Alzheimer Disease
Conditions
Keywords
caregiver burden, Alzheimer disease and related disorders, elderly, pharmaceutical care, optimization of drug prescribing, psychosocial intervention
Brief summary
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.
Interventions
BEHAVIORALPsychosocial intervention
Caregivers included in this group will benefit from a multi-component intervention with three collective sessions and individual interview in face-to-face or by phone according to the follow-up time.
OTHERPharmaceutical care and psychosocial support
Caregivers included in this group will benefit from the same multi-component intervention that group psychosocial intervention with the integration of pharmaceutical care by a clinical pharmacist. The clinical pharmacist will intervene in: 1) the pharmaceutical need assessment of the caregivers considering their medication management and the medication management of their relatives at the inclusion; 2) a collective session on medication management; and 3) personalized interviews to consider needs, medication problems and difficulties in the therapeutic optimization process.
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| caregiver's burden | Change from Baseline at 18-months follow-up | The caregiver burden is measured using the Zarit Burden Index (ZBI) questionnaire. The ZBI is a subjective measure of burden that includes 22 items exploring the caregiver's perception and feelings about care situations. Each item was evaluated using a 5-point Likert scale ranging from 0 (never) to 4 (almost always), which are summed. The score range is 0-88, a higher score indicating a higher burden level. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| caregiver's anxiety | Change from Baseline at 18-months follow-up | anxiety measured by scale HARD |
| caregiver's depression | Change from Baseline at 18-months follow-up | depression measured by Geriatric Depression Scale (GDS) |
| patient's quality of life | Change from Baseline at 18-months follow-up | Quality of life measured by questionnaire Alzheimer Disease Related Quality of Life (ADRQL scale) |
| patient's behavioral disorders | Change from Baseline at 18-months follow-up | behavioral disorders measured by questionnaire Neuropsychiatric Index (NPI) |
| caregiver's quality of life | Change from Baseline at 18-months follow-up | Quality of life measured by questionnaire EUROQOL 5D |
| Occurrence of medical consultation | Change from Baseline at 18-months follow-up | number of medical consultation in patients and caregivers |
| Occurrence of recourse to emergency service | Change from Baseline at 18-months follow-up | occurrence of recourse to emergency service in patients and caregivers |
| Occurrence of hospitalizations | Change from Baseline at 18-months follow-up | number of hospitalization in patients and caregivers |
| Occurrence of admission in institution | Change from Baseline at 18-months follow-up | occurrence of admission in institution in patients |
| patient's functional autonomy | Change from Baseline at 18-months follow-up | functional autonomy measured by IADL scale (Instrumental Activities of Daily Living) |
Countries
France
Contacts
Primary ContactTeddy Novais, PharmD, PhD student
Backup ContactChristelle Mouchoux, PharmD, PhD
Outcome results
None listed