Pharmaceutical Collaborative Care Integrated to a Multidisciplinary Psychosocial Program

Alzheimer Disease Clinical Trial

— PHARMAID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02802371
• Other study ID #: 69HCL14_0450
• Status: Recruiting
• Phase: N/A
• Start date: August 2016
• Est. completion date: February 2020

Study information

• Verified date: January 2019
• Source: Hospices Civils de Lyon
• Contact: Teddy Novais, PharmD, PhD student
• Phone: (0)4 72 43 20 66
• Email: teddy.novais[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Behavioral:
• Psychosocial 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.

Other:
• Pharmaceutical 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.

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	caregiver's quality of life	Quality of life measured by questionnaire EUROQOL 5D	Change from Baseline at 18-months follow-up
Secondary	caregiver's anxiety	anxiety measured by scale HARD	Change from Baseline at 18-months follow-up
Secondary	caregiver's depression	depression measured by Geriatric Depression Scale (GDS)	Change from Baseline at 18-months follow-up
Secondary	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
Secondary	patient's behavioral disorders	behavioral disorders measured by questionnaire Neuropsychiatric Index (NPI)	Change from Baseline at 18-months follow-up
Secondary	patient's functional autonomy	functional autonomy measured by IADL scale (Instrumental Activities of Daily Living)	Change from Baseline at 18-months follow-up
Secondary	Occurrence of medical consultation	number of medical consultation in patients and caregivers	Change from Baseline at 18-months follow-up
Secondary	Occurrence of recourse to emergency service	occurrence of recourse to emergency service in patients and caregivers	Change from Baseline at 18-months follow-up
Secondary	Occurrence of hospitalizations	number of hospitalization in patients and caregivers	Change from Baseline at 18-months follow-up
Secondary	Occurrence of admission in institution	occurrence of admission in institution in patients	Change from Baseline at 18-months follow-up