An interventional study of MejoraCare in Quality of Life, Stress and Emotional Adjustment, sponsored by Universidad Autónoma de Encarnación. Completed at 1 site in Paraguay. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-27.
Sponsored by Universidad Autónoma de Encarnación · Not applicable, Interventional, and Supportive care
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.
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:
For health care providers, MejoraCare dashboard provides the following functionalities:
The specific objectives of MejoraCare-Paraguay are:
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 138 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →This is the only study on the registry with Universidad Autónoma de Encarnación as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
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
mHealth solution to support remote monitoring of symptoms and patient empowerment through education.
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.
Time frame: Baseline, 1, and 3, 6 and 12 months
MejoraCare app Usability
Usability of the MejoraCare app will be measured through the SUS questionnaire at the end of the study. This questionnaire will only be completed by patients allocated to intervention group, and gives a global view on the subjective assessment of usability of a technology system
Time frame: 1 month
Satisfaction with the MejoraCare app
Satisfaction with the MejoraCare app will be measured through the CSQ questionnaire at the end of the study. This questionnaire will only be completed by patients allocated to the intervention group. This questionnaire is used to measure global patient satisfaction
Time frame: 1 month
Change in Self-efficacy
Change in Self-efficacy will be measured through the GSES-12 questionnaire. The scale is composed of 12 items and has 3 factors: Initiative (willingness to initiate behavior), Effort (willingness to make an effort to complete the behavior), and Persistence (persevering to complete the task in the face of adversity).
Time frame: Baseline, 1, 3, 6 and 12 months
Change in Anxiety
Change in anxiety will be measured through the GAD-2 questionnaire. The Generalized Anxiety Disorder Questionnaire-2 (GAD-2; Kroenke et al., 2007; García-Campayo et al., 2012) is a 2-item self-report that can be used to screen and detect symptoms of anxiety.
Time frame: Baseline, 1, 3, 6 and 12 months
Change in Depression
Change in depression will be measured through the PHQ-2 questionnaire. The Patient Health Questionnaire-2 (PHQ-2; Kroenke et al., 2003; Rodríguez-Muñoz et al., 2017) is a 2-item self-report questionnaire that is used to screen and detect depressive symptomatology. Items responses are rated on a 4-point Likert-scale (0 = not at all, 3 = nearly every day).
Time frame: Baseline, 1, 3, 6 and 12 months
Change in Health Empowerment
Change in empowerment will be measured through the EAS questionnaire. The scale measures the degree of empowerment in health-care, assessing self-control, self-efficacy, problem-solving, psychosocial coping, support, motivation, and decision-making
Time frame: Baseline, 1, 3, 6 and 12 months
Change in Coping with Stress
Change in coping will be measured through the PSS-4 questionnaire. The short version, PSS-4, is an economical and simple psychological instrument to administer, comprehend, and score. It measures the degree to which situations in one's life over the past month are appraised as stressful.
Time frame: Baseline, 1, 3, 6 and 12 months
Technological profile
It is an ad-hoc scale design to asses the prior knowledge/skill of participants in the use of common technologies as mobiles phones or the computer. The scale has 9 items that score independently in a scale ranging from 0 to 4. Higher scores are associated with a better knowledge in the use of technologies
Time frame: Baseline
mHealth App Usability Questionnaire
It is an scale for assess the usability of mHealth applications. The scale has 26 items rated on a 7-point Likert-scale (1 = totally disagree, 7 = totally agree). Higher scores are related to a better opinion regarding the mobile application
Time frame: 1 month
Telehealth Questionnaire (TUQ)
It is an scale for assess the utility of mHealth applications. The scale has 16 items rated on a 7-point Likert-scale (1 = totally disagree, 7 = totally agree). Higher scores are related to a better experience regarding the mobile application
Time frame: 1 month
COMPUTER FLUENCY SCALE (CFS)
It is a scale to assess the openness of the participant to use technologies in their daily life. The scale has 7 items rated on a 5-point Likert-scale (1 = totally disagree, 5 = totally agree). Higher scores are related to a higher comodity in the use of technologies
Time frame: Baseline
Plan to share: No
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.