Patient and family experience of the clinical-care pathway for teduglutide in patients with short bowel syndrome and type 3 intestinal failure
| ISRCTN | ISRCTN40592528 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40592528 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | NHS001478 |
| Sponsor | University of Manchester |
| Funder | Shire |
- Submission date
- 12/04/2019
- Registration date
- 29/04/2019
- Last edited
- 06/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
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 gastrointestinal 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 March 2023
Who is funding the study?
Funding provided by Shire Pharmaceuticals
Who is the main contact?
Dr Anne-Marie Sowerbutts
annemarie.sowerbutts@manchester.ac.uk
Contact information
Scientific
5. 328 Jean McFarlane Building
School of Health Sciences
University of Manchester
Oxford Rd
Manchester
M13 9PL
United Kingdom
 ORCID ID |
0000-0003-3094-1488 |
|---|---|
| Phone | 0161 306 7888 |
| annemarie.sowerbutts@manchester.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single-centre longitudinal cohort study |
| Secondary study design | Case series |
| Study type | Participant information sheet |
| Scientific title | Patient and family experience of the pathway for glucagon-like peptide 2 analogue |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 | Behavioural |
| Primary outcome measure(s) |
The primary aim of this research is the patient and carer experience of the teduglutide pathway. |
| Key secondary outcome measure(s) |
There are no secondary outcome measures. |
| Completion date | 31/03/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 8 |
| Total final enrolment | 8 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 05/06/2019 |
| Date of final enrolment | 30/06/2022 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Salford
M6 8HD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 22/06/2021 | 06/06/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | 06/06/2023 | No | Yes |
Additional files
- ISRCTN40592528_PlainEnglishResults.pdf
- Plain English results
Editorial Notes
06/06/2023: Publication reference and plain English results added.
11/07/2022: The final enrolment number has been added.
21/03/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2020 to 30/06/2022.
2. The overall trial end date was changed from 31/03/2022 to 31/03/2023.
3. The intention to publish date was changed from 31/03/2022 to 30/06/2023.
15/06/2021: The following changes were made to the trial record:
1. The overall end date was changed from 30/06/2021 to 31/03/2022.
2. The intention to publish date was changed from 30/06/2022 to 31/03/2022.
3. The plain English summary was updated to reflect these changes.
20/04/2020: Due to current public health guidance, recruitment for this study has been paused.
09/12/2019: The following changes have been made:
1. The recruitment end date has been changed from 01/11/2019 to 30/06/2020.
2. The overall trial end date has been changed from 21/12/2020 to 30/06/2021.
3. The intention to publish date has been changed from 31/12/2021 to 30/06/2022.
25/04/2019: Trial’s existence confirmed by East of England - Cambridgeshire and Hertfordshire Research Ethics Committee (NHS HRA)
