NCT02901535

Brief Summary

The purpose of this study is to determine the effectiveness of telemedicine multifaceted intervention in symptoms patients with chronic obstructive pulmonary disease.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

2.3 years

First QC Date

September 12, 2016

Last Update Submit

January 16, 2017

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

telemedicinechronic obstructive pulmonary diseasePrimary Health carespirometry

Outcome Measures

Primary Outcomes (1)

  • Symptoms

    Modified Medical Research Council Dyspnea Scale (difference in mMRC)

    20 a 22 weeks

Secondary Outcomes (2)

  • Spirometry - FEV1

    20 a 22 weeks

  • Spirometry - FVC

    20 a 22 weeks

Study Arms (2)

Control

ACTIVE COMPARATOR

Spirometry in baseline Spirometry - 20 weeks

Other: SpirometryOther: Spirometry - 20 weeks

Intervention

EXPERIMENTAL

Spirometry in baseline Teleconsultation Telemonitoring Spirometry - 20 weeks

Other: SpirometryOther: telemonitoringOther: teleconsultationOther: Spirometry - 20 weeks

Interventions

SpirometryOTHER

Spirometry in baseline

ControlIntervention
telemonitoringOTHER

telemonitoring (phone call nurse - 45 and 90 days)

Intervention
teleconsultationOTHER

teleconsultation (general practioner received phone call to respiratory care)

Intervention
Spirometry - 20 weeksOTHER

Spirometry (20 weeks)

ControlIntervention

Eligibility Criteria

Age12 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • spirometry from TelessaudeRS-Universidade Federal do Rio Grande do Sul (from randomization cluster), Modified Medical Research Council Dyspnea \> 0

You may not qualify if:

  • normal or restrictive spirometry, low quality spirometries (inadequate)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TelessaudeRS-Universidade Federal do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90670000, Brazil

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Remote Consultation

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Referral and ConsultationProfessional PracticeOrganization and AdministrationHealth Services AdministrationTelemedicineDelivery of Health CarePatient Care Management

Study Officials

  • Erno Harzheim, PhD

    Federal University of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcelo R. Gonçalves, PhD

CONTACT

5191175156marcelorog@gmail.com

Cynthia G Molina-Bastos, MD

CONTACT

5191322585cyncarol@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2016

First Posted

September 15, 2016

Study Start

April 1, 2015

Primary Completion

July 1, 2017

Study Completion

December 1, 2017

Last Updated

January 18, 2017

Record last verified: 2017-01

Locations

BR(1)