- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01920256
Provider-Initiated Regular Remote Interventions for Optimal Type 2 Diabetes Care
Patients with type 2 diabetes can attain superior disease outcomes if multiple therapy goals are simultaneously achieved and maintained. In reality, therapy goals are seldom achieved, and patients become susceptible to devastating complications and greater health care expenses. Studies have shown that regular monitoring and therapy adjustments are a prerequisite to achieving and maintaining therapy goals. Unfortunately implementation of regular monitoring and therapy adjustments have been hindered by high clinic workload and shortage of endocrinologists. Due to this shortage, endocrine care is accessible to less than 20% of patients with type 2 diabetes. The overwhelming majority are managed by providers who may lack the necessary expertise or time to deliver optimal disease management, particularly when insulin is prescribed.
Objectives: We hypothesize that type 2 diabetes endocrine clinics for high-risk patients that complement primary care, personalize the frequency of remote disease interventions and employ infrequent face-to-face outpatient visits, will achieve comparable clinical outcomes and patient satisfaction compared to usual endocrine clinic care, while reducing workload and increasing the clinic capacity. The intervention clinic will employ regular remote communications initiated by the endocrinologists, based on tailored individual plans. Frequent remote monitoring and interventions will reinforce attainment of the therapy goals and allow a decrease in the frequency of outpatient visits. In turn, the clinic workload will decrease and it will be able to accommodate more patients with type 2 diabetes than traditional endocrine clinics. The aims of the study are to test this new endocrine clinic model in a clinical trial by monitoring clinical parameters, patient satisfaction and clinical workload. The long-term objectives are to modify the current model of endocrine care for patients with type 2 diabetes.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Michigan
-
Ann Arbor, Michigan, États-Unis, 48109
- University of Michigan Health System
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Men or women aged ≥18 years of age;
- Clinical diagnosis of type 2 diabetes (as defined by the American Diabetes Association 2);
- Treated with insulin or at least two diabetes medications;
- Have A1C ≥8.0% and ≤11.0%;
- Able and willing to use telephone or other sorts of communication regularly between clinic visits.
Exclusion Criteria:
- Do not speak English;
- Unwilling or unable to provide informed consent;
- Have any condition associated with life expectancy of less than 3 years;
- Have an active mental illness or substance abuse
Plan d'étude
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 |
|---|---|
|
Expérimental: Personalized type 2 diabetes care.
Remote, personalized type 2 diabetes clinic provided by an endocrinologist using frequent remote contacts for medication adjustments.
|
Diabetes and comorbidities will be managed with 1 clinic visit per year and frequent adjustments made remotely.
|
|
Comparateur actif: Usual Endocrine Care
Usual Endocrine care will be provided by an endocrinologist.
|
Diabetes and comorbidities management will provided by an endocrinologist
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in baseline A1C (glycated hemoglobin) at 12 months
Délai: 12 months
|
Measure of long-term blood glucose control and efficacy of intervention
|
12 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in baseline lipids at 12 months
Délai: 12 months
|
Measure of total cholesterol, LDL, and Triglycerides
|
12 months
|
|
Change in baseline blood pressure at 12 months
Délai: 12 months
|
Systolic and diastolic blood pressure
|
12 months
|
|
All cause mortality
Délai: 12 months
|
Record deaths due to any cause
|
12 months
|
|
Acute complications
Délai: 12 months
|
Cardiovascular events, cerebrovascular events, peripheral vascular events, limb ulcers and amputations, severe hypoglycemia, and other unscheduled emergency department and hospital visits
|
12 months
|
|
Change in baseline Quality of life at 12 months
Délai: 12 months
|
Short Form-36
|
12 months
|
|
Change in baseline insulin satisfaction at 12 months
Délai: 12 months
|
Insulin Therapy Satisfaction Questionnaire
|
12 months
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Clinic retention
Délai: 12 months
|
Missed visits, missed phone calls, lost to follow up and drops outs will be recorded for both groups
|
12 months
|
|
Cost
Délai: 12 months
|
Resource utilization and cost for both groups
|
12 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Israel Hodish, MD, PhD, University of Michigan
Publications et liens utiles
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 (Réel)
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
- UMichigan
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 .