Dialogue Aimed at Reducing Anxiety in Patients With Severe COPD (DIACOL)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease; Anxiety
• Intervention / Treatment: Behavioral: Psychoeducative intervention

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 Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Capital Region of Denmark
    • Hillerød, Capital Region of Denmark, Denmark, 3400
      • Nordsjællands Hospital, Department of Pulmonary & Infectious Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Psychoeducative intervention; A psychoeducative dialogue and one telephone booster session	Behavioral: Psychoeducative intervention; Patient-education about feelings, cognitions, behaviors and bodily sensations related to management of dyspnea and associated anxiety
No Intervention: Usual care; Usual care according to current guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Number of admissions	Number of admission during the three months follow-up period	Three months
Length of Stay (LOS)	Length of stay in hospitals during the three months follow-up period	Three months

Collaborators and Investigators

• Sponsor: Nordsjaellands Hospital
• Investigators: Study Director: Julie Midtgaard, PHD, The University Hospital Centre for Health Research, Copenhagen University Hospital, Rigshospitalet

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: February 6, 2015
• First Submitted That Met QC Criteria: February 11, 2015
• First Posted (Estimate): February 19, 2015

Study Record Updates

• Last Update Posted (Estimate): June 23, 2016
• Last Update Submitted That Met QC Criteria: June 22, 2016
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: COPD; dyspnea; HADS; Psychoeducative
• Additional Relevant MeSH Terms: Mental Disorders; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Anxiety Disorders
• Other Study ID Numbers: DIACOL