Effectiveness of a Virtual Intervention to Healthcare Professionals to Improve Attitudes About Patient Empowerment - eMPODERA Project

Chronic Disease Clinical Trial

— 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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02757781
• Other study ID #: PI15/00164
• Status: Not yet recruiting
• Phase: N/A
• First received: April 25, 2016
• Last updated: May 1, 2016
• Start date: July 2016
• Est. completion date: December 2018

Study information

• Verified date: May 2016
• Source: Avedis Donabedian Research Institute
• Contact: Carola Orrego, PhD
• Phone: 34 932076608
• Email: corrego[@]fadq.org
• Is FDA regulated: No
• Health authority: Spain: Ministry of HealthSpain: Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 272
• Est. completion date: December 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Chronic Disease

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Avedis Donabedian Research Institute	Gerencia de Atención Primaria, Madrid, Servicio Canario de Salud

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Patient-Provider Orientation Scale (PPOS) at 12 months	PPOS is a questionnaire administrated to healthcare professionals	At baseline and 12 months	No
Secondary	Change from Patient Activation Measure (PAM) at 12 months	PAM is validated questionnaire to measure patient activation (administrated to patients)	Baseline and 12 months	No