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

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.

Study Overview

• Status: Completed
• Conditions: Geriatric Assessment
• Intervention / Treatment: Other: Questionnaires

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.

• Study Type: Observational
• Enrollment (Actual): 289

Contacts and Locations

Study Locations

• France
  • Martinique
    • Fort-de-France, Martinique, France, 97200
      • CHU de Martinique

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient taking at least one oral medication for two weeks or more, regarless of the pathology.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital Center of Martinique

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 18, 2018
• Primary Completion (ACTUAL): December 18, 2019
• Study Completion (ACTUAL): December 18, 2019

Study Registration Dates

• First Submitted: September 19, 2018
• First Submitted That Met QC Criteria: September 20, 2018
• First Posted (ACTUAL): September 24, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 10, 2020
• Last Update Submitted That Met QC Criteria: July 8, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Geriatry; Rupture of galenic; Ederly patients; Drug class
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: 18_RIPH3-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No