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 [GLP-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
30/06/2021
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
30/06/2020
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
30/06/2022
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list