- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03979560
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 (NUTRIACTIF)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ile-de-France
-
Paris, Ile-de-France, France, 75018
- Département de Gériatrie, Hôpital Bichat
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
In addition to screening/inclusion visits (D0), three follow-up home visits are scheduled at D7, D45 and D90 for both study groups. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of level of autonomy according Activities of Daily Living (ADL) score
Time Frame: 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.
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assessment of of dependency according Gerontological autonomy group iso-resources (AGGIR ) score
Time Frame: 18 mois
|
18 mois
|
Assessment of undernutrition according Mini Nutritional Assessment (MNA)
Time Frame: 18 months
|
18 months
|
Assessment of gait, balance and muscle according Short Physical Performance Battery (SPPB) score
Time Frame: 18 months
|
18 months
|
Measuring quality of life according EuroQol- 5 Dimension (EQ-5D) scale
Time Frame: 18 months
|
18 months
|
Assessment of comorbidity according Cumulative Illness Rating Scale-Geriatric (CIRS-G) scale
Time Frame: 18 months
|
18 months
|
Assessment caregiver burden according Caregiver Subjective and Objective Burden (Zarit) scale
Time Frame: 18 months
|
18 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-A02973-50
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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