The Utility of Telemedicine in the Management of Migraine: A Pilot Study :MK0974-071-00
Collecte de données
Données recueillies dès le début de l'étude - ProspectiveMaladies du cerveau+8
+ Maladies du système nerveux central
+ Maladies du système nerveux
Écologique ou Communautaire
Analyse de données collectives pour comprendre l'impact de l'environnement ou du mode de vie sur la santé d'une population.Résumé
Date de début de l'étude : 1 octobre 2012
Date à laquelle le premier participant a commencé l'étude.After obtaining informed consent, patients will be randomly assigned to receive their follow-up care via telemedicine or in-office visits. All subjects will complete a MIDAS questionnaire and allodynia questionnaire at their initial visit. Follow-up visits will be scheduled at 4-6 weeks, 3, 6, 9 and 12 months. In-person follow-up visits will be conducted in the standard fashion of the current physician's practice, with the initial intake conducted by an ophthalmic technician or resident, followed by the physician visit. Telemedicine visits will be conducted by the physician and recorded. Similar information will be gathered in both groups including: current medications, interim medical and headache history (including visits to the ED or hospitalizations for headache), description of headache, response to treatment (including adverse reactions), allergies, blood pressure and weight. Subjects randomized to telemedicine will be asked to have their blood pressure and weight measured within 5 days of their telemedicine session at a location convenient to them. We will record the length of each visit. Subjects in the in-person group, will be queried about travel time, and the total amount of time for the visit, and any activities missed to attend the visit. We will also ask about other costs associated with attending the office visit, such as child care. At the one-year follow-up visit, subjects will complete the MIDAS, allodynia questionnaire, Modified Group Health Association of America's Consumer Satisfaction scale, and have the opportunity to express their views on the aspect of care received in a semi-structured interview. The follow-up questionnaires may be completed on line (telemedicine group, optional for in-person group) or on paper (in-person group). Headache diaries will be provided on line or may be done on paper, a smartphone, or a computer program of the subject's choosing. All subjects will be able to access the physician by telephone, using MyChart, or with additional non-study visits as needed. Subjects will be responsible for the cost of the medications, treatments prescribed, and laboratory monitoring needed for their condition. Support staff will be available to help set up the video system for subjects assigned to the telemedicine group who are in need of assistance.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.45 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Écologique ou communautaire
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 89 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria:• Ages 18 - 89 years Diagnosis of migraine with or without aura, menstrual migraine, hemiplegic migraine Able to provide informed consent Able, in the opinion of the investigator, to reliably perform all aspects of the study Ownership of or access to a computer and high speed internet Criteria for Exclusion of Subjects: Age less than 18 years Headache type is not migraine No ownership or access to a computer or high speed internet Unfamiliar with basic computer operations or uncomfortable using a computer Unwilling to participate Unable to read English (because of assessment tools) History of another medical, psychiatric, social or behavioral problem that, in the opinion of the investigator, makes it unlikely that they will be able to complete the study activities. Questions regarding mood and anxiety are asked of all patients as part of their initial evaluation for headache.
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Objectifs de l'étude
Objectifs principaux
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Universit of Texas Southwestern
Dallas, United StatesOuvrir Universit of Texas Southwestern dans Google Maps