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

May 10, 2016 updated by: Avedis Donabedian Research Institute

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

272

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
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 Names:
  • educational intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At baseline and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Avedis Donabedian Research Institute

Collaborators

Servicio Canario de Salud
Gerencia de Atención Primaria, Madrid

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

April 25, 2016

First Submitted That Met QC Criteria

April 29, 2016

First Posted (Estimate)

May 2, 2016

Study Record Updates

Last Update Posted (Estimate)

May 12, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI15/00164

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not plan to make individual participant data available

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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