NCT01650480|CompletedEarly Phase 1DMC
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
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Sponsor study identifier
Secondary identifiers
REGISTRY · UKCRN ID
interventional
44
1 country
1
Study Start
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2013
Actual (reported)Study Completion
December 2013
Actual (reported)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-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
July 23, 2012
Actual (reported)July 26, 2012
Actual (reported)September 2013
Actual (reported)December 2013
Actual (reported)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
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Royal Infirmary of Edinburgh
Edinburgh, City of Edinburgh, EH16 4SA, United Kingdom
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.
Hilary Pinnock, Dr
University of Edinburgh
44 participants (actual enrollment reported by the registry).
First Submitted
July 23, 2012
First Posted
July 26, 2012
Study Start
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
Chronic Obstructive Pulmonary Disease Transcription Factor and Cytokine Study
Contact the study team to confirm eligibility.
Primary Completion
September 2013
Actual (reported)Study Completion
December 2013
Actual (reported)Last Updated
February 12, 2014
Record last verified: 2012-07
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Source: ClinicalTrials.gov.
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