Clinical and Medico-economic Evaluation of Taken Care Associating Nutritional Support and Adapted… (NCT03979560) | Clinical Trial Compass
TerminatedNot Applicable
Clinical and Medico-economic Evaluation of Taken Care Associating Nutritional Support and Adapted Physical Activity for Malnourished, or at Risk of Undernutrition, Elderly People on Discharge From Hospital
Stopped: Lack of inclusion of patients
France47 participantsStarted 2019-06-28
Plain-language summary
In the hospital, one out of every two elderly people is malnourished. This condition of undernutrition generally worsens during hospitalization, where the effects of polypathology and psychological distress are added. Muscle loss due to inadequate dietary intake, hypermetabolism and immobilization results in the onset or worsening of mobility disorders and functional decline. After hospitalization, 30-50% of elderly people hospitalized in emergency in medical departments have lost autonomy in daily life. Nutritional management and adaptive physical activity (APA) could have synergistic action to improve the nutritional status and mobility of elderly patients. The short duration of the average stay the acute geriatric units (10-15 days) is not enough to renew, nor to re-educate patients. It seems important to continue these actions at home. The implementation of programs combining nutrition and adapted physical activity (APA) at the hospital exit has not been studied to date. We formulate the hypothesis that in elderly people who are malnourished or at risk of undernutrition, after hospitalization, a personalized home intervention combining nutritional advice and appropriate physical activity will limit their loss of autonomy.
Who can participate
Age range
70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men or women aged at least 70
* Hospitalized in acute geriatrics (UGA), with expected return to home directly after the UGA
* Undernourished or at risk of undernutrition (MNA SF12)
* Able to walk 4 metres without third party assistance
* Able to understand and consent to the study
* Good understanding of the French language
* Living in Paris (department 75)
* Patient affiliated with a social security scheme
* Having read the information note and having agreed to participate in the study by signing the consent.
Exclusion Criteria:
* Life expectancy less than 6 months
* Chronic inflammatory pathology
* Progressive cancer
* Severe renal failure (creatinine clearance \< 30ml/min/1.73 m2)
* NYHA Stage III or IV Dyspnea
* Chronic respiratory failure (oxygen therapy at home)
* Liver failure (TP \< 50%)
* Severe depression
* severe dementia, according to DSM V criteria
* swallowing disorders with inhalation pneumonia
* corticosteroids (\> 10 mg prednisone/day long-term or equivalent)
* Systolic blood pressure \>200 mmHg
* Unstabilized acute coronary syndrome
* decompensated heart failure
* Severe, uncontrolled ventricular rhythm disorders
* High risk embolic intracardiac thrombus
* Presence of medium to large pericardial effusion
* Recent history of thrombophlebitis with or without pulmonary embolism
* Obstacle to severe and/or symptomatic left ventricular ejection
* Severe and symptomatic pulmonary hypertension
* Inability to perform appropriate physical act…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessment of level of autonomy according Activities of Daily Living (ADL) score