Longitudinal evaluation of the impact of parenteral nutrition

• Research type

  Research Study

• Full title

  Longitudinal Evaluation of Patient Outcomes and Impact Assessment on Family Members of Home Parenteral Nutrition: New Directions for Research

• IRAS ID

  270162

• Contact name

  Sorrel Burden

• Contact email

  sorrel.burden@manchester.ac.uk

• Sponsor organisation

  University of Manchester

• Duration of Study in the UK

  1 years, 11 months, 30 days

• Research summary

  Providing a person with food through a vein is known as parenteral nutrition (PN) or artificial tube feeding. This process is used when nutrients from food can't be taken in by the intestine (intestinal failure). Patients with type 3 intestinal failure are completely reliant on artificial feeding and often manage this at home; home parenteral nutrition (HPN). HPN therapy is life saving for these patients.
  It is important to assess patients quality of life and their own reported effects of the HPN. The Parenteral Nutrition Impact Questionnaire (PNIQ) is a proven tool for measuring quality of life when receiving HPN.
  A recent study involving the use of the PNIQ in multiple hospitals in the UK, showed that those on fewer nights of HPN had better quality of life than those on more nights of HPN. Whilst this was useful for looking at quality of life at one time point, it is now important to assess change in quality life over time and any impact on family members quality of life.
  This study will recruit HPN patients across the UK and ask them to complete the PNIQ survey at several different time points. This will assess the impact of HPN over time. Family members involved in the participants HPN care will also be asked to complete a carer burden survey (at one time point) to assess the impact of HPN on carers.
  The study is being funded by Shire Pharmaceuticals Ltd.

  Lay Summary of Results:

  Some people cannot absorb food through their gut and need to be fed through a vein. This is called parenteral nutrition (PN). When patients rely on this long-term at home, it's known as home parenteral nutrition (HPN); a life-saving treatment for people with intestinal failure.

  This study looked at how HPN affects patients’ quality of life and also the impact on their family members. Over 570 patients across 15 NHS sites in the UK completed a custom-built questionnaire (called the PNIQ) several times to track how their quality of life changed. Around 340 family members also answered questions about how HPN care affected them.

  Patients who needed HPN on fewer days each week reported a better quality of life. However, even when treatment needs changed slightly, it could still make a difference. About 1 in 4 family members reported moderate to severe stress, especially those with their own health problems or less support from the healthcare system.

  This is the largest UK study of its kind and shows that reducing the need for HPN can help improve people’s lives. It also highlights the importance of offering better support to families who help care for someone on HPN.
  Has the registry been updated to include summary results?: Yes
  If yes - please enter the URL to summary results: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fwww.clinicaltrials.gov%252Fstudy%252FNCT04234490%253Fterm%253DAREA%25255BBasicSearch%25255D&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7C821a2696bb3344757ea408ddd4fabfa8%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638900895603977192%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=UfcJx%2FPBbvTySRE%2Fr3JPWfxDvHV5iCscpZw0MmocWCw%3D&reserved=0(parenteral%2520nutrition)%26rank%3D7/NBTI/6i2-AQ/AQ/4d777308-99a9-42d9-8fb1-d6567f9ddb5c/3/OxOtie7g11
  If no – why not?:
  Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Yes
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  If pending, date when dissemination is expected:
  If no, explain why you didn't follow it:
  Have participants been informed of the results of the study?: Yes
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  Shared with PIs of each site
  If pending, date when feedback is expected:
  If no, explain why they haven't:
  Have you enabled sharing of study data with others?: No
  If yes, describe or provide URLs to how it has been shared:
  If no, explain why sharing hasn't been enabled: N/A
  Have you enabled sharing of tissue samples and associated data with others?: No
  If yes, describe or provide a URL:
  If no, explain why: N/A
  Captcha: 03AFcWeA4PTNwpHYhts3r_5ha2Zq-7q_y2i0rHFTkDE7yVS3kzYgUqfQw_8Rl_As0-d-7_PdS_sSW0KUCodgVT-4sd-sYawo4hXaCiKLVRP9qCBktyX-VzDhhBYjm-7QAnyi5myr-Fxuce7W8zgCjlaXcmS2TSWEzJlBB2zGR-FfR9NSqfbUwSU1XZz9ytj3M7rT7QdwEVk-HTfWxvfftpWjLlQicVRiCXGNxMXTrV3Gbd947FVM1_GHdnZMal5uBW5Lhoo4HGAOqaQmmM9M9KR7tepDmOyIEOl4QK1YuFHJ1YzMvtkGfxR1Hbg8v-3D_eFwhMF_L7sMbGLDLce7b4hxzLWOUhgynyzC5kjv1gHNTGpQwdcPFwEIko0PdTZEcE93xbAQnUrxeTxvFW9cB1NrL5-q7FWf-HqZNVk1SZfHw8ObCppdG5p9tebTIL56YgBlluRm-43lFNO5G5qVeSDJ4P3BA2G7On_jkgKmKZ_fE_hUSC3nPZjMuCC91WnhTqorp-cP2Y8vDXcWUD7WWhzKXyBjj3RCiajbBqqx_MQzT9IXptQYiJiqkfJGXezpBF0lrkeTkQP3xfy7viL43tvQ6I9CJqlX9bDjYlRlLs6pQc6Rh4ScVyU9CMB0Fo9lRaXVQPwNMrXmiQ5JOC6uk-8RMnB2E2LR_9QgayVYDAMOpWLZmebZJ8HJ2KrPoFVBnd5GzcK1wEbzeh1ye-jAK6A2lms4X1wT26r9MDoP7KWpuUohf75QMdHcZ4dikyvFOLs6QkpwaEMNkYXn9XOI14udyn4fpvH-GaoEIG5aiRZTaGnek0kX9BDXSUy6fH30wA0a1-fIHMtJCssuJcdDAAj-raY3bQ2brJFyDb79baPkdPh3lLDinYXBBjAKLsEuC8cJGkbCth9HVQKlST168mtMvm7g-bendhmyfh9q7t7jVNcLlxySMKQ3QpQZ1mkH4Nx2K9I5lnAQfe

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  19/LO/1971

• Date of REC Opinion

  23 Dec 2019

• REC opinion

  Further Information Favourable Opinion