Telehealth Tinnitus Intervention for Patients with TBI

TBI 患者的远程医疗耳鸣干预

• 批准号: 8181312
• 负责人: JAMES A HENRY
• 金额: --
• 依托单位: PORTLAND VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-10-01 至 2014-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8181312
• 关键词: Accounting; Address; Adverse effects; Afghanistan; Aftercare; Anxiety; Appointment; Auditory; Auditory system; Blast Cell; Blast Injuries; Categories; Clinical; Clinical Research; Clinical Trials Design; Cognitive; Cognitive Therapy; Conflict (Psychology); Consent; Consent Forms; Counseling; Data Analyses; Development; Disabled Persons; Ear; Emotional; Epidemiologic Studies; Equipment and supply inventories; Evaluation; Event; Evidence based program; Exposure to; Freedom; Functional disorder; Geographic Locations; Gunshot wound; Hearing; Hearing Aids; Home environment; Hospitals; Human Resources; Individual; Injury; Instruction; Intervention; Iraq; Mails; Medical; Medical center; Memory; Mental Depression; Methods; Military Personnel; Nature; Noise; Outcome Measure; Pain; Participant; Patients; Pharmaceutical Preparations; Pilot Projects; Post-Traumatic Stress Disorders; Protocols documentation; Psychologist; Questionnaires; Randomized; Randomized Clinical Trials; Reporting; Research; Secondary to; Series; Services; Site; Sleep Disorders; Sports; Symptoms; TBI Patients; Telephone; Testing; Tinnitus; Trauma; Traumatic Brain Injury; Treatment Efficacy; Vehicle crash; Veterans; Violence; abstracting; assault; base; brief intervention; cost; design; evidence base; experience; falls; flyer; handicapping condition; hearing impairment; improved; indexing; interest; intervention program; meetings; member; novel; operation; prevent; primary outcome; programs; screening; self help; telehealth; treatment as usual

DESCRIPTION (provided by applicant): Project Summary/Abstract Traumatic brain injury (TBI) is strongly associated with tinnitus. Tinnitus management for Veterans and military personnel with TBI has become a critical concern. Our research has focused on developing effective, evidence-based methods of tinnitus management for Veterans. These efforts led to the development of Progressive Tinnitus Management (PTM). We are completing a pilot study to adapt PTM to meet the unique tinnitus management needs of Veterans and military members with TBI using a novel home-based telehealth program called Telehealth Tinnitus Intervention (TTI). Preliminary data analyses indicate that TTI is effective. The present study will modify the TTI program in accordance with pilot study findings and evaluate the modified TTI using a randomized clinical trial design. During the first 3 months, TTI will be further modified for more efficient implementation and to improve efficiency and therapeutic efficacy. Information about the study and recruitment flyers will be provided to all potential recruitment sites. The flyer will include a toll-free telephone number and interested callers talk to the Research Assistant (RA) who conducts screening to determine: (a) if the caller has a tinnitus problem warranting the intervention; (b) the caller's probable TBI status; and (c) if the caller has had a hearing evaluation within the past 2 years (and uses hearing aids if recommended). Callers who pass screening are sent a package containing the informed consent form (ICF) and baseline questionnaires. About one week after screening, the Research Coordinator (RC) calls the candidate to (a) explain the ICF; (b) assess capacity to consent; and (c) provide instructions for completing and returning the questionnaires and ICF. After the signed ICF has been received by the RC, the Study Psychologist calls the participant to determine TBI status and conduct screening for anxiety, depression, PTSD, and sleep disorder. Following this call, the RC randomizes the participant to receive either immediate-TTI or Usual Care (UC). (UC participants will receive TTI after 6 months.) The total number of participants required (based on power analysis) is 336. The predicted number of subjects for each category (based on the pilot study recruitment rates) are 168 for mild TBI, 24 for moderate/severe TBI, and 144 for no TBI (total n=336). TTI intervention involves a series of seven telephone appointments, conducted at approximately 2, 3, 4, 5, and 6 weeks, and 3 and 6 months after receipt of the signed ICF. Prior to TTI Appointment 1, participants receive a self-help workbook by mail. At Appointment 1 (week 2) the Psychologist initiates intervention based on Cognitive-Behavioral Therapy (CBT), which is continued at Appointments 3 and 5 (weeks 4 and 6). At Appointment 2 (week 3), the Study Audiologist initiates audiologic counseling, which continues at Appointments 4, 6, and 7 (week 5, months 3 and 6). Additional appointments can be made if necessary to meet intervention needs. Participants complete questionnaires at baseline and at 3, 6, 9, and 12 months post- baseline. The UC group receives TTI after completing the 6-month questionnaires. The primary outcome measure is the Tinnitus Handicap Inventory.

描述（由申请人提供）： 项目摘要/摘要创伤性脑损伤（TBI）与耳鸣密切相关。 TBI的退伍军人和军事人员的耳鸣管理已成为一个关键问题。我们的研究重点是为退伍军人开发有效的，基于证据的耳鸣管理方法。这些努力导致了进步性耳鸣管理（PTM）的发展。我们正在完成一项试点研究，以适应PTM，以使用TBI使用新型的家庭远程医疗计划，以满足退伍军人和军人对独特的耳鸣管理需求，名为Telehealth Tinnitus Issestion（TTI）。初步数据分析表明TTI有效。本研究将根据初步研究发现修改TTI程序，并使用随机临床试验设计评估修改后的TTI。 在最初的三个月中，将进一步修改TTI，以进行更有效的实施并提高效率和治疗功效。有关研究和招聘传单的信息将提供给所有潜在的招聘场所。传单将包括免费电话号码和感兴趣的呼叫者与研究助理（RA）进行筛选以确定：（a）呼叫者是否有耳鸣问题，需要进行干预； （b）呼叫者的TBI状态； （c）如果呼叫者在过去2年内进行了听证会评估（并且建议使用助听器）。通过筛选的呼叫者将发送一个包含知情同意书（ICF）和基线问卷的软件包。筛选后约一个星期，研究协调员（RC）呼吁候选人（a）解释ICF； （b）评估同意的能力； （c）提供完成和返回问卷和ICF的说明。 RC收到签名的ICF后，研究心理学家呼吁参与者确定TBI状态并进行焦虑，抑郁，PTSD和睡眠障碍的筛查。在此通话之后，RC随机将参与者随机接收即时TTI或通常的护理（UC）。 （UC参与者将在6个月后接收TTI。）所需的参与者总数（基于权力分析）为336。每个类别的受试者的预测受试者数量（基于Pilot研究招聘率）为168，为168个，24对于中等/重度TBI，无TBI为144（总n = 336）。 TTI干预涉及一系列七个电话约会，在收到签名的ICF后约2、3、4、5和6周以及3和6个月进行。在TTI任命1之前，参与者通过邮件收到一个自助工作簿。在约会1（第2周），心理学家根据认知行为疗法（CBT）启动干预措施，该疗法在第3和5周（第4和6周）继续进行。在约会2（第3周）中，研究听力学家启动了听力学咨询，该咨询继续在约会4、6和7（第5周，第3和第6周）中继续进行。如有必要，可以进行其他约会以满足干预需求。参与者在基线和基线后3、6、9和12个月填写问卷。 UC组完成了为期6个月的问卷后，将收到TTI。主要结果指标是耳鸣障碍库存。