一种嵌入咨询方案中的监测与反馈工具，用于增加初级保健中慢性阻塞性肺疾病（COPD）或2型糖尿病患者的身体活动：一项三臂整群随机对照试验的研究方案
A monitoring and feedback tool embedded in a counselling protocol to increase physical activity of patients with COPD or type 2 diabetes in primary care: study protocol of a three-arm cluster randomised controlled trial.
作者信息
Verwey Renée, van der Weegen Sanne, Spreeuwenberg Marieke, Tange Huibert, van der Weijden Trudy, de Witte Luc
机构信息
School for Public Health and Primary Care (CAPHRI), Maastricht University, Maastricht, the Netherlands.
出版信息
BMC Fam Pract. 2014 May 12;15:93. doi: 10.1186/1471-2296-15-93.
BACKGROUND
Physical activity is important for a healthy lifestyle. Although physical activity can delay complications and decrease the burden of the disease, the level of activity of patients with chronic obstructive pulmonary disease (COPD) or type 2 Diabetes Mellitus (DM2) is often far from optimal. To stimulate physical activity, a monitoring and feedback tool, consisting of an accelerometer linked to a smart phone and webserver (It's LiFe! tool), and a counselling protocol for practice nurses in primary care was developed (the Self-management Support Program). The main objective of this study is to measure the longitudinal effects of this counselling protocol and the added value of using the tool.
METHODS/DESIGN: This three-armed cluster randomised controlled trial with 120 participants with COPD and 120 participants with DM2 (aged 40-70), compares the counselling protocol with and without the use of the tool (group 1 and 2) with usual care (group 3). Recruitment takes place at GP practices in the southern regions of the Netherlands. Randomisation takes place at the practice level. The intended sample (three arms of 8 practices) powers the study to detect a 10-minute difference of moderate and intense physical activity per day between groups 1 and 3. Participants in the intervention groups have to visit the practice nurse 3-4 times for physical activity counselling, in a 4-6-month period. Specific activity goals tailored to the individual patient's preferences and needs will be set. In addition, participants in group 1 will be instructed to use the tool in daily life. The primary outcome, physical activity, will be measured in all groups with a physical activity monitor (PAM). Secondary outcomes are quality of life, general - and exercise - self-efficacy, and health status. Follow-up will take place after 6 and 9 months. Separately, a process evaluation will be conducted to explore reasons for trial non-participation, and the intervention's acceptability for participating patients and nurses.
DISCUSSION
Results of this study will give insight into the effects of the It's LiFe! monitoring and feedback tool combined with care from a practice nurse for people with COPD or DM2 on physical activity.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT01867970.
背景
体育活动对健康的生活方式很重要。虽然体育活动可以延缓并发症并减轻疾病负担，但慢性阻塞性肺疾病（COPD）或2型糖尿病（DM2）患者的活动水平往往远未达到最佳状态。为了促进体育活动，开发了一种监测和反馈工具，该工具由连接到智能手机和网络服务器的加速度计（“It's LiFe！”工具）以及针对初级保健中执业护士的咨询方案（自我管理支持计划）组成。本研究的主要目的是衡量该咨询方案的纵向效果以及使用该工具的附加价值。
方法/设计：这项三臂整群随机对照试验纳入了120名COPD患者和120名DM2患者（年龄在40 - 70岁之间），将使用工具和不使用工具的咨询方案（第1组和第2组）与常规护理（第3组）进行比较。招募在荷兰南部地区的全科医生诊所进行。随机分组在诊所层面进行。预期样本（8个诊所的三个组）使该研究有能力检测第1组和第3组之间每天中度和剧烈体育活动10分钟的差异。干预组的参与者必须在4 - 6个月内拜访执业护士3 - 4次以接受体育活动咨询。将根据个体患者的偏好和需求设定具体的活动目标。此外，第1组的参与者将被指导在日常生活中使用该工具。主要结局指标，即体育活动，将在所有组中使用体育活动监测器（PAM）进行测量。次要结局指标包括生活质量、总体和运动自我效能以及健康状况。将在6个月和9个月后进行随访。另外，将进行一项过程评估，以探究不参与试验的原因以及干预措施对参与患者和护士的可接受性。
讨论
本研究结果将深入了解“ It's LiFe！”监测和反馈工具结合执业护士护理对COPD或DM2患者体育活动的影响。
试验注册
ClinicalTrials.gov：NCT01867970。
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