Clinical trial NCT04659746: MejoraCare-Paraguay: mHealth Solution for Chronic Patients During the COVID-19 Outbreak in Paraguay
Official title: mHealth Technology to Optimize Mental Health in Chronic Patients During the COVID-19 Outbreak in Paraguay
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Stress
Emotional Adjustment
Keywords: COVID-19
Quality of Life
mHealth
Self-efficacy
Emotional Adjustment
Remote Monitoring
Lead sponsor: Universidad Autónoma de Encarnación
Sponsor class: OTHER
Collaborators: name: Adhera Health, Inc.
name: University of Valencia
First posted: 2020-12-09
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: MejoraCare-Paraguay main objective is to test a mHealth solution (MejoraCare app) to be used for the education and empowerment of chronic patients (COPD, cancer, diabetes, heart disease. hypertension, etc.), and for supporting healthcare professionals to monitor and better understand patients' evolution during the COVID-19 outbreak (MejoraCare dashboard).

This mHealth solution is built upon the Adhera platform, which has already been validated in other therapeutic areas such as smoking cessation.

MejoraCare is expected to raise awareness, educate and empower chronic patients, promoting behavioral changes towards adhering to healthier lifestyles thus reducing the risk of COVID-19 infection while providing emotional regulation support aiming at improving their mental health, quality of life, and emotional well-being.

Detailed description: MejoraCare-Paraguay main objective is to test an mHealth solution (MejoraCare app) to be used for the education and empowerment of chronic patients (COPD, cancer, diabetes, heart disease. hypertension, etc.), and for supporting healthcare professionals to monitor and better understand patients' evolution during the COVID-19 outbreak (MejoraCare dashboard).

This mHealth solution is built upon the Adhera platform, which has already been validated in other therapeutic areas such as smoking cessation.

Its objective is two-fold: on the one hand, MejoraCare will provide the target population with an educational resource to improve their self-efficacy and knowledge about the disease and, on the other hand, to provide them with tools for the regulation of stress, anxiety and negative emotions generated in this high-risk population due to the COVID-19 outbreak situation.

MejoraCare is expected to raise awareness, educate and empower chronic patients, promoting behavioral changes towards adhering to healthier lifestyles thus reducing the risk of COVID-19 infection, while providing emotional regulation support aiming at improving their mental health, quality of life, and emotional well-being.

Personalized health education embedded into MejoraCare app covers the following topics:

* Prevention of COVID-19
* Reinforcement of self-management behaviors for chronic conditions (e.g., physical activity).
* Modules for improving resilience and coping skills related to stress and negative emotions related to the COVID-19 outbreak (e.g., isolation at home).

For health care providers, MejoraCare dashboard provides the following functionalities:

* Segmentation, monitoring, and follow-up of potential positive cases of COVID19 patients and people at special risk
* Support to patients undergoing quarantine at home recovery phase, including remote monitoring of symptoms and a means to contact them in the cases that are deemed necessary by the healthcare professionals.

The specific objectives of MejoraCare-Paraguay are:

1. To analyze the impact of the MejoraCare mHealth solution in terms of mental health, quality of life, and emotional well-being in chronic patients at risk of COVID-19 infection.
2. To analyze the acceptance of the technology by patients and professionals.

This study expects to demonstrate the benefits that an mHealth intervention may have on supporting mental health, quality of life, and emotional well-being for vulnerable patients during the COVID-19 outbreak.

The "info-demia" of constant news about the virus, along with the restrictive/lockdown measures that are being enforced by the governments to reduce the pandemic progression pose a great challenge for the emotional stress for people in general, and with a higher impact on a vulnerable population, especially for those living with chronic conditions that seem to worsen the prognostic in case of infection. Besides, as the pandemic continues its spread, health services are being challenged due to the lack of resources to cope with such a high demand for potential positive cases. In some cases, this affects the quality of care of chronic patients, who also refrain from attending their routine appointments due to the fear of infection. Therefore, reinforcement and behavioral guidance are needed to allow people living with chronic conditions to know and understand which are the measures they need to take to prevent the infection, or how to act in the event that they are infected. Besides, it is necessary to provide this population with tools to support the prevention of psychological and emotional problems that can worsen their health status and, therefore, their quality of life.

mHealth solutions rely on a technology (smartphones) which already has a high level of penetration in the population, makes their widespread highly scalable, and can be released with relatively low costs. If developed under strong quality and safety requirements, they can be a perfect fit for building public health strategies on top of them. On the other hand, the lack of specific digital solutions to educate and empower chronic patients in disease prevention techniques for COVID-19 and other infectious diseases with a relatively high mortality rate among the vulnerable population like the seasonal flu puts them in an even more risky situation to get infected.

Eligibility criteria: Inclusion Criteria:

* Legal adults (18+)
* Patients suffering from, at least, one chronic disease.
* Patients owning an Android smartphone and internet connection
* Patients with a minimum level of digital literacy (being able to send text messages)
* Patients able to read and understand Spanish
* Signs the informed consent

Exclusion Criteria:

* Diagnosed with any mental disorder
* Withdraws the consent to participate in the study

Primary outcomes:
measure: Change on Health-related Quality of Life
timeFrame: Baseline, 1, and 3, 6 and 12 months
Secondary outcomes:
measure: MejoraCare app Usability
timeFrame: 1 month
measure: Satisfaction with the MejoraCare app
timeFrame: 1 month
measure: Change in Self-efficacy
timeFrame: Baseline, 1, 3, 6 and 12 months
measure: Change in Anxiety
timeFrame: Baseline, 1, 3, 6 and 12 months
measure: Change in Depression
timeFrame: Baseline, 1, 3, 6 and 12 months
measure: Change in Health Empowerment
timeFrame: Baseline, 1, 3, 6 and 12 months
measure: Change in Coping with Stress
timeFrame: Baseline, 1, 3, 6 and 12 months
Other outcomes:
measure: Technological profile
timeFrame: Baseline
measure: mHealth App Usability Questionnaire
timeFrame: 1 month
measure: Telehealth Questionnaire (TUQ)
timeFrame: 1 month
measure: COMPUTER FLUENCY SCALE (CFS)
timeFrame: Baseline
Locations:
city: Encarnación
country: Paraguay
facility: Hospital Regional de Encarnación
state: Itapúa
Study officials:
affiliation: Universitat de València-Estudi General
name: Rosa María Baños, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Escriva-Martinez T, Vara MD, Czeraniuk N, Denis M, Nunez-Benjumea FJ, Fernandez-Luque L, Jimenez-Diaz A, Traver V, Llull JJ, Martinez-Millana A, Garces-Ferrer J, Miragall M, Herrero R, Enriquez A, Schaefer V, Cervera-Torres S, Villasanti C, Cabral CV, Fernandez I, Banos RM. mHealth intervention to improve quality of life in patients with chronic diseases during the COVID-19 crisis in Paraguay: A study protocol for a randomized controlled trial. PLoS One. 2022 Nov 8;17(11):e0273290. doi: 10.1371/journal.pone.0273290. eCollection 2022.