Malnutrition
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Abbott Nutrition
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nutritional Status | Baseline to Week 12 | Measured by the Mini Nutritional Assessment (MNA) 18 questions; 30 total point scale where lower number indicates risk of malnutrition |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Barthel Index of Activities of Daily Living | Baseline to Week 12 | Subject completed assessment of 10 functions; Sum of scores range from 0-100 scaled in positive direction |
| Functional Ambulation Classification Scale (FAC) | Baseline to Week 12 | 6-level scale assesses ambulation status; scaled in the positive direction; the higher level indicates greater ambulation |
| Short Physical Performance Battery (SPPB) | Week 12 | Timed assessments of balance, gait speed and chair standing; Scaled in the negative direction |
| Compliance with Nutritional Supplement | Baseline to Week 12 | Subject completed consumption dairy |
Other
| Measure | Time frame | Description |
|---|---|---|
| Healthcare provider satisfaction questionnaire | Week 12 | HCP completed questionnaire; 3 to 5 category responses scaled in negative direction |
| Blood Chemistries - Chemistry Profile | Baseline to Week 12 | Blood chemistries collected per standard of care |
| Medication Use | Baseline to Week 12 | Medications prescribed |
| Subject satisfaction questionnaire | Week 12 | Subject completed questionnaire; Responses 1 to 10 scaled in the positive direction |
| Blood Chemistries - Hematology Profile | Baseline to Week 12 | Hematology blood chemistries collected per standard of care |
| Blood Chemistries - Lipid Panel | Baseline to Week 12 | Lipid panel blood chemistries collected per standard of care |
| Body Mass Index | Baseline to Week 12 | BMI calculated Weight (kg)/Height (m)2 |
| Length of Stay in Hospital | Week 12 | Information collected for hospital admission and discharge dates |
Countries
Spain
Outcome results
None listed