Chronic Obstructive Pulmonary DiseasePhase 4DIACOLNCT02366390
Dialogue Aimed at Reducing Anxiety in Patients With Severe COPD
A Phase 4 study testing Psychoeducative intervention in people with Chronic Obstructive Pulmonary Disease and Anxiety, run by Nordsjaellands Hospital at 1 site in Denmark.
Trial summary
The purpose of this trial is to determine whether a minimal homebased psychoeducative intervention is effective in management of anxiety and dyspnea in patients with severe chronic obstructive pulmonary disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Anxiety
- What is being tested?
- Psychoeducative intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2015to Apr 2016
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with a confirmed diagnosis of COPD and classified as category C or D according to the Global initiative for Obstructive Lung Disease (GOLD), and who have a HADS - anxiety subscale score ≥ 8 and are willing to participate and able to provide written informed consent
Who cannot join
- Patients with a psychiatric diagnosis or pulmonary cancer or patients who are involved in any other interventional clinical trial
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Nordsjællands Hospital, Department of Pulmonary & Infectious Diseases
Hillerød, Capital Region of Denmark, 3400
About this study
Official title: Efficacy of a Minimal Homebased Psychoeducative Intervention Versus Usual Care for the Management of Anxiety and Dyspnea in Patients With Severe Chronic Obstructive Pulmonary Disease
The purpose of this trial is to determine whether a minimal homebased psychoeducative intervention is effective in management of anxiety and dyspnea in patients with severe chronic obstructive pulmonary disease.
Read the detailed description
In patients with severe chronic obstructive pulmonary disease (COPD) anxiety and dyspnea are described as the primary symptoms with a high impact on the patients quality of life and use of social services. Both pharmacological and non-pharmacological strategies aimed at reducing anxiety in patients with severe illness are challenged by low compliance and/or side-effect, which emphasized the need of focusing on treatment strategies that addresses the issues characteristic for a population with severe pulmonary disease.
The trial is a single-centre randomised clinical trial that test the hypothesis that a minimal homebased psychoeducative intervention reduces anxiety in patients with severe COPD. The primary outcome is anxiety assessed by the hospital and anxiety and depression scale (HADS), subscale for anxiety (HADS-A). Secondary outcomes are mastery of dyspnea measured by the Chronic Respiratory Questionnaire (CRQ), Health-related Quality of Life (HRQL) measured by the St. George Respiratory Questionnaire (SGRQ) and depression measured by the HADS, subscale for depression (HADS-D). The outcomes will be assessed at follow-up four weeks and three months after the intervention.
The trial population consist of patients with severe COPD affiliated the Department of Pulmonary \& Infectious Diseases at Nordsjællands Hospital. Based on a sample size calculation sixty-six patients with severe COPD and associated anxiety will be randomised 1:1 to either intervention plus usual care or to usual care.
The intervention consist of a minimal psychoeducative dialogue delivered in the patient's home follow by a telephone booster session after two weeks. The intervention is based on a manual, where the theoretical foundation is cognitive behavior theory. The intervention is carried out by a nurse.
Our primary outcome of interest is intra-individual differences in HADS-A scores between baseline and last follow-up after three months. To analyse this with-in group difference in outcome we use paired t-test or Wilcoxon signed-rank. Differences between the groups will similarly be assessed with two-sample t-test or Wilcoxon rank-sum test. Same strategy will be used analyzing the secondary outcomes CRQ, SGRQ and HADS-D.
To include all points of follow-up and to evaluate the development with-in group and between groups we use a longitudinal regression model. Because of an expected high number of drop outs, the censuring due to death and missing data due to possibly lost to follow up will be handled appropriately, under supervision and in collaboration with an experienced bio-statistician. The sample size calculation is based on HADS-A, a paired design and a estimated drop-out of 33.3 %.
The trial is designed with the aim of giving nurses and other health professionals an instrument clinically applicable in proving care for patients with severe COPD and associated anxiety. Positive or negative results of the trial will be submitted to international journals.
- Conditions
- Chronic Obstructive Pulmonary Disease, Anxiety
- Being tested
- Psychoeducative intervention
- Keywords
- Psychoeducative, HADS, COPD, dyspnea
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Anxiety Disorders, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducative interventionBehavioural
Patient-education about feelings, cognitions, behaviors and bodily sensations related to management of dyspnea and associated anxiety
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducative intervention | Experimental | A psychoeducative dialogue and one telephone booster session Receives: Behavioral: Psychoeducative intervention |
| Usual care | No intervention | Usual care according to current guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HADS-A score from baseline to three months follow-up
The Hospital Anxiety and Depression Scale (HADS), subscale for anxiety HADS-A is a self-completed questionnaire that measure symptoms of general anxiety
Measured: Three months
Secondary outcomes (5)
Change in CRQ score from baseline to three months follow-up
The Chronic Respiratory Questionnaire (CRQ) is a self-completed questionnaire measuring Health Related Quality of Life (HRQL) and mastery of dyspnea
Measured: Three months
Change in SGRQ score from baseline to three months follow-up
The St. George´s Respiratory Questionnaire (SGRQ) is a self-completed questionnaire that measure HRQL
Measured: Three months
Change in HADS-D score from baseline to three months follow-up
The Hospital Anxiety and Depression Scale (HADS), subscale for depression (HADS-D) ia a self-completed questionnaire that measure symptoms of general depression
Measured: Three months
Number of admissions
Number of admission during the three months follow-up period
Measured: Three months
Length of Stay (LOS)
Length of stay in hospitals during the three months follow-up period
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie Midtgaard, PHD, Study director, The University Hospital Centre for Health Research, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02366390
- Sponsor's protocol ID
- DIACOL
- Acronym
- DIACOL
- Status last verified
- Oct 2015
- First submitted
- 6 Feb 2015
- Last updated
- 23 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Bove DG, Overgaard D, Lomborg K, Lindhardt BO, Midtgaard J. Efficacy of a minimal home-based psychoeducative intervention versus usual care for managing anxiety and dyspnoea in patients with severe chronic obstructive pulmonary disease: a randomised controlled trial protocol. BMJ Open. 2015 Jul 7;5(7):e008031. doi: 10.1136/bmjopen-2015-008031.
PubMed 26152326
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Minimal Homebased Psychoeducative Intervention Versus Usual Care for the Management of Anxiety and Dyspnea in Patients With Severe Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02366390
- Acronym / sponsor ID
- DIACOL / DIACOL
- Conditions
- Chronic Obstructive Pulmonary Disease, Anxiety
- Keywords
- Psychoeducative, HADS, COPD, dyspnea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 19 Feb 2015 (estimated)
- 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.
The purpose of this trial is to determine whether a minimal homebased psychoeducative intervention is effective in management of anxiety and dyspnea in patients with severe chronic obstructive pulmonary disease.
Detailed description
In patients with severe chronic obstructive pulmonary disease (COPD) anxiety and dyspnea are described as the primary symptoms with a high impact on the patients quality of life and use of social services. Both pharmacological and non-pharmacological strategies aimed at reducing anxiety in patients with severe illness are challenged by low compliance and/or side-effect, which emphasized the need of focusing on treatment strategies that addresses the issues characteristic for a population with severe pulmonary disease.
The trial is a single-centre randomised clinical trial that test the hypothesis that a minimal homebased psychoeducative intervention reduces anxiety in patients with severe COPD. The primary outcome is anxiety assessed by the hospital and anxiety and depression scale (HADS), subscale for anxiety (HADS-A). Secondary outcomes are mastery of dyspnea measured by the Chronic Respiratory Questionnaire (CRQ), Health-related Quality of Life (HRQL) measured by the St. George Respiratory Questionnaire (SGRQ) and depression measured by the HADS, subscale for depression (HADS-D). The outcomes will be assessed at follow-up four weeks and three months after the intervention.
The trial population consist of patients with severe COPD affiliated the Department of Pulmonary \& Infectious Diseases at Nordsjællands Hospital. Based on a sample size calculation sixty-six patients with severe COPD and associated anxiety will be randomised 1:1 to either intervention plus usual care or to usual care.
The intervention consist of a minimal psychoeducative dialogue delivered in the patient's home follow by a telephone booster session after two weeks. The intervention is based on a manual, where the theoretical foundation is cognitive behavior theory. The intervention is carried out by a nurse.
Our primary outcome of interest is intra-individual differences in HADS-A scores between baseline and last follow-up after three months. To analyse this with-in group difference in outcome we use paired t-test or Wilcoxon signed-rank. Differences between the groups will similarly be assessed with two-sample t-test or Wilcoxon rank-sum test. Same strategy will be used analyzing the secondary outcomes CRQ, SGRQ and HADS-D.
To include all points of follow-up and to evaluate the development with-in group and between groups we use a longitudinal regression model. Because of an expected high number of drop outs, the censuring due to death and missing data due to possibly lost to follow up will be handled appropriately, under supervision and in collaboration with an experienced bio-statistician. The sample size calculation is based on HADS-A, a paired design and a estimated drop-out of 33.3 %.
The trial is designed with the aim of giving nurses and other health professionals an instrument clinically applicable in proving care for patients with severe COPD and associated anxiety. Positive or negative results of the trial will be submitted to international journals.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychoeducative intervention | Experimental | Behavioral: Psychoeducative interventionA psychoeducative dialogue and one telephone booster session |
| Usual care | No intervention | –Usual care according to current guidelines. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a confirmed diagnosis of COPD and classified as category C or D according to the Global initiative for Obstructive Lung Disease (GOLD), and who have a HADS - anxiety subscale score ≥ 8 and are willing to participate and able to provide written informed consent
Key exclusion criteria (1 listed)
- Patients with a psychiatric diagnosis or pulmonary cancer or patients who are involved in any other interventional clinical trial
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 |
|---|---|---|
| Psychoeducative interventionPatient-education about feelings, cognitions, behaviors and bodily sensations related to management of dyspnea and associated anxiety | Behavioural | Psychoeducative intervention |
Primary outcome
Change in HADS-A score from baseline to three months follow-up
Time frame: Three months
The Hospital Anxiety and Depression Scale (HADS), subscale for anxiety HADS-A is a self-completed questionnaire that measure symptoms of general anxiety
5 secondary outcomes
Change in CRQ score from baseline to three months follow-up
Time frame: Three months
Change in SGRQ score from baseline to three months follow-up
Time frame: Three months
Change in HADS-D score from baseline to three months follow-up
Time frame: Three months
Number of admissions
Time frame: Three months
Length of Stay (LOS)
Time frame: Three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2016.
- Derived from this study: PubMed 26152326Bove DG, Overgaard D, Lomborg K, Lindhardt BO, Midtgaard J. Efficacy of a minimal home-based psychoeducative intervention versus usual care for managing anxiety and dyspnoea in patients with severe chronic obstructive pulmonary disease: a randomised controlled trial protocol. BMJ Open. 2015 Jul 7;5(7):e008031. doi: 10.1136/bmjopen-2015-008031.
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
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.
Julie Midtgaard, PHD study director
The University Hospital Centre for Health Research, Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Psychoeducative intervention in people with Chronic Obstructive Pulmonary Disease and Anxiety, run by Nordsjaellands Hospital at 1 site in Denmark.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 23 Jun 2016. 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 Denmark. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HADS-A score from baseline to three months follow-up (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02366390, which also lists 1 linked publication.
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 23 Jun 2016.