Acupuncture for Symptom Management in Veterans with Hepatitis C

针灸治疗丙型肝炎退伍军人的症状

• 批准号: 8597281
• 负责人: Patricia Taylor-Young
• 金额: --
• 依托单位: PORTLAND VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-02-01 至 2014-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8597281
• 关键词: Acupuncture Therapy; Acupuncture procedure; Adherence; Adverse effects; Affect; Antiviral Agents; Antiviral Therapy; Caring; Chronic; Cirrhosis; Complement; Data; Disease; Effectiveness; Epidemiologic Studies; Equipment and supply inventories; Evaluation; Fatigue; Goals; Health Surveys; Healthcare; Hepatitis C; Hepatitis C virus; Individual; Infection; Intervention; Interview; Liver diseases; Living Costs; Measures; Mental Depression; Methods; Outcome; Pain; Participant; Patients; Pilot Projects; Population; Primary carcinoma of the liver cells; Protocols documentation; Provider; Public Health; Qualitative Methods; Quality of life; Questionnaires; Randomized Controlled Trials; Research; Sample Size; Sampling; Staging; Symptoms; Time; Treatment Protocols; Treatment outcome; United States; Veterans; Visual Analogue Pain Scale; care burden; center for epidemiological studies depression scale; depressive symptoms; experience; health administration; improved; interferon therapy; liver transplantation; longitudinal design; programs; prospective; psychologic; symptom management

DESCRIPTION (provided by applicant): The primary aim of the proposed mixed method pilot study is to describe the experience of two groups of Veterans with hepatitis C (HCV): (1) Veterans that have HCV, but who are not undergoing antiviral treatment and (2) Veterans that have HCV and who are receiving antiviral treatment. An additional aim is to determine the acceptability and feasibility of an 8 week acupuncture program in managing symptoms commonly experienced by both groups. This pilot study will allow us to calculate a sample size for a full-scale trial. We will also establish whether there is sufficient benefit from acupuncture therapy to warrant further study with a randomized control trial. The study will use a prospective descriptive longitudinal design using qualitative and quantitative methods. Mixed methods are justified for this study because the two methods complement each other and the combined use of quantitative and qualitative data allows for a more in-depth understanding of the acceptability and feasibility of using acupuncture to manage the symptoms commonly experienced by individuals with HCV and individuals with HCV on antiviral therapy. Research Aim #1: To describe, using qualitative methods, the experience of undergoing acupuncture therapy for symptom management in (1) Veterans with HCV and who are not receiving antiviral therapy and (2) Veterans with HCV who are receiving antiviral therapy. Research Aim #2: To explore and describe the acceptability and feasibility of acupuncture therapy for symptom management in (1) Veterans with HCV and who are not receiving antiviral therapy and (2) Veterans with HCV who are receiving antiviral therapy. Research Aim #3: To explore and describe symptom (depression, pain, and fatigue) changes over time following acupuncture in (1) Veterans with HCV and who are not receiving antiviral therapy and (2) Veterans with HCV who are receiving antiviral therapy. Project Methods: The convenience sample will include 20 veterans with HCV and 20 veterans with HCV undergoing antiviral therapy. Quantitative data will be obtained using the Brief Fatigue Inventory(c) (BFI), Visual Analogue Pain Scale (VAS 100), Center for Epidemiological Studies Depression Scale (CES-D), Memorial Symptom Assessment Scale- short form (MSAS-SF) and VR-36. Data will be collected over a period of 12 weeks from 20 individuals with HCV and 20 individuals with HCV undergoing antiviral therapy. Qualitative data will be collected from a subset of the larger quantitative sample. Individuals will attend two acupuncture sessions each week for a total of 8 weeks. The acupuncture will be administered in a group setting. Outcomes will be collected at baseline, weeks 2, 4, 6, 8, and participants will complete a questionnaire packet at weeks 1 and 2 after the final acupuncture session. Qualitative data will be collected from a subset of individuals of the larger quantitative sample. A total of 8-10 individuals with HCV and 8-10 individuals with HCV undergoing antiviral therapy will be interviewed. The first interview will take place before the first acupuncture session and the second between week 6 and 8 of the acupuncture intervention. As part of our assessment of the feasibility of acupuncture therapy for symptoms in HCV patients, we will measure compliance with treatment (acupuncture). These will be obtained for each of the two study groups. Qualitative data will be analyzed using content analysis.

描述（由申请人提供）： 拟议的混合方法试点研究的主要目的是描述两组患有丙型肝炎 (HCV) 的退伍军人的经历：(1) 患有 HCV，但未接受抗病毒治疗的退伍军人；(2) 患有 HCV 的退伍军人以及正在接受抗病毒治疗的人。另一个目的是确定为期 8 周的针灸计划在管理两组常见症状方面的可接受性和可行性。这项试点研究将使我们能够计算全面试验的样本量。我们还将确定针灸疗法是否有足够的益处，以保证通过随机对照试验进行进一步研究。该研究将采用定性和定量方法的前瞻性描述性纵向设计。本研究证明混合方法是合理的，因为这两种方法相辅相成，定量和定性数据的结合使用可以更深入地了解使用针灸治疗 HCV 和 HCV 患者常见症状的可接受性和可行性。接受抗病毒治疗的 HCV 患者。研究目标#1：使用定性方法描述 (1) 患有 HCV 且未接受抗病毒治疗的退伍军人和 (2) 患有 HCV 且正在接受抗病毒治疗的退伍军人接受针灸治疗进行症状管理的经验。研究目标#2：探索和描述针灸疗法用于症状管理的可接受性和可行性（1）患有丙型肝炎且未接受抗病毒治疗的退伍军人和（2）患有丙型肝炎且正在接受抗病毒治疗的退伍军人。研究目标#3：探索和描述 (1) 患有 HCV 且未接受抗病毒治疗的退伍军人和 (2) 患有 HCV 且正在接受抗病毒治疗的退伍军人针灸后症状（抑郁、疼痛和疲劳）随时间的变化。项目方法：方便样本将包括 20 名患有 HCV 的退伍军人和 20 名正在接受抗病毒治疗的 HCV 退伍军人。定量数据将通过简短疲劳量表(c) (BFI)、视觉模拟疼痛量表 (VAS 100)、流行病学研究中心抑郁量表 (CES-D)、纪念症状评估量表 - 简式 (MSAS-SF) 获得和VR-36。数据将在 12 周内从 20 名 HCV 感染者和 20 名接受抗病毒治疗的 HCV 感染者中收集。定性数据将从较大定量样本的子集中收集。个人每周将参加两次针灸课程，总共 8 周。针灸将在小组中进行。结果将在基线、第 2、4、6、8 周收集，参与者将在最后一次针灸疗程后的第 1 周和第 2 周填写问卷包。定性数据将从较大定量样本的一部分个体中收集。将采访总共 8-10 名 HCV 感染者和 8-10 名正在接受抗病毒治疗的 HCV 感染者。第一次访谈将在第一次针灸疗程之前进行，第二次访谈将在针灸干预的第 6 周至第 8 周之间进行。作为我们评估针灸治疗 HCV 患者症状可行性的一部分，我们将衡量治疗（针灸）的依从性。这些将为两个研究组中的每一个获得。将使用内容分析来分析定性数据。