Clinical trial NCT03681899: Evaluation of Rupture of Galenic Practices at Home in a Population Aged 65 or Older
Official title: Evaluation of Rupture of Galenic Practices at Home in a Population Aged 65 or Older
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Geriatric Assessment
Keywords: Rupture of galenic
Ederly patients
Geriatry
Drug class
Lead sponsor: University Hospital Center of Martinique
Sponsor class: OTHER
First posted: 2018-09-24
Enrollment: 289
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient taking at least one oral medication for two weeks or more, regarless of the pathology.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Subjects aged 65 or over;
* Patient taking at least one oral medication for two weeks or more;
* Patient affiliated to a social security scheme;
* Patient who has agreed to reply to the questionnaire or, in case of inability to agree, agreement obtained from the caregiver or guardian/curator.

Exclusion Criteria:

* Patient unable to answer questionnaires and without a referent caregiver capable of reply ;
* Patient having changed residence for two weeks or less;
* Patient residing in a residential care facility for dependent elderly people.

Primary outcomes:
measure: 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.
timeFrame: 12 months
Secondary outcomes:
measure: To determine 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
timeFrame: 12 months
measure: To determine 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
timeFrame: 12 months
measure: To determine the actors of the drug administration in a population of subjects aged 65 years of or over at home
timeFrame: 12 months
measure: To determine the actors of the drug administration in a population of subjects aged 65 years of or over at home
timeFrame: 12 months
measure: 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
timeFrame: 12 months
measure: 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
timeFrame: 12 months
measure: To determine the modalities of rupture of galenic in a population of subjects aged 65 or over at home
timeFrame: 12 months
measure: To determine the modalities of rupture of galenic in a population of subjects aged 65 or over at home
timeFrame: 12 months
Other outcomes:
Locations:
city: Fort-de-France
country: France
facility: CHU de Martinique
state: Martinique
Study officials:
References: