Evaluate the Effectiveness of a Virtual Community of Practice
ConditionChronic Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-60
SponsorGerencia de Atención Primaria, Madrid
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Middleagedpeople (30-60 years old)
with multimorbidity (≥=2 chronic diseases).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
virtual community of practice
BehavioralThe intervention group will be offered participation for 12 months in a VCoP based ona gamified web-based application.
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: virtual community of practiceExperimental treatment 1 intervention
Group B: control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
the Patient Activation Measure (PAM)
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.
Time frame
Baseline2
the Patient Activation Measure (PAM)
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.
Time frame
12 months3
the Patient Activation Measure (PAM)
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.
Time frame
18 monthsSecondary outcomes
1
Patient Health Questionnaire-9
It is a short instrument, designed to be self-administered. It consists of 9 items that evaluate the presence of depressive symptoms present in the last 2 weeks. Each item has a severity index: 0 = "never", 1 = "some days", 2 = "more than half of the days" and 3 = "almost every day". The puntuation is between 0 and 27 (worse puntuation).
Time frame
Baseline2
Patient Health Questionnaire-9
It is a short instrument, designed to be self-administered. It consists of 9 items that evaluate the presence of depressive symptoms present in the last 2 weeks. Each item has a severity index: 0 = "never", 1 = "some days", 2 = "more than half of the days" and 3 = "almost every day". The puntuation is between 0 and 27 (worse puntuation).
Time frame
12 months3
Patient Health Questionnaire-9
It is a short instrument, designed to be self-administered. It consists of 9 items that evaluate the presence of depressive symptoms present in the last 2 weeks. Each item has a severity index: 0 = "never", 1 = "some days", 2 = "more than half of the days" and 3 = "almost every day". The puntuation is between 0 and 27 (worse puntuation).
Time frame
18 months4
Hospital Anxiety and Depression Scale (HADS)
It is a 14-item questionnaire composed of two sub-scales (HAD-A: anxiety and HAD-D: depression), of 7 items each that are scored from 0 to 3. The puntuation is between 0 and 21 (worse puntuation). The authors recommend points of 8 for possible cases and \>10 for probable cases on both subscales.
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov