一项移动健康干预措施在提高多病共存和心力衰竭患者健康素养及自我管理能力方面的开发与效果：一项随机对照试验方案

Development and Effectiveness of a Mobile Health Intervention in Improving Health Literacy and Self-management of Patients With Multimorbidity and Heart Failure: Protocol for a Randomized Controlled Trial.

作者信息

Bas-Sarmiento Pilar, Fernández-Gutiérrez Martina, Poza-Méndez Miriam, Marín-Paz Antonio Jesús, Paloma-Castro Olga, Romero-Sánchez José Manuel

机构信息

Institute of Research and Innovation in Biomedical Sciences of the Province of Cádiz (INiBICA), University of Cádiz, Cádiz, Spain.

Department of Nursing and Physiotherapy, University of Cádiz, Cádiz, Spain.

出版信息

JMIR Res Protoc. 2022 Apr 29;11(4):e35945. doi: 10.2196/35945.

DOI:10.2196/35945

PMID:35486437

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9107042/

Abstract

BACKGROUND

Patients with multimorbidity and complex health needs are defined as a priority by the World Health Organization (WHO) and the European Union. There is a need to develop appropriate strategies with effective measures to meet the challenge of chronicity, reorienting national health systems. The increasing expansion of mobile health (mHealth) interventions in patient communication, the reduction of health inequalities, improved access to health care resources, adherence to treatment, and self-care of chronic diseases all point to an optimistic outlook. However, only few mobile apps demonstrate their effectiveness in these patients, which is diminished when they are not based on evidence, or when they are not designed by and for users with different levels of health literacy (HL).

OBJECTIVE

This study aims to evaluate the efficacy of an mHealth intervention relative to routine clinical practice in improving HL and self-management in patients with multimorbidity with heart failure (HF) and complex health needs.

METHODS

This is a randomized, multicenter, blinded clinical trial evaluating 2 groups, namely, a control group (standard clinical practice) and an intervention group (standard clinical practice and an ad hoc designed mHealth intervention previously developed), for 12 months.

RESULTS

The contents of the mHealth intervention will address user-perceived needs based on the development of user stories regarding diet, physical exercise, cardiac rehabilitation, therapeutic adherence, warning signs and symptoms, and emotional management. These contents have been validated by expert consensus. The creation and development of the contents of the mHealth intervention (app) took 18 months and was completed during 2021. The mobile app is expected to be developed by the end of 2022, after which it will be applied to the experimental group as an adjunct to standard clinical care during 12 months.

CONCLUSIONS

The trial will demonstrate whether the mobile app improves HL and self-management in patients with HF and complex health needs, improves therapeutic adherence, and reduces hospital admissions. This study can serve as a starting point for developing other mHealth tools in other pathologies and for their generalization to other contexts.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04725526; https://tinyurl.com/bd8va27w.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/35945.

摘要

背景

患有多种疾病且有复杂健康需求的患者被世界卫生组织（WHO）和欧盟列为优先关注对象。需要制定适当的策略并采取有效措施来应对慢性病的挑战，重新调整国家卫生系统。移动健康（mHealth）干预在患者沟通、减少健康不平等、改善医疗资源获取、提高治疗依从性以及慢性病自我管理方面的不断扩展，都指向了一个乐观的前景。然而，只有少数移动应用程序在这些患者中证明了其有效性，当它们缺乏证据基础，或者不是由具有不同健康素养（HL）水平的用户设计并为其设计时，有效性会降低。

目的

本研究旨在评估相对于常规临床实践，移动健康干预对改善患有心力衰竭（HF）和复杂健康需求的多种疾病患者的健康素养和自我管理的疗效。

方法

这是一项随机、多中心、双盲临床试验，对两组进行为期12个月的评估，即对照组（标准临床实践）和干预组（标准临床实践以及先前开发的专门设计的移动健康干预）。

结果

移动健康干预的内容将基于关于饮食、体育锻炼、心脏康复、治疗依从性、警示症状和情绪管理的用户故事的开发，来满足用户感知到的需求。这些内容已通过专家共识得到验证。移动健康干预（应用程序）内容的创建和开发耗时18个月，于2021年完成。预计移动应用程序将于2022年底开发完成，之后将在12个月内作为标准临床护理的辅助手段应用于实验组。