确定慢性多症状退伍军人随机远程保健试点研究的可行性和可接受性。

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Charity B Breneman, Kamila Pollin, Timothy Chun, Lucas Crock, Walter Jachimowicz, Rebecca A McCullers, Ryan C Brewster, Adil Alaoui, Anas Belouali, Michael J Roy, Matthew J Reinhard, Michelle E Costanzo
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引用次数: 0

摘要

背景:向以患者为中心的整体医疗保健模式的转变为退伍军人慢性多症状疾病(CMI)的症状管理提供了一种有希望的方法。一种旨在减少认知控制失调的行为干预可能是有帮助的,认知控制失调是CMI退伍军人中常见的损伤的组成部分。因此,本研究旨在探讨远程健康心理和身体(MAP)训练干预的可行性、安全性和可接受性。方法:采用两组随机试验,参与者被随机分为两组,一组接受为期8周的定向MAP训练方案(dMAP),每周通过短信接受指导;另一组接受为期8周的自我指导MAP训练(sgMAP),除了干预目标外不接受指导。除了分娩外,两组的MAP干预措施是相同的,包括每周两次MAP培训课程和一次电话健康指导课程。该研究的主要目的是评估可行性(例如,招募、保留和依从率;远程医疗MAP干预的安全性(如不良事件)和可接受性(如满意度)。结果:在44名可能符合条件的退伍军人中,26名被随机分配到dMAP组(n = 13)或sgMAP组(n = 13),招募率为59%(26/44例患者)。2名受试者在随机化后退出,共24名受试者用于分析。终点和3个月随访时的保留率为79.2% (19/24;dMAP:sgMAP = 9:10)和62.5% (15/24;dMAP:sgMAP = 7:8)。参与者平均完成了48.2%的MAP课程(7.7/16次;dMAP:sgMAP = 7.9:7.5次)和82.8%的健康指导(6.6/8次;dMAP:sgMAP = 7.2:6.2 sessions)。缺失的数据很少,没有与研究相关的不良事件的报道。接受度很高,因为退伍军人对可穿戴设备感到满意,并重视健康指导支持。结论:本初步研究为大规模随机对照试验的可行性提供了见解,该试验通过促进冥想和体育活动来增强认知控制以促进自我调节。未来的努力应该扩大招聘策略,增加内部数据质量监控。试验注册:NCT04164667,回顾性注册于2019年11月12日,https://clinicaltrials.gov/study/NCT04164667。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Determining the feasibility and acceptability of a randomized telehealth pilot study for veterans with chronic multisymptom illness.

Determining the feasibility and acceptability of a randomized telehealth pilot study for veterans with chronic multisymptom illness.

Background: The shift toward a patient-centered and whole health care model offers a promising approach for the management of symptoms among veterans with chronic multisymptom illness (CMI). A behavioral intervention aimed at reducing cognitive control dysregulation which is a component of impairments common among veterans with CMI may be helpful. Therefore, a pilot study was conducted to explore the feasibility, safety, and acceptability of a telehealth mental and physical (MAP) training intervention among veterans with CMI.

Methods: Utilizing a two-arm randomized trial, participants were either randomized to 8 weeks of a directed MAP training protocol (dMAP) that received weekly guidance via text messaging or 8 weeks of self-guided MAP training (sgMAP) which did not receive guidance aside from the intervention goals. The MAP intervention was the same for both groups except for the delivery and consisted of two MAP training sessions and one telephone health coaching session per week. The primary aim of the study was to evaluate the feasibility (e.g., recruitment, retention, and adherence rates; amount of missing data), safety (e.g., adverse events), and acceptability (e.g., satisfaction) of a telehealth MAP intervention.

Results: Out of 44 potentially eligible veterans, 26 were randomized to either the dMAP group (n = 13) or the sgMAP group (n = 13), resulting in a recruitment rate of 59% (26/44 patients). Two participants withdrew after randomization, resulting in 24 participants used for analyses. The retention rates at endpoint and 3-month follow-up were 79.2% (19/24; dMAP:sgMAP = 9:10) and 62.5% (15/24; dMAP:sgMAP = 7:8), respectively. Participants completed an average of 48.2% of the MAP sessions (7.7/16 sessions; dMAP:sgMAP = 7.9:7.5 sessions) and 82.8% of the health coaching sessions (6.6/8 sessions; dMAP:sgMAP = 7.2:6.2 sessions). Missing data was minimal, and no adverse events related to the study were reported. Acceptability was high as veterans were satisfied with the wearables and valued the health coaching support.

Conclusions: This pilot study provides insights into the feasibility of a large-scale randomized control trial that promotes meditation and physical activity to augment cognitive control to facilitate self-regulation. Future efforts should expand recruitment strategies and add internal data quality monitoring.

Trial registration: NCT04164667, retrospectively registered November 12, 2019, https://clinicaltrials.gov/study/NCT04164667.

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来源期刊
Pilot and Feasibility Studies
Pilot and Feasibility Studies Medicine-Medicine (miscellaneous)
CiteScore
2.70
自引率
5.90%
发文量
241
审稿时长
9 weeks
期刊介绍: Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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