Protocol for a Cluster Randomised Trial of a Goal-Oriented Care Approach for Multimorbidity Patients Supported by a Digital Platform
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Disease
- Sponsor
- Universidade Nova de Lisboa
- Enrollment
- 1380
- Primary Endpoint
- Health related quality of life
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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.
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Health related quality of life
Time Frame: Participants will be asked to fill in the SF-12 questionnaire at baseline and at 12 months.
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.
Secondary Outcomes
- 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.)
- Mental health status(Participants will complete the HADS-A and HADS-D questionnaire at baseline and at 12 months.)
- 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.)