- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00031265
Efficacy of a Family Telephone Intervention for Stroke
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Stroke is a major health problem which affects an estimated half million persons each year. In many cases family members assume the long-term burden of care after hospital discharge. Methods such as family education, peer support groups, and counseling are available to help meet the needs of caregivers, by enhancing their coping abilities. Family intervention also potentially benefits patients by improving the quality of caregiving skills. Few investigations have examined the benefits of family intervention methods.
This trial will study the effectiveness of a family-based, telephone-administered intervention called Family Intervention: Telephone Tracking (FITT) for acute stroke patients and their caregivers. Study patients will be recruited from those admitted to the Rhode Island Hospital following an acute stroke. All patients and caregivers will receive standard medical care. In addition, these patients and their caregivers will be randomly assigned to one of two treatment conditions: FITT or no intervention. Treatments will begin once the patient returns home and will continue for a six-month period.
During the trial, specially trained staff will carefully monitor the progress of the stroke patient and his/her family member, checking for changing in thinking, concentration, attention, memory, mood, and family functioning that sometimes occurs in stroke. Participants will be contacted by telephone every week for 6 weeks, then every 2 weeks for 2 months, and then monthly for 2 months. The telephone calls will check on how the participants are doing after discharge and will assist with questions and concerns.
Type d'étude
Inscription
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
-
-
Rhode Island
-
Providence, Rhode Island, États-Unis, 02769
- Rhode Island Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion criteria:
- age > 35 years,
- MRI or CAT scan proof of stroke or definitive hemiplegia, and
- competency to sign an informed consent form.
Exclusion criteria:
- presence of subarachnoid hemorrhage, transient ischemic attack or subdural hematoma,
- significant medical disorder severe enough to require hospitalization within the 3 months prior to stroke,
- functional psychosis,
- absence of a caregiver (anyone living within a 30 minute drive who is available and willing to attend to patient),
- admitted from nursing home (since these patients are likely to return to the nursing home) and
- inability to speak English.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Ivan W. Miller, Ph.D.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
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
- R01NS037840 (Subvention/contrat des NIH des États-Unis)
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 .
Essais cliniques sur Family Intervention Telephone Tracking
-
Children's National Research InstituteNational Institute of Nursing Research (NINR); National Institutes of Health... et autres collaborateursActif, ne recrute pas
-
National Institute of Diabetes and Digestive and...ComplétéDiabète sucré, Type 2États-Unis
-
The University of Hong KongComplétéActivité physiqueHong Kong
-
Northwell HealthComplétéDépression postpartum | Mauvais traitements envers les enfants, soupçonnés | Maltraitance des enfants non précisée, confirméeÉtats-Unis
-
University of Alabama, TuscaloosaNational Institute of Nursing Research (NINR)ComplétéLa douleur | Soins palliatifs | Troubles de la rétention, cognitifs | Autre maladie chroniqueÉtats-Unis
-
IWK Health CentreCanadian Institutes of Health Research (CIHR)ComplétéTrouble oppositionnel avec provocation | Trouble du comportementCanada
-
IWK Health CentreMcGill University; Canadian Institutes of Health Research (CIHR); University... et autres collaborateursActif, ne recrute pasTroubles neurodéveloppementaux | Troubles du comportementCanada