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一项基于动机性访谈干预以提高阻塞性睡眠呼吸暂停综合征患者持续气道正压通气依从性的随机对照试验的研究方案:MotivAir研究

Study protocol of a randomized controlled trial of motivational interviewing-based intervention to improve adherence to continuous positive airway pressure in patients with obstructive sleep apnea syndrome: The MotivAir study.

作者信息

Rapelli Giada, Pietrabissa Giada, Angeli Licia, Manzoni Gian Mauro, Tovaglieri Ilaria, Perger Elisa, Garbarino Sergio, Fanari Paolo, Lombardi Carolina, Castelnuovo Gianluca

机构信息

Department of Psychology, Catholic University of the Sacred Heart, Milan, Italy.

Psychology Research Laboratory, Istituto Auxologico Italiano IRCCS, Milan, Italy.

出版信息

Front Psychol. 2022 Aug 25;13:947296. doi: 10.3389/fpsyg.2022.947296. eCollection 2022.

DOI:10.3389/fpsyg.2022.947296
PMID:36092104
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9456614/
Abstract

OBJECTIVE

This study aims to evaluate the effectiveness of the MotivAir program-a phone-based intervention based on Motivational Interviewing (MI) principles and techniques-in enhancing adherence to Continuous Positive Airway Pressure (CPAP) therapy among patients with Obstructive Sleep Apnea Syndrome (OSAS).

METHODS

A multicenter randomized controlled trial (RCT) design with random allocation at the level of the individual will be conducted to compare the impact of the experimental program (usual care MI) with a control group receiving usual care only in improving selected clinical and psychological parameters in the patients. A minimum sample of 80 participants (40 patients per group) will be recruited in each center according to the inclusion criteria. After the initial screening, participants will be randomly assigned to either the experimental group or the control condition. The program will last 180 days and will be delivered by a trained nurse. The impact of the MotivAir program on selected primary (adherence to CPAP in terms of average hours of usage per night and the Apnea-Hypopnea Index, AHI) and secondary (motivation, perceived competence, quality of life, sleepiness) outcomes will be measured at baseline, and after 1-, 3-, and 6-month from CPAP initiation.

DISCUSSION

Participants are expected to show an increased level of adherence to CPAP and to acquire the skills and self-confidence necessary to deal with the psychological consequences of their chronic condition.

摘要

目的

本研究旨在评估MotivAir项目(一种基于动机性访谈(MI)原则和技巧的电话干预措施)在提高阻塞性睡眠呼吸暂停综合征(OSAS)患者持续气道正压通气(CPAP)治疗依从性方面的有效性。

方法

将进行一项多中心随机对照试验(RCT),在个体层面进行随机分配,以比较实验项目(常规护理+MI)与仅接受常规护理的对照组在改善患者选定的临床和心理参数方面的影响。每个中心将根据纳入标准招募至少80名参与者(每组40名患者)。在初步筛查后,参与者将被随机分配到实验组或对照组。该项目将持续180天,由一名经过培训的护士实施。将在基线时以及开始使用CPAP后的1个月、3个月和6个月测量MotivAir项目对选定的主要结局(每晚平均使用小时数和呼吸暂停低通气指数(AHI)方面的CPAP依从性)和次要结局(动机、自我效能感、生活质量、嗜睡)的影响。

讨论

预计参与者对CPAP的依从性水平会提高,并获得应对其慢性病心理后果所需的技能和自信。

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