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)

This study has been completed.
Sponsor:
Collaborator:
The Dunhill Medical Trust
Information provided by (Responsible Party):
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT01650480
First received: July 23, 2012
Last updated: February 11, 2014
Last verified: July 2012
  Purpose

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 Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Other: HELP-COPD action plan
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (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)

Resource links provided by NLM:


Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • FACIT [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • MRC Dyspnoea score [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Dyspnoea 12 [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • COPD Assessment Test (CAT) [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • The Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • FACIT Spiritual Well-Being sub-scale (FACIT-Sp) [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Palliative care Outcome Scale (POS) [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • EQ-5D [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: January 2012
Study Completion Date: December 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT01650480     History of Changes
Other Study ID Numbers: 2012/R/RES/02, 12243
Study First Received: July 23, 2012
Last Updated: February 11, 2014
Health Authority: United Kingdom: Department of Health

Keywords provided by University of Edinburgh:
COPD
holistic
pilot
intervention

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 01, 2014