Condition category
Digestive System
Date applied
12/04/2019
Date assigned
29/04/2019
Last edited
25/04/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Patients with short bowel syndrome and type three intestinal failure cannot absorb sufficient nutrition from food via the intestines and are dependent on artificial feeding given directly into the vein. Teduglutide has been licensed for use in these patients and may reduce their requirements for parenteral nutrition (teduglutide is an analogue of human glucagon-like peptide-2 [GLP-2], which preserves mucosal integrity by promoting growth and repair of the intestine). Although patients taking the drug are routinely monitored via a strict clinical pathway at a specialist intestinal failure unit, there has been little research into the patient and family experience of complying with the pathway and of taking the drug.

Who can participate?
To be eligible patients must be over 18 years of age, treated at Salford Royal hospital, have short bowel syndrome, suitable for teduglutide, and dependent on parenteral nutrition at least twice a week.

What does the study involve?
Each patient will be asked to nominate a family member involved in their care to take part. Patients will inject themselves with teduglutide and be monitored weekly by the healthcare team. Patients will be interviewed at baseline and four times during the treatment about their experiences. Patients will be asked to take photographs to showing their life on parenteral nutrition and the transition back to normal food. They will also be asked to draw or indicate on a map where they go and connections they have with other people. Patients will also complete questionnaires indicating their health related quality of life. Their nutritional status and body composition will be measured by height, weight, bioelectrical impedance, hand grip strength, food diaries and activity levels. Family members or friends taking part will be interviewed three times during the treatment to find out how changes in the patients nutrition and clinical monitoring is affecting them.

What are the possible benefits and risks of participating?
The possible benefit is that some patients have found that they can reduce volume of total parenteral nutrition (TPN) they need or they have reduced the number of nights that they need to take TPN. Patients have reported that reducing the number of nights they need TPN has improved their quality of life.

Taking part in the study involves close monitoring and clinic visits. In addition, some people have side effects from teduglutide. These include gastro-intestinal symptoms, heart problems, anxiety, respiratory infections and influenza like illness, fluid balance problems, headaches and insomnia. There is also an increased risk of gastrointestinal cancer on the drug. However, whilst on the study participants will be closely monitored.

Where is the study run from?
Salford Royal Hospital, Manchester, UK

When is the study starting and how long is it expected to run for?
May 2019 to November 2019

Who is funding the study?
Funding provided by Shire Pharmaceuticals

Who is the main contact?
Dr Anne-Marie Sowerbutts
annemarie.sowerbutts@manchester.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anne-Marie Sowerbutts

ORCID ID

http://orcid.org/0000-0003-3094-1488

Contact details

5. 328 Jean McFarlane Building
School of Health Sciences
University of Manchester
Oxford Rd
Manchester
M13 9PL
United Kingdom
0161 306 7888
annemarie.sowerbutts@manchester.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

NHS001478

Study information

Scientific title

Patient and family experience of the pathway for glucagon-like peptide 2 analogue

Acronym

Study hypothesis

To determine if a clinical care pathway for teduglutide (glucagon-like peptide 2 analogue) is practical and offers benefits for patients and their families

Ethics approval

Approved11/04/2019, East of England - Cambridgeshire and Hertfordshire Research Ethics Committee (Fiedlder Centre, Hatfield Business Park, Hatfield Avenue, Hatfield, AL10 9TP; 02071048035; nrescommittee.eastofengland-cambsandherts@nhs.net), ref:19/EE/0062

Study design

Single-centre longitudinal cohort study

Primary study design

Observational

Secondary study design

Case series

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format

Condition

Intestinal failure

Intervention

This is a mixed method study looking at the patient and family experience of the clinical pathway of teduglutide and how patients and families experience any transfer from parenteral nutrition to normal diet. A patient and family member will be interviewed about their experiences and these will be placed in the context of the clinical pathway and with various quantitative measures of patient health.

Qualitative interviewing has been chosen as the best method of investigating that experience. In line with a person centered approach we will use participatory mapping and photo-elicitation as triggers for the interviews.

Quantitative measures will allow the qualitative interviews to be put in a context. Patients will complete health and quality of life questionnaires: Parenteral Nutrition Impact Questionnaire, Elphs Activities of Daily living, Hospital anxiety and Depression Scale, Patient Health Questionnaire - 9, have anthropometric measures and nutritional status measures taken.

Total duration of observation: 12 months. Total duration of follow up: 12 months.

Intervention type

Drug

Phase

Not Applicable

Drug names

Primary outcome measure

The primary aim of this research is the patient and carer experience of the teduglutide pathway.
This will be measured by:
1. Patient interviews taken at baseline, 6 weeks, 24 weeks and 52 weeks ±4 weeks
2. Patient questionnaires: Parenteral Nutrition Impact questionnaire, Activities of daily living questionnaire, EQ-5D-5L, Hospital and anxiety 3. and depression scale, Patient health questionnaire-9 taken at baseline, 16 weeks, 36 weeks and 52 weeks
3. 3 day food diaries taken at baseline, 16 weeks, 36 weeks and 52 weeks
4. Handgrip strength taken at baseline, 16 weeks, 36 weeks and 52 weeks
5. Bioelectrical impendence taken at baseline, 16 weeks, 36 weeks and 52 weeks
6. Family member interview at 6 weeks, 24 weeks and 52 weeks ±4 weeks

Secondary outcome measures

There are no secondary outcome measures.

Overall trial start date

01/09/2019

Overall trial end date

21/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Diagnosed with short bowel syndrome or intestinal failure
2. Metabolically stable,
3. Apyrexial
4. Able to give informed consent
5. Can speak English
6. Stable on PN following a period of postsurgical intestinal adaption
7. Dependent on receiving PN at least twice a week
8. Able to inject themselves with Tedugutide
9. Managed by the IFU at Salford Royal NHS Trust

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

8

Participant exclusion criteria

1. Under 18 years of age
2. Not suitable for Teduglutide:
2.1 Pregnant or planning conception in the next 12 months
2.2 History of malignancies within the last five years
2.3 Severe hepatic or renal impairment
3. Clinically unstable concomitant diseases: cardiovascular, respiratory, renal, infectious, endocrine, hepatic, or central nervous system.

Recruitment start date

05/06/2019

Recruitment end date

01/11/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Salford Royal NHS Trust
Stott Ln
Salford
M6 8HD
United Kingdom

Sponsor information

Organisation

University of Manchester

Sponsor details

Oxford Rd
Manchester
M13 9PL
United Kingdom
(+44) 161 275 5106
FBMHethics@manchester.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

Shire

Alternative name(s)

Shire plc

Funding Body Type

private sector organisation

Funding Body Subtype

For-profit companies (industry)

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date

Intention to publish date

31/12/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

25/04/2019: Trial’s existence confirmed by East of England - Cambridgeshire and Hertfordshire Research Ethics Committee (NHS HRA)