Ignite Creation Date:
2024-05-06 @ 7:32 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06046326
Status:
RECRUITING
Last Update Posted:
2024-04-04
First Post:
2023-06-22
Brief Title:
Evaluate the Effectiveness of a Virtual Community of Practice
Sponsor:
Gerencia de Atención Primaria Madrid
Organization:
Gerencia de Atención Primaria Madrid
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 peoples 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 paindiscomfort and anxietydepression 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
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 peoples 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 paindiscomfort and anxietydepression 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None