Vinaya Manchaiah, Jerker Rönnberg, Gerhard Andersson, Thomas Lunner
{"title":"在基于互联网的听力残疾人士配戴前咨询中使用 \"患者历程 \"模型:从一次失败的临床试验中汲取的经验教训。","authors":"Vinaya Manchaiah, Jerker Rönnberg, Gerhard Andersson, Thomas Lunner","doi":"10.1186/1472-6815-14-3","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Persons with a hearing impairment have various experiences during their 'journey' through hearing loss. In our previous studies we have developed 'patient journey' models of person with hearing impairment and their communication partners (CPs). The study was aimed to evaluate the effectiveness of using the patient journey model in the internet-based pre-fitting counseling of a person with hearing disability (ClinicalTrials.gov Protocol Registration System: NCT01611129, registered 2012 May 14).</p><p><strong>Method: </strong>The study employed a randomized controlled trial (RCT) with waiting list control (WLC) design. Even though we had intended to recruit 158 participants, we only managed to recruit 80 participants who were assigned to one of two groups: (1) Intervention group; and (2) WLC. Participants from both groups completed a 30 day internet-based counseling program (group 2 waited for a month before intervention) based on the 'patient journey' model. Various outcome measures which focus on self-reported hearing disability, self-reported depression and anxiety, readiness to change and self-reported hearing disability acceptance were administered pre- and post-intervention.</p><p><strong>Results: </strong>The trial results suggest that the intervention was not feasible. Treatment compliancy was one of the main problems with a high number of dropouts. Only 18 participants completed both pre- and post-intervention outcome measures. Their results were included in the analysis. Results suggest no statistically significant differences among groups over time in all four measures.</p><p><strong>Conclusions: </strong>Due to the limited sample size, no concrete conclusions can be drawn about the hypotheses from the current study. Furthermore, possible reasons for failure of this trial and directions for future research are discussed.</p>","PeriodicalId":39843,"journal":{"name":"BMC Ear, Nose and Throat Disorders","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2014-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3991917/pdf/","citationCount":"0","resultStr":"{\"title\":\"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.\",\"authors\":\"Vinaya Manchaiah, Jerker Rönnberg, Gerhard Andersson, Thomas Lunner\",\"doi\":\"10.1186/1472-6815-14-3\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Persons with a hearing impairment have various experiences during their 'journey' through hearing loss. In our previous studies we have developed 'patient journey' models of person with hearing impairment and their communication partners (CPs). The study was aimed to evaluate the effectiveness of using the patient journey model in the internet-based pre-fitting counseling of a person with hearing disability (ClinicalTrials.gov Protocol Registration System: NCT01611129, registered 2012 May 14).</p><p><strong>Method: </strong>The study employed a randomized controlled trial (RCT) with waiting list control (WLC) design. Even though we had intended to recruit 158 participants, we only managed to recruit 80 participants who were assigned to one of two groups: (1) Intervention group; and (2) WLC. Participants from both groups completed a 30 day internet-based counseling program (group 2 waited for a month before intervention) based on the 'patient journey' model. Various outcome measures which focus on self-reported hearing disability, self-reported depression and anxiety, readiness to change and self-reported hearing disability acceptance were administered pre- and post-intervention.</p><p><strong>Results: </strong>The trial results suggest that the intervention was not feasible. Treatment compliancy was one of the main problems with a high number of dropouts. Only 18 participants completed both pre- and post-intervention outcome measures. Their results were included in the analysis. Results suggest no statistically significant differences among groups over time in all four measures.</p><p><strong>Conclusions: </strong>Due to the limited sample size, no concrete conclusions can be drawn about the hypotheses from the current study. Furthermore, possible reasons for failure of this trial and directions for future research are discussed.</p>\",\"PeriodicalId\":39843,\"journal\":{\"name\":\"BMC Ear, Nose and Throat Disorders\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2014-04-07\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3991917/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"BMC Ear, Nose and Throat Disorders\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1186/1472-6815-14-3\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMC Ear, Nose and Throat Disorders","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1186/1472-6815-14-3","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"Medicine","Score":null,"Total":0}
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.
Background: Persons with a hearing impairment have various experiences during their 'journey' through hearing loss. In our previous studies we have developed 'patient journey' models of person with hearing impairment and their communication partners (CPs). The study was aimed to evaluate the effectiveness of using the patient journey model in the internet-based pre-fitting counseling of a person with hearing disability (ClinicalTrials.gov Protocol Registration System: NCT01611129, registered 2012 May 14).
Method: The study employed a randomized controlled trial (RCT) with waiting list control (WLC) design. Even though we had intended to recruit 158 participants, we only managed to recruit 80 participants who were assigned to one of two groups: (1) Intervention group; and (2) WLC. Participants from both groups completed a 30 day internet-based counseling program (group 2 waited for a month before intervention) based on the 'patient journey' model. Various outcome measures which focus on self-reported hearing disability, self-reported depression and anxiety, readiness to change and self-reported hearing disability acceptance were administered pre- and post-intervention.
Results: The trial results suggest that the intervention was not feasible. Treatment compliancy was one of the main problems with a high number of dropouts. Only 18 participants completed both pre- and post-intervention outcome measures. Their results were included in the analysis. Results suggest no statistically significant differences among groups over time in all four measures.
Conclusions: Due to the limited sample size, no concrete conclusions can be drawn about the hypotheses from the current study. Furthermore, possible reasons for failure of this trial and directions for future research are discussed.
期刊介绍:
BMC Ear, Nose and Throat Disorders is an open access journal publishing original peer-reviewed research articles in all aspects of the prevention, diagnosis and management of ear, nose and throat disorders, as well as related molecular genetics, pathophysiology, and epidemiology. BMC Ear, Nose and Throat Disorders (ISSN 1472-6815) is indexed/tracked/covered by PubMed, CAS, EMBASE, Scopus and Google Scholar.