Chronic DiseaseeMPODERANCT02757781
Effectiveness of a Virtual Intervention for Professionals to Improve Their Attitudes Towards Patient Empowerment.
A study testing Community of Practice in people with Chronic Disease, run by Avedis Donabedian Research Institute.
Trial summary
The eMPODERA study aims to assess the effectiveness of a Community of Practice (CdP) virtual in improving attitudes of primary care professionals on the empowerment of patients with chronic diseases. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Community of Practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clusters:
- Primary Care Centres (PCC) with Electronic Record system with more than 1 year of implementation
- PCC belongs to the Automonous Comunities of Canary Island, Catalonia and Madrid
- Healthcare professionals:
- Acceptance to participate
- stable contract with the Primary care centre
- Physician or Nurses
Who cannot join
- Clusters:
- Primary Care Centres where its directors do not accept to participate in the trial
- Healthcare professionals:
- Students
- Medical and Nursing residents
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness of a Virtual Intervention (CoP) for Professionals to Improve Their Attitude Towards the Empowerment of Patients With Chronic Disease: Cluster Randomised Controlled Trial (eMPODERA Project)
The eMPODERA study aims to assess the effectiveness of a Community of Practice (CdP) virtual in improving attitudes of primary care professionals on the empowerment of patients with chronic diseases.
Read the detailed description
Main Objective: to assess the effectiveness of a Community of Practice (CdP) virtual in improving attitudes of health professionals in primary care on the empowerment of patients with chronic diseases.
Methodology:
Design: cluster randomised controlled.
Scope: primary care centers (PCC) belonging to the Regions of Catalonia, Madrid and Canary Islands.
Population: primary care health professionals (family doctors and nurses).
Sample size: 270 healthcare professionals and 1382 patients.
Randomization: Randomization unit: PCC; unit of analysis: primary care health professionals. 9 pairs of PCC by region will be randomly selected and randomly assigned to the intervention or control group. Randomization will be performed after the selection of professionals and patients.
Intervention: the intervention group will be offered participation for 12 months in a virtual CdP based on a web 2.0 platform. The control group will receive usual training.
Measurements: the primary outcome will be measured by Patient-Provider Orientation Scale (PPOS) questionnaire at baseline and 12 months. Secondary outcomes: sociodemographic of professionals; sociodemographic and clinical characteristics of patients; Patient Activation Measure (PAM) questionnaire for patient activation; outcomes regarding use of the CdP.
Analysis: A linear mixed-effects regression to estimate the effect of participating in the CdP will be estimated. Additionally, an analysis of how the CdP is functioning through techniques of social network analysis and control charts will be performed.
- Conditions
- Chronic Disease
- Being tested
- Community of Practice
- Keywords
- Patient empowerment, Patient involvement, Patient participation, Healthcare professional attitudes, Chronic diseases
- Medical subject headings
- Chronic Disease, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community of PracticeBehavioural
Also called educational intervention
The intervention group will be offered participation for 12 months in a virtual CdP based on a web 2.0 platform. The control group will receive usual training.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Group of healthcare professionals that NOT receive the intervention (community of practice) |
| Intervention group | Experimental | Group of healthcare professionals that receive the intervention (community of practice) Receives: Behavioral: Community of Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Patient-Provider Orientation Scale (PPOS) at 12 months
PPOS is a questionnaire administrated to healthcare professionals
Measured: At baseline and 12 months
Secondary outcomes (1)
Change from Patient Activation Measure (PAM) at 12 months
PAM is validated questionnaire to measure patient activation (administrated to patients)
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startJul 2016
- Primary completionOct 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 272 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avedis Donabedian Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Servicio Canario de Salud, Gerencia de Atención Primaria, Madrid
- Responsible party
- Sponsor
- Investigators
- Carola Orrego, PhD, Principal investigator, Avedis Donabedian Research InstituteLilisbeth Perestelo, PhD, Principal investigator, Servicio de Evaluación del Servicio Canario de la SaludAna I Gonzalez, MD, Principal investigator, Unidad de Apoyo Técnico de la Gerencia Asistencial de Atención Primaria de la Comunidad de MadridCarlos Bermejo, RN,Msc, Principal investigator, Unidad de Apoyo Técnico de la Gerencia Asistencial de Atención Primaria de la Comunidad de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757781
- Sponsor's protocol ID
- PI15/00164
- Acronym
- eMPODERA
- Status last verified
- May 2016
- First submitted
- 25 Apr 2016
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is not plan to make individual participant data available
Publications
Koatz D, Torres-Castano A, Salrach-Arnau C, Perestelo-Perez L, Ramos-Garcia V, Gonzalez-Gonzalez AI, Pacheco-Huergo V, Toledo-Chavarri A, Gonzalez-Pacheco H, Orrego C. Exploring value creation in a virtual community of practice: a framework analysis for knowledge and skills development among primary care professionals. BMC Med Educ. 2024 Feb 7;24(1):121. doi: 10.1186/s12909-024-05061-6.
