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一项针对慢性肌肉骨骼疼痛的基于互联网的疼痛教育与锻炼计划的可行性、可用性及实施背景:ReabilitaDOR计划的试点试验

Feasibility, Usability, and Implementation Context of an Internet-Based Pain Education and Exercise Program for Chronic Musculoskeletal Pain: Pilot Trial of the ReabilitaDOR Program.

作者信息

Fioratti Iuri, Miyamoto Gisela Cristiane, Fandim Junior Vitorino, Ribeiro Camila Pereira Pontes, Batista Geovana Domingues, Freitas Gabriella Evangelista, Palomo Andressa Santos, Reis Felipe José Jandré Dos, Costa Leonardo Oliveira Pena, Maher Christopher G, Saragiotto Bruno Tirotti

机构信息

Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo, São Paulo, Brazil.

Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health, Amsterdam, Netherlands.

出版信息

JMIR Form Res. 2022 Aug 30;6(8):e35743. doi: 10.2196/35743.

Abstract

BACKGROUND

Internet-based self-management programs and telerehabilitation initiatives have increased and have been extensively used for delivering health care in many areas. These programs overcome common barriers that patients face with traditional face-to-face health care, such as travel expenditures, lack of time, and high demand on the public health system. During the COVID-19 pandemic, this mode of web-based health care delivery had become more popular. However, there is still a lack of studies testing this mode of delivery in low- and middle-income countries. To gain a better understanding of the context, feasibility, and factors involved in the implementation of a web-based program, pilot and implementation studies are necessary. These studies can better inform whether a strategy is feasible, acceptable, and adequate for its purposes and for optimizing resource allocation.

OBJECTIVE

This study aims to evaluate the feasibility, usability, and implementation context of a self-management internet-based program based on exercises and pain education (ReabilitaDOR) in people with chronic musculoskeletal pain and to compare this program with a program using only a web-based self-management booklet.

METHODS

The study design was a parallel pilot study of a prospectively registered, assessor-blinded, 2-arm randomized controlled trial with economic evaluation. This study was performed using waiting lists of physiotherapy and rehabilitation centers and advertisements on social media networks. The participants were 65 patients with chronic musculoskeletal pain aged between 18 and 60 years. The effects of an 8-week telerehabilitation program based on exercises and pain education (intervention group) were compared with those of a program based only on a web-based self-management booklet (control group). The main outcome measures were implementation outcomes of patients' perceptions of acceptability, appropriateness, feasibility, and usability of the program and the societal costs and feasibility of the main trial at 8-week posttreatment follow-up. Adverse events were also analyzed.

RESULTS

In total, 56 participants were analyzed at the 8-week follow-up. The intervention group showed responses with a mean of 4.5 (SD 0.6) points for acceptability, 4.5 (SD 0.5) points for appropriateness, and 4.5 (SD 0.6) points for feasibility measured on a 1 to 5 scale. All patients in the intervention group showed satisfactory responses to the system usability outcome. There is satisfactory evidence for the feasibility of the main trial. For costs related to the interventions, health care, patients, and loss of productivity at 8 weeks, we found a total expenditure of US $278.30 per patient in the intervention group and US $141.52 per patient in the control group. No adverse events were reported during the intervention period.

CONCLUSIONS

We found that the ReabilitaDOR program is feasible, appropriate, and acceptable from the users' implementation perspective. This system was considered usable by all the participants, and the main trial seemed feasible. Cost data were viable to be collected, and the program is likely to be safe.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04274439; https://clinicaltrials.gov/ct2/show/NCT04274439.

摘要

背景

基于互联网的自我管理项目和远程康复计划不断增加,并已在许多领域广泛用于提供医疗保健服务。这些项目克服了患者在传统面对面医疗保健中面临的常见障碍,如交通费用、时间不足以及对公共卫生系统的高需求。在新冠疫情期间,这种基于网络的医疗保健提供模式变得更加流行。然而,在低收入和中等收入国家,仍缺乏对这种提供模式的研究。为了更好地了解基于网络的项目实施的背景、可行性和相关因素,开展试点和实施研究很有必要。这些研究可以更好地说明一种策略对于其目的以及优化资源分配而言是否可行、可接受和适当。

目的

本研究旨在评估基于运动和疼痛教育的自我管理互联网项目(ReabilitaDOR)在慢性肌肉骨骼疼痛患者中的可行性、可用性和实施背景,并将该项目与仅使用基于网络的自我管理手册的项目进行比较。

方法

本研究设计为一项前瞻性注册、评估者盲法、双臂随机对照试验的平行试点研究,并进行经济评估。本研究利用物理治疗和康复中心的等候名单以及社交媒体网络上的广告开展。参与者为65名年龄在18至60岁之间的慢性肌肉骨骼疼痛患者。将基于运动和疼痛教育的8周远程康复项目(干预组)的效果与仅基于网络自我管理手册的项目(对照组)的效果进行比较。主要结局指标为患者对项目的可接受性、适宜性、可行性和可用性的感知的实施结局,以及治疗后8周主要试验的社会成本和可行性。还对不良事件进行了分析。

结果

在8周随访时共分析了56名参与者。干预组在1至5分的量表上,可接受性平均得分为4.5(标准差0.6)分,适宜性平均得分为4.5(标准差0.5)分,可行性平均得分为4.5(标准差0.6)分。干预组的所有患者对系统可用性结局均表现出满意的反应。有充分证据表明主要试验具有可行性。对于干预、医疗保健、患者以及8周时生产力损失相关的成本,我们发现干预组每位患者的总支出为278.30美元,对照组每位患者为141.52美元。干预期间未报告不良事件。

结论

我们发现,从用户实施的角度来看,ReabilitaDOR项目是可行、适宜且可接受的。该系统被所有参与者认为可用,主要试验似乎可行。成本数据能够收集,且该项目可能是安全的。

试验注册

ClinicalTrials.gov NCT04274439;https://clinicaltrials.gov/ct2/show/NCT04274439

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/00ee/9472033/d28d347a9c09/formative_v6i8e35743_fig1.jpg

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