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

Geriatric Assessment Clinical Trial

— CRUSHAGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03681899
• Other study ID #: 18_RIPH3-07
• Status: Completed
• Start date: September 18, 2018
• Est. completion date: December 18, 2019

Study information

• Verified date: October 2019
• Source: University Hospital Center of Martinique
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 289
• Est. completion date: December 18, 2019
• Est. primary completion date: December 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Geriatric Assessment
• Rupture

Intervention

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).

Locations

Country	Name	City	State
France	CHU de Martinique	Fort-de-France	Martinique

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Center of Martinique

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Calculation of the prevalence of galenic rupture by dividing the number of persons with at least one rupture of galenic by the number of persons included in the study.	12 months
Secondary	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	Number of participants for each drug class	12 months
Secondary	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	Percentage of participants for each drug class	12 months
Secondary	To determine the actors of the drug administration in a population of subjects aged 65 years of or over at home	Number of participants for each actor	12 months
Secondary	To determine the actors of the drug administration in a population of subjects aged 65 years of or over at home	Percentage of participants for each actor	12 months
Secondary	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	Binary logistic regression with variable to explain, the rupture of galenic	12 months
Secondary	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	Binary logistic regression with variable as explanatory variables, the medical and sociodemographic factors	12 months
Secondary	To determine the modalities of rupture of galenic in a population of subjects aged 65 or over at home	Number of paticipants for each modality	12 months
Secondary	To determine the modalities of rupture of galenic in a population of subjects aged 65 or over at home	Percentage of paticipants for each modality	12 months