Multimorbidity Management Supported by a Digital Platform

Chronic Disease Clinical Trial

Official title:

Protocol for a Cluster Randomised Trial of a Goal-Oriented Care Approach for Multimorbidity Patients Supported by a Digital Platform

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05593835
• Other study ID #: METHIS_CRTMB2022
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2025
• Est. completion date: May 31, 2027

Study information

• Verified date: November 2023
• Source: Universidade Nova de Lisboa
• Contact: Luís V. Lapão, PhD
• Phone: +351 937234449
• Email: luis.lapao[@]nms.unl.pt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to assess whether the use of the METHIS digital platform using a patient-centered approach contributes to an improvement in the quality of life, mental health and physical activity of patients with multimorbidity followed up in Primary Health Care. Practices will be randomly allocated between: providing access to consultations through the METHIS platform (intervention) or following patients by the traditional method (control). They will complete questionnaires on quality of life, mental health and report the number of steps taken, at the beginning and end of the study.

Description:

A superiority, cluster randomised trial will be conducted at Primary Health Care Practices (1:1 allocation ratio). All public practices in the Lisbon and Tagus Valley Region, Portugal, not involved in a previous pilot trial, will be eligible. The intervention combines a training programme and a customised Information System (METHIS). Both are designed to help clinicians to adopt a Goal-Oriented Care Model approach and to encourage patients and carers to play a more active role in autonomous healthcare.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1380
• Est. completion date: May 31, 2027
• Est. primary completion date: January 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• community-dwelling people

• aged 50 or older

• with complex multimorbidity (co-occurrence of three or more chronic conditions affecting three or more different body systems)

• with access to an Internet connection and a communication technology device

Exclusion Criteria:

• inability to: provide informed consent, to read or write, inability to access an email or electronic device, even when helped by an informal caregiver

Related Conditions & MeSH terms

• Chronic Disease

Intervention

Device:
• METHIS Platform
The METHIS platform is a digital healthcare platform, supported by three databases using PostreSQL (based in relational SQL). One of the databases allows adequate internal testing before production. Another database of production (secured with unique access codes) will be created to retrieve data from the practices' and the last database for the research data, where pseudonymised production data can be analysed for research purposes. The platform is integrated (via FCCN Scientific Computation Unit of the Portuguese Fundação para a Ciência e a Tecnologia) with the Software Zoom® to allow encrypted teleconsultations, with a guarantee that each patient connection is unique. The digital platform is web-based, and it can be used in multiple devices.

Other:
• Goal-Oriented Care Training Program
The training program will have three stages: initial face-to-face training, which will happen before the data collection, followed by remote, asynchronous training during a 12-month period, and a final seminar to discuss the results and inquire about the usability of the GOC model and the METHIS platform. The course will be offered to the intervention group one month before the start of patient recruitment, and for the control group at least one month after the end of data collection.

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Universidade Nova de Lisboa	Administração Regional de Saúde de Lisboa e Vale do Tejo, Portugal, NOVA Medical School, NOVA School of Science and Technology i FCT NOVA, Universidade Lusófona de Humanidades e Tecnologias, University Hospital, Geneva

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* Note: There are 42 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health related quality of life	Participants will be asked to fill in the SF-12 questionnaire which generates a physical component score (PCS) and a mental component score (MCS). The primary outcome will be the mean difference in the variation (delta) of the PCS of SF-12 between baseline and 12 months. The SF-12 can be filled in 2-4 minutes, and it is validated for the Portuguese population. Minimum important differences validated across large populations and multiple disease categories are a change in between 2 and 3 points from the population mean of 50.	Participants will be asked to fill in the SF-12 questionnaire at baseline and at 12 months.
Secondary	Mental health status	Participants will be asked to complete the Hospital Anxiety and Depression Scale questionnaire (HADS-A and HADS-D, respectively). The investigators will calculate the mean difference in the variation (delta) in HADS-A and HADS-D between baseline and 12 months. Although HADS was designed for inpatients it was posteriorly validated in the primary care outpatient setting. A minimum important difference of 1.5 has been reported in other chronic disorders.	Participants will complete the HADS-A and HADS-D questionnaire at baseline and at 12 months.
Secondary	Physical activity	Physical activity will be monitored through the number of steps walked daily. To assess the number of steps per day, a smart band with a triaxial Accelerometer will be used in both arms of the trial. Although traditional step counters use pedometers to detect daily step counts, accelerometers are more accurate and sensitive to lower force accelerations (e.g., slow walking) being considered the current standard for collecting physical activity data. Sedentary older adults and individuals living with disability and chronic illness benefit from a physically active lifestyle, with approximately 4,600- 5,500 daily steps. The lowest median values for steps/day found is in disabled older adults (1214 steps/day) and by people living with COPD (2237 steps/day).	Participants will wear the SmartBand for 12 months.
Secondary	Number of serious adverse events (clinician-reported)	These will be the safety outcomes chosen for this trial. In both trial arms, data about patient mortality will be collected and combined with data on occurrence of emergency department visits and hospital admissions as a proxy for serious adverse events. This information is available through the Portuguese common EHR. Due to legal requirements, after death, the information about hospital admissions and other contacts with healthcare organisations ceases to be available to the attending physician.	Family physicians will be asked, at 6 and 12 months after randomization, to check the life status of enrolled patients and whether patients in the trial were admitted to a hospital or had a visit to an emergency service since the randomization date.
Secondary	Number of potentially missed diagnoses (clinician-reported)	These will be a second safety outcome. The investigators will ask clinicians in the intervention arm if they are aware of any serious diagnosis that might have been missed due to the intervention.	Potentially missed diagnoses will be reported 6 months after the intervention phase. In this way a compromise between avoiding recall bias and allowing enough time for a missed diagnosis to become clinically apparent is achieved.