition to the face-to-face education process currently used at the CHR, this project will develop two modes of eHealth education.
Education mode 1 (control) is comprised of participants educated using CHR's current traditional face-to-face delivery method, with printed materials and written log journals.
These participants will be trained to use the University's web portal if they elect to access internet-based diabetes information.
This allows for the tracking of the type and amounts of diabetes information accessed by participants.
Education mode 2 (static interface) participants will be educated using digitized forms of the traditional materials provided by CHR as well as an electronic log journal (e-journal) where participants will record their diabetes-related outcomes and behavioural information.
Education mode 2 will be assessed and approved by CHR.
Education mode 3 (dynamic interface) participants will be educated using the digitized traditional materials from education mode 2 as well as an enhanced dynamic e-journal (visualization of blood glucose and alerts).
In addition, this mode will provide informative disease-related internet sites and diabetes news and articles vetted by the medical team.
Participants and health professionals will then be able to electronically discuss the content and quality of this information (discussion board).
New sites and articles will be added on an ongoing basis.
Participants will also have access to a chat room that will encourage information sharing with other education mode 3 participants and health professionals at CHR. Education mode 3 will be assessed and approved by CHR.
Type d'étude
Interventionnel
Inscription (Réel)
79
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Alberta
-
Lethbridge, Alberta, Canada
- Calgary Health Region's offices across southwestern Alberta
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Aged 18 or older
- Literate
- Not participating in other clinical trials
- Diabetes diagnosed within the last three months
- Type 2 diabetes
- No medical conditions that could compromise metabolic control
- No linguistic, cognitive or psychosocial barriers that would hinder study completion
- Computer and internet literate
- Access to high-speed internet
Exclusion Criteria:
- Under the age of 18
- Not literate
- Participating in other clinical trials
- Diabetes diagnosed greater than three months ago
- Type 1 diabetes
- Gestational diabetes
- Additional medical conditions that could compromise metabolic control
- Linguistic, cognitive or psychosocial barriers that would hinder study completion
- Not computer and internet literate
- No access to high-speed internet
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur placebo: Education mode 1 (control)
Education mode 1 (control) is comprised of participants educated using CHR's current traditional face-to-face delivery method, with printed materials and written log journals.
These participants will be trained to use the University's web portal if they elect to access internet-based diabetes information.
This allows for the tracking of the type and amounts of diabetes information accessed by participants.
|
In addition to the face-to-face education process currently used at the CHR, Education mode 1 (control), Education mode 2 (static interface) and Education mode 3 (dynamic interface) will be used.
|
Comparateur actif: Education mode 2 (static interface)
Education mode 2 (static interface) participants will be educated using digitized forms of the traditional materials provided by CHR as well as an electronic log journal (e-journal) where participants will record their diabetes-related outcomes and behavioural information.
Education mode 2 will be assessed and approved by CHR.
|
In addition to the face-to-face education process currently used at the CHR, Education mode 1 (control), Education mode 2 (static interface) and Education mode 3 (dynamic interface) will be used.
|
Comparateur actif: Education mode 3 (dynamic interface)
Education mode 3 (dynamic interface) participants will be educated using the digitized traditional materials from education mode 2 as well as an enhanced dynamic e-journal (visualization of blood glucose and alerts).
In addition, this mode will provide informative disease-related internet sites and diabetes news and articles vetted by the medical team.
Participants and health professionals will then be able to electronically discuss the content and quality of this information (discussion board).
New sites and articles will be added on an ongoing basis.
Participants will also have access to a chat room that will encourage information sharing with other education mode 3 participants and health professionals at CHR. Education mode 3 will be assessed and approved by CHR.
|
In addition to the face-to-face education process currently used at the CHR, Education mode 1 (control), Education mode 2 (static interface) and Education mode 3 (dynamic interface) will be used.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Changes in A1C
Délai: baseline, 3, 6, 9, 12 months
|
A1C is a measure of metabolic control in diabetes.
For this study changes in A1C from baseline to 3, 6, 9 and 12 months were measured.
All A1C were measured in provincial laboratories using 6.1% as the upper limit of normal for individuals without diabetes.
|
baseline, 3, 6, 9, 12 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
a reduction in the cost of delivering health information and education processes
Délai: baseline and 12 months
|
Secondary effects could include a change in the cost of delivering health information and education processes.
Potential changes to self-care management practices of people with type II diabetes could lead to a reduced utilization of the heath care system resulting in a positive economic impact.
|
baseline and 12 months
|
Changes in Diabetes Knowledge
Délai: baseline, 3, 6, 9, 12 months
|
Changes in diabetes knowledge from baseline to 3, 6, 9, and 12 months will be measured using a 23 item multiple choice questionnaire devolopped by Fitzgerald et al 1998.
|
baseline, 3, 6, 9, 12 months
|
Changes in Diabetes self-care activities
Délai: Baseline, 3, 6, 9 and 12 months
|
Changes in diabetes self-care activities from base line to 3, 6, 9, and 12 months will be measured the diabetes self-care activities tool evaluated by Toobert at al (2000).
|
Baseline, 3, 6, 9 and 12 months
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Angela M Downey, PhD, CMA, FCMA, University of Lethbridge
- Chercheur principal: Helen Kelley, PhD, University of Lethbridge
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 avril 2007
Achèvement primaire (Réel)
1 décembre 2008
Achèvement de l'étude (Réel)
1 décembre 2009
Dates d'inscription aux études
Première soumission
3 mars 2011
Première soumission répondant aux critères de contrôle qualité
8 mai 2012
Première publication (Estimation)
10 mai 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
10 mai 2012
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 mai 2012
Dernière vérification
1 mai 2012
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- LAWSON-686
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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