Clinical trial NCT02802371: Pharmaceutical Collaborative Care Integrated to a Multidisciplinary Psychosocial Program
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer Disease
Keywords: caregiver burden
Alzheimer disease and related disorders
elderly
pharmaceutical care
optimization of drug prescribing
psychosocial intervention
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-06-16
Enrollment: 240
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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.

Primary outcomes:
measure: caregiver's burden
timeFrame: Change from Baseline at 18-months follow-up
Secondary outcomes:
measure: caregiver's quality of life
timeFrame: Change from Baseline at 18-months follow-up
measure: caregiver's anxiety
timeFrame: Change from Baseline at 18-months follow-up
measure: caregiver's depression
timeFrame: Change from Baseline at 18-months follow-up
measure: patient's quality of life
timeFrame: Change from Baseline at 18-months follow-up
measure: patient's behavioral disorders
timeFrame: Change from Baseline at 18-months follow-up
measure: patient's functional autonomy
timeFrame: Change from Baseline at 18-months follow-up
measure: Occurrence of medical consultation
timeFrame: Change from Baseline at 18-months follow-up
measure: Occurrence of recourse to emergency service
timeFrame: Change from Baseline at 18-months follow-up
measure: Occurrence of hospitalizations
timeFrame: Change from Baseline at 18-months follow-up
measure: Occurrence of admission in institution
timeFrame: Change from Baseline at 18-months follow-up
Other outcomes:
Locations:
city: Villeurbanne
country: France
facility: 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
Study officials:
affiliation: 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.
name: Christelle Mouchoux, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.