Dialogue Aimed at Reducing Anxiety in Patients With Severe COPD

NCT ID: NCT02366390

Last Updated: 2016-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2016-04-30

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Psychoeducative intervention

A psychoeducative dialogue and one telephone booster session

Group Type: EXPERIMENTAL

Psychoeducative intervention

Intervention Type: BEHAVIORAL

Patient-education about feelings, cognitions, behaviors and bodily sensations related to management of dyspnea and associated anxiety

Usual care

Usual care according to current guidelines.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Psychoeducative intervention

Patient-education about feelings, cognitions, behaviors and bodily sensations related to management of dyspnea and associated anxiety

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nordsjaellands Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julie Midtgaard, PHD

Role: STUDY_DIRECTOR

The University Hospital Centre for Health Research, Copenhagen University Hospital, Rigshospitalet

Locations

Nordsjællands Hospital, Department of Pulmonary & Infectious Diseases

Hillerød, Capital Region of Denmark, Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 26152326 (View on PubMed)

Other Identifiers

DIACOL

Identifier Type: -

Identifier Source: org_study_id