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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03681899
Recruitment Status : Completed
First Posted : September 24, 2018
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital Center of Martinique

Study Description
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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.


Condition or disease Intervention/treatment
Geriatric Assessment 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 Design
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Study Type : Observational
Actual Enrollment : 289 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Rupture of Galenic Practices at Home in a Population Aged 65 or Older
Actual Study Start Date : September 18, 2018
Actual Primary Completion Date : December 18, 2019
Actual Study Completion Date : December 18, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Groups and Cohorts
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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).


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient taking at least one oral medication for two weeks or more, regarless of the pathology.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03681899


Locations
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France
CHU de Martinique
Fort-de-France, Martinique, France, 97200
Sponsors and Collaborators
University Hospital Center of Martinique
More Information
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Responsible Party: University Hospital Center of Martinique
ClinicalTrials.gov Identifier: NCT03681899    
Other Study ID Numbers: 18_RIPH3-07
First Posted: September 24, 2018    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Center of Martinique:
Rupture of galenic
Ederly patients
Geriatry
Drug class
Additional relevant MeSH terms:
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Rupture
Wounds and Injuries