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) (HELP-COPD)

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)

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 Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Other: HELP-COPD action plan

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • City of Edinburgh
    • Edinburgh, City of Edinburgh, United Kingdom, EH16 4SA
      • Royal Infirmary of Edinburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Intervention group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
The St George Respiratory Questionnaire (SGRQ)	3 and 6 months
MRC Dyspnoea score	3 and 6 months
Dyspnoea 12	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

Collaborators and Investigators

• Sponsor: University of Edinburgh
• Collaborators: The Dunhill Medical Trust
• Investigators: Principal Investigator: Hilary Pinnock, Dr, University of Edinburgh

Publications and helpful links

General Publications

• Kendall M, Buckingham S, Ferguson S, MacNee W, Sheikh A, White P, Worth A, Boyd K, Murray SA, Pinnock H. Exploring the concept of need in people with very severe chronic obstructive pulmonary disease: a qualitative study. BMJ Support Palliat Care. 2018 Dec;8(4):468-474. doi: 10.1136/bmjspcare-2015-000904. Epub 2015 Aug 26.

Helpful Links

• HELP-COPD

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: July 23, 2012
• First Submitted That Met QC Criteria: July 25, 2012
• First Posted (Estimate): July 26, 2012

Study Record Updates

• Last Update Posted (Estimate): February 12, 2014
• Last Update Submitted That Met QC Criteria: February 11, 2014
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: COPD; intervention; pilot; holistic
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2012/R/RES/02; 12243 (Registry Identifier: UKCRN ID)