PubMed 38326814Orrego C, Perestelo-Perez L, Gonzalez-Gonzalez AI, Ballester-Santiago M, Koatz D, Pacheco-Huergo V, Rivero-Santana A, Ramos-Garcia V, Fernandez NM, Torres-Castano A, Bermejo-Caja C. A Virtual Community of Practice to Improve Primary Health Care Professionals' Attitudes Toward Patient Empowerment (e-MPODERA): A Cluster Randomized Trial. Ann Fam Med. 2022 May-Jun;20(3):204-210. doi: 10.1370/afm.2799.
PubMed 35606139Bermejo-Caja CJ, Koatz D, Orrego C, Perestelo-Perez L, Gonzalez-Gonzalez AI, Ballester M, Pacheco-Huergo V, Del Rey-Granado Y, Munoz-Balsa M, Ramirez-Puerta AB, Canellas-Criado Y, Perez-Rivas FJ, Toledo-Chavarri A, Martinez-Marcos M; e-MPODERA group. Acceptability and feasibility of a virtual community of practice to primary care professionals regarding patient empowerment: a qualitative pilot study. BMC Health Serv Res. 2019 Jun 20;19(1):403. doi: 10.1186/s12913-019-4185-z.
PubMed 31221215Gonzalez-Gonzalez AI, Orrego C, Perestelo-Perez L, Bermejo-Caja CJ, Mora N, Koatz D, Ballester M, Del Pino T, Perez-Ramos J, Toledo-Chavarri A, Robles N, Perez-Rivas FJ, Ramirez-Puerta AB, Canellas-Criado Y, Del Rey-Granado Y, Munoz-Balsa MJ, Becerril-Rojas B, Rodriguez-Morales D, Sanchez-Perruca L, Vazquez JR, Aguirre A. Effectiveness of a virtual intervention for primary healthcare professionals aimed at improving attitudes towards the empowerment of patients with chronic diseases: study protocol for a cluster randomized controlled trial (e-MPODERA project). Trials. 2017 Oct 30;18(1):505. doi: 10.1186/s13063-017-2232-9.
PubMed 29084597
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Virtual Intervention (CoP) for Professionals to Improve Their Attitude Towards the Empowerment of Patients With Chronic Disease: Cluster Randomised Controlled Trial (eMPODERA Project)
- ClinicalTrials.gov ID
- NCT02757781
- Acronym / sponsor ID
- eMPODERA / PI15/00164
- Conditions
- Chronic Disease
- Keywords
- Patient empowerment, Patient involvement, Patient participation, Healthcare professional attitudes, Chronic diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 272 participants (estimated)
- Lead sponsor
- Avedis Donabedian Research InstituteUniversity, hospital or other
- Collaborators
- Servicio Canario de Salud, Gerencia de Atención Primaria, Madrid
- Study start
- Jul 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 2 May 2016 (estimated)
- 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.
The eMPODERA study aims to assess the effectiveness of a Community of Practice (CdP) virtual in improving attitudes of primary care professionals on the empowerment of patients with chronic diseases.
Detailed description
Main Objective: to assess the effectiveness of a Community of Practice (CdP) virtual in improving attitudes of health professionals in primary care on the empowerment of patients with chronic diseases.
Methodology:
Design: cluster randomised controlled.
Scope: primary care centers (PCC) belonging to the Regions of Catalonia, Madrid and Canary Islands.
Population: primary care health professionals (family doctors and nurses).
Sample size: 270 healthcare professionals and 1382 patients.
Randomization: Randomization unit: PCC; unit of analysis: primary care health professionals. 9 pairs of PCC by region will be randomly selected and randomly assigned to the intervention or control group. Randomization will be performed after the selection of professionals and patients.
Intervention: the intervention group will be offered participation for 12 months in a virtual CdP based on a web 2.0 platform. The control group will receive usual training.
Measurements: the primary outcome will be measured by Patient-Provider Orientation Scale (PPOS) questionnaire at baseline and 12 months. Secondary outcomes: sociodemographic of professionals; sociodemographic and clinical characteristics of patients; Patient Activation Measure (PAM) questionnaire for patient activation; outcomes regarding use of the CdP.
Analysis: A linear mixed-effects regression to estimate the effect of participating in the CdP will be estimated. Additionally, an analysis of how the CdP is functioning through techniques of social network analysis and control charts will be performed.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Group of healthcare professionals that NOT receive the intervention (community of practice) |
| Intervention group | Experimental | Behavioral: Community of PracticeGroup of healthcare professionals that receive the intervention (community of practice) |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Primary Care Centres (PCC) with Electronic Record system with more than 1 year of implementation
- PCC belongs to the Automonous Comunities of Canary Island, Catalonia and Madrid
- Acceptance to participate
- stable contract with the Primary care centre
- Physician or Nurses
Key exclusion criteria (5 listed)
- Primary Care Centres where its directors do not accept to participate in the trial
- Students
- Medical and Nursing residents
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 |
|---|---|---|
| Community of PracticeAlso: educational interventionThe intervention group will be offered participation for 12 months in a virtual CdP based on a web 2.0 platform. The control group will receive usual training. | Behavioural | Intervention group |
Primary outcome
Change from Patient-Provider Orientation Scale (PPOS) at 12 months
Time frame: At baseline and 12 months
PPOS is a questionnaire administrated to healthcare professionals
1 secondary outcome
Change from Patient Activation Measure (PAM) at 12 months
Time frame: Baseline and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
- Derived from this study: PubMed 38326814Koatz D, Torres-Castano A, Salrach-Arnau C, Perestelo-Perez L, Ramos-Garcia V, Gonzalez-Gonzalez AI, Pacheco-Huergo V, Toledo-Chavarri A, Gonzalez-Pacheco H, Orrego C. Exploring value creation in a virtual community of practice: a framework analysis for knowledge and skills development among primary care professionals. BMC Med Educ. 2024 Feb 7;24(1):121. doi: 10.1186/s12909-024-05061-6.
- Derived from this study: PubMed 35606139Orrego C, Perestelo-Perez L, Gonzalez-Gonzalez AI, Ballester-Santiago M, Koatz D, Pacheco-Huergo V, Rivero-Santana A, Ramos-Garcia V, Fernandez NM, Torres-Castano A, Bermejo-Caja C. A Virtual Community of Practice to Improve Primary Health Care Professionals' Attitudes Toward Patient Empowerment (e-MPODERA): A Cluster Randomized Trial. Ann Fam Med. 2022 May-Jun;20(3):204-210. doi: 10.1370/afm.2799.
- Derived from this study: PubMed 31221215Bermejo-Caja CJ, Koatz D, Orrego C, Perestelo-Perez L, Gonzalez-Gonzalez AI, Ballester M, Pacheco-Huergo V, Del Rey-Granado Y, Munoz-Balsa M, Ramirez-Puerta AB, Canellas-Criado Y, Perez-Rivas FJ, Toledo-Chavarri A, Martinez-Marcos M; e-MPODERA group. Acceptability and feasibility of a virtual community of practice to primary care professionals regarding patient empowerment: a qualitative pilot study. BMC Health Serv Res. 2019 Jun 20;19(1):403. doi: 10.1186/s12913-019-4185-z.
- Derived from this study: PubMed 29084597Gonzalez-Gonzalez AI, Orrego C, Perestelo-Perez L, Bermejo-Caja CJ, Mora N, Koatz D, Ballester M, Del Pino T, Perez-Ramos J, Toledo-Chavarri A, Robles N, Perez-Rivas FJ, Ramirez-Puerta AB, Canellas-Criado Y, Del Rey-Granado Y, Munoz-Balsa MJ, Becerril-Rojas B, Rodriguez-Morales D, Sanchez-Perruca L, Vazquez JR, Aguirre A. Effectiveness of a virtual intervention for primary healthcare professionals aimed at improving attitudes towards the empowerment of patients with chronic diseases: study protocol for a cluster randomized controlled trial (e-MPODERA project). Trials. 2017 Oct 30;18(1):505. doi: 10.1186/s13063-017-2232-9.
- Individual participant dataSharing planned: No. There is not plan to make individual participant data available
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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. This study is not recruiting at the moment.
Carola Orrego, PhD principal investigator
Avedis Donabedian Research Institute
Lilisbeth Perestelo, PhD principal investigator
Servicio de Evaluación del Servicio Canario de la Salud
Ana I Gonzalez, MD principal investigator
Unidad de Apoyo Técnico de la Gerencia Asistencial de Atención Primaria de la Comunidad de Madrid
Questions about this trial
What is this clinical trial studying?
A study testing Community of Practice in people with Chronic Disease, run by Avedis Donabedian Research Institute.
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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carola Orrego, PhD (34 932076608, corrego@fadq.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Patient-Provider Orientation Scale (PPOS) at 12 months (time frame: At baseline and 12 months). 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 NCT02757781, which also lists 4 linked publications.
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 May 2016.