Adherence, MedicationCOPAPI-GNCT06059235
Concordance : a New Concept for Clinical Pharmacy in Partnership With Patients at a Geriatric Day Clinic
A study testing pharmaceutical care in people with Adherence, Medication, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The goal of this clinical trial is to assess the impact of pharmaceutical consultations in older patients having a comprehensive geriatric assessment at geriatric day-clinic. The main question it aims to answer is: What is the impact on patient adherence Participants will benefit from medication history taking… Read more about this study
- Who is it for?
- Ages 75 to 125 years
- Conditions the study is for
- Adherence, Medication
- What is being tested?
- pharmaceutical care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Jan 2023to 1 Nov 2024
- 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 75 to 125 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 75+
- patients admitted to the geriatric day hospital for a geriatric assessment will be eligible for the project. A geriatric assessment comprises 2 consultations at the geriatric day hospital: a "major assessment" consultation, where the patient meets the members of the multidisciplinary team, and a "results" consultation, where the geriatrician provides the patient with care recommendations.
Who cannot join
- less than 75
- not speaking French
- exlusion based on geriatrician advice
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques universitaires Saint-Luc
Brussels, 1200
Gilard Isabelle, 0032 2 764 3559, copapig@saintluc.uclouvain.be
About this study
The goal of this clinical trial is to assess the impact of pharmaceutical consultations in older patients having a comprehensive geriatric assessment at geriatric day-clinic. The main question it aims to answer is: What is the impact on patient adherence Participants will benefit from medication history taking, medication review, therapeutic education, shared decision-making and follow-up phone call. Researchers will compare with a control group, benefiting from medication history taking and usual care from the geriatric day-clinic.
Read the detailed description
Research question: What is the impact of a clinical pharmacy activity (including a medication history, a medication review, therapeutic education, a shared decision step and a follow-up call) on medication adherence in elderly patients followed up for geriatric assessment at the geriatric day hospital? Design: Intervention study, randomized, controlled, open-label, with evaluation at 2 months. The study will run from January 1, 2023 to September 1, 2024 (20 months), at the CUSL geriatric day hospital.
Participants: patients admitted to the geriatric day hospital for a geriatric assessment will be eligible for the project. A geriatric assessment comprises 2 consultations at the geriatric day hospital: a "assessment" consultation, where the patient meets the members of the multidisciplinary team, and a "results" consultation, where the geriatrician provides the patient with care recommendations.
The general practitioners, pharmacists and nursing home referral nurse (if applicable) of the participants in the intervention group will be invited to take part in a satisfaction survey.
Intervention: The intervention includes several clinical pharmacy activities
- Medication history (during assessment consultation)
- Medication review and consultation with the geriatrician
- Therapeutic education (during results consultation)
- Shared decision-making (during results consultation)
- One-week follow-up call Control: usual care. Outcomes: primary: comparison at 1.5 months (telephone FUP) after outcome consultation of ASK-20 total Adherence Survey score (measures medication adherence and identifies barriers to adherence).
Secondary outcomes measured at 1.5 months:
- ASK-20 TBC measures
- EQ5D quality-of-life scores
- number of inappropriate medications according to STOPP\&START
- number of drug interactions DDI
- pain score
- hospital admissions during the FUP period Various indicators related to pharmaceutical activity will also be collected.
This project will serve as a rationale for the long-term development of a clinical pharmacy activity at the day hospital, and will help maintain CUSL's status as an innovator in clinical pharmacy.
- Conditions
- Adherence, Medication
- Being tested
- pharmaceutical care
- Keywords
- pharmaceutical care, geriatrics, consultation, medication review
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pharmaceutical careOther
consultation with a pharmacist performing advanced pharmaceutical care : Package of clinical pharmacy activities including :
Medication history (during assessment consultation) Medication review and consultation with the geriatrician Therapeutic education (during results consultation) Shared decision (at results consultation) One-week follow-up call + usual care
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Package of clinical pharmacy activities including :
* Medication history (during assessment consultation)
* Medication review and consultation with the geriatrician
* Therapeutic education (during results consultation)
* Shared decision (at results consultation)
* One-week follow-up call + usual care Receives: Other: pharmaceutical care |
| controle | No intervention | Medication history (during assessment consultation) + usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of barriers to adherence as measured by ASK-20 score (the sum of raw ASK-20 item scores)
ASK-20 (questionnaire) consists of 20 clinically actionable items representing multiple factors that affect medication adherence. Each of the 20 items score from 1 to 5. A score of 20 means low barriers to adherence; A score of 100 means maximum barriers to adherence. Comparizon of ASK-20 score from baseline to 6weeks in both arms. Hahn SR, Park J, Skinner EP, Yu-Isenberg KS, Weaver MB, Crawford B, Flowers PW. Development of the ASK-20 adherence barrier survey. Curr Med Res Opin. 2008 Jul;24(7):2127-38. doi: 10.1185/03007990802174769. Epub 2008 Jun 12. PMID: 18554431.
