Anxiety Clinical Trial
— DIACOLOfficial 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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Denmark | Nordsjællands Hospital, Department of Pulmonary & Infectious Diseases | Hillerød | Capital Region of Denmark |
Lead Sponsor | Collaborator |
---|---|
Nordsjaellands Hospital |
Denmark,
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 |
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