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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Nutritional Status | Measured by the Mini Nutritional Assessment (MNA) 18 questions; 30 total point scale where lower number indicates risk of malnutrition | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Barthel Index of Activities of Daily Living | Subject completed assessment of 10 functions; Sum of scores range from 0-100 scaled in positive direction | Baseline to Week 12 |
| Functional Ambulation Classification Scale (FAC) |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Chemistries - Chemistry Profile | Blood chemistries collected per standard of care | Baseline to Week 12 |
| Blood Chemistries - Hematology Profile | Hematology blood chemistries collected per standard of care |
Inclusion Criteria:
Exclusion Criteria:
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The study population will include older men and women who are free living (outpatient) or residing in a nursing home, who meet all enrollment criteria. Subjects will be recruited by the investigator(s) from each study site.
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| Name | Affiliation | Role |
|---|---|---|
| Maria Camprubi, PhD | Abbott | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Alcorcón | Alcorcón | 28922 | Spain | |||
| Complejo Asistencial de Avila |
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6-level scale assesses ambulation status; scaled in the positive direction; the higher level indicates greater ambulation
| Baseline to Week 12 |
| Short Physical Performance Battery (SPPB) | Timed assessments of balance, gait speed and chair standing; Scaled in the negative direction | Week 12 |
| Compliance with Nutritional Supplement | Subject completed consumption dairy | Baseline to Week 12 |
| Baseline to Week 12 |
| Blood Chemistries - Lipid Panel | Lipid panel blood chemistries collected per standard of care | Baseline to Week 12 |
| Body Mass Index | BMI calculated Weight (kg)/Height (m)2 | Baseline to Week 12 |
| Length of Stay in Hospital | Information collected for hospital admission and discharge dates | Week 12 |
| Healthcare provider satisfaction questionnaire | HCP completed questionnaire; 3 to 5 category responses scaled in negative direction | Week 12 |
| Subject satisfaction questionnaire | Subject completed questionnaire; Responses 1 to 10 scaled in the positive direction | Week 12 |
| Medication Use | Medications prescribed | Baseline to Week 12 |
| Ávila |
| 50003 |
| Spain |
| Hospital Cruz Roja Gijón | Gijón | 33202 | Spain |
| Hospital Universitario de Guadalajara | Guadalajara | 19002 | Spain |
| Hospital Infanta Elena | Huelva | 21080 | Spain |
| Hospital Universitario de Gran Canaria Doctor Negrin | Las Palmas | 35010 | Spain |
| Complejo Asistencial Universitario de León | León | 24071 | Spain |
| Hospital Universitario Clínico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario Fundación Jiménez Díaz | Madrid | 28040 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Virgen del Puerto | Plasencia | 10600 | Spain |
| Hospital Universitario De Salamanca | Salamanca | 37007 | Spain |
| Hospital Nuestra Señora de Candelaria | Santa Cruz de Tenerife | 38010 | Spain |
| Hospital Universitario Virgen de Valme | Seville | 41014 | Spain |
| Hospital General Universitario de Valencia | Valencia | 46014 | Spain |
| Hospital Universitario Dr. Peset | Valencia | 46017 | Spain |
| Hospital Clínico Universitario de Valladolid | Valladolid | 47003 | Spain |
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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