Interstitial Lung DiseaseNCT03300583
Toward Self-management in ILD
An observational study of Interstitial Lung Disease and Idiopathic Pulmonary Fibrosis, run by Kingston University at 2 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis, Connective Tissue Related ILD
- What is being tested?
- Focus groups and Semi-structured interviews
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 16 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Jun 2018to 30 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Diagnosed with Interstitial Lung disease (all types apart from sarcoidosis)
- Age >18 years
- At least one consultation with a health care professional
- Currently caring for a participant with ILD
- Involved in the clinical management and treatment of ILD patients
Who cannot join
- Diagnosed with sarcoidosis
- Unable to communicate in English
- Severity of condition and commodities preventing participation
- CAREGIVERS
- Unable to communicate in English
- CLINICIANS:
- Health care professionals not directly involved in management or treatment of ILD patients
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
St George's Hospital London
London, SW17 ORE
University College Hospital
London
About this study
Official title: Toward a Model of Self-management; Identifying Gaps and Needs in Services for Patients With Interstitial Lung Disease
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.
Read more
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.
- Conditions
- Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis, Connective Tissue Related ILD, Chronic Hypersensitivity Pneumonitis, Fibrotic Lung Disease
- Being tested
- Focus groups, Semi-structured interviews
- Keywords
- Interstitial lung disease, Self-Management, Service provision
- Medical subject headings
- Lung Diseases, Interstitial, Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus groupsBehavioural
Focus group discussion led by the PI and facilitated by another researcher.
Semi-structured interviewsBehavioural
1:1 semi-structured interviews led by the PI
| Study group | Role | What they receive |
|---|---|---|
| ILD patients | Patients from all types of ILD who are under the care of the two collaborating hospitals. Receives: Behavioral: Focus groups | |
| Family/Carers | Family and carers of patients with ILD who are or have been treated in the two collaborating hospitals. Receives: Behavioral: Focus groups | |
| Clinicians | Clinicians from the two collaborating hospitals and GPs from the nearby areas who treat and refer patients with ILD. Receives: Behavioral: Semi-structured interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceptions of service needs and gaps in current services among ILD patients, carers and clinicians
Exploratory method, conducted using semi-structured 1:1 interviews and focus groups
Measured: 1-2 hours
Secondary outcomes (4)
Differences in perceptions between participating ILD patients, carers and clinicians
Exploratory method, conducted using semi-structured interviews and focus groups
Measured: 1-2 hours
Presentation and explanation of diagnosis and its implications to ILD patients and carers
Exploratory method using semi-structured interviews and focus groups
Measured: 1-2 hours
Presentation and explanation of information about the management of the disease to ILD patients and carers
Exploratory method using semi-structured interviews and focus groups
Measured: 1-2 hours
Recommended solutions for better self-management
Exploratory method using semi-structured interviews and focus groups
Measured: 1-2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start1 Jun 2018
- Primary completion30 Oct 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kingston University
- Sponsor type
- University, hospital or other
- Collaborators
- St. George's Hospital, London, University College London Hospitals
- Responsible party
- Principal investigator, Dimitra Nikoletou, Kingston University
- Investigators
- Dimitra Nikoletou, PhD, Principal investigator, Kingston University and St George's University of London- Joint Faculty- Health, Social care and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300583
- Sponsor's protocol ID
- 16.0151
- Status last verified
- Feb 2021
- First submitted
- 28 Sep 2017
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A unique identification number will be allocated to each participant and data will not be shared without being anonymised
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toward a Model of Self-management; Identifying Gaps and Needs in Services for Patients With Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT03300583
- Acronym / sponsor ID
- 16.0151
- Conditions
- Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis, Connective Tissue Related ILD, Chronic Hypersensitivity Pneumonitis, Fibrotic Lung Disease
- Keywords
- Interstitial lung disease, Self-Management, Service provision
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Kingston UniversityUniversity, hospital or other
- Collaborators
- St. George's Hospital, London, University College London Hospitals
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 3 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ILD patients | – | Behavioral: Focus groupsPatients from all types of ILD who are under the care of the two collaborating hospitals. |
| Family/Carers | – | Behavioral: Focus groupsFamily and carers of patients with ILD who are or have been treated in the two collaborating hospitals. |
| Clinicians | – | Behavioral: Semi-structured interviewsClinicians from the two collaborating hospitals and GPs from the nearby areas who treat and refer patients with ILD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Diagnosed with Interstitial Lung disease (all types apart from sarcoidosis)
- Age >18 years
- At least one consultation with a health care professional
- Currently caring for a participant with ILD
- Involved in the clinical management and treatment of ILD patients
Key exclusion criteria (7 listed)
- Diagnosed with sarcoidosis
- Unable to communicate in English
- Severity of condition and commodities preventing participation
- CAREGIVERS
- Unable to communicate in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus groupsFocus group discussion led by the PI and facilitated by another researcher. | Behavioural | Family/Carers, ILD patients |
| Semi-structured interviews1:1 semi-structured interviews led by the PI | Behavioural | Clinicians |
Primary outcome
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
4 secondary outcomes
Differences in perceptions between participating ILD patients, carers and clinicians
Time frame: 1-2 hours
Presentation and explanation of diagnosis and its implications to ILD patients and carers
Time frame: 1-2 hours
Presentation and explanation of information about the management of the disease to ILD patients and carers
Time frame: 1-2 hours
Recommended solutions for better self-management
Time frame: 1-2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Individual participant dataSharing planned: No. A unique identification number will be allocated to each participant and data will not be shared without being anonymised
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dimitra Nikoletou, PhD principal investigator
Kingston University and St George's University of London- Joint Faculty- Health, Social care and Education
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Disease and Idiopathic Pulmonary Fibrosis, run by Kingston University at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceptions of service needs and gaps in current services among ILD patients, carers and clinicians (time frame: 1-2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.