Clinical trial NCT03882944: An Observational Study of a Nutritional Supplement in an Older Malnourished or at Risk of Malnutrition, Hip Fracture Population
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2019-03-20
Enrollment: 310
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Nutritional Status
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Barthel Index of Activities of Daily Living
timeFrame: Baseline to Week 12
measure: Functional Ambulation Classification Scale (FAC)
timeFrame: Baseline to Week 12
measure: Short Physical Performance Battery (SPPB)
timeFrame: Week 12
measure: Compliance with Nutritional Supplement
timeFrame: Baseline to Week 12
Other outcomes:
measure: Blood Chemistries - Chemistry Profile
timeFrame: Baseline to Week 12
measure: Blood Chemistries - Hematology Profile
timeFrame: Baseline to Week 12
measure: Blood Chemistries - Lipid Panel
timeFrame: Baseline to Week 12
measure: Body Mass Index
timeFrame: Baseline to Week 12
measure: Length of Stay in Hospital
timeFrame: Week 12
measure: Healthcare provider satisfaction questionnaire
timeFrame: Week 12
measure: Subject satisfaction questionnaire
timeFrame: Week 12
measure: Medication Use
timeFrame: Baseline to Week 12
Locations:
city: Alcorcón
country: Spain
facility: Hospital de Alcorcón
city: Gijón
country: Spain
facility: Hospital Cruz Roja Gijón
city: Guadalajara
country: Spain
facility: Hospital Universitario de Guadalajara
city: Huelva
country: Spain
facility: Hospital Infanta Elena
city: Las Palmas
country: Spain
facility: Hospital Universitario de Gran Canaria Doctor Negrin
city: León
country: Spain
facility: Complejo Asistencial Universitario de León
city: Madrid
country: Spain
facility: Hospital Universitario Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Plasencia
country: Spain
facility: Hospital Virgen del Puerto
city: Salamanca
country: Spain
facility: Hospital Universitario De Salamanca
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Nuestra Señora de Candelaria
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de Valme
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitario Dr. Peset
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: Ávila
country: Spain
facility: Complejo Asistencial de Avila
Study officials:
affiliation: Abbott
name: Maria Camprubi, PhD
role: STUDY_CHAIR
References: