Chronic Obstructive Pulmonary DiseaseNCT03762330
Structured Comprehensive Intervention to Stimulate Self- Management and Improve Quality of Life in COPD Patients
A study testing COPD structured self-management plan. in people with Chronic Obstructive Pulmonary Disease, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- COPD structured self-management plan.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 19 Jan 2019to Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
EAP Montcada i Reixac
Barcelona, 08110
Maite Lopez, Nurse, +24 93 3268901, tlopezl@gencat.cat
About this study
Official title: Effect of a Structured Comprehensive Intervention to Stimulate Self- Management and Improve Quality of Life in People With Chronic Obstructive Pulmonary Disease(COPD). A Randomised Clinical Trial.
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.
Read the detailed description
Chronic Obstructive Pulmonary Disease (COPD) is a great magnitude public health problem with an associated increased mortality and a high cost (consumption of health care resources and loss of health related quality of life (HRQoL)). The comprehensive approach to this complex disease, focusing self-care promotion, improves HRQoL and the patients" clinical status, as shown by several studies, although further investigation is needed to confirm these results in the field of Primary Care (PC) and to formulate clear recommendations on the more effective type of intervention.
Hypothesis: In (moderate-severe) COPD patients, a structured self-management intervention plan in the setting of primary care, is more effective than usual treatment on the main outcomes associated with the disease: HRQoL, lung function, exacerbations and hospital admissions, at 6, 12 and 24 months of follow-up.
Objectives: To evaluate the impact of a comprehensive intervention plan to promote self-care and improve HRQoL in people with COPD in PC.
Methods: Multicenter randomized controlled trial, conducted at PC centers in Barcelona.
Determinations: Specific standardized and validated questionnaires, as the St George's Respiratory for the HRQoL. Statistical analysis: Intention to treat analysis. Descriptive statistics of the variables of the intervention and the control group to assess their homogeneity at the beginning of the study. An analysis of variance (ANOVA) will be used to assess differences among intervention groups.
Expected results: A significant improvement in HRQoL attributable to the intervention performed in patients with COPD Applicability and Relevance: To implement the intervention plan in clinical practice and to standardize its content.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- COPD structured self-management plan.
- Keywords
- quality of life, self-management,, structured plan, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COPD structured self-management plan.Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| COPD structured self-management plan | Active comparator | Participants will receive usual care for COPD and in addition, a structured self-management education plan. Receives: Behavioral: COPD structured self-management plan. |
| Usual care | No intervention | COPD participants receiving only usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline at 6 ,12 and 24 months
Secondary outcomes (16)
Intensity of symptoms related to COPD
COPD Assessment Test (CAT) : It consists of 8 questions with 5 possible answers valued from 0 to 5 (values close to 0: better health status)
Measured: Change from baseline at 6 ,12 and 24 months
Dyspnea score severity
Dyspnea severity assessed by the modified scale of the Medical Research Council (mMRC). Range 0-4 (none to maximum)
Measured: Change from baseline at 6 ,12 and 24 months
Changes in the Body mass index, Obstruction, Dyspnea, Exacerbations Index (BODEx index )
Index including BMI (Body mass index), Obstruction, Dyspnea, Exacerbations. with possible answers from 0-3, each item. Range: 0-9. Mild: 0-2 Moderate: 3-4 Severe ≥5
Measured: Change from baseline at 6 ,12 and 24 months
Number of COPD exacerbations
Number of COPD exacerbations requiring a visit to primary care physician
Measured: at 6 ,12 and 24 months from baseline
Number of hospital admissions due to COPD exacerbation
Number of hospital admissions due to COPD exacerbation
Measured: at 6 ,12 and 24 months from baseline
Changes in Anxiety and depression scales
Goldberg's anxiety-depression scale (GADS): is an 18-item self-report symptom inventory that was developed by Goldberg and colleagues from 36 items in the Psychiatric Assessment Schedule. The GADS score is based on responses of 'yes' or 'no' to nine depression and nine anxiety items, asking how respondents have been feeling in the past month. Goldberg et al. (1988) considered patients with anxiety scores of 5 or more or with depression scores of 2 or more as having a 50% chance of a clinically important disturbance
Measured: Change from baseline at 6 ,12 and 24 months
Changes in forced vital capacity (FVC)
Value of FVC measured with forced spirometry
Measured: Change from baseline at 6 ,12 and 24 months
Changes in forced expiratory volume at the first second (FEV1)
Value of FEV1 measured with forced spirometry
Measured: Change from baseline at 6 ,12 and 24 months
Results of the Test of Adherence to Inhalers (TAI test)
TAI test. Includes 10 questions self-completed by patient. Range of each questions; 1worse compliance and 5 best compliance. The total score of the 10 items gives a total from 1-50.
Measured: Change from baseline at 6 ,12 and 24 months
Use of long-acting beta-adrenergic bronchodilator in monotherapy
Use of long-acting beta-adrenergic bronchodilator in monotherapy (yes or no)
Measured: At baseline and at 6 ,12 and 24 months
Use of long-acting anticholinergic bronchodilator in monotherapy
Use of long-acting anticholinergic bronchodilator in monotherapy (yes or no)
Measured: At baseline and at 6 ,12 and 24 months
Use of a double therapy of long-acting beta-adrenergic bronchodilator and long-acting anticholinergic bronchodilator
Use of a double therapy of long-acting beta-adrenergic bronchodilator and long-acting anticholinergic bronchodilator (yes or no)
Measured: At baseline and at 6 ,12 and 24 months
Use of a double therapy of long-acting beta-adrenergic bronchodilator and short-acting anticholinergic bronchodilator
Use of a double therapy of long-acting beta-adrenergic bronchodilator and short-acting anticholinergic bronchodilator (yes or no)
Measured: At baseline and at 6 ,12 and 24 months
Use of a triple therapy of long-acting beta-adrenergic bronchodilator and long-acting anticholinergic bronchodilator plus inhaled steroids
Use of a triple therapy of long-acting beta-adrenergic bronchodilator plus long-acting anticholinergic bronchodilator plus inhaled steroids (yes or no)
Measured: At baseline and at 6 ,12 and 24 months
Use of a triple therapy of long-acting beta-adrenergic bronchodilator and short-acting anticholinergic bronchodilator plus inhaled steroids
Use of a triple therapy of long-acting beta-adrenergic bronchodilator and short-acting anticholinergic bronchodilator plus inhaled steroids (yes or no)
Measured: At baseline and at 6 ,12 and 24 months
Use of Roflumilast
Use of Roflumilast (yes or no)
Measured: At baseline and at 6 ,12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start19 Jan 2019
- Primary completionJan 2021 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Catala de Salut
- Responsible party
- Sponsor
- Investigators
- Maite Lopez Luque, Principal investigator, Servei Catala de la Salut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03762330
- Sponsor's protocol ID
- P17/055
- Status last verified
- Jul 2020
- First submitted
- 14 Nov 2018
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Structured Comprehensive Intervention to Stimulate Self- Management and Improve Quality of Life in People With Chronic Obstructive Pulmonary Disease(COPD). A Randomised Clinical Trial.
- ClinicalTrials.gov ID
- NCT03762330
- Acronym / sponsor ID
- P17/055
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- quality of life, self-management,, structured plan, COPD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Institut Catala de Salut
- Study start
- 19 Jan 2019 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 3 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic Obstructive Pulmonary Disease (COPD) is a great magnitude public health problem with an associated increased mortality and a high cost (consumption of health care resources and loss of health related quality of life (HRQoL)). The comprehensive approach to this complex disease, focusing self-care promotion, improves HRQoL and the patients" clinical status, as shown by several studies, although further investigation is needed to confirm these results in the field of Primary Care (PC) and to formulate clear recommendations on the more effective type of intervention.
Hypothesis: In (moderate-severe) COPD patients, a structured self-management intervention plan in the setting of primary care, is more effective than usual treatment on the main outcomes associated with the disease: HRQoL, lung function, exacerbations and hospital admissions, at 6, 12 and 24 months of follow-up.
Objectives: To evaluate the impact of a comprehensive intervention plan to promote self-care and improve HRQoL in people with COPD in PC.
Methods: Multicenter randomized controlled trial, conducted at PC centers in Barcelona.
Determinations: Specific standardized and validated questionnaires, as the St George's Respiratory for the HRQoL. Statistical analysis: Intention to treat analysis. Descriptive statistics of the variables of the intervention and the control group to assess their homogeneity at the beginning of the study. An analysis of variance (ANOVA) will be used to assess differences among intervention groups.
Expected results: A significant improvement in HRQoL attributable to the intervention performed in patients with COPD Applicability and Relevance: To implement the intervention plan in clinical practice and to standardize its content.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD structured self-management plan | Active comparator | Behavioral: COPD structured self-management plan.Participants will receive usual care for COPD and in addition, a structured self-management education plan. |
| Usual care | No intervention | –COPD participants receiving only usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COPD structured self-management plan.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 | Behavioural | COPD structured self-management plan |
Primary outcome
Quality of life St. George´s Respiratory Questionnaire (SGRQ)
Time frame: Change from baseline at 6 ,12 and 24 months
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.
16 secondary outcomes
Intensity of symptoms related to COPD
Time frame: Change from baseline at 6 ,12 and 24 months
Dyspnea score severity
Time frame: Change from baseline at 6 ,12 and 24 months
Changes in the Body mass index, Obstruction, Dyspnea, Exacerbations Index (BODEx index )
Time frame: Change from baseline at 6 ,12 and 24 months
Number of COPD exacerbations
Time frame: at 6 ,12 and 24 months from baseline
Number of hospital admissions due to COPD exacerbation
Time frame: at 6 ,12 and 24 months from baseline
Changes in Anxiety and depression scales
Time frame: Change from baseline at 6 ,12 and 24 months
Changes in forced vital capacity (FVC)
Time frame: Change from baseline at 6 ,12 and 24 months
Changes in forced expiratory volume at the first second (FEV1)
Time frame: Change from baseline at 6 ,12 and 24 months
Results of the Test of Adherence to Inhalers (TAI test)
Time frame: Change from baseline at 6 ,12 and 24 months
Use of long-acting beta-adrenergic bronchodilator in monotherapy
Time frame: At baseline and at 6 ,12 and 24 months
Use of long-acting anticholinergic bronchodilator in monotherapy
Time frame: At baseline and at 6 ,12 and 24 months
Use of a double therapy of long-acting beta-adrenergic bronchodilator and long-acting anticholinergic bronchodilator
Time frame: At baseline and at 6 ,12 and 24 months
Use of a double therapy of long-acting beta-adrenergic bronchodilator and short-acting anticholinergic bronchodilator
Time frame: At baseline and at 6 ,12 and 24 months
Use of a triple therapy of long-acting beta-adrenergic bronchodilator and long-acting anticholinergic bronchodilator plus inhaled steroids
Time frame: At baseline and at 6 ,12 and 24 months
Use of a triple therapy of long-acting beta-adrenergic bronchodilator and short-acting anticholinergic bronchodilator plus inhaled steroids
Time frame: At baseline and at 6 ,12 and 24 months
Use of Roflumilast
Time frame: At baseline and at 6 ,12 and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maite Lopez Luque principal investigator
Servei Catala de la Salut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COPD structured self-management plan. in people with Chronic Obstructive Pulmonary Disease, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maite Lopez Luque (93 326 89 01, tlopezl@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life St. George´s Respiratory Questionnaire (SGRQ) (time frame: Change from baseline at 6 ,12 and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2020.