MejoraCare-Paraguay: mHealth Solution for Chronic Patients During the COVID-19 Outbreak in Paraguay

NCT04659746 | Completed DMC

• 1 other identifier: PINV 20-9
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life; Stress; Emotional Adjustment

Keywords

COVID-19; Quality of Life; mHealth; Self-efficacy; Emotional Adjustment; Remote Monitoring

Outcome Measures

Primary Outcomes (1)

• Change on Health-related Quality of Life

  The Health-related Quality of Life will be measured through the EuroQoL-5D-3L questionnaire measures health related quality of life. The questionnaire consist of five dimensions: mobility, self care, ordinary activities, discomfort, and mood state related to anxiety and depression. Each item ranges form no problem to a lot of problems.

  Baseline, 1, and 3, 6 and 12 months

Secondary Outcomes (7)

• MejoraCare app Usability

  1 month

• Satisfaction with the MejoraCare app

  1 month

• Change in Self-efficacy

  Baseline, 1, 3, 6 and 12 months

• Change in Anxiety

  Baseline, 1, 3, 6 and 12 months

• Change in Depression

  Baseline, 1, 3, 6 and 12 months

Other Outcomes (4)

• Technological profile

  Baseline

• mHealth App Usability Questionnaire

  1 month

• Telehealth Questionnaire (TUQ)

  1 month

Study Arms (2)

Control

NO INTERVENTION

Participants allocated to the control group will receive the routine care and follow-up for chronic patients in Pandemic situation at Hospital Regional de Encarnación (Encarnación, Paraguay), according to epidemiological surveillance and preventive isolation management protocol released by the Ministry of Health of Paraguay (URL: https://www.mspbs.gov.py/dependencias/portal/adjunto/c1c79a-ProtocoloVigilanciaEpidemiolgica.pdf)

Intervention

EXPERIMENTAL

Participants allocated to the intervention group will follow the same routine care as the control group. Additionally, they will receive access to the MejoraCare app. The MejoraCare app delivers the following functionalities: * Remote symptoms monitoring through an electronic Patient Reported Outcome (ePRO) * Patient empowerment through personalized educational resources promoting healthy lifestyles

Device: MejoraCare

Interventions

MejoraCare DEVICE

mHealth solution to support remote monitoring of symptoms and patient empowerment through education.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad Autónoma de Encarnación: lead
• Adhera Health, Inc.: collaborator
• University of Valencia: collaborator

Study Sites (1)

Hospital Regional de Encarnación

Encarnación, Itapúa, 6000, Paraguay

Location

Related Publications (1)

• 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.

  PMID: 36346807 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Rosa María Baños, PhD

  Universitat de València-Estudi General

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 9, 2020
• Study Start: December 9, 2020
• Primary Completion: February 28, 2021
• Study Completion: December 9, 2021
• Last Updated: January 27, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)