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Clinical Trials/NCT01650480
NCT01650480
Completed
Early Phase 1

HELPing Older People With Very Severe Chronic Obstructive Pulmonary Disease (COPD) Towards the End of Their Lives: Developing, Piloting and Refining a Practical Intervention (HELP-COPD)

University of Edinburgh1 site in 1 country44 target enrollmentJanuary 2012

Overview

Phase
Early Phase 1
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Sponsor
University of Edinburgh
Enrollment
44
Locations
1
Primary Endpoint
FACIT
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

The purpose of this study is to develop, refine and pilot a novel complex (HELP-COPD) assessment, undertaken during or immediately after a hospital admission, which addresses the holistic care needs of people with severe chronic obstructive pulmonary disease (COPD).

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
December 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Registered with Lothian General Practice
  • Admitted with an exacerbation of COPD as their primary diagnosis at Royal Infirmary of Edinburgh

Exclusion Criteria

  • People with lung cancer
  • People unable to give informed consent and complete questionnaire booklets in English

Outcomes

Primary Outcomes

FACIT

Time Frame: 3 and 6 months

The Functional Assessment of Chronic Illness Therapy (FACIT) measurement system has a core of 27 validated questions in four domains: Physical, Social/Family, Emotional, and Functional well-being. Scores range from 0 (worst quality of life) to 108, and are responsive to change with a minimum clinically important difference for improvement of 5.5. A sub-scale of 10 questions for use in lung cancer is considered to be appropriate in other respiratory conditions.

Secondary Outcomes

  • MRC Dyspnoea score(3 and 6 months)
  • Dyspnoea 12(3 and 6 months)
  • The St George Respiratory Questionnaire (SGRQ)(3 and 6 months)
  • COPD Assessment Test (CAT)(3 and 6 months)
  • The Hospital Anxiety and Depression Scale (HADS)(3 and 6 months)
  • FACIT Spiritual Well-Being sub-scale (FACIT-Sp)(3 and 6 months)
  • Palliative care Outcome Scale (POS)(3 and 6 months)
  • EQ-5D(3 and 6 months)

Study Sites (1)

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