Pathway for glucagon-like peptide 2 analogue
Research type
Research Study
Full title
Patient and family experience of the pathway for glucagon-like peptide 2 analogue
IRAS ID
254958
Contact name
Sorrel Burden
Contact email
Sponsor organisation
University of Manchester
ISRCTN Number
ISRCTN40592528
Duration of Study in the UK
2 years, 6 months, 0 days
Research summary
Research Summary
What is the patient and family experience of teduglutide for managing short bowel syndrome and type 3 intestinal failure?
Patients with short bowel syndrome and type three intestinal failure cannot absorb sufficient nutrition from food and are dependent for 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. However, 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.
The study is being conducted at Salford Royal and to be eligible patients must be treated at the hospital, have short bowel syndrome, suitable for teduglutide and dependent on parenteral nutrition at least twice a week. 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 what impact changes in the patients nutrition and clinical monitoring is having on them.
Funding provided by Shire PharmaceuticalsSummary of Results
Lay summary of patient and family experience of the pathway for glucagon-like peptide 2 analogue study
This study looked at how patients with short bowel syndrome and intestinal failure experience taking a medication called teduglutide (a glucagon-like peptide 2 analogue) and following the required monitoring. These patients are unable to get enough nutrition from food alone, so they rely on artificial feeding through a vein called parenteral nutrition.
Teduglutide has been approved for use in these patients because it might help them absorb more nutrition from food and rely less on parenteral nutrition. However, taking the medication means patients need to be closely watched by their healthcare team at a specialized unit for intestinal failure.
Not much research has been done on how patients and their families feel about taking this medication and going through the monitoring process. That's what this study aimed to find out.
The study took place from 2019 to 2023 at Salford Royal hospital. To participate, patients had to be treated at the hospital, have short bowel syndrome, rely on parenteral nutrition at least twice a week, and agree to inject themselves with teduglutide. Patients were also asked if they had family members or friends involved in their care, and if so, they could nominate them to participate in the study too.
A total of 10 patients and 6 family members took part in 32 interviews to share their experiences with the medication and the required monitoring.
The patients found the monitoring process for teduglutide to be difficult, and not all of them were able to follow it completely. Only one patient was able to stop using parenteral nutrition altogether. The other patients experienced only minor improvements and had many side effects, so they decided to stop taking the medication.
Despite the challenges, the patients didn't regret trying teduglutide. They wanted to explore every possibility of reducing their reliance on parenteral nutrition and improving their lives. Teduglutide offers another treatment option for intestinal failure and gives patients a chance to reduce their need for parenteral nutrition.
The study was funded by Takeda, and the University of Manchester sponsored it.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
19/EE/0062
Date of REC Opinion
11 Apr 2019
REC opinion
Further Information Favourable Opinion