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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)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Under-nutrition or Risk of Undernutrition | Other: Intervention | Not Applicable |
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 : | Interventional (Clinical Trial) |
| Estimated 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 : | April 29, 2019 |
| Estimated Primary Completion Date : | December 2019 |
| Estimated Study Completion Date : | November 2020 |
| 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. |
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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. |
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.
|
- 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.
- Assessment of of dependency according Gerontological autonomy group iso-resources (AGGIR ) score [ Time Frame: 18 mois ]
- Assessment of undernutrition according Mini Nutritional Assessment (MNA) [ Time Frame: 18 months ]
- Assessment of gait, balance and muscle according Short Physical Performance Battery (SPPB) score [ Time Frame: 18 months ]
- Measuring quality of life according EuroQol- 5 Dimension (EQ-5D) scale [ Time Frame: 18 months ]
- Assessment of comorbidity according Cumulative Illness Rating Scale-Geriatric (CIRS-G) scale [ Time Frame: 18 months ]
- Assessment caregiver burden according Caregiver Subjective and Objective Burden (Zarit) scale [ Time Frame: 18 months ]
| Ages Eligible for Study: | 70 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
| France | |
| Département de Gériatrie, Hôpital Bichat | |
| Paris, Ile-de-France, France, 75018 | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 9, 2019 | ||||
| First Posted Date ICMJE | June 7, 2019 | ||||
| Last Update Posted Date | June 7, 2019 | ||||
| Actual Study Start Date ICMJE | April 29, 2019 | ||||
| Estimated Primary Completion Date | December 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | 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 | ||||
| Official Title ICMJE | 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 | ||||
| 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. | ||||
| Detailed Description |
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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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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| Condition ICMJE | Under-nutrition or Risk of Undernutrition | ||||
| Intervention ICMJE | 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.
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Unknown status | ||||
| Estimated Enrollment ICMJE |
532 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | November 2020 | ||||
| Estimated Primary Completion Date | December 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 70 Years and older (Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03979560 | ||||
| Other Study ID Numbers ICMJE | 2017-A02973-50 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Gérond'if | ||||
| Study Sponsor ICMJE | Gérond'if | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Gérond'if | ||||
| Verification Date | June 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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