DT-ILD: Specialist dietetic support for people with fibrotic interstitial lung disease who are malnourished

Upcoming study
Expected to open June 2023
This study is currently recruiting
Expected to close January 2024
This study is closed
This study closed in January 2024
We will update this page with study results when available.
Information on study results are included below
This study closed in January 2024

What next?

Original listing:

What next?

Original listing:

About this study

Malnutrition is when the someone doesn't get enough nutrients from food to meet the demands of the body. This can be due to a variety of reasons such as an increase in the energy requirements due to the lungs working harder. Or it could be due to the antifibrotic medication that can cause significant side effects, including poor appetite, diarrhoea, nausea, vomiting and weight loss.

The consequences of malnutrition can significantly impact quality of life, increase risk of infection and hospital admission, and is thought to potentially link with survival length. Very little research has been carried out to investigate how to best support people who are facing these challenges.

The DT-ILD study aims to find out if patients are willing to see a dietitian and if this can have a positive impact on their food intake.

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What is involved?

You will be assigned to one of two groups. One group will receive information about diet and poor appetite through a booklet. This will include general strategies to help improve your food intake and focuses on energy and protein intake. The other group will receive 5 sessions with a registered dietitian, and will include personalised nutritional advice to optimise intake. This will include focus on energy and protein intake, in addition to support to help you cope with the impact of symptoms that can affect food intake.

Both groups will have their nutritional status assessed at different timepoints throughout the study. This can include height, weight, handgrip strength. You will also be asked to write down your food and drink intake for three days, both at the start of the study and then again after 3 months. Your quality of life will also be assessed using a questionnaire.

Summary of involvement

Study duration of 3 months

Assigned to one of 2 groups:

Group 1 will be provided with a dietary advice booklet

Group 2 will have 5 personalised sessions with a dietitian

Nutritional assessment - such as height, weight, diet diaries

Questionnaires

Study can be run fully virtually or via the telephone

Can I take part?

You may be able to take part if you are diagnosed with a fibrotic interstitial lung disease and are malnourished.

In research studies, there are lots of different reasons why you may or may not be able to take part. These are known as inclusion and exclusion criteria (see list below). Only the clinical trial team will be able to fully determine whether you are able to take part in the study. You can withdraw at any point.

If you are not able to take part in this research study, there may be other opportunities for you to take part in different studies.

To find our more about other research opportunities visit our research finder main page.

You may be able to join this study if all of these apply:

BMI of 20 and below (if under the age of 75)

OR

BMI of 21 and below (if over the age of 75)

OR

In the last 12 months you have experienced significant unintentional weight loss, regardless of BMI

You will not be able to join the study of any of the following applies:

Other health conditions that require a specialised diet, such as enteral feeding

You have less than 6 weeks expected to live

Introduction of antifibrotic treatment (nintedanib or pirfenidone), immunosuppressive treatments or corticosteroids during the study

What difference could taking part make?

Taking part in research provides the opportunity to have an active involvement in your healthcare, help you to understand the disease more and the effects it has on your day to day life. Research studies, such as this, have the potential to help develop new supportive options that could help improve the quality of people’s lives for those with PF, both now and in the future.

Taking part in this study will help researchers to understand if dietetic support can help people with fibrotic ILD who are facing challenges with their nutritional status and dietary intake.

Where does the study take place?

Study locations

Royal Brompton

Harefield Hospital

How to take part

If you are interested in taking part, please ask your healthcare team about the study or contact Rasleen Kahai by emailing ILD-Dietetics@rbht.nhs.uk or phoning on 020 7352 8121 ext 84454

Further information

The summary on this page provides information about an opportunity to participate in research. More detailed information about the study can be found via the following the links and through contacting the research team.

If you have any questions about this research study, please speak to your medical team and contact the researchers directly via:

r.kahai@rbht.nhs.uk

This study is supported by

Royal Brompton & Harefield NHS Foundation Trust
Study ID number:
NCT06016959

APF does not endorse or recommend any specific study. All responsibility for the study remains with the sponsors and investigators.

Every effort is made to keep these details up to date. If you are aware of any inaccuracies, please email research@actionpf.org