Skip to main content
OpenTrials
Completed

NCT Number: NCT01650480

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)

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).

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Royal Infirmary of Edinburgh

Edinburgh, City of Edinburgh, EH16 4SA, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HELP-COPD action plan

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • The Dunhill Medical Trust

Registry information

Official study 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)

Acronym: HELP-COPD

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 26, 2012
Registry last updated
Feb 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.