Chronic DiseasesNCT06046326
Evaluate the Effectiveness of a Virtual Community of Practice
A study testing virtual community of practice in people with Chronic Diseases, run by Gerencia de Atención Primaria, Madrid at 3 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Diseases
- What is being tested?
- virtual community of practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 3 sitesSpain
- Study dates
- 1 Jun 2024to 1 Dec 2026
- 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Middleagedpeople (30-60 years old)
- with multimorbidity (≥=2 chronic diseases).
Who cannot join
- 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 locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain3 sites, 3 recruiting
- Recruiting
Gerencia Asistencial Atención Primaria
Madrid, Madrid, 28035
González A González, Doctor, 915290742, aisabel.gonzalezg@salud.madrid.org
- Recruiting
Gerencia Asistencial Atención Primaria
Madrid, Madrid, 28035
González A González, 915290742, aisabel.gonzalezg@salud.madrid.org
- Recruiting
González Atención González
Madrid, Madrid, 28035
González A González, doctor, 915290742, aisabel.gonzalezg@salud.madrid.org
González A González, 915290742, aisabel.gonzalezg@salud.madrid.org
About this study
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.
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.
Read more
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.
Read the 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
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.
- Conditions
- Chronic Diseases
- Being tested
- virtual community of practice
- Keywords
- Chronic Diseases, Virtual community of practice empowerment
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual community of practiceBehavioural
The intervention group will be offered participation for 12 months in a VCoP based ona gamified web-based application.
| Study group | Role | What they receive |
|---|---|---|
| virtual community of practice | Experimental | The intervention group will be offered participation for 12 months in a VCoP based ona gamified web-based application. Receives: Behavioral: virtual community of practice |
| control group | No intervention | 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 theplatform. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: 12 months
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.
Measured: 18 months
Secondary outcomes (12)
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).
Measured: Baseline
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).
Measured: 12 months
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).
Measured: 18 months
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.
Measured: Baseline
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.
Measured: 12 months
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.
Measured: 18 months
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
Measured: Baseline
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
Measured: 12 months
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
Measured: 18 months
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)
Measured: Baseline
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)
Measured: 12 months
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)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Jun 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gerencia de Atención Primaria, Madrid
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046326
- Sponsor's protocol ID
- PI22/01124
- Status last verified
- Feb 2025
- First submitted
- 22 Jun 2023
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Campillejo A, Gefaell-Larrondo I, Ramos-Garcia V, Koatz D, Santos-Alvarez A, Barrio-Cortes J, Gomez-Rueda S, Calderon-Larranaga A, Cifuentes P, Company-Sancho C, Dominguez-Coello S, Garcia-Garcia FJ, Garrido-Elustondo S, Gonzalez de Leon B, Ramon-Vazquez J, Martin C, Suarez-Fernandez C, Parra-Caballero P, Vicente-Rabaneda EF, Quiroga-Colina P, Ramirez-Puerta AB, Ruiz-Lopez M, Tello-Bernabe ME, Sanchez-Gamborino E, Ugalde-Abiega B, Vall-Roque H, Duarte-Diaz A, Abt-Sacks A, Hernandez-Yumar A, Torres-Castano A, Alvarez-Perez Y, Muth C, van den Akker M, Montori VM, Orrego C, Perestelo-Perez L, Gonzalez-Gonzalez AI. Implementation of a virtual community of practice to promote the empowerment of middle-aged people with multimorbidity: study protocol of a randomised controlled trial. BMJ Open. 2024 May 24;14(5):e084937. doi: 10.1136/bmjopen-2024-084937.
PubMed 38803252
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06046326
- Acronym / sponsor ID
- PI22/01124
- Conditions
- Chronic Diseases
- Keywords
- Chronic Diseases, Virtual community of practice empowerment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Gerencia de Atención Primaria, MadridOther government
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| virtual community of practice | Experimental | Behavioral: virtual community of practiceThe intervention group will be offered participation for 12 months in a VCoP based ona gamified web-based application. |
| control group | No intervention | –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 theplatform. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Middleagedpeople (30-60 years old)
- with multimorbidity (≥=2 chronic diseases).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| virtual community of practiceThe intervention group will be offered participation for 12 months in a VCoP based ona gamified web-based application. | Behavioural | virtual community of practice |
Primary outcome
the Patient Activation Measure (PAM)
Time frame: Baseline
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.
the Patient Activation Measure (PAM)
Time frame: 12 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.
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.
12 secondary outcomes
Patient Health Questionnaire-9
Time frame: Baseline
Patient Health Questionnaire-9
Time frame: 12 months
Patient Health Questionnaire-9
Time frame: 18 months
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline
Hospital Anxiety and Depression Scale (HADS)
Time frame: 12 months
Hospital Anxiety and Depression Scale (HADS)
Time frame: 18 months
Treatment Burden Questionnaire-TBQ
Time frame: Baseline
Treatment Burden Questionnaire-TBQ
Time frame: 12 months
Treatment Burden Questionnaire-TBQ
Time frame: 18 months
European quality of life-5 dimensions. E5-5D-5L questionnaire
Time frame: Baseline
European quality of life-5 dimensions. E5-5D-5L questionnaire
Time frame: 12 months
European quality of life-5 dimensions. E5-5D-5L questionnaire
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Derived from this study: PubMed 38803252Campillejo A, Gefaell-Larrondo I, Ramos-Garcia V, Koatz D, Santos-Alvarez A, Barrio-Cortes J, Gomez-Rueda S, Calderon-Larranaga A, Cifuentes P, Company-Sancho C, Dominguez-Coello S, Garcia-Garcia FJ, Garrido-Elustondo S, Gonzalez de Leon B, Ramon-Vazquez J, Martin C, Suarez-Fernandez C, Parra-Caballero P, Vicente-Rabaneda EF, Quiroga-Colina P, Ramirez-Puerta AB, Ruiz-Lopez M, Tello-Bernabe ME, Sanchez-Gamborino E, Ugalde-Abiega B, Vall-Roque H, Duarte-Diaz A, Abt-Sacks A, Hernandez-Yumar A, Torres-Castano A, Alvarez-Perez Y, Muth C, van den Akker M, Montori VM, Orrego C, Perestelo-Perez L, Gonzalez-Gonzalez AI. Implementation of a virtual community of practice to promote the empowerment of middle-aged people with multimorbidity: study protocol of a randomised controlled trial. BMJ Open. 2024 May 24;14(5):e084937. doi: 10.1136/bmjopen-2024-084937.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual community of practice in people with Chronic Diseases, run by Gerencia de Atención Primaria, Madrid at 3 sites in Spain.
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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Patient Activation Measure (PAM) (time frame: Baseline). The study lists 3 primary outcomes in all. 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 NCT06046326, which also lists 1 linked publication.
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 12 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.