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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | No Intervention | Patients and caregivers randomized in the control group will receive the current management in geriatric or memory consultation without multidisciplinary psychosocial intervention and pharmaceutical collaborative care.There will be a history of the drugs prescribing leading to pharmaceutical recommendations by the pharmacist-clinician, but the recommendations will not be transmitted to the referring physicians of patients and caregivers. | |
| Psychosocial intervention | Active Comparator | Psychosocial intervention including collective sessions and individual interview in face-to-face and by phone. These sessions will allow an extended psychosocial follow-up over one year. |
|
| Pharmaceutical care and psychosocial support | Experimental | Pharmaceutical collaborative care integrated in a psychosocial program. The clinical pharmacist will intervene in: 1) the pharmaceutical need assessment of caregivers; 2) collective session on medication management; and 3) optimization of drug prescribing. These collective and individual sessions of pharmaceutical care will allow an extended 18 month follow-up. Psychosocial intervention including collective sessions and individual interview in face-to-face and by phone. These sessions will allow an extended psychosocial follow-up over one year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychosocial intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| caregiver's burden | 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. | Change from Baseline at 18-months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| caregiver's quality of life | Quality of life measured by questionnaire EUROQOL 5D | Change from Baseline at 18-months follow-up |
| caregiver's anxiety | anxiety measured by scale HARD |
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Inclusion Criteria:
for the patients:
for the caregivers:
Exclusion Criteria:
for the patients:
for the caregivers:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Teddy Novais, PharmD, PhD student | Contact | (0)4 72 43 20 66 | +33 | teddy.novais@chu-lyon.fr |
| Christelle Mouchoux, PharmD, PhD | Contact | (0)4 72 43 20 65 | +33 | Christelle.mouchoux@chu-lyon.fr |
| Name | Affiliation | Role |
|---|---|---|
| Christelle Mouchoux, PharmD, PhD | 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, Lyon, France. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 | Recruiting | Villeurbanne | 69100 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37397433 | Derived | Novais T, Qassemi S, Cestac P, McCambridge C, Villars H, Zueras A, Decaudin B, Dambrine M, Huvent-Grelle D, Roche J, Schoenenburg S, Federico D, Nier AC, Krolak-Salmon P, Mouchoux C. Impact of pharmaceutical care integrated at a psychosocial intervention to reduce caregiver's burden in Alzheimer's disease or related dementias: Negative results at 18 months and difficulties to conduct PHARMAID RCT. Contemp Clin Trials Commun. 2023 Apr 22;33:101146. doi: 10.1016/j.conctc.2023.101146. eCollection 2023 Jun. | |
| 28007635 |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000083626 | Psychosocial Intervention |
| D010593 | Pharmaceutical Services |
| D000067250 | Psychiatric Rehabilitation |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Pharmaceutical care and psychosocial support | Other | 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. |
|
| Change from Baseline at 18-months follow-up |
| caregiver's depression | depression measured by Geriatric Depression Scale (GDS) | Change from Baseline at 18-months follow-up |
| patient's quality of life | Quality of life measured by questionnaire Alzheimer Disease Related Quality of Life (ADRQL scale) | Change from Baseline at 18-months follow-up |
| patient's behavioral disorders | behavioral disorders measured by questionnaire Neuropsychiatric Index (NPI) | Change from Baseline at 18-months follow-up |
| patient's functional autonomy | functional autonomy measured by IADL scale (Instrumental Activities of Daily Living) | Change from Baseline at 18-months follow-up |
| Occurrence of medical consultation | number of medical consultation in patients and caregivers | Change from Baseline at 18-months follow-up |
| Occurrence of recourse to emergency service | occurrence of recourse to emergency service in patients and caregivers | Change from Baseline at 18-months follow-up |
| Occurrence of hospitalizations | number of hospitalization in patients and caregivers | Change from Baseline at 18-months follow-up |
| Occurrence of admission in institution | occurrence of admission in institution in patients | Change from Baseline at 18-months follow-up |
| France |
|
| Derived |
| Novais T, Moutet C, Delphin-Combe F, Dauphinot V, Colin C, Krolak-Salmon P, Mouchoux C; PHARMAID study group. PHARMAID study protocol: Randomized controlled trial to assess the impact of integrated pharmaceutical care at a psychosocial intervention on caregiver's burden in Alzheimer's disease or related diseases. Contemp Clin Trials. 2017 Feb;53:137-142. doi: 10.1016/j.cct.2016.12.020. Epub 2016 Dec 19. |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012046 | Rehabilitation |
| D013812 | Therapeutics |