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)

NCT ID: NCT01650480

Last Updated: 2014-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Intervention group

Group Type EXPERIMENTAL

HELP-COPD action plan

Intervention Type OTHER

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.

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Dunhill Medical Trust

OTHER

Sponsor Role collaborator

University of Edinburgh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hilary Pinnock, Dr

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Locations

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Royal Infirmary of Edinburgh

Edinburgh, City of Edinburgh, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 26310525 (View on PubMed)

Related Links

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Other Identifiers

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12243

Identifier Type: REGISTRY

Identifier Source: secondary_id

2012/R/RES/02

Identifier Type: -

Identifier Source: org_study_id

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