NCT03762330

Brief Summary

This study evaluates the effect of of a structured self-management intervention plan in patients with chronic obstructive pulmonary disease in primary care setting.Half of the participants will receive the self-management plan while the other half will receive usual care.

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
300

participants targeted

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

Timeline
Completed

Started Jan 2019

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

First Submitted

Initial submission to the registry

November 14, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 3, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 19, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

July 31, 2020

Status Verified

July 1, 2020

Enrollment Period

2 years

First QC Date

November 14, 2018

Last Update Submit

July 30, 2020

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

quality of lifeself-management,structured planCOPD

Outcome Measures

Primary Outcomes (1)

  • Quality of life St. George´s Respiratory Questionnaire (SGRQ)

    St. George´s Respiratory Questionnaire (SGRQ).Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Number of items: 50 items Number of domains \& categories : 2 parts (3 components). Part 1 : Symptoms component (frequency \& severity) with a 1, 3 or 12-month recall (best performance with 3- and 12-month recall); Part 2: Activities that cause or are limited by breathlessness; Impact components (social functioning, psychological disturbances resulting from airways disease) refer to current state as the recall. Scaling of items Part I (Symptoms): several scales; Part II (Activity and Impacts): dichotomous (true/false) except last question (4-point Likert scale). Scores range from 0 to 100, with higher scores indicating more limitations.

    Change from baseline at 6 ,12 and 24 months

Secondary Outcomes (16)

  • Intensity of symptoms related to COPD

    Change from baseline at 6 ,12 and 24 months

  • Dyspnea score severity

    Change from baseline at 6 ,12 and 24 months

  • Changes in the Body mass index, Obstruction, Dyspnea, Exacerbations Index (BODEx index )

    Change from baseline at 6 ,12 and 24 months

  • Number of COPD exacerbations

    at 6 ,12 and 24 months from baseline

  • Number of hospital admissions due to COPD exacerbation

    at 6 ,12 and 24 months from baseline

  • +11 more secondary outcomes

Study Arms (2)

COPD structured self-management plan

ACTIVE COMPARATOR

Participants will receive usual care for COPD and in addition, a structured self-management education plan.

Behavioral: COPD structured self-management plan.

Usual care

NO INTERVENTION

COPD participants receiving only usual care

Interventions

COPD structured self-management plan.BEHAVIORAL

Education plan , including knowledge of the disease, healthy life habits, correct use of inhalers, skills to control symptoms and strategies to face the disease and exacerbations

COPD structured self-management plan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with at least one visit at the primary care physician during the past year
  • Patients with a diagnosis of moderate (FEV1 50% - 80%) or severe (FEV1 30% - 50%) COPD
  • Patients treated with inhaled bronchodilators and accepting to participate in the study.

You may not qualify if:

  • Patients unable to come to the primary care centre
  • Patients with cognitive impairment and/or a severe mental condition.
  • Patients with a diagnosis of asthma, tuberculosis or other chronic respiratory disease.
  • Patients needing chronic oxygen therapy.
  • Patients with any terminal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EAP Montcada i Reixac

Barcelona, 08110, Spain

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Maite Lopez Luque

    Servei Catala de la Salut

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maite Lopez Luque

CONTACT

93 326 89 01tlopezl@gencat.cat

Patricia Lloberes, Dr

CONTACT

+34 627906580plloberes@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2018

First Posted

December 3, 2018

Study Start

January 19, 2019

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

July 31, 2020

Record last verified: 2020-07

Locations

ES(1)