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Effectiveness of a Virtual Intervention for Professionals to Improve Their Attitudes Towards Patient Empowerment. (eMPODERA)

Primary Purpose

Chronic Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Community of Practice
Sponsored by
Avedis Donabedian Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Disease focused on measuring Patient empowerment, Patient involvement, Patient participation, Healthcare professional attitudes, Chronic diseases

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Clusters:

- Primary Care Centres where its directors do not accept to participate in the trial

Healthcare professionals:

  • Students
  • Medical and Nursing residents

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control Group

    Intervention group

    Arm Description

    Group of healthcare professionals that NOT receive the intervention (community of practice)

    Group of healthcare professionals that receive the intervention (community of practice)

    Outcomes

    Primary Outcome Measures

    Change from Patient-Provider Orientation Scale (PPOS) at 12 months
    PPOS is a questionnaire administrated to healthcare professionals

    Secondary Outcome Measures

    Change from Patient Activation Measure (PAM) at 12 months
    PAM is validated questionnaire to measure patient activation (administrated to patients)

    Full Information

    First Posted
    April 25, 2016
    Last Updated
    May 10, 2016
    Sponsor
    Avedis Donabedian Research Institute
    Collaborators
    Servicio Canario de Salud, Gerencia de Atención Primaria, Madrid
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02757781
    Brief Title
    Effectiveness of a Virtual Intervention for Professionals to Improve Their Attitudes Towards Patient Empowerment.
    Acronym
    eMPODERA
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2016 (undefined)
    Primary Completion Date
    October 2017 (Anticipated)
    Study Completion Date
    December 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Avedis Donabedian Research Institute
    Collaborators
    Servicio Canario de Salud, Gerencia de Atención Primaria, Madrid

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Disease
    Keywords
    Patient empowerment, Patient involvement, Patient participation, Healthcare professional attitudes, Chronic diseases

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    272 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    Group of healthcare professionals that NOT receive the intervention (community of practice)
    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    Group of healthcare professionals that receive the intervention (community of practice)
    Intervention Type
    Behavioral
    Intervention Name(s)
    Community of Practice
    Other Intervention Name(s)
    educational intervention
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change from Patient-Provider Orientation Scale (PPOS) at 12 months
    Description
    PPOS is a questionnaire administrated to healthcare professionals
    Time Frame
    At baseline and 12 months
    Secondary Outcome Measure Information:
    Title
    Change from Patient Activation Measure (PAM) at 12 months
    Description
    PAM is validated questionnaire to measure patient activation (administrated to patients)
    Time Frame
    Baseline and 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: Clusters: - Primary Care Centres where its directors do not accept to participate in the trial Healthcare professionals: Students Medical and Nursing residents
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Carola Orrego, PhD
    Phone
    34 932076608
    Email
    corrego@fadq.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Carola Orrego, PhD
    Organizational Affiliation
    Avedis Donabedian Research Institute
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Lilisbeth Perestelo, PhD
    Organizational Affiliation
    Servicio de Evaluación del Servicio Canario de la Salud
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Ana I Gonzalez, MD
    Organizational Affiliation
    Unidad de Apoyo Técnico de la Gerencia Asistencial de Atención Primaria de la Comunidad de Madrid
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Carlos Bermejo, RN,Msc
    Organizational Affiliation
    Unidad de Apoyo Técnico de la Gerencia Asistencial de Atención Primaria de la Comunidad de Madrid
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    There is not plan to make individual participant data available
    Citations:
    PubMed Identifier
    35606139
    Citation
    Orrego 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. Erratum In: Ann Fam Med. 2022 Jul-Aug;20(4):357.
    Results Reference
    derived
    PubMed Identifier
    31221215
    Citation
    Bermejo-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.
    Results Reference
    derived
    PubMed Identifier
    29084597
    Citation
    Gonzalez-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.
    Results Reference
    derived

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