Geriatric AssessmentCRUSHAGENCT03681899
Evaluation of Rupture of Galenic Practices at Home in a Population Aged 65 or Older
An observational study of Geriatric Assessment, run by University Hospital Center of Martinique at 1 site in France.
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 ...). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Geriatric Assessment
- What is being tested?
- Questionnaires
- Type of treatment
- Pill or oral medicine
- How many people
- 289 participants
- Where
- 1 siteFrance
- Study dates
- 18 Sep 2018to 18 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patient taking at least one oral medication for two weeks or more, regarless of the pathology.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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 ...).
Read more
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.
Read the 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.
- Conditions
- Geriatric Assessment
- Being tested
- Questionnaires
- Keywords
- Rupture of galenic, Ederly patients, Geriatry, Drug class
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
- 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Number of participants for each drug class
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start18 Sep 2018
- Primary completion18 Dec 2019
- Study completion18 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geriatric AssessmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03681899
- Sponsor's protocol ID
- 18_RIPH3-07
- Acronym
- CRUSHAGE
- Status last verified
- Oct 2019
- First submitted
- 19 Sep 2018
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Rupture of Galenic Practices at Home in a Population Aged 65 or Older
- ClinicalTrials.gov ID
- NCT03681899
- Acronym / sponsor ID
- CRUSHAGE / 18_RIPH3-07
- Conditions
- Geriatric Assessment
- Keywords
- Rupture of galenic, Ederly patients, Geriatry, Drug class
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Study start
- 18 Sep 2018 (actual)
- Primary completion
- 18 Dec 2019 (actual)
- Study completion
- 18 Dec 2019 (actual)
- First posted
- 24 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects aged of 65 years or older | – | Other: QuestionnairesSubjects aged of 65 years or older, taking at least one oral medication for two weeks or more. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patient taking at least one oral medication for two weeks or more, regarless of the pathology.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Other | Subjects aged of 65 years or older |
Primary outcome
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.
8 secondary outcomes
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
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
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
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
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
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
To determine the modalities of rupture of galenic in a population of subjects aged 65 or over at home
Time frame: 12 months
To determine the modalities of rupture of galenic in a population of subjects aged 65 or over at home
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Geriatric Assessment, run by University Hospital Center of Martinique at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2020.