- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03304535
Social Worker in an Eye-Care Service
The Impact of a Social Worker in a Glaucoma Eye-Care Service: A Prospective Study
Aperçu de l'étude
Statut
Les conditions
Description détaillée
An appointment will be scheduled for participant to meet with a social worker. The appointment may happen on day of participant's scheduled clinic appointment or on another mutually decided upon date and time. Should participant choose to participate, this first visit will be Visit 1 for the study.
Visit 1: Baseline
Informed consent will be obtained demonstrating an interest in participating.
A visit with the social worker will take place during Visit 1. This session will be held in a private office and allows participant time for discussion regarding any challenges, struggles and/or barriers they may be experiencing.
The following baseline questionnaires/surveys will be administered:
Modified Patient Activation Measure - measures participant confidence in taking care of their own health.
Distress Thermometer - measures participant distress level during the past week.
Patient Health Questionnaire -measures depression symptoms and severity if any.
Clinical information will be taken from participant's medical record. There may be follow-up questions related to data if information is unclear or incomplete.
Upon completion of Visit 1, participant will receive a satisfaction survey to evaluate how participant satisfaction with social worker interaction.
Social Worker Interventions: After Visit 1 and before Visit 2
The social worker will develop an intervention for participant during Visit 1 appointment. As many calls or in person meetings participant requires will take place. There will be no limit and it will be determined by participant's needs.
Visit 2: Follow-up After 6 Months
Upon completion of participant's six month follow-up in the study, the following questionnaires/surveys will be administered:
Modified Patient Activation Measure - measures how confident participant is at taking care of their own health.
Distress Thermometer - measures how much distress participant has been experiencing in the past week.
Patient Health Questionnaire - measures if participant has symptoms of depression and the severity of those symptoms.
Satisfaction Survey - measures how satisfied participant is with the social worker interaction.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19107
- Wills Eye Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Patients seen at Wills Eye Hospital in the Glaucoma Service
- Glaucoma of any type, characterized by glaucomatous optic neuropathy and corresponding visual field (VF) defect
- Referred to staff social worker for intervention
- Ability to read, write, speak and understand English
Exclusion Criteria:
- None
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in response to Patient Health Questionnaire 9
Délai: 6 months
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Measures participant levels of depression based on questions related to depressive symptoms.
The investigator will assess change in the number of participants with major, moderate, and minimal depressive symptoms.
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6 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in response to Distress thermometer
Délai: 6 months
|
Measures participant level of distress on a scale of 1 to 10 and asks additional questions regarding contributors to distress.
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6 months
|
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Change in response to Modified Patient Activation Measure 13
Délai: 6 months
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Measures participant self-capacity for and confidence regarding glaucoma management.
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6 months
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Descriptive results of the Social Worker Baseline Assessment
Délai: 6 months
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Social worker will assess each participant's internal and external barriers to care, limitations, and strengths that may help them to manage their glaucoma.
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6 months
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Scott J Fudemberg, MD, Wills Eye Hospital
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 (Réel)
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
- IRB#15-XXX
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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