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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01650480
Recruitment Status : Completed
First Posted : July 26, 2012
Last Update Posted : February 12, 2014
The Dunhill Medical Trust
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Other: HELP-COPD action plan Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
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)
Study Start Date : January 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
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.

No Intervention: Control group

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. The St George Respiratory Questionnaire (SGRQ) [ Time Frame: 3 and 6 months ]
  2. MRC Dyspnoea score [ Time Frame: 3 and 6 months ]
  3. Dyspnoea 12 [ Time Frame: 3 and 6 months ]
  4. COPD Assessment Test (CAT) [ Time Frame: 3 and 6 months ]
  5. The Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 3 and 6 months ]
  6. FACIT Spiritual Well-Being sub-scale (FACIT-Sp) [ Time Frame: 3 and 6 months ]
  7. Palliative care Outcome Scale (POS) [ Time Frame: 3 and 6 months ]
  8. EQ-5D [ Time Frame: 3 and 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01650480

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United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, City of Edinburgh, United Kingdom, EH16 4SA
Sponsors and Collaborators
University of Edinburgh
The Dunhill Medical Trust
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Principal Investigator: Hilary Pinnock, Dr University of Edinburgh
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Edinburgh Identifier: NCT01650480    
Other Study ID Numbers: 2012/R/RES/02
12243 ( Registry Identifier: UKCRN ID )
First Posted: July 26, 2012    Key Record Dates
Last Update Posted: February 12, 2014
Last Verified: July 2012
Keywords provided by University of Edinburgh:
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases