NCT05593835

Multimorbidity Management Supported by a Digital Platform

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,380 (estimated)
• Sponsor: Universidade Nova de Lisboa · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Chronic Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-01
• Primary completion: 2026-01-30
• Completion: 2027-05-31
• First posted: 2022-10-25
• Last updated: 2023-11-29