NUTRIACTIF: 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

Sponsor

Gérond'if (Other)

Overall Status

Unknown status

CT.gov ID

NCT03979560

Collaborator

(none)

532

Enrollment

Location

Arms

18.1

Anticipated Duration (Months)

29.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Under-nutrition or Risk of Undernutrition	Other: Intervention	N/A

Detailed Description

Interventional study with minimal risk and constraints, prospective, multicentre, randomised and controlled.

Population of interest:

Older people at least 70 years, malnourished or at risk of malnutrition, on discharge from hospital
Informal caregivers of patients included in study

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:

Interventional arm : Nutrition intervention with appropriate physical activity for 186 patients
Control arm: standard care for 186 other patients And up to 160 informal caregivers (family members) in both groups, or 80 caregivers per group (one caregiver per patient).

Inclusion period: 15 months. Follow-up period: 3 months/subject (patients and caregivers) Total length of study: 18 months

Study Design

Study Type:

Interventional

Anticipated Enrollment :

532 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Apr 29, 2019

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Nov 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control 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.
Experimental: Nutrition intervention with appropriate physical activity Intervention at home of professionals: Patients in this arm will benefit from 14 home interventions 7 home nutrition support (NS) sessions in 3 months or 1 session every 10 days (+/-4 days). These sessions will be conducted by a dietician from the company "Saveurs et Vie". 7 home sessions of adaptive physical activity (APA) in 3 months, one session every 10 days (+/-4 days). These sessions will be conducted by professionals from association group "Siel Bleu". In addition to screening/inclusion visits (D0), three follow-up home visits are scheduled at D7, D45 and D90 for both study groups.	Other: Intervention 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.

Arm

Intervention/Treatment

No Intervention: Control

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.

Experimental: Nutrition intervention with appropriate physical activity

Intervention at home of professionals: Patients in this arm will benefit from 14 home interventions 7 home nutrition support (NS) sessions in 3 months or 1 session every 10 days (+/-4 days). These sessions will be conducted by a dietician from the company "Saveurs et Vie". 7 home sessions of adaptive physical activity (APA) in 3 months, one session every 10 days (+/-4 days). These sessions will be conducted by professionals from association group "Siel Bleu". In addition to screening/inclusion visits (D0), three follow-up home visits are scheduled at D7, D45 and D90 for both study groups.

Other: Intervention

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.

Outcome Measures

Primary Outcome Measures

Assessment of level of autonomy according Activities of Daily Living (ADL) score [18 months]
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.

Secondary Outcome Measures

Assessment of of dependency according Gerontological autonomy group iso-resources (AGGIR ) score [18 mois]
Assessment of undernutrition according Mini Nutritional Assessment (MNA) [18 months]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 activities
Subject participating or having participated in a therapeutic trial within the last 3 months
Refusal to participate
Person under guardianship, guardianship or safeguard of justice