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)

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— HELP-COPD  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01650480
• Other study ID #: 2012/R/RES/02
• Secondary ID: 12243
• Status: Completed
• Phase: Phase 0
• First received: July 23, 2012
• Last updated: February 11, 2014
• Start date: January 2012
• Est. completion date: December 2013

Study information

• Verified date: July 2012
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Department of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• HELP-COPD action plan
The trial specialist nurse trained in palliative aspects of respiratory care will arrange a meeting to suit the patients' clinical condition and convenience. During the meeting the HELP-COPD action plan will be worked through by the patient and study nurse, and any areas of concern will be identified. Based on the findings of the assessment, a range of actions points may be generated. All referrals will be made through the usual channels. Issues that have arisen from the assessment will be clearly recorded on the HELP-COPD action plan and by ensuring that all agencies and the patient have copies of the plan it is hoped that the planned action points will be reviewed and implementation facilitated. The action plan will be reviewed by the study nurse who will contact the patient at 1, 3 and 6 months to check progress with action points.

Locations

Country	Name	City	State
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh	City of Edinburgh

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	The Dunhill Medical Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FACIT	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.	3 and 6 months	No
Secondary	The St George Respiratory Questionnaire (SGRQ)		3 and 6 months	No
Secondary	MRC Dyspnoea score		3 and 6 months	No
Secondary	Dyspnoea 12		3 and 6 months	No
Secondary	COPD Assessment Test (CAT)		3 and 6 months	No
Secondary	The Hospital Anxiety and Depression Scale (HADS)		3 and 6 months	No
Secondary	FACIT Spiritual Well-Being sub-scale (FACIT-Sp)		3 and 6 months	No
Secondary	Palliative care Outcome Scale (POS)		3 and 6 months	No
Secondary	EQ-5D		3 and 6 months	No

External Links

•   HELP-COPD