- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01930656
Mobile Device to Help FRAX® Screening
The Effectiveness of Using Mobile Device and the World Health Organization Fracture Risk Assessment Tool (FRAX®) to Assist Osteoporosis Assessment and Management
Background: The Taiwanese FRAX® (Fracture Risk Assessment Tool) calculator is available online for clinical use. Our Taiwanese Osteoporosis Clinical Treatment Guidelines suggests using the American high risk cut-points for considering treatment but also suggests deriving domestic cut-points from cost-effective approach. Establishing cost-effective domestic cut-points for policy suggestions coupled with mobile devices with wireless access would potentially increase the usage of FRAX® tool.
Objectives: 1) Using literature review to establish cost-effectiveness FRAX® cut-points. 2) To assess the effectiveness of mobile devices assisted FRAX® tool based osteoporosis diagnostic and management model. 3) To provide FRAX® based reimbursement policy suggestions.
Methods: 1) Investigators will use FRAX®, cost-effectiveness and other key words to search Pubmed and international osteoporosis guidelines to better understand the clinical applications of FRAX® in other countries. Investigators will also search epidemiological data for osteoporosis, facture, quality of life and cost to establish domestic cost-effeteness, and translational approach FRAX® cut-points. 2) Three targeting populations from National Taiwan University Hospital (NTUH) are selected for prospective study (Group A: geriatric health exam clinics with American cut-points, group B: orthopedic clinics with translational approach cut-points and group C: endocrine clinics with cost-effectiveness cut-points,). A mobile device with app application coupled with the FRAX® tool is used by a trained research assistant during clinic waiting periods to screen and enroll high risk (75 from each clinic) adults with informed consents. Participants are referred to geriatric clinics for systemic osteoporosis diagnoses and managements. Percentage of participants that meet the current NHI medication reimbursement regulation and percentage of self-pay medications are calculated. Analysis is stratified by age and gender. 3) The impacts of 3 different cut-points on increment NHI reimbursement are estimated. An osteoporosis expert group meeting is to be held for FRAX® based osteoporosis medication reimbursement modifications to the NHI and the Department of Health.
Expected Outcomes: 1) To establish the mobile device assisted FRAX® based osteoporosis screening and management model. 2) Base on the study results and expert consensus, investigators will provide policy suggestions of FRAX® based reimbursement modifications.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Taipei, Taïwan, 100
- National Taiwan University Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- age 40-90
- screen high risk from FRAX
Exclusion Criteria:
- treated with anti-osteoporosis medications within last 3-12 months (depends on medication types)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Group A, B, C
Group A- American cut-point Group B- Translational approach cut-point Group C- Cost-effectiveness cut-point
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Number of enrollment cases
Délai: in 6 month
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target 75 in each group, total 225
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in 6 month
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Ding-Cheng Chan, MD, PhD, National Taiwan University Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
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 (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 201208029RIC
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