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

Early Phase 1

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Other: HELP-COPD action plan

• Registration Number: NCT01650480
• Lead Sponsor: University of Edinburgh

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Status Verified: 2012-07
• Study First Submitted: 2012-07-23
• Study First Submitted QC: 2012-07-25
• Study First Posted: 2012-07-26
• Primary Completion: 2013-09
• Study Completion: 2013-12
• Last Update Submitted: 2014-02-11
• Last Update Posted: 2014-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Intervention group	HELP-COPD action plan	-

Primary Outcome Measures

Name	Time	Method
FACIT	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Royal Infirmary of Edinburgh; 🇬🇧 Edinburgh, City of Edinburgh, United Kingdom