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The purpose of this pilot study is to determine the effect of 3 months use of enhanced Oral Nutritional Supplement (ONS) on physical function and functional performance in malnourished elderly patients.
The purpose of this pilot study is to determine the effect of 3 months use of enhanced Oral Nutritional Supplementation (ONS) on muscle accretion and functional performance in malnourished elderly patients. The objectives of this study are to determine feasibility of recruitment, adherence to intervention and retention of the sample, as well as the capacity of subjects to complete functional and muscle mass measures for a planned multi-centre Randomized Controlled Trial (RCT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | No Intervention | Standard of care could include liberalized diet consisting of 3 meals and snacks served daily or the standard oral nutrition supplementation (ONS) routinely used in the hospital, as prescribed by the medical team.These routine meals and snacks are the "standard of care." | |
| Ensure | Experimental | Patients randomized to Enhanced Oral Nutritional Supplementation (ONS) will receive the standard of care hospital menu (3 meals and snacks per day) plus 2 cans of Ensure (or similar product) per day while in hospital and will continue 2 cans per day of Ensure when discharged home until they have been receiving the enhanced ONS for a total of 90 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ensure | Dietary Supplement | Comparison of enhanced oral nutrition supplementation versus standard of care |
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| Measure | Description | Time Frame |
|---|---|---|
| Hospital Readmission Rate | The number of participants who are re-admitted to hospital within 90 days of randomization. This healthcare utilization outcome will be used to determine the cost-benefit of enhanced Oral Nutritional Supplementation. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Successful recruitment | We will view this pilot study as demonstrating feasibility of recruitment if we are able to recruit 60 patients over twelve months (approximately 5 patients per month for the overall study). | 1 year |
| Adherence to treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam Rahman, MD, FRCPC | St.Joseph's Health Care, London ON | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LHSC-University Hospital | London | Ontario | N6A 5A5 | Canada |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Patients will be randomized via REDCap (Research Electronic Data Capture), a secure, centralized web-based randomization module to:
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Adherence to the study treatments will be defined as ≥85% of patients were given the allocated intervention. Preliminary estimates of non-administration of the trial intervention are needed, along with strategies that maximize exposure to the intervention.
| 90 days |