Measured: 6weeks
Secondary outcomes (6)
count of barriers to adherence measured by TBC ASK-20 (Total Barrier Count)
Each of the 20 items Of the ASK-20 (questionnaire) was dichotomized as positive - indicating a barrier, or negative. TBC counts the barriers per patient. Comparison of TBC from baseline to 6 weeks in both arms. Hahn SR, Park J, Skinner EP, Yu-Isenberg KS, Weaver MB, Crawford B, Flowers PW. Development of the ASK-20 adherence barrier survey. Curr Med Res Opin. 2008 Jul;24(7):2127-38. doi: 10.1185/03007990802174769. Epub 2008 Jun 12. PMID: 18554431.
Measured: 6weeks
quality of life measured with EQ5D (Visual analogical scale) score
Quality of life questionnaire. Comparison of estimated quality of life between baseline and 6 weeks in both arms
Measured: 6weeks
number of inappropriate medications per patient according to STOPP/START
Detection od potentially inappropriate medications (PIM) using STOPP\&START version 2 in medication treatment and comparison of number of PIM between baseline and 6 weeks in both arms
Measured: 6weeks
number of Drug-drug interactions per patient from the Anrys list
Comparison in both arms of drug-drug interactions detected at baseline and 6 weeks in medication treatment according to Anrys et al. Anrys P, Spinewine A. An International Consensus List of Potentially Clinically Significant Drug-Drug Interactions in Older People: Clinical Utility? J Am Med Dir Assoc. 2022 Mar;23(3):522. doi: 10.1016/j.jamda.2021.11.038. Epub 2022 Jan 10. PMID: 35026145.
Measured: 6weeks
pain severity (from EQ-D)
Comparison of pain reported in EQ5D questionnaire from baseline to 6 weeks in both groups
Measured: 6weeks
number of hospital admissions reported by patient
comparison of reported hospitalisations in both groups during the study period (questionnaire)
Measured: 6weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start9 Jan 2023
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adherence, MedicationStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059235
- Sponsor's protocol ID
- COPAPI-G
- Acronym
- COPAPI-G
- Status last verified
- Sep 2023
- First submitted
- 21 Mar 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concordance : a New Concept for Clinical Pharmacy in Partnership With Patients at a Geriatric Day Clinic
- ClinicalTrials.gov ID
- NCT06059235
- Acronym / sponsor ID
- COPAPI-G / COPAPI-G
- Conditions
- Adherence, Medication
- Keywords
- pharmaceutical care, geriatrics, consultation, medication review
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 28 Sep 2023 (actual)
- 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.
The goal of this clinical trial is to assess the impact of pharmaceutical consultations in older patients having a comprehensive geriatric assessment at geriatric day-clinic. The main question it aims to answer is: What is the impact on patient adherence Participants will benefit from medication history taking, medication review, therapeutic education, shared decision-making and follow-up phone call. Researchers will compare with a control group, benefiting from medication history taking and usual care from the geriatric day-clinic.
Detailed description
Research question: What is the impact of a clinical pharmacy activity (including a medication history, a medication review, therapeutic education, a shared decision step and a follow-up call) on medication adherence in elderly patients followed up for geriatric assessment at the geriatric day hospital? Design: Intervention study, randomized, controlled, open-label, with evaluation at 2 months. The study will run from January 1, 2023 to September 1, 2024 (20 months), at the CUSL geriatric day hospital.
Participants: patients admitted to the geriatric day hospital for a geriatric assessment will be eligible for the project. A geriatric assessment comprises 2 consultations at the geriatric day hospital: a "assessment" consultation, where the patient meets the members of the multidisciplinary team, and a "results" consultation, where the geriatrician provides the patient with care recommendations.
The general practitioners, pharmacists and nursing home referral nurse (if applicable) of the participants in the intervention group will be invited to take part in a satisfaction survey.
Intervention: The intervention includes several clinical pharmacy activities
- Medication history (during assessment consultation)
- Medication review and consultation with the geriatrician
- Therapeutic education (during results consultation)
- Shared decision-making (during results consultation)
- One-week follow-up call Control: usual care. Outcomes: primary: comparison at 1.5 months (telephone FUP) after outcome consultation of ASK-20 total Adherence Survey score (measures medication adherence and identifies barriers to adherence).
Secondary outcomes measured at 1.5 months:
- ASK-