Evaluate the Effectiveness of a Virtual Community of Practice

Chronic Diseases Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06046326
• Other study ID #: PI22/01124
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: September 2023
• Source: Gerencia de Atención Primaria, Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Exclusion criteria:

• Low probability of cooperation in the study

• with a terminal illness, physical or mental disability that prevents answering the questionnaires correctly

• 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 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:

participant sociodemographics variables The main variable will be measured using the Patient Activation Measure (PAM) questionnaire at baseline, 6, 12 and 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 variables:

Patient Health Questionnaire at baseline, 6, 12 and 18 months 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).

Hospital Anxiety and Depression Scale at baseline, 6, 12 and 18 months 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.

Treatment Burden Questionnaire at baseline, 6, 12 and 18 months It is a questionnaire of 13 items that uses a Likert scale that ranges from 0 (not a problem) to 20 (it is an important problem) and that assesses the burden related to taking medication, self-care, laboratory tests, medical appointments, the need for organization, administrative tasks, compliance with diet and physical activity and the social impact of treatment. The puntuation is between 0 and 260 (worse puntuation).

European quality of life. Euroqol-5D at baseline, 6, 12 and 18 months Assesses health-related quality of life (HRQoL) both in the general population and in groups of patients with different pathologies. It comprises 5 dimensions (mobility, self-care, activities of daily living, pain/discomfort, and anxiety/depression). Each dimension has 3 items that are scored from 1, no problems, to 3, many problems. There is a visual analogue scale that scores from 0 (worst health status imaginable) to 100 (best health status imaginable)

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: June 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Diseases

Intervention

Behavioral:
• virtual community of practice
The intervention group will be offered participation for 12 months in a VCoP based ona gamified web-based application.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gerencia de Atención Primaria, Madrid

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	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.	12 months
Primary	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.	18 months
Secondary	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).	Baseline
Secondary	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).	12 months
Secondary	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).	18 months
Secondary	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.	Baseline
Secondary	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.	12 months
Secondary	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.	18 months
Secondary	Treatment Burden Questionnaire-TBQ	It is a questionnaire of 13 items that uses a Likert scale that ranges from 0 (not a problem) to 20 (it is an important problem) and that assesses the burden related to taking medication, self-care, laboratory tests, medical appointments, the need for organization, administrative tasks, compliance with diet and physical activity and the social impact of treatment. The puntuation is between 0 and 260 (worse puntuation). on the self-administered Treatment Burden Questionnaire - TBQ	Baseline
Secondary	Treatment Burden Questionnaire-TBQ	It is a questionnaire of 13 items that uses a Likert scale that ranges from 0 (not a problem) to 20 (it is an important problem) and that assesses the burden related to taking medication, self-care, laboratory tests, medical appointments, the need for organization, administrative tasks, compliance with diet and physical activity and the social impact of treatment. The puntuation is between 0 and 260 (worse puntuation). on the self-administered Treatment Burden Questionnaire - TBQ	12 months
Secondary	Treatment Burden Questionnaire-TBQ	It is a questionnaire of 13 items that uses a Likert scale that ranges from 0 (not a problem) to 20 (it is an important problem) and that assesses the burden related to taking medication, self-care, laboratory tests, medical appointments, the need for organization, administrative tasks, compliance with diet and physical activity and the social impact of treatment. The puntuation is between 0 and 260 (worse puntuation). on the self-administered Treatment Burden Questionnaire - TBQ	18 months
Secondary	European quality of life-5 dimensions. E5-5D-5L questionnaire	Assesses health-related quality of life (HRQoL) both in the general population and in groups of patients with different pathologies. It comprises 5 dimensions (mobility, self-care, activities of daily living, pain/discomfort, and anxiety/depression). Each dimension has 3 items that are scored from 1, no problems, to 3, many problems. There is a visual analogue scale that scores from 0 (worst health status imaginable) to 100 (best health status imaginable)	Baseline
Secondary	European quality of life-5 dimensions. E5-5D-5L questionnaire	Assesses health-related quality of life (HRQoL) both in the general population and in groups of patients with different pathologies. It comprises 5 dimensions (mobility, self-care, activities of daily living, pain/discomfort, and anxiety/depression). Each dimension has 3 items that are scored from 1, no problems, to 3, many problems. There is a visual analogue scale that scores from 0 (worst health status imaginable) to 100 (best health status imaginable)	12 months
Secondary	European quality of life-5 dimensions. E5-5D-5L questionnaire	Assesses health-related quality of life (HRQoL) both in the general population and in groups of patients with different pathologies. It comprises 5 dimensions (mobility, self-care, activities of daily living, pain/discomfort, and anxiety/depression). Each dimension has 3 items that are scored from 1, no problems, to 3, many problems. There is a visual analogue scale that scores from 0 (worst health status imaginable) to 100 (best health status imaginable)	18 months