Toward Self-management in ILD

• Sponsor: Kingston University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03300583
• Collaborator: St. George's Hospital, London (Other), University College London Hospitals (Other)
• Enrollment: 16
• Locations: 2
• Actual Duration (Months): 31
• Patients Per Site: 8
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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	Phase
Interstitial Lung Disease; Idiopathic Pulmonary Fibrosis; Connective Tissue Related ILD; Chronic Hypersensitivity Pneumonitis; Fibrotic Lung Disease	Behavioral: Focus groups; Behavioral: Semi-structured interviews

Study Design

• Study Type: Observational
• Actual Enrollment: 16 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: Jun 1, 2018
• Actual Primary Completion Date: Oct 30, 2020
• Actual Study Completion Date: Dec 30, 2020

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Perceptions of service needs and gaps in current services among ILD patients, carers and clinicians [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 [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 [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 [1-2 hours]

   Exploratory method using semi-structured interviews and focus groups

4. Recommended solutions for better self-management [1-2 hours]

   Exploratory method using semi-structured interviews and focus groups

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St George's Hospital London	London		United Kingdom	SW17 ORE
2	University College Hospital	London		United Kingdom

Sponsors and Collaborators

• Kingston University
• St. George's Hospital, London
• University College London Hospitals

Investigators

• Principal Investigator: Dimitra Nikoletou, PhD, Kingston University and St George's University of London- Joint Faculty- Health, Social care and Education

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dimitra Nikoletou, Associate Professor, Kingston University
• ClinicalTrials.gov Identifier: NCT03300583
• Other Study ID Numbers: 16.0151
• First Posted: Oct 3, 2017
• Last Update Posted: Feb 21, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dimitra Nikoletou, Associate Professor, Kingston University: Interstitial lung disease; Self-Management; Service provision
• Additional relevant MeSH terms: Pneumonia; Lung Diseases; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Lung Diseases, Interstitial; Alveolitis, Extrinsic Allergic; Hypersensitivity

Study Results

No Results Posted as of Feb 21, 2021