Pharmaceutical Collaborative Care Integrated to a Multidisciplinary Psychosocial Program (PHARMAID)

January 9, 2019 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Villeurbanne, France, 69100
        • Recruiting
        • 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
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
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.
Active Comparator: 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.
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.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
caregiver's burden
Time Frame: 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.
Change from Baseline at 18-months follow-up

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: 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.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Anticipated)

February 1, 2020

Study Completion (Anticipated)

February 1, 2020

Study Registration Dates

First Submitted

June 8, 2016

First Submitted That Met QC Criteria

June 13, 2016

First Posted (Estimate)

June 16, 2016

Study Record Updates

Last Update Posted (Actual)

January 10, 2019

Last Update Submitted That Met QC Criteria

January 9, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL14_0450

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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