NCT01650480

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 26, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 12, 2014

Status Verified

July 1, 2012

Enrollment Period

1.7 years

First QC Date

July 23, 2012

Last Update Submit

February 11, 2014

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPDholisticpilotintervention

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 and 6 months

Secondary Outcomes (8)

  • The St George Respiratory Questionnaire (SGRQ)

    3 and 6 months

  • MRC Dyspnoea score

    3 and 6 months

  • Dyspnoea 12

    3 and 6 months

  • COPD Assessment Test (CAT)

    3 and 6 months

  • The Hospital Anxiety and Depression Scale (HADS)

    3 and 6 months

  • +3 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL
Other: HELP-COPD action plan

Control group

NO INTERVENTION

Interventions

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.

Intervention group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Registered with Lothian General Practice
  • Admitted with an exacerbation of COPD as their primary diagnosis at Royal Infirmary of Edinburgh

You may not qualify if:

  • People with lung cancer
  • People unable to give informed consent and complete questionnaire booklets in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Infirmary of Edinburgh

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

Location

Related Publications (1)

  • 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.

    PMID: 26310525DERIVED

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hilary Pinnock, Dr

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2012

First Posted

July 26, 2012

Study Start

January 1, 2012

Primary Completion

September 1, 2013

Study Completion

December 1, 2013

Last Updated

February 12, 2014

Record last verified: 2012-07

Locations

GB(1)