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)
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- University of Edinburgh
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- FACIT
Study 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Supportive Care
- Masking
- Single (Investigator)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Intervention group
Intervention: HELP-COPD action plan (Other)
Control group
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)