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

NCT ID: NCT03681899

Last Updated: 2020-07-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 289 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-18
• Study Completion Date: 2019-12-18

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.

Conditions

Geriatric Assessment

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Subjects aged of 65 years or older

Subjects aged of 65 years or older, taking at least one oral medication for two weeks or more.

Questionnaires

Intervention Type: OTHER

• 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).

Interventions

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).

Intervention Type: OTHER

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Center of Martinique

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Martinique

Fort-de-France, Martinique, France

Countries

France

Other Identifiers

18_RIPH3-07

Identifier Type: -

Identifier Source: org_study_id