Informations générales (source: ClinicalTrials.gov)

NCT02802371 Statut inconnu
Evaluation of the Impact of Personalized Pharmaceutical Collaborative Care Integrated to a Multidisciplinary Psychosocial Program on the Burden Felt by Caregivers of Elderly Patients With Alzheimer's Disease and Related Disorders and Evaluated at 18-month Follow-up (PHARMAID)
Interventional
  • Maladie d'Alzheimer
N/A
Hospices Civils de Lyon (Voir sur ClinicalTrials)
août 2016
février 2020
29 juin 2024
Caring for patients with Alzheimer Disease or Related Disorders (ADRD) is accompanied with a caregiver burden that increases with the progression of the disease. This burden can have physical, psychological, emotional, social and financial issue on the informal caregivers who are often represented as hidden secondary patients. They frequently have a higher risk of developing mood disorders as depression, anxiety, stress, sleep disorders and a lower quality of life associated with a greater use of psychotropic drugs. They also incur higher risk of heart disease and mortality. The embrittlement of the caregiver is a major factor of early institutionalization of patient. In the PIXEL study, the mean age of the men caregivers was 73.9 years and 64.8 for the women caregivers. Elderly themselves, especially spouses, the informal caregivers are also exposed to common chronic diseases and associated polypharmacy with a higher risk of developing drug-related problems due to aging and negligence of their own health care. These risks are increased mainly in the elderly because of changes in pharmacokinetic and pharmacodynamic parameters related to aging, acute or chronic diseases and the potentially inappropriate prescription (PIP). Previous studies have shown the effectiveness and positive impact of optimization of the therapeutics by a clinical pharmacist on the reduction of drug-related problems, length of hospital stay, readmission rates, quality of life and mortality. The patient's medication management is usually delegated to the informal caregiver, who must also manage his own treatment. The caregiver may face difficulties with therapeutics (e.g., inappropriate dosage form, adverse effects and patient refusal) that could impact on its compliance with treatment or that of his relative. No previous study has evaluated the impact of pharmaceutical collaborative care including personalized interview with a clinical pharmacist and optimization of drug prescribing among patients with ADRD and their caregivers. However, many studies have assessed the effectiveness of non-pharmacological interventions on caregiver burden, mood disorders and the patient institutionalization. Meta-analysis showed a moderate improvement of the caregiver burden. The main objective of the PHARMAID study is to measure the impact of personalized pharmaceutical collaborative care integrated to a multidisciplinary psychosocial program on the burden of ADRD caregivers and assessed at 18-month follow-up.
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Etablissements

Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Pharmacy unit and Clinical Research Center VCF (" Aging Brain Frailty ") University hospital of Lyon, Charpennes Hospital / University Lyon / INSERM, U1028; CNRS, UMR5292; Lyon Neuroscience Research Center - 69100 - Villeurbanne - France Teddy Novais, PharmD, PhD student En recrutement Contact (sur clinicalTrials)

Critères

Tous
Inclusion Criteria:

for the patients:

- Patients aged 65 and over;

- Patients with ADRD;

- Patients suffering from mild to moderate stages of the disease, defined by the
Mini-Mental Score Examination (MMSE), with scores of 25 to 16/30;

- Patients living at home;

- Patients received in a geriatric or memory consultation of a study recruiting
centers;

- Patients with the ability to express themselves orally or in writing in French
sufficiently to carry out clinical assessments;

- Patients who are not opposed to the research;

for the caregivers:

- Caregivers aged 55 and over;

- Nonprofessional caregivers living with the patient or providing support to him/her
at least 10 hours a week for the activities of daily living;

- Caregivers with the ability to follow the program at the discretion of the
investigator;

- Caregivers with the ability to express themselves orally or in writing in French
sufficiently to carry out clinical assessments;

- Caregivers who are not opposed to the research.


for the patients:

- Institutionalized patients.

for the caregivers:

- Caregivers involved in another support program for the caregivers;

- Caregivers whose the level of acceptance of the disease does not allow the
participation in the study.