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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| ClinicalTrials.gov Identifier: NCT01650480 |
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Recruitment Status :
Completed
First Posted : July 26, 2012
Last Update Posted : February 12, 2014
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Sponsor:
University of Edinburgh
Collaborator:
The Dunhill Medical Trust
Information provided by (Responsible Party):
University of Edinburgh
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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 |
| 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
| 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 :
- 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 :
- The St George Respiratory Questionnaire (SGRQ) [ Time Frame: 3 and 6 months ]
- MRC Dyspnoea score [ Time Frame: 3 and 6 months ]
- Dyspnoea 12 [ Time Frame: 3 and 6 months ]
- COPD Assessment Test (CAT) [ Time Frame: 3 and 6 months ]
- The Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 3 and 6 months ]
- FACIT Spiritual Well-Being sub-scale (FACIT-Sp) [ Time Frame: 3 and 6 months ]
- Palliative care Outcome Scale (POS) [ Time Frame: 3 and 6 months ]
- 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 |
Criteria
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 ClinicalTrials.gov identifier (NCT number): NCT01650480
Locations
| United Kingdom | |
| Royal Infirmary of Edinburgh | |
| Edinburgh, City of Edinburgh, United Kingdom, EH16 4SA | |
Sponsors and Collaborators
University of Edinburgh
The Dunhill Medical Trust
Investigators
| Principal Investigator: | Hilary Pinnock, Dr | University of Edinburgh |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Edinburgh |
| ClinicalTrials.gov 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:
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COPD holistic pilot intervention |
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases |