Compliance to Oral Nutritional Supplements (ONS) in Undernourished Frail Older Adults Living at H… (NCT03501290) | Clinical Trial Compass
CompletedNot Applicable
Compliance to Oral Nutritional Supplements (ONS) in Undernourished Frail Older Adults Living at Home.
France62 participantsStarted 2016-06-01
Plain-language summary
In this study, patients are supposed to take Fortimel® Protein, an Oral Nutritional Supplement (ONS) recommended in case of malnutrition once daily during the study period.
Three visits will be planned for each patient enrolled in the study (baseline visit, visits of follow-up at 4 weeks and 12 weeks). Phone calls will be regularly organized during one month or three months according to the duration of supplementation.
The primary purpose of the OFraDDom study is to assess the compliance with ONS (respect by the patient of the physician's prescription) at the end of the first month.
Data regarding the beneficial effects of ONS, or compliance with ONS in frail elderly population, are very limited. The study could complete knowledge about oral nutritional supplementation in the undernourished frail elderly people and help to demonstrate that oral nutritional supplements have benefits on nutritional status and physical performances in frail elderly people.
Who can participate
Age range
65 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:
* Community dwelling
* Pre-frail or frail as defined by Fried criteria: at least a low score on one of the following:
* Weight loss
* Exhaustion
* Physical Activity
* Walk time
* Grip strength
* Undernutrition defined as at least one of the following criteria :
* weight loss (≥ 5% in 1 month or ≥ 10% in 6 months),
* BMI \< 21 kg/m2
* or global MNA \<23.5
* Informed consent
* Willingness and ability to comply with the protocol, including:
* Participation in study visits
* Taking the study products every day
* Ability to perform test for physical functioning and frailty status
* Ability to understand and fill out questionnaires
Exclusion Criteria:
* Dependency or loss of autonomy: ADL\<4
* Dementia
* MMSE ≤ \<20 if study partner, MMSE\<22 if loss of study partner
* Use of enteral nutrition
* Major depression: Geriatric Depression Scale \>8
* Cancer with acute treatment (chemotherapy, radiotherapy)
* Allergy to cow milk proteins
* Galactosemia
* Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements.
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.