Evaluate the Effectiveness of a Virtual Community of Practice Via a Web-based Application Versus Individual and Self-administered Online Education to Improve the Activation of Middle-aged People with Multimorbidity.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 240
- Locations
- 4
- Primary Endpoint
- the Patient Activation Measure (PAM)
Study Overview
Brief Summary
Objective: To evaluate and compare the effectiveness and cost-effectiveness of a Virtual Community of Practice (VCoP) via a web-based application versus individual and self-administered online education to improve the activation of middle-aged people with multimorbidity.
Design: Randomized controlled pragmatic clinical trial with two parallel arms and 18 months follow-up.
Setting: Primary health centres and hospitals (Catalonia, Madrid, and the Canary Islands). Population: Middleaged people (30-60 years old) with multimorbidity (≥=2 chronic diseases). Sample size: 240 patients.
Randomization: all participants will be randomly assigned to the intervention (VCoP) or the active control group. Data analysis will be blinded to intervention allocation. Intervention: The intervention group will be offered participation for 12 months in a VCoP based on a gamified web-based application. The control group will receive individual, content-focused education through a web platform that will cover the same topics as the VCoP but will be self-administered and without social interaction within the platform.
Measurements: The main variable will be measured using the Patient Activation Measure (PAM) questionnaire at baseline, 6, 12 and 18 months. Secondary variables: participant sociodemographics, depression (PHQ-9), anxiety (HADS-A), treatment burden (TBQ), quality of life (EQ-5D-5L), variables related to the use of health resources and to the use of the VCoP. Analysis: Mixed-effects linear regression will be used to determine the effects of the VCoP on the changes in patient activation. Scores at baseline, 6, 12 and 18 months will be included as a fixed effect variable, and the patient and health professional as random effect variables. Analyses will be performed on an intention-to-treat basis. An economic evaluation will be carried out to analyze the cost-effectiveness of the VCoP compared to active control, from the National Health System and social perspectives.
Detailed Description
Objective: To evaluate and compare the effectiveness and cost-effectiveness of a Virtual Community of Practice (VCoP) via a web-based application versus individual and self-administered online education to improve the activation of middle-aged people with multimorbidity.
Design: Randomized controlled pragmatic clinical trial with two parallel arms and 18 months follow-up.
Setting: Primary health centres and hospitals (Catalonia, Madrid, and the Canary Islands). Population:
Inclusion criteria:
- Age between 30 and 60 years
- diagnosis of ≥ 2 chronic diseases
- have a computer with an Internet connection or another mobile device (tablet or smartphone)
- be able to follow the requirements of the study have signed the informed consent
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Middleagedpeople (30-60 years old)
- •with multimorbidity (≥=2 chronic diseases).
Exclusion Criteria
- •Low probability of cooperation in the study
- •situation of transients or displaced persons, institutionalized, with some terminal illness, physical or mental disability that prevents them from answering the questionnaires correctly.
- •When the contact telephone number/email is not available in the CAP/hospital database.
Outcomes
Primary Outcomes
the Patient Activation Measure (PAM)
Time Frame: 18 months
It consists of 13 items that assess people's knowledge, skills, and confidence in self-care for their health and medical care, measured using a 1-4 Likert scale with a total score that is transferred to a scale between 0 and 100.
Secondary Outcomes
- Patient Health Questionnaire-9(18 months)
- Treatment Burden Questionnaire-TBQ(18 months)
- European quality of life-5 dimensions. E5-5D-5L questionnaire(18 months)
- Hospital Anxiety and Depression Scale (HADS)(18 months)