Dialogue Aimed at Reducing Anxiety in Patients With Severe COPD

Anxiety Clinical Trial

— DIACOL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02366390
• Other study ID #: DIACOL
• Status: Completed
• Phase: Phase 4
• First received: February 6, 2015
• Last updated: June 22, 2016
• Start date: February 2015
• Est. completion date: April 2016

Study information

• Verified date: October 2015
• Source: Nordsjaellands Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients with a psychiatric diagnosis or pulmonary cancer or patients who are involved in any other interventional clinical trial

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Psychoeducative intervention
Patient-education about feelings, cognitions, behaviors and bodily sensations related to management of dyspnea and associated anxiety

Locations

Country	Name	City	State
Denmark	Nordsjællands Hospital, Department of Pulmonary & Infectious Diseases	Hillerød	Capital Region of Denmark

Sponsors (1)

Lead Sponsor	Collaborator
Nordsjaellands Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Three months	No
Secondary	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	Three months	No
Secondary	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	Three months	No
Secondary	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	Three months	No
Secondary	Number of admissions	Number of admission during the three months follow-up period	Three months	No
Secondary	Length of Stay (LOS)	Length of stay in hospitals during the three months follow-up period	Three months	No