Pharmaceutical Collaborative Care Integrated to a Multidisciplinary Psychosocial Program

Not Applicable

• Conditions: Alzheimer Disease
• Interventions: Behavioral: Psychosocial intervention; Other: Pharmaceutical care and psychosocial support

• Registration Number: NCT02802371
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-06-08
• Study First Submitted QC: 2016-06-13
• Study First Posted: 2016-06-16
• Study Start: 2016-08
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-09
• Last Update Posted: 2019-01-10
• Primary Completion: 2020-02
• Study Completion: 2020-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psychosocial intervention	Psychosocial intervention	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	Pharmaceutical care and psychosocial support	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
caregiver's quality of life	Change from Baseline at 18-months follow-up	Quality of life measured by questionnaire EUROQOL 5D
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)
patient's functional autonomy	Change from Baseline at 18-months follow-up	functional autonomy measured by IADL scale (Instrumental Activities of Daily Living)
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

Trial Locations

Locations (1)

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; 🇫🇷 Villeurbanne, France