Erlen Judith A, Sereika Susan M
Center for Research in Chronic Disorders, School of Nursing, University of Pittsburgh, 440 Victoria Bldg., Pittsburgh, PA 15261, USA.
Nurs Res. 2006 Mar-Apr;55(2 Suppl):S17-22. doi: 10.1097/00006199-200603001-00004.
Researchers have been conducting efficacy and effectiveness studies on interventions that address medication-taking behavior in patients with HIV infection. However, they also must examine the fidelity to the research protocol for the delivery of the intervention.
The aims of this study were to determine the level of fidelity to each of the specified end points (number of intervention sessions, session duration, number of telephone calls per session, the length of time between sessions, sessions with multiple interventions, and attrition from the intervention protocol) in the delivery of the 12-week, nurse-delivered, structured telephone intervention designed to improve medication adherence and to determine the factors (race, gender, and socioeconomic status) related to participation in the intervention.
This descriptive correlational study was a substudy of a larger randomized clinical trial (N = 200) testing the effectiveness of a 12-week nurse-delivered intervention designed to improve medication adherence to antiretroviral medications in persons with HIV infection. The Intervention Tracking Form was used to collect data on all intervention delivery end points during the delivery of the structured intervention. A sociodemographic questionnaire was used to collect the sociodemographic characteristics of the sample.
Two thirds of the sample (n = 66) were male, and slightly more than half were White. The average age was 39.68 (SD = 7.98) years. The average number of intervention sessions delivered was 8.1 (SD = 4.07). Participants were more likely to receive the first five intervention sessions (n = 77, 77.8%), and 21 (21.2%) dropped out of treatment before it was completed. Nearly one quarter (n = 24, 24.2%) of the sample had doubled-up interventions. Intervention sessions lasted, on average, 11.3 min. Typically, more than one telephone call was needed before the participant was reached (M = 2.2). The mean number of days between sessions was 11.5 days. Women were more likely to have doubled-up interventions (p = .036). There was a marginally significant difference (p = .075) in the number of sessions received between the Whites and non-Whites: Whites (M = 8.8, SD = 3.9) received slightly more sessions compared with non-Whites (M = 7.24, SD = 4.2). When examining the interaction effects between the demographic factors considered, a race-by-income effect was observed for the mean number of attempts to contact the participant (p = .044).
These results demonstrate a lack of fidelity to the research intervention protocol. Factors beyond the researchers' control may have influenced fidelity to the intervention protocol.
研究人员一直在对针对艾滋病毒感染患者服药行为的干预措施进行疗效和效果研究。然而，他们还必须检查干预措施实施过程中对研究方案的依从性。
本研究的目的是确定在实施为期12周、由护士提供的结构化电话干预措施（旨在提高药物依从性）时，对每个指定终点（干预疗程数、疗程时长、每个疗程的电话次数、疗程之间的时间间隔、包含多种干预措施的疗程以及干预方案的损耗率）的依从程度，并确定与参与干预措施相关的因素（种族、性别和社会经济地位）。
这项描述性相关性研究是一项更大规模随机临床试验（N = 200）的子研究，该试验测试了一项为期12周、由护士提供的干预措施对提高艾滋病毒感染者抗逆转录病毒药物依从性的有效性。在实施结构化干预期间，使用干预跟踪表收集所有干预实施终点的数据。使用社会人口统计学问卷收集样本的社会人口统计特征。
样本中有三分之二（n = 66）为男性，略多于一半为白人。平均年龄为39.68岁（标准差 = 7.98）。平均实施的干预疗程数为8.1个（标准差 = 4.07）。参与者更有可能接受前五个干预疗程（n = 77，77.8%），21人（21.2%）在治疗完成前退出。样本中近四分之一（n = 24，24.2%）有重复干预。干预疗程平均持续11.3分钟。通常，在联系到参与者之前需要拨打不止一个电话（M = 2.2）。疗程之间的平均天数为11.5天。女性更有可能有重复干预（p = .036）。白人和非白人接受的疗程数存在边缘显著差异（p = .075）：白人（M = 8.8，标准差 = 3.9）接受的疗程略多于非白人（M = 7.24，标准差 = 4.2）。在检查所考虑的人口统计学因素之间的交互作用时，观察到在联系参与者的平均尝试次数上存在种族与收入的交互作用（p = .044）。
这些结果表明对研究干预方案缺乏依从性。研究人员无法控制的因素可能影响了对干预方案的依从性。
