NCT03681899

Evaluation of Rupture of Galenic Practices at Home in a Population Aged 65 or Older

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 289 (actual)
• Sponsor: University Hospital Center of Martinique · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

Elderly people frequently take several medications and are exposed to iatrogenic risks. The oral route is the preferred route of administration. The effectiveness and the safety of the drugs depend in particular on the modes of administration (frequency of the intake, respect of the doses and the galenic ...). However, these modalities are very little known concerning the treatments intake at home in the elderly population. In a health facility welcoming geriatric patients, the rupture of galenic is frequent and favored by swallowing disorders, dependence, the increase in age, the presence of cognitive disorders or psycho-behavioral disorders. The consequences of the rupture of galenic are numerous, concern the patients but also the caregivers who administer the treatments.

Detailed description

Primary objective : \- Estimate the rupture of galenic prevalence of at least one molecule in a population of subjects aged 65 years or over living at home and taking at least one oral drug for 2 weeks or more. Secondary objectives: * Identify the drug classes most frequently involved in the rupture of galenic in a population of subjects aged 65 years of age or over at home; * Identify the actors of the drug administration in a population of subjects aged 65 years of or over at home; * To determine the medical and sociodemographic factors associated with the rupture of galenic in a population of subjects aged 65 years or over at home; * To determine the modalities of rupture of galenic in a population of subjects aged 65 or over at home.

Conditions

• Geriatric Assessment

Interventions

Type	Name	Description
OTHER	Questionnaires	* Socio-demographic data (age, sex, place of residence, and family status, last occupation, existence or not of a primary caregiver (family and / or professional)); * Medical and surgical history (Charlson Comorbidity Scale); * Assessment of oral/dental condition * Record of drug treatments (number of oral medications per day, therapeutic class, number of daily intakes); * Oral treatments intake modalities (galenic breakdown of one or more drugs, usual or occasional, modalities of rupture, person responsible for the drugs, mixing with food / drink); * Autonomy evaluation (Lawton and Katz scales); * Mobility assessment (anamnestic evaluation); * Evaluation of Thyme (GDS 4 items); * Psycho-behavioral disorders, * Assessment of swallowing (presence of a diagnosis of dysphagia or suspicion based on anamnestic data).

Timeline

• Start date: 2018-09-18
• Primary completion: 2019-12-18
• Completion: 2019-12-18
• First posted: 2018-09-24
• Last updated: 2020-07-10

Locations

1 site across 1 country: France