Internet-based Pre-fitting Counseling of Persons With Hearing Impairment
16 avril 2013 mis à jour par: Thomas Lunner
Use of the 'Patient Journey' Model in the Internet-based Pre-fitting Counseling of a Person With Hearing Impairment: A Randomized Controlled Trial
The purpose of this study is to determine whether the use of 'patient journey' model in internet-based counseling of a person with hearing impairment is a feasible approach in management of emotional and social consequences, anxiety and depression, readiness to change and acceptance of hearing loss.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
80
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Swansea, Royaume-Uni, CB1 1PT
- Department of Vision and Hearing Sciences, Anglia Ruskin University
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Linköping, Suède, 58185
- The Swedish Institute for Disability Research, Linköping University
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Ages over 18 years old
- Have symptoms of hearing difficulty
- Access to internet
Exclusion Criteria:
- HHQ results too low (i.e., below 20),
- Participants using hearing aids
- Those with additional disabilities (e.g., visual impairment, learning disability, dementia, and so on) which may affect individuals' ability to participate in an internet-based program
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: reading about hearing loss and its management
General self-reading reading about hearing loss and its management This would run for 30 days and the participants have to manage their own time.
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Stage 1 - introduction to the concept of the patient journey and presenting the participants series of questions which may help them to explore their journey through hearing loss; Stage 2 - patient journey model of PHI and 2 case examples will be presented.
The PHI will be advised to compare their journey to the model presented and identify the similarities and differences; Stage 3 - communication partners' journey model will be presented and the PHI will be asked to consider how interactions between each other may affect various things in the physical, mental and social domains; and Stage 4 - patients will be encouraged to think about how the PHI & CP may influence each other during their journey through hearing loss, how they can overcome some of the difficulties they may be experiencing and to think about the potential benefits and the challenges from the audiological management.
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Expérimental: Internet-based counseling
This would involve 4 stages of designated internet sessions and additional tasks which the patients can complete in their own time.
This programme should be completed within 30 days.
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Stage 1 - introduction to the concept of the patient journey and presenting the participants series of questions which may help them to explore their journey through hearing loss; Stage 2 - patient journey model of PHI and 2 case examples will be presented.
The PHI will be advised to compare their journey to the model presented and identify the similarities and differences; Stage 3 - communication partners' journey model will be presented and the PHI will be asked to consider how interactions between each other may affect various things in the physical, mental and social domains; and Stage 4 - patients will be encouraged to think about how the PHI & CP may influence each other during their journey through hearing loss, how they can overcome some of the difficulties they may be experiencing and to think about the potential benefits and the challenges from the audiological management.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Hearing Handicap Questionnaire (HHQ)
Délai: One week pre-treatment, One week post treatment, Six-moths follow-up
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Change from baseline in reported emotional and social consequences due to hearing impairment one week post treatment. Hearing Handicap Questionnaire (HHQ) - Change from baseline |
One week pre-treatment, One week post treatment, Six-moths follow-up
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Hospital Anxiety and Depression Scale (HADS)
Délai: One week pre-treatment, One week post treatment, Six moths follow-up
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Change from baseline in reported depression and anxiety symptoms one week post treatment. Hospital Anxiety and Depression Scale (HADS) - Change from baseline |
One week pre-treatment, One week post treatment, Six moths follow-up
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University of Rhode Island Change Assessment Scale (URICA)
Délai: One week pre-treatment, One week post treatment, Six months follow-up
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Change from baseline in readiness for change one week post treatment.
University of Rhode Island Change Assessment Scale (URICA) - Change from baseline.
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One week pre-treatment, One week post treatment, Six months follow-up
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Hearing Impairment Acceptance Questionnaire (HIAQ)
Délai: One week pre-treatment, One week post treatment, Six months follow-up
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Change from baseline in acceptance of hearing loss one week post treatment.
Hearing Impairment Acceptance Questionnaire (HIAQ) - Change from baseline.
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One week pre-treatment, One week post treatment, Six months follow-up
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Manchaiah VK, Stephens D, Andersson G, Ronnberg J, Lunner T. Use of the 'patient journey' model in the internet-based pre-fitting counseling of a person with hearing disability: study protocol for a randomized controlled trial. Trials. 2013 Jan 24;14:25. doi: 10.1186/1745-6215-14-25.
- Manchaiah V, Ronnberg J, Andersson G, Lunner T. Use of the 'patient journey' model in the internet-based pre-fitting counseling of a person with hearing disability: lessons from a failed clinical trial. BMC Ear Nose Throat Disord. 2014 Apr 7;14(1):3. doi: 10.1186/1472-6815-14-3.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 novembre 2012
Achèvement primaire (Réel)
1 février 2013
Achèvement de l'étude (Réel)
1 février 2013
Dates d'inscription aux études
Première soumission
14 mai 2012
Première soumission répondant aux critères de contrôle qualité
31 mai 2012
Première publication (Estimation)
4 juin 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
17 avril 2013
Dernière mise à jour soumise répondant aux critères de contrôle qualité
16 avril 2013
Dernière vérification
1 avril 2013
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- FAS-IT-03
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 .