Polibienestar Research Institute, University of Valencia, Valencia, Spain.
CIBER-Obn Physiopathology of Obesity and Nutrition, Instituto de Salud Carlos III, Madrid, Spain.
PLoS One. 2022 Nov 8;17(11):e0273290. doi: 10.1371/journal.pone.0273290. eCollection 2022.
Patients with chronic disease represent an at-risk group in the face of the COVID-19 crisis as they need to regularly monitor their lifestyle and emotional management. Coping with the illness becomes a challenge due to supply problems and lack of access to health care facilities. It is expected these limitations, along with lockdown and social distancing measures, have affected the routine disease management of these patients, being more pronounced in low- and middle-income countries with a flawed health care system.
The purpose of this study is to describe a protocol for a randomized controlled trial to test the efficacy of the Adhera® MejoraCare Digital Program, an mHealth intervention aimed at improving the quality of life of patients with chronic diseases during the COVID-19 outbreak in Paraguay.
A two-arm randomized controlled trial will be carried out, with repeated measures (baseline, 1-month, 3-month, 6-month, and 12-month) under two conditions: Adhera® MejoraCare Digital Program or waiting list. The primary outcome is a change in the quality of life on the EuroQol 5-Dimensions 3-Levels Questionnaire (EQ-5D-3L). Other secondary outcomes, as the effect on anxiety and health empowerment, will be considered. All participants must be 18 years of age or older and meet the criteria for chronic disease. A total of 96 participants will be recruited (48 per arm).
It is expected that the Adhera® MejoraCare Digital Program will show significant improvements in quality of life and emotional distress compared to the waiting list condition. Additionally, it is hypothesized that this intervention will be positively evaluated by the participants in terms of usability and satisfaction. The findings will provide new insights into the viability and efficacy of mHealth solutions for chronic disease management in developing countries and in times of pandemic.
ClinicalTrials.gov NCT04659746.
在 COVID-19 危机面前，慢性病患者是一个高危群体，因为他们需要定期监测自己的生活方式和情绪管理。由于供应问题和获得医疗保健设施的机会有限，应对疾病成为一项挑战。预计这些限制因素，加上封锁和社会隔离措施，会影响这些患者的常规疾病管理，在医疗体系不完善的中低收入国家，这种影响更为明显。
本研究旨在描述一项随机对照试验的方案，以测试 Adhera® MejoraCare 数字计划的疗效，该计划是一种 mHealth 干预措施，旨在改善巴拉圭 COVID-19 爆发期间慢性病患者的生活质量。
将进行一项两臂随机对照试验，在两种条件下进行重复测量（基线、1 个月、3 个月、6 个月和 12 个月）：Adhera® MejoraCare 数字计划或候补名单。主要结果是欧洲五维健康量表 3 级问卷（EQ-5D-3L）的生活质量变化。还将考虑其他次要结果，如对焦虑和健康赋权的影响。所有参与者必须年满 18 岁，并符合慢性病标准。将招募 96 名参与者（每组 48 名）。
预计 Adhera® MejoraCare 数字计划将在生活质量和情绪困扰方面与候补名单条件相比显示出显著改善。此外，假设该干预措施在可用性和满意度方面将得到参与者的积极评价。研究结果将为发展中国家在大流行期间使用 mHealth 解决方案管理慢性病的可行性和疗效提供新的见解。
ClinicalTrials.gov NCT04659746。
