Quality of LifeMejoraCare_PNCT04659746
MejoraCare-Paraguay: mHealth Solution for Chronic Patients During the COVID-19 Outbreak in Paraguay
A study testing MejoraCare in people with Quality of Life and Stress, run by Universidad Autónoma de Encarnación at 1 site in Paraguay.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Stress, Emotional Adjustment
- What is being tested?
- MejoraCare
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteParaguay
- Study dates
- 9 Dec 2020to 9 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Diagnosed with any mental disorder
- Withdraws the consent to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: mHealth Technology to Optimize Mental Health in Chronic Patients During the COVID-19 Outbreak in Paraguay
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.
Read the 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:
- 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.
- 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.
- Conditions
- Quality of Life, Stress, Emotional Adjustment
- Being tested
- MejoraCare
- Keywords
- COVID-19, Quality of Life, mHealth, Self-efficacy, Emotional Adjustment, Remote Monitoring
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MejoraCareDevice
mHealth solution to support remote monitoring of symptoms and patient empowerment through education.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: MejoraCare |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1, and 3, 6 and 12 months
Secondary outcomes (7)
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
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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.
Measured: Baseline, 1, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start9 Dec 2020
- Primary completion28 Feb 2021
- Study completion9 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autónoma de Encarnación
- Sponsor type
- University, hospital or other
- Collaborators
- Adhera Health, Inc., University of Valencia
- Responsible party
- Sponsor
- Investigators
- Rosa María Baños, PhD, Principal investigator, Universitat de València-Estudi General
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04659746
- Sponsor's protocol ID
- PINV 20-9
- Acronym
- MejoraCare_P
- Status last verified
- Jan 2022
- First submitted
- 7 Dec 2020
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36346807
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mHealth Technology to Optimize Mental Health in Chronic Patients During the COVID-19 Outbreak in Paraguay
- ClinicalTrials.gov ID
- NCT04659746
- Acronym / sponsor ID
- MejoraCare_P / PINV 20-9
- Conditions
- Quality of Life, Stress, Emotional Adjustment
- Keywords
- COVID-19, Quality of Life, mHealth, Self-efficacy, Emotional Adjustment, Remote Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Universidad Autónoma de EncarnaciónUniversity, hospital or other
- Collaborators
- Adhera Health, Inc., University of Valencia
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 9 Dec 2021 (actual)
- First posted
- 9 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: MejoraCareParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Diagnosed with any mental disorder
- Withdraws the consent to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MejoraCaremHealth solution to support remote monitoring of symptoms and patient empowerment through education. | Device | Intervention |
Primary outcome
Change on Health-related Quality of Life
Time frame: Baseline, 1, and 3, 6 and 12 months
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.
7 secondary outcomes
MejoraCare app Usability
Time frame: 1 month
Satisfaction with the MejoraCare app
Time frame: 1 month
Change in Self-efficacy
Time frame: Baseline, 1, 3, 6 and 12 months
Change in Anxiety
Time frame: Baseline, 1, 3, 6 and 12 months
Change in Depression
Time frame: Baseline, 1, 3, 6 and 12 months
Change in Health Empowerment
Time frame: Baseline, 1, 3, 6 and 12 months
Change in Coping with Stress
Time frame: Baseline, 1, 3, 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- Derived from this study: PubMed 36346807Escriva-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosa María Baños, PhD principal investigator
Universitat de València-Estudi General
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MejoraCare in people with Quality of Life and Stress, run by Universidad Autónoma de Encarnación at 1 site in Paraguay.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Paraguay. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on Health-related Quality of Life (time frame: Baseline, 1, and 3, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04659746, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2022.