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。患有 TBI 的退伍军人和军事人员的耳鸣管理已成为一个重要问题。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。这些努力促成了渐进式耳鸣管理 (PTM) 的发展。我们正在完成一项试点研究，旨在利用名为远程医疗耳鸣干预 (TTI) 的新型家庭远程医疗计划，调整 PTM 以满足患有 TBI 的退伍军人和军人独特的耳鸣管理需求。初步数据分析表明TTI是有效的。本研究将根据试点研究结果修改 TTI 计划，并使用随机临床试验设计评估修改后的 TTI。 在前3个月内，TTI将进一步修改，以更有效地实施并提高效率和治疗效果。有关研究和招聘传单的信息将提供给所有潜在的招聘网站。传单上将包含一个免费电话号码，感兴趣的来电者可以与研究助理 (RA) 交谈，研究助理会进行筛选以确定： (a) 来电者是否有耳鸣问题，需要进行干预； (b) 致电者可能患有 TBI 状态； (c) 呼叫者是否在过去 2 年内进行过听力评估（并在建议的情况下使用助听器）。通过筛选的来电者会收到一个包含知情同意书 (ICF) 和基线调查问卷的包裹。筛选后大约一周，研究协调员 (RC) 会致电候选人 (a) 解释 ICF； (b) 评估同意的能力； (c) 提供填写和返还调查问卷和 ICF 的说明。 RC 收到签署的 ICF 后，研究心理学家会要求参与者确定 TBI 状态并进行焦虑、抑郁、创伤后应激障碍 (PTSD) 和睡眠障碍筛查。在此通话之后，RC 随机分配参与者接受立即 TTI 或常规护理 (UC)。 （UC 参与者将在 6 个月后接受 TTI。）所需的参与者总数（基于功效分析）为 336 名。每个类别的预测受试者数量（基于试点研究招募率）为 168 名轻度 TBI，24 名中度/重度 TBI 为 144 例，无 TBI 为 144 例（总计 n=336）。 TTI 干预涉及一系列七次电话预约，分别在收到签署的 ICF 后约 2、3、4、5 和 6 周以及 3 和 6 个月进行。在 TTI 预约 1 之前，参与者会通过邮件收到一本自助工作簿。在第 1 次预约（第 2 周），心理学家开始基于认知行为疗法 (CBT) 进行干预，并在第 3 次和第 5 次预约（第 4 周和第 6 周）继续进行干预。在预约 2（第 3 周），研究听力学家开始听力咨询，并在预约 4、6 和 7（第 5 周、第 3 和 6 个月）继续进行。如有必要，可以进行额外预约以满足干预需求。参与者在基线以及基线后 3、6、9 和 12 个月完成问卷。 UC组在完成6个月的调查问卷后接受TTI。主要结果指标是耳鸣障碍量表。