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

NCT03681899 | Completed

• 1 other identifier: 18_RIPH3-07
• Study Type: observational
• Target: 289
• Locations: 1 country
• Sites: 1

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.

Conditions

Geriatric Assessment

Keywords

Rupture of galenic; Ederly patients; Geriatry; Drug class

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

  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

  12 months

• To determine the actors of the drug administration in a population of subjects aged 65 years of or over at home

  12 months

• To determine the actors of the drug administration in a population of subjects aged 65 years of or over at home

  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

  12 months

Study Arms (1)

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

Interventions

Questionnaires 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).

Subjects aged of 65 years or older

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Center of Martinique: lead

Study Sites (1)

CHU de Martinique

Fort-de-France, Martinique, 97200, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: September 24, 2018
• Study Start: September 18, 2018
• Primary Completion: December 18, 2019
• Study Completion: December 18, 2019
• Last Updated: July 10, 2020

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)