Chronic Obstructive Pulmonary Disease (COPD)Early Phase 1HELP-COPDNCT01650480
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)
A Early Phase 1 study testing HELP-COPD action plan in people with Chronic Obstructive Pulmonary Disease (COPD), run by University of Edinburgh at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- HELP-COPD action plan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2012to Dec 2013
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Registered with Lothian General Practice
- Admitted with an exacerbation of COPD as their primary diagnosis at Royal Infirmary of Edinburgh
Who cannot join
- People with lung cancer
- People unable to give informed consent and complete questionnaire booklets in English
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Infirmary of Edinburgh
Edinburgh, City of Edinburgh, EH16 4SA
About this study
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)
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).
- Being tested
- HELP-COPD action plan
- Keywords
- COPD, holistic, pilot, intervention
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HELP-COPD action planOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Other: HELP-COPD action plan |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 and 6 months
Secondary outcomes (8)
The St George Respiratory Questionnaire (SGRQ)
Measured: 3 and 6 months
MRC Dyspnoea score
Measured: 3 and 6 months
Dyspnoea 12
Measured: 3 and 6 months
COPD Assessment Test (CAT)
Measured: 3 and 6 months
The Hospital Anxiety and Depression Scale (HADS)
Measured: 3 and 6 months
FACIT Spiritual Well-Being sub-scale (FACIT-Sp)
Measured: 3 and 6 months
Palliative care Outcome Scale (POS)
Measured: 3 and 6 months
EQ-5D
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startJan 2012
- Primary completionSep 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- The Dunhill Medical Trust
- Responsible party
- Sponsor
- Investigators
- Hilary Pinnock, Dr, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01650480
- Sponsor's protocol ID
- 2012/R/RES/02
- Other IDs
- 12243
- Acronym
- HELP-COPD
- Status last verified
- Jul 2012
- First submitted
- 23 Jul 2012
- Last updated
- 12 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 26310525
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01650480
- Acronym / sponsor ID
- HELP-COPD / 2012/R/RES/02
- Keywords
- COPD, holistic, pilot, intervention
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- The Dunhill Medical Trust
- Study start
- Jan 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 26 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: HELP-COPD action plan |
| Control group | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Registered with Lothian General Practice
- Admitted with an exacerbation of COPD as their primary diagnosis at Royal Infirmary of Edinburgh
Key exclusion criteria (2 listed)
- People with lung cancer
- People unable to give informed consent and complete questionnaire booklets in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HELP-COPD action planThe 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. | Other | Intervention group |
Primary outcome
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.
8 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2014.
- Derived from this study: PubMed 26310525Kendall 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.
- HELP-COPDLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilary Pinnock, Dr principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing HELP-COPD action plan in people with Chronic Obstructive Pulmonary Disease (COPD), run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FACIT (time frame: 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01650480, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2014.