NCT02802371

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable alzheimer-disease

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 16, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

January 10, 2019

Status Verified

January 1, 2019

Enrollment Period

3.5 years

First QC Date

June 8, 2016

Last Update Submit

January 9, 2019

Conditions

Alzheimer Disease

Keywords

caregiver burdenAlzheimer disease and related disorderselderlypharmaceutical careoptimization of drug prescribingpsychosocial intervention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • caregiver's quality of life

    Change from Baseline at 18-months follow-up

  • caregiver's anxiety

    Change from Baseline at 18-months follow-up

  • caregiver's depression

    Change from Baseline at 18-months follow-up

  • patient's quality of life

    Change from Baseline at 18-months follow-up

  • patient's behavioral disorders

    Change from Baseline at 18-months follow-up

  • +5 more secondary outcomes

Study Arms (3)

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.

Behavioral: Psychosocial intervention

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.

Other: Pharmaceutical care and psychosocial support

Interventions

Psychosocial interventionBEHAVIORAL

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.

Psychosocial intervention
Pharmaceutical care and psychosocial supportOTHER

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.

Pharmaceutical care and psychosocial support

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (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, 69100, France

RECRUITING

Related Publications (2)

  • 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.

    PMID: 37397433DERIVED

  • 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.

    PMID: 28007635DERIVED

MeSH Terms

Conditions

Alzheimer DiseaseCaregiver Burden

Interventions

Psychosocial InterventionPharmaceutical ServicesPsychiatric Rehabilitation

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersStress, PsychologicalBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and ServicesRehabilitationTherapeutics

Study Officials

  • 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

Central Study Contacts

Teddy Novais, PharmD, PhD student

CONTACT

(0)4 72 43 20 66teddy.novais@chu-lyon.fr

Christelle Mouchoux, PharmD, PhD

CONTACT

(0)4 72 43 20 65Christelle.mouchoux@chu-lyon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2016

First Posted

June 16, 2016

Study Start

August 1, 2016

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

January 10, 2019

Record last verified: 2019-01

Locations

FR(1)