An Observational Study of a Nutritional Supplement in an Older Malnourished or at Risk of Malnutrition, Hip Fracture Population

Abbott

Status: Completed

Conditions: Malnutrition

Study type: Observational

Funder types: Industry

Identifiers

NCT03882944

DA20

Details and patient eligibility

About

This non-interventional, prospective, observational study is designed to observe the use of high calorie, high protein oral nutritional supplement in malnourished or at risk of malnutrition patients after hip fracture surgery, as assessed by a clinician. Subjects will be enrolled and observed for a period of 12 weeks.

Enrollment: 310 patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject has voluntarily signed and dated an informed consent form, approved by an Independent Ethics Committee, prior to any participation in the study.
• Subject is considered malnourished, or is at risk for malnutrition
• Subject conforms to the requirements set forth on the study product label.
• Subject has an estimated, or measured, glomerular filtration rate >30ml/min/1.73m2 (MDRD equation).
• Subject has been elected for hip fracture surgery and is within three days since surgery.
• The study physician determines the subject is fit to participate.
• Subject is under the care of a health care professional for malnutrition, or is at risk for malnutrition, and has recently been prescribed study oral nutritional supplement by their health care professional.
• After surgery, the subject is free living, resides in a nursing home, or remains in hospital and has an expected length of hospital stay < 15 days.

Exclusion criteria

• Subject has known dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder, or any other psychological condition that may interfere with study product consumption AND does not have a caregiver who can assist them with adherence to the study protocol.
• Subject has active cancer and the study physician determines the subject is not suitable for the study.
• Subject has uncontrolled diabetes.
• Subject is known to be allergic or intolerant to any ingredient found in the study product.
• Participation in another study that has not been approved as a concomitant study.