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Completed

NCT Number: NCT03681899

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

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.

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Key information

Conditions

Geriatric Assessment

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Martinique

Fort-de-France, Martinique, 97200, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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.

    Time frame: 12 months

    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.

Secondary outcomes

  1. 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

    Time frame: 12 months

    Number of participants for each drug class

  2. 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

    Time frame: 12 months

    Percentage of participants for each drug class

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

    Time frame: 12 months

    Number of participants for each actor

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

    Time frame: 12 months

    Percentage of participants for each actor

  5. 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

    Time frame: 12 months

    Binary logistic regression with variable to explain, the rupture of galenic

  6. 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

    Time frame: 12 months

    Binary logistic regression with variable as explanatory variables, the medical and sociodemographic factors

  7. To determine the modalities of rupture of galenic in a population of subjects aged 65 or over at home

    Time frame: 12 months

    Number of paticipants for each modality

  8. To determine the modalities of rupture of galenic in a population of subjects aged 65 or over at home

    Time frame: 12 months

    Percentage of paticipants for each modality

Sponsors and collaborators

Lead sponsor

University Hospital Center of Martinique

Other

Registry information

Acronym: CRUSHAGE

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 24, 2018
Registry last updated
Jul 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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