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

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ClinicalTrials.gov Identifier: NCT02757781
Recruitment Status : Unknown
Verified May 2016 by Avedis Donabedian Research Institute.
Recruitment status was:  Not yet recruiting
First Posted : May 2, 2016
Last Update Posted : May 12, 2016
Sponsor:
Collaborators:
Servicio Canario de Salud
Gerencia de Atención Primaria, Madrid
Information provided by (Responsible Party):
Avedis Donabedian Research Institute

Tracking Information
First Submitted Date  ICMJE April 25, 2016
First Posted Date  ICMJE May 2, 2016
Last Update Posted Date May 12, 2016
Study Start Date  ICMJE July 2016
Estimated Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2016)
Change from Patient Activation Measure (PAM) at 12 months [ Time Frame: Baseline and 12 months ]
PAM is validated questionnaire to measure patient activation (administrated to patients)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of a Virtual Intervention for Professionals to Improve Their Attitudes Towards Patient Empowerment.
Official Title  ICMJE 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)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Condition  ICMJE Chronic Disease
Intervention  ICMJE Behavioral: Community of Practice
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.
Other Name: educational intervention
Study Arms  ICMJE
  • No Intervention: Control Group
    Group of healthcare professionals that NOT receive the intervention (community of practice)
  • Experimental: Intervention group
    Group of healthcare professionals that receive the intervention (community of practice)
    Intervention: Behavioral: Community of Practice
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 29, 2016)
272
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02757781
Other Study ID Numbers  ICMJE PI15/00164
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is not plan to make individual participant data available
Responsible Party Avedis Donabedian Research Institute
Study Sponsor  ICMJE Avedis Donabedian Research Institute
Collaborators  ICMJE
  • Servicio Canario de Salud
  • Gerencia de Atención Primaria, Madrid
Investigators  ICMJE
Principal Investigator: Carola Orrego, PhD Avedis Donabedian Research Institute
Principal Investigator: Lilisbeth Perestelo, PhD Servicio de Evaluación del Servicio Canario de la Salud
Principal Investigator: Ana I Gonzalez, MD Unidad de Apoyo Técnico de la Gerencia Asistencial de Atención Primaria de la Comunidad de Madrid
Principal Investigator: Carlos Bermejo, RN,Msc Unidad de Apoyo Técnico de la Gerencia Asistencial de Atención Primaria de la Comunidad de Madrid
PRS Account Avedis Donabedian Research Institute
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP