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Chronic DiseaseNCT05593835

Multimorbidity Management Supported by a Digital Platform

A study testing METHIS Platform and Goal-Oriented Care Training Program in people with Chronic Disease, run by Universidade Nova de Lisboa.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Chronic Disease
What is being tested?
METHIS Platform and Goal-Oriented Care Training Program
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,380 participants
Where
No sites listed yet
Study dates
1 Jun 2025to 31 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Luís V. Lapão, PhD contact

+351 937234449

luis.lapao@nms.unl.pt

Bruno Heleno, PhD contact

+351 218803000 ext. 26045

bruno.heleno@nms.unl.pt

About this study

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

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.

Read the 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
Being tested
METHIS Platform, Goal-Oriented Care Training Program
Keywords
Primary Health Care, Information Management, Research Design, Telemedicine, Digital Health, Patient-Centered Care, Goal-Oriented Care
Medical subject headings
Chronic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • METHIS PlatformDevice

    Also called Goal-Oriented Care Information System, GOC Information System

    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.

  • Goal-Oriented Care Training ProgramOther

    Also called GOC 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.

Study groups in NCT05593835
Study groupRoleWhat they receive
METHIS InterventionExperimentalThe 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.
Receives: Device: METHIS Platform; Other: Goal-Oriented Care Training Program
ControlNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Participants will be asked to fill in the SF-12 questionnaire at baseline and at 12 months.

Secondary outcomes (4)

  1. 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.

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

  2. 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).

    Measured: Participants will wear the SmartBand for 12 months.

  3. 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.

    Measured: 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.

  4. 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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2022
  2. Study start1 Jun 2025 (estimated)
  3. Primary completion30 Jan 2026 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Cluster Randomised Trial
Masking
None (open label)
Enrolment
1,380 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05593835
Sponsor's protocol ID
METHIS_CRTMB2022
Status last verified
Nov 2023
First submitted
3 Oct 2022
Last updated
29 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The complete research dataset will be stored in an encrypted and secure location with the purpose of being accessed for secondary analyses or comparative studies or per request of the patients involved or the Research and Ethics Committee. For legal reasons, the investigators will not disclose the database or grant access for data reproduction. However, processed data may be made available upon request to the research team, with appropriate justification.

Publications

  • Onder G, Palmer K, Navickas R, Jureviciene E, Mammarella F, Strandzheva M, Mannucci P, Pecorelli S, Marengoni A; Joint Action on Chronic Diseases and Promoting Healthy Ageing across the Life Cycle (JA-CHRODIS). Time to face the challenge of multimorbidity. A European perspective from the joint action on chronic diseases and promoting healthy ageing across the life cycle (JA-CHRODIS). Eur J Intern Med. 2015 Apr;26(3):157-9. doi: 10.1016/j.ejim.2015.02.020. Epub 2015 Mar 18.

    PubMed 25797840

  • Mercer S, Furler J, Moffat K, Fischbacher-Smith D, Sanci LA, World Health Organization, et al. Multimorbidity: Technical Series on Safer Primary Care. Geneva, Switzerland: World Health Organization; 2016

  • Quinaz Romana G, Kislaya I, Salvador MR, Cunha Goncalves S, Nunes B, Dias C. [Multimorbidity in Portugal: Results from The First National Health Examination Survey]. Acta Med Port. 2019 Feb 1;32(1):30-37. doi: 10.20344/amp.11227. Epub 2019 Feb 1. Portuguese.

    PubMed 30753801

  • Amer Nordin A, Mohd Hairi F, Choo WY, Hairi NN. Care Recipient Multimorbidity and Health Impacts on Informal Caregivers: A Systematic Review. Gerontologist. 2019 Sep 17;59(5):e611-e628. doi: 10.1093/geront/gny072.

    PubMed 29982539

  • van der Aa MJ, van den Broeke JR, Stronks K, Plochg T. Patients with multimorbidity and their experiences with the healthcare process: a scoping review. J Comorb. 2017 Jan 27;7(1):11-21. doi: 10.15256/joc.2017.7.97. eCollection 2017.

    PubMed 29090185

  • Fortin M, Lapointe L, Hudon C, Vanasse A, Ntetu AL, Maltais D. Multimorbidity and quality of life in primary care: a systematic review. Health Qual Life Outcomes. 2004 Sep 20;2:51. doi: 10.1186/1477-7525-2-51.

    PubMed 15380021

  • Makovski TT, Schmitz S, Zeegers MP, Stranges S, van den Akker M. Multimorbidity and quality of life: Systematic literature review and meta-analysis. Ageing Res Rev. 2019 Aug;53:100903. doi: 10.1016/j.arr.2019.04.005. Epub 2019 Apr 30.

    PubMed 31048032

  • Marengoni A, von Strauss E, Rizzuto D, Winblad B, Fratiglioni L. The impact of chronic multimorbidity and disability on functional decline and survival in elderly persons. A community-based, longitudinal study. J Intern Med. 2009 Feb;265(2):288-95. doi: 10.1111/j.1365-2796.2008.02017.x.

    PubMed 19192038

  • Boyd CM, Darer J, Boult C, Fried LP, Boult L, Wu AW. Clinical practice guidelines and quality of care for older patients with multiple comorbid diseases: implications for pay for performance. JAMA. 2005 Aug 10;294(6):716-24. doi: 10.1001/jama.294.6.716.

    PubMed 16091574

  • Cairo Notari S, Sader J, Caire Fon N, Sommer JM, Pereira Miozzari AC, Janjic D, Nendaz M, Audetat MC. Understanding GPs' clinical reasoning processes involved in managing patients suffering from multimorbidity: A systematic review of qualitative and quantitative research. Int J Clin Pract. 2021 Sep;75(9):e14187. doi: 10.1111/ijcp.14187. Epub 2021 May 5.

    PubMed 33783098

  • Damarell RA, Morgan DD, Tieman JJ. General practitioner strategies for managing patients with multimorbidity: a systematic review and thematic synthesis of qualitative research. BMC Fam Pract. 2020 Jul 1;21(1):131. doi: 10.1186/s12875-020-01197-8.

    PubMed 32611391

  • Spencer-Bonilla G, Quinones AR, Montori VM; International Minimally Disruptive Medicine Workgroup. Assessing the Burden of Treatment. J Gen Intern Med. 2017 Oct;32(10):1141-1145. doi: 10.1007/s11606-017-4117-8. Epub 2017 Jul 11.

    PubMed 28699060

  • Whitehead L, Palamara P, Allen J, Boak J, Quinn R, George C. Nurses' perceptions and beliefs related to the care of adults living with multimorbidity: A systematic qualitative review. J Clin Nurs. 2022 Oct;31(19-20):2716-2736. doi: 10.1111/jocn.16146. Epub 2021 Dec 6.

    PubMed 34873763

  • Muth C, Blom JW, Smith SM, Johnell K, Gonzalez-Gonzalez AI, Nguyen TS, Brueckle MS, Cesari M, Tinetti ME, Valderas JM. Evidence supporting the best clinical management of patients with multimorbidity and polypharmacy: a systematic guideline review and expert consensus. J Intern Med. 2019 Mar;285(3):272-288. doi: 10.1111/joim.12842. Epub 2018 Dec 10.

    PubMed 30357955

  • Kernick D, Chew-Graham CA, O'Flynn N. Clinical assessment and management of multimorbidity: NICE guideline. Br J Gen Pract. 2017 May;67(658):235-236. doi: 10.3399/bjgp17X690857. No abstract available.

    PubMed 28450343

Questions about this trial

What is this clinical trial studying?

A study testing METHIS Platform and Goal-Oriented Care Training Program in people with Chronic Disease, run by Universidade Nova de Lisboa.

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 4 inclusion and 1 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: opening soon, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Luís V. Lapão, PhD (+351 937234449, luis.lapao@nms.unl.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health related quality of life (time frame: Participants will be asked to fill in the SF-12 questionnaire at baseline and at 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 NCT05593835, which also lists 43 linked publications.

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 29 Nov 2023.

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