Alzheimer DiseasePHARMAIDNCT02802371
Pharmaceutical Collaborative Care Integrated to a Multidisciplinary Psychosocial Program
A study testing Psychosocial intervention and Pharmaceutical care and psychosocial support in people with Alzheimer Disease, run by Hospices Civils de Lyon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Psychosocial intervention and Pharmaceutical care and psychosocial support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2016to Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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;
Show all 14Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- 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
Villeurbanne, 69100
Teddy Novais, PharmD, PhD student, (0)4 72 43 20 66 ext. +33, teddy.novais@chu-lyon.fr
Christelle Mouchoux, PharmD, PhD, (0)4 72 43 20 65 ext. +33, Christelle.mouchoux@chu-lyon.fr
About this study
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
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.
- Conditions
- Alzheimer Disease
- Being tested
- Psychosocial intervention, Pharmaceutical care and psychosocial support
- Keywords
- caregiver burden, Alzheimer disease and related disorders, elderly, pharmaceutical care, optimization of drug prescribing, psychosocial intervention
- Medical subject headings
- Alzheimer Disease, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial interventionBehavioural
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Pharmaceutical care and psychosocial support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline at 18-months follow-up
Secondary outcomes (10)
caregiver's quality of life
Quality of life measured by questionnaire EUROQOL 5D
Measured: Change from Baseline at 18-months follow-up
caregiver's anxiety
anxiety measured by scale HARD
Measured: Change from Baseline at 18-months follow-up
caregiver's depression
depression measured by Geriatric Depression Scale (GDS)
Measured: Change from Baseline at 18-months follow-up
patient's quality of life
Quality of life measured by questionnaire Alzheimer Disease Related Quality of Life (ADRQL scale)
Measured: Change from Baseline at 18-months follow-up
patient's behavioral disorders
behavioral disorders measured by questionnaire Neuropsychiatric Index (NPI)
Measured: Change from Baseline at 18-months follow-up
patient's functional autonomy
functional autonomy measured by IADL scale (Instrumental Activities of Daily Living)
Measured: Change from Baseline at 18-months follow-up
Occurrence of medical consultation
number of medical consultation in patients and caregivers
Measured: Change from Baseline at 18-months follow-up
Occurrence of recourse to emergency service
occurrence of recourse to emergency service in patients and caregivers
Measured: Change from Baseline at 18-months follow-up
Occurrence of hospitalizations
number of hospitalization in patients and caregivers
Measured: Change from Baseline at 18-months follow-up
Occurrence of admission in institution
occurrence of admission in institution in patients
Measured: Change from Baseline at 18-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startAug 2016
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christelle Mouchoux, PharmD, PhD, Principal investigator, 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.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02802371
- Sponsor's protocol ID
- 69HCL14_0450
- Acronym
- PHARMAID
- Status last verified
- Jan 2019
- First submitted
- 8 Jun 2016
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 37397433Novais 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.
PubMed 28007635
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02802371
- Acronym / sponsor ID
- PHARMAID / 69HCL14_0450
- Conditions
- Alzheimer Disease
- Keywords
- caregiver burden, Alzheimer disease and related disorders, elderly, pharmaceutical care, optimization of drug prescribing, psychosocial intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 16 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Psychosocial interventionPsychosocial 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 | Experimental | Other: Pharmaceutical care and psychosocial supportPharmaceutical 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (14 listed)
- 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;
Key exclusion criteria (5 listed)
- Institutionalized patients.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychosocial interventionCaregivers 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. | Behavioural | Psychosocial intervention |
| Pharmaceutical care and psychosocial supportCaregivers 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. | Other | Pharmaceutical care and psychosocial support |
Primary outcome
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.
10 secondary outcomes
caregiver's quality of life
Time frame: Change from Baseline at 18-months follow-up
caregiver's anxiety
Time frame: Change from Baseline at 18-months follow-up
caregiver's depression
Time frame: Change from Baseline at 18-months follow-up
patient's quality of life
Time frame: Change from Baseline at 18-months follow-up
patient's behavioral disorders
Time frame: Change from Baseline at 18-months follow-up
patient's functional autonomy
Time frame: Change from Baseline at 18-months follow-up
Occurrence of medical consultation
Time frame: 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 hospitalizations
Time frame: Change from Baseline at 18-months follow-up
Occurrence of admission in institution
Time frame: Change from Baseline at 18-months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
- Derived from this study: PubMed 37397433Novais 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.
- Derived from this study: PubMed 28007635Novais 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christelle Mouchoux, PharmD, PhD principal investigator
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychosocial intervention and Pharmaceutical care and psychosocial support in people with Alzheimer Disease, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Teddy Novais, PharmD, PhD student ((0)4 72 43 20 66 ext. +33, teddy.novais@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
caregiver's burden (time frame: Change from Baseline at 18-months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02802371, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2019.