Minimal-Massive Intervention in Elderly Patients With Dysphagia (NCT02396992) | Clinical Trial Compass
CompletedNot Applicable
Minimal-Massive Intervention in Elderly Patients With Dysphagia
Spain62 participantsStarted 2014-03
Plain-language summary
The purpose of this study is to apply a minimal-massive intervention (minimal recommendations to maximal number of patients) to elderly (\>70 years) hospitalized patients with oropharyngeal dysphagia (OD). The intervention will consist of early screening and assessment of OD, malnutrition and oral hygiene. Patients will be given recommendations for adaptation of volume and viscosity of fluids, nutritional support and good oral hygiene practices and followed at 3, 6, 9 and 12 months after discharge. In every point of the follow-up period, patients will be re-evaluated to adjust recommendations and to verify their compliance with the treatment.
The objectives of the intervention are to have an impact on complications related to OD (avoid impaired safety alterations and improve nutritional and oral health status and reduce) and to reduce readmissions, readmissions for pneumonia and morbimortality.
Who can participate
Age range
70 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:
* Older patients (≥70 years) admitted to Unit 5 and 8 of Hospital de Mataró.
* With OD diagnosed by the V-VST.
* Patients that have signed the informed consent form.
* Patients without any exclusion criteria.
Exclusion Criteria:
* Patients not able to comply with the protocol.
* Patients currently participating in any clinical trial or during the 4 last weeks.
* Patients with severe dementia or inability to communicate (GDS ≥ 6).
* Patients of the Intensive Care Unit.
* Patients with low functionality (Barthel pre-admission ≤ 40).
* Patients with high mortality risk (Walter score \> 6).
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.
What they're measuring
1
Reduction of incidence of respiratory infections due to the intervention.