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Toward Self-management in ILD

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ClinicalTrials.gov Identifier: NCT03300583
Recruitment Status : Recruiting
First Posted : October 3, 2017
Last Update Posted : March 5, 2019
Sponsor:
Collaborators:
St. George's Hospital, London
University College London Hospitals
Information provided by (Responsible Party):
Dimitra Nikoletou, Kingston University

Brief Summary:

Treating and caring for people with long term conditions accounts for a substantial proportion of health care resources. Self-management is advocated as a mechanism that can empower service users with long term conditions to choose healthier options and also transform the relationship between service user and caregivers from one in which the former is a passive recipient of care to one in which they are an active partner in decision-making.

Interstitial lung disease (ILD) is one such long term condition. Patients with ILD often express concern about the lack of information on possible rehabilitation programmes and other services that could potentially improve self-management of the disease. In addition, there is a general perception about a lack of co-ordination between health care professionals especially in relation to referral to services for comprehensive management of the disease. Therefore, the needs of patients with ILD and their carers, and possible gaps in service provision need to be explored further.

In this study, the investigators propose to explore the needs of ILD patients from all types of ILD and all stages of severity and to also involve carers and clinicians. The investigators will conduct three focus groups for patients and carers and six one-to-one interviews with clinicians to explore perceptions about service gaps and needs in two ILD centres in South and North London, UK.

This study will provide valuable information to develop the building blocks of a self-management resource and will enable the investigators to make it specific to the different types of ILD.


Condition or disease Intervention/treatment
Interstitial Lung Disease Idiopathic Pulmonary Fibrosis Connective Tissue Related ILD Chronic Hypersensitivity Pneumonitis Fibrotic Lung Disease Behavioral: Focus groups Behavioral: Semi-structured interviews

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Toward a Model of Self-management; Identifying Gaps and Needs in Services for Patients With Interstitial Lung Disease
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : July 30, 2019
Estimated Study Completion Date : September 30, 2019


Group/Cohort Intervention/treatment
ILD patients
Patients from all types of ILD who are under the care of the two collaborating hospitals.
Behavioral: Focus groups
Focus group discussion led by the PI and facilitated by another researcher.

Family/Carers
Family and carers of patients with ILD who are or have been treated in the two collaborating hospitals.
Behavioral: Focus groups
Focus group discussion led by the PI and facilitated by another researcher.

Clinicians
Clinicians from the two collaborating hospitals and GPs from the nearby areas who treat and refer patients with ILD.
Behavioral: Semi-structured interviews
1:1 semi-structured interviews led by the PI




Primary Outcome Measures :
  1. Perceptions of service needs and gaps in current services among ILD patients, carers and clinicians [ Time Frame: 1-2 hours ]
    Exploratory method, conducted using semi-structured 1:1 interviews and focus groups


Secondary Outcome Measures :
  1. Differences in perceptions between participating ILD patients, carers and clinicians [ Time Frame: 1-2 hours ]
    Exploratory method, conducted using semi-structured interviews and focus groups

  2. Presentation and explanation of diagnosis and its implications to ILD patients and carers [ Time Frame: 1-2 hours ]
    Exploratory method using semi-structured interviews and focus groups

  3. Presentation and explanation of information about the management of the disease to ILD patients and carers [ Time Frame: 1-2 hours ]
    Exploratory method using semi-structured interviews and focus groups

  4. Recommended solutions for better self-management [ Time Frame: 1-2 hours ]
    Exploratory method using semi-structured interviews and focus groups



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with Interstitial Lung disease (ILD), their carers and healthcare professionals involved in their care in two hospitals in South and North London, UK.
Criteria

PATIENTS

Inclusion Criteria:

  • Diagnosed with Interstitial Lung disease (all types apart from sarcoidosis)
  • Age >18 years
  • At least one consultation with a health care professional

Exclusion Criteria:

  • Diagnosed with sarcoidosis
  • Unable to communicate in English
  • Severity of condition and commodities preventing participation

CAREGIVERS

Inclusion Criteria:

- Currently caring for a participant with ILD

Exclusion Criteria:

- Unable to communicate in English

CLINICIANS:

Inclusion Criteria:

- Involved in the clinical management and treatment of ILD patients

Exclusion Criteria:

- Health care professionals not directly involved in management or treatment of ILD patients


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03300583


Contacts
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Contact: Dimitra Nikoletou, PhD +44 208 725 2277 ext 2277 d.nikoletou@sgul.kingston.ac.uk
Contact: Gill Mein, MSc +44 208 725 4642 G.Mein@sgul.kingston.ac.uk

Locations
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United Kingdom
St George's Hospital London Recruiting
London, United Kingdom, SW17 ORE
Contact: Raminder Aul, MD       Raminder.Aul@stgeorges.nhs.uk   
University College Hospital Not yet recruiting
London, United Kingdom
Contact: Melissa Heightman, MD       melissa.heightman@nhs.net   
Contact: Helene Bellas, BSc         
Sponsors and Collaborators
Kingston University
St. George's Hospital, London
University College London Hospitals
Investigators
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Principal Investigator: Dimitra Nikoletou, PhD Kingston University and St George's University of London- Joint Faculty- Health, Social care and Education

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Responsible Party: Dimitra Nikoletou, Associate Professor, Kingston University
ClinicalTrials.gov Identifier: NCT03300583     History of Changes
Other Study ID Numbers: 16.0151
First Posted: October 3, 2017    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: A unique identification number will be allocated to each participant and data will not be shared without being anonymised

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dimitra Nikoletou, Kingston University:
Interstitial lung disease
Self-Management
Service provision
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Pneumonia
Alveolitis, Extrinsic Allergic
Hypersensitivity
Respiratory Tract Diseases
Immune System Diseases
Respiratory Tract Infections
Respiratory Hypersensitivity
Hypersensitivity, Immediate