Multimorbidity Management Supported by a Digital Platform

NCT05593835 | Not Yet Recruiting

• 1 other identifier: METHIS_CRTMB2022
• Study Type: interventional
• Target: 1,380
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Disease

Keywords

Primary Health Care; Information Management; Research Design; Telemedicine; Digital Health; Patient-Centered Care; Goal-Oriented Care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Mental health status

  Participants will complete the HADS-A and HADS-D questionnaire at baseline and at 12 months.

• Physical activity

  Participants will wear the SmartBand for 12 months.

• Number of serious adverse events (clinician-reported)

  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.

• Number of potentially missed diagnoses (clinician-reported)

  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.

Study Arms (2)

METHIS Intervention

EXPERIMENTAL

The METHIS intervention will consist of two components. The first component is a Goal-Oriented Care (GOC) Training Program for health professionals. The training program will include the concept of personalised care, methods of goal elation, implications of GOC in healthcare practice, and how METHIS platform can be used to support the application of GOC. The training will be implemented through a blended-learning, continuous education program that will be credited by Nova University of Lisbon. The second component is a GOC information system. This will be the digital platform METHIS, which will be designed to nudge clinicians to adopt a GOC and to encourage patients and caregivers to take an active role in healthcare. The investigators will adapt an existing platform that was developed for a pilot study during the COVID-19 pandemic, that promotes care coordination, optimises disease prioritisation, and patient self-management.

Device: METHIS Platform; Other: Goal-Oriented Care Training Program

Control

NO INTERVENTION

The control group in this trial will be the best usual care, using the standard Electronic Health Records available to the practice. Our understanding of what "best usual care" is for people with multimorbidity is informed by qualitative research in an earlier stage of this project. Our results suggest that healthcare professionals often provide disease-driven care. When faced with multiple healthcare problems, they prioritise based on 1) patient complaints; 2) which condition is less well controlled; or 3) which condition is more likely to adversely impact on patient Health Related-Quality of life. General practitioners and primary care nurses are often not familiar with the Goal-Oriented Care model. However, they already try to implement some of its principles such as identifying patient goals and supporting shared decision making.

Interventions

METHIS Platform DEVICE

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.

Also known as: Goal-Oriented Care Information System, GOC Information System

METHIS Intervention

Goal-Oriented Care Training Program OTHER

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.

Also known as: GOC Training Program

METHIS Intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Nova de Lisboa: lead
• Administração Regional de Saúde de Lisboa e Vale do Tejo, Portugal: collaborator
• Universidade Lusófona de Humanidades e Tecnologias: collaborator
• NOVA Medical School: collaborator
• NOVA School of Science and Technology ı FCT NOVA: collaborator
• University Hospital, Geneva: collaborator

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MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Luís V. Lapão, PhD

  Universidade Nova de Lisboa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luís V. Lapão, PhD

CONTACT

+351 937234449; luis.lapao@nms.unl.pt

Bruno Heleno, PhD

CONTACT

+351 218803000; bruno.heleno@nms.unl.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster Randomised Trial

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 25, 2022
• Study Start: June 1, 2025
• Primary Completion: January 30, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: After the study ends and for 5 years.
• Access Criteria: The trial protocol, the main paper with the trial results and a short paper with the results of the final physician survey will be published in peer-review journals.