I. Essential project data

Item

Subitem

Recommendation

1. Study title

Brief descriptive title.

If possible, provide information about the intervention to be performed in the study (for example the name or type of).

2. Study objectives

Justification for carrying out the study

Describe the main objectives of the study.

Provide a brief theoretical background and/or justification for its realization.

3. Methods

Study design

Study population

Intervention

Ethical Aspects

Statistical analysis

Describe which study model and approach were chosen, inclusion and exclusion criteria for the study population and techniques for selecting subjects, data collection locations, data storage sources, and recording/output platforms and analysis of the collected data.

Describe in detail:

1) type of technology chosen (mobile, text messages, teleservice, among others);

2) how the intervention will take place in the study participants with details for each selected group, including activities to support and support treatment adherence carried out during the intervention;

3) place where the intervention is intended to be carried out (ambulatory, hospitalization, home care, among others);

4) expected time of intervention (start and end date);

5) expected number of interventions or dosage (how many times a day, week, month, among others);

It is strongly recommended to record the changes made to the intervention since its initial proposal, facilitating the subsequent comparison between what was planned and what happened in reality.

It is strongly recommended to describe the procedures performed for the randomization of the clinical trial and for data analysis, including statistical methods.

Submit the research for approval by the Ethics Committee of an accredited. Teaching and Research institution and prepare a Free and Informed Consent Form for the study participants, ensuring the confidentiality and security of their personal data.

4. Results

Population groups

Data collect

Intervention outcomes

Intervention damage

Complementary results

Describe variations in the initial and final number of participants in the groups, demographic, epidemiological and clinical characteristics, reasons for loss and/or exclusion of subjects.

Detail the outcomes of the intervention for each group of participants and the harms of the intervention, if any.

Record complementary results, such as subgroup analysis, adjusted analysis, or other results extracted from the intervention that may complement the study findings.

II. Data for team meeting

Item

Subitem

Recommendation

5. Level of Health Care

Primary, Secondary or Tertiary Health Care

Record the level of Health Care where the intervention will be implemented, specifying whether in basic health units, home care, units with a family health strategy, emergency care units, outpatient care and/or medium and high complexity hospitals.

6. Clinical algorithms

Clinical care protocols

Record what and how are the care protocols or clinical algorithms practiced at the target location for the implementation of the intervention.

Develop an algorithm incorporating digital health technology into the clinical routines and algorithms of the service where the tool will be implemented together with professionals involved in the daily provision of health care.

Carry out a comparison of results between traditional intervention and intervention plus the digital health tool.

7. Team involved in implementation

Students, healthcare professionals, patients

Register who will use, in practice, the digital health tool during the health intervention.

Register necessary training for those who will use the tool.

III. Data for the development of the digital health tool

Item

Subitem

Recommendation

8. Development methodology

Describe in detail the methodology used for the development of the software, the technology chosen for the development and the architecture of the system and data operation.

9. Requirements

Describe the essential elements used to define software requirements.

Describe, if applicable and possible, the needs and expectations of users in relation to the developed tool.

10. User experience Design (UX)

Describe the steps designed for user interaction with the tool from the first use to the evaluation at the end of use.

Describe the opinions and suggestions issued by users at the beginning and at the end of the implementation of the tool.

11. Data storage and management

Database model

Deployment manager system

Describe what definitions for the database model and management system to implement.

12. Auxiliary equipment

Describe whether any auxiliary communication or information recording equipment will be used connected to the tool to obtain and/or exchange patient data.

13. Interoperability, security and reliability

Describe in detail the approach taken to issues of system interoperability and security and reliability in the transit of electronic clinical data and documents.

IV. Project Management Data

Item

Subitem

Recommendation

14. Start of planning

Project Structure

Describe the methodology chosen for project management and the steps to be taken to fulfill the product management scope, considering its restrictions and assumptions.

Study the feasibility of the product and carry out a financial planning resulting from its implementation.

15. Execution

Schedule

User engagement and focus

Describe in detail the schedule of actions planned for the project development time, according to the defined methodology, specifying those responsible for each activity.

It is strongly recommended that in the project execution stage, the management focus is on the user, constantly promoting actions for their engagement/adherence to the use of the developed tool and their feedback on non-use, if it occurs.

16. Monitoring

Periodically describe the results of the meetings with the research team and the results extracted in the field.

It is strongly recommended to record difficulties of any nature related to the project reported throughout the process by users.

17. Project closure

Create project closure reports with the collected information and data analysis, recommended in this checklist and a lessons learned report to be consulted with each new research to be developed.