Dialogue Aimed at Reducing Anxiety in Patients With Severe COPD

NCT02366390 | Completed Phase 4

• 1 other identifier: DIACOL
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; Anxiety

Keywords

Psychoeducative; HADS; COPD; dyspnea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in CRQ score from baseline to three months follow-up

  Three months

• Change in SGRQ score from baseline to three months follow-up

  Three months

• Change in HADS-D score from baseline to three months follow-up

  Three months

• Number of admissions

  Three months

• Length of Stay (LOS)

  Three months

Study Arms (2)

Psychoeducative intervention

EXPERIMENTAL

A psychoeducative dialogue and one telephone booster session

Behavioral: Psychoeducative intervention

Usual care

NO INTERVENTION

Usual care according to current guidelines.

Interventions

Psychoeducative intervention BEHAVIORAL

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

Psychoeducative intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Nordsjaellands Hospital: lead

Study Sites (1)

Nordsjællands Hospital, Department of Pulmonary & Infectious Diseases

Hillerød, Capital Region of Denmark, 3400, Denmark

Location

Related Publications (1)

• 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.

  PMID: 26152326 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Anxiety Disorders; Dyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Julie Midtgaard, PHD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2015
• First Posted: February 19, 2015
• Study Start: February 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: June 23, 2016

Record last verified: 2015-10

Locations

DK (1)