NCT01595971

Brief Summary

The purpose of this study is to evaluate the effectiveness of multifaceted educational interventions in the care of asthma, conducted remotely over the platform TelessaúdeRS in teams of the Family Health Strategy and the consequent clinical improvement patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
467

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 12, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 10, 2012

Completed
Last Updated

May 15, 2017

Status Verified

September 1, 2016

Enrollment Period

1.3 years

First QC Date

May 9, 2012

Last Update Submit

May 12, 2017

Conditions

Keywords

AsthmaContinuing educationPrimary health care

Outcome Measures

Primary Outcomes (1)

  • Symptom burden, measured as the number of self-reported asthma symptom days (ASD). ASD is based on 2 week recall.

    The definition of a symptom day includes presence of any of the four types of asthma symptoms: wheeze, cough, night time awakening ou shortness of breath. The results will be collected through the application of standardized questionnaires.

    six months

Secondary Outcomes (3)

  • Asthma control

    6 months

  • Health care utilization

    6 meses

  • Proportion of patients in use inhaled corticosteroids

    6 meses

Study Arms (2)

continuing education

EXPERIMENTAL

RESPIRANET is a multifaceted intervention directed at professionals of the Family Health Teams in the inner cities.Includes telemedicine, reminders, video conferences, educational materials for patients and consultants.

Behavioral: Continuing education

Usual Care

PLACEBO COMPARATOR

usual care

Other: usual care

Interventions

Includes telemedicine, reminders, video conferences, educational materials for patients and consultants.

Also known as: RESPIRANET
continuing education

Received the usual care provided

Usual Care

Eligibility Criteria

Age5 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Practice:Participate in the Telessaúde/RS. Minimal staff consisting of a general practitioner, nurse, nurse and community health agents (CHA), ability to give at least ten patients diagnosed with asthma, located in a municipality to make available for free inhaled medication (short-acting bronchodilators and corticosteroids ) for the treatment of asthma and willingness to participate in the study.
  • Patients: 5 to 45 years with a diagnosis of asthma made by a physician and register at least one consultation for asthma or an asthma-related hospitalization during the year preceding the beginning of the study.

You may not qualify if:

  • Patients with other chronic diseases with pulmonary complications such as tuberculosis, cancer and cystic fibrosis or those with severe mental illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

Related Links

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Erno Harzheim, PHD

    Federal University of Rio Grande do Sul

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2012

First Posted

May 10, 2012

Study Start

August 12, 2010

Primary Completion

December 16, 2011

Study Completion

December 16, 2011

Last Updated

May 15, 2017

Record last verified: 2016-09

Locations