An Observational Study of a Nutritional Supplement in an Older Malnourished or at Risk of Malnutrition, Hip Fracture Population
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| ClinicalTrials.gov Identifier: NCT03882944 |
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Recruitment Status :
Recruiting
First Posted : March 20, 2019
Last Update Posted : July 9, 2021
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Sponsor:
Abbott Nutrition
Information provided by (Responsible Party):
Abbott Nutrition
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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.
| Condition or disease |
|---|
| Malnutrition |
| Study Type : | Observational |
| Estimated Enrollment : | 385 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | A Prospective, Observational Study of the Effect of a High Calorie and Protein Oral Nutritional Supplement, in an Older Malnourished or at Risk of Malnutrition, Hip Fracture Population |
| Actual Study Start Date : | February 20, 2020 |
| Estimated Primary Completion Date : | February 2022 |
| Estimated Study Completion Date : | February 2022 |
Resource links provided by the National Library of Medicine
Primary Outcome Measures :
- Nutritional Status [ Time Frame: 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 Outcome Measures :
- Barthel Index of Activities of Daily Living [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Week 12 ]Timed assessments of balance, gait speed and chair standing; Scaled in the negative direction
- Compliance with Nutritional Supplement [ Time Frame: Baseline to Week 12 ]Subject completed consumption dairy
Other Outcome Measures:
- Blood Chemistries - Chemistry Profile [ Time Frame: Baseline to Week 12 ]Blood chemistries collected per standard of care
- Blood Chemistries - Hematology Profile [ Time Frame: Baseline to Week 12 ]Hematology blood chemistries collected per standard of care
- Blood Chemistries - Lipid Panel [ Time Frame: Baseline to Week 12 ]Lipid panel blood chemistries collected per standard of care
- Body Mass Index [ Time Frame: Baseline to Week 12 ]BMI calculated Weight (kg)/Height (m)2
- Length of Stay in Hospital [ Time Frame: Week 12 ]Information collected for hospital admission and discharge dates
- Healthcare provider satisfaction questionnaire [ Time Frame: Week 12 ]HCP completed questionnaire; 3 to 5 category responses scaled in negative direction
- Subject satisfaction questionnaire [ Time Frame: Week 12 ]Subject completed questionnaire; Responses 1 to 10 scaled in the positive direction
- Medication Use [ Time Frame: Baseline to Week 12 ]Medications prescribed
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| Ages Eligible for Study: | 75 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
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.
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03882944
Contacts
| Contact: Kristen DeLuca | 614-624-5455 | kristen.deluca@abbott.com |
Locations
Show 18 study locations
Sponsors and Collaborators
Abbott Nutrition
Investigators
| Study Chair: | Maria Camprubi, PhD | Abbott |
| Responsible Party: | Abbott Nutrition |
| ClinicalTrials.gov Identifier: | NCT03882944 |
| Other Study ID Numbers: |
DA20 |
| First Posted: | March 20, 2019 Key Record Dates |
| Last Update Posted: | July 9, 2021 |
| Last Verified: | July 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Malnutrition Hip Fractures Nutrition Disorders Femoral Fractures |
Fractures, Bone Wounds and Injuries Hip Injuries Leg Injuries |