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Lack of inclusion of patients
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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.
Interventional study with minimal risk and constraints, prospective, multicentre, randomised and controlled.
Population of interest:
Intervention at home of professionals:
Mixed intervention: nutritional support, carried out by the dieticians of " Saveurs et Vie ", in seven sessions over three months, combined with an adapted physical activity intervention (APA), carried out by " Siel Bleu " professionals, also at a frequency of seven sessions over three months, for a total of fourteen sessions.
Control arm will benefit from usual support (depending on practices of the department, prescription or not of oral nutritional supplements and physiotherapy at home, but without home intervention of adapted physical activity professionals or dieticians).
In addition to screening/inclusion visits (D0), three follow-up home visits are scheduled at D7, D45 and D90 for both study groups.
Inclusion visit (D0), performed in hospital in geriatric ward prior to hospital discharge. Verification of inclusion criteria, collection of consent by investigator, randomization, collection of inclusion data (socio-educational level, family status, assessment of autonomy (ADL, IADL, AGGIR) number of drugs, comorbidity (CIRS-G), cognitive status, biology performed during hospitalization (albumin, CRP, Vitamin D) and discharge prescription (NOC, nutritional advice, physiotherapy) are programmed to D7, D45 and D90 for both study arms.
Follow-up visits to D7, D45 and D90, carried out at home by a clinal research technician mandated by sponsor (Gérond'if). Assessment of autonomy (ADL, IADL, AGGIR scale), nutritional status (weight, height, self-evaluation of appetite, MNA), functional status (Grinding strength, 4-metre walking speed, SPPB), quality of life (EQ-5D), frequency and transit time of home help workers, whether family or professional. Acceptability of interventions for the home intervention arm.
2 patient/arms, a total of 372 patients divided as follows:
Inclusion period: 15 months. Follow-up period: 3 months/subject (patients and caregivers) Total length of study: 18 months
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | The control group will benefit from the usual support (depending on the practices of the department, prescription or not of oral nutritional supplements and physiotherapy at home, but without home intervention of adapted physical activity professionals or dieticians). In addition to screening/inclusion visits (D0), three follow-up home visits are scheduled at D7, D45 and D90 for both study groups. | |
| Nutrition intervention with appropriate physical activity | Experimental | Intervention at home of professionals: Patients in this arm will benefit from 14 home interventions
In addition to screening/inclusion visits (D0), three follow-up home visits are scheduled at D7, D45 and D90 for both study groups. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention | Other | Nutritional support in seven sessions spread over three months, combined with an adapted physical activity intervention (APA), also at a frequency of seven sessions spread over three months, or fourteen home sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of level of autonomy according Activities of Daily Living (ADL) score | To assess the effect of taken care associating nutritional support and adapted physical activity (APA) on the independence of elderly people who are malnourished or at risk of malnutrition at the end of their stay in hospital. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of of dependency according Gerontological autonomy group iso-resources (AGGIR ) score | 18 mois | |
| Assessment of undernutrition according Mini Nutritional Assessment (MNA) | 18 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Département de Gériatrie, Hôpital Bichat | Paris | Île-de-France Region | 75018 | France |
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| Assessment of gait, balance and muscle according Short Physical Performance Battery (SPPB) score |
| 18 months |
| Measuring quality of life according EuroQol- 5 Dimension (EQ-5D) scale | 18 months |
| Assessment of comorbidity according Cumulative Illness Rating Scale-Geriatric (CIRS-G) scale | 18 months |
| Assessment caregiver burden according Caregiver Subjective and Objective Burden (Zarit) scale | 18 months |
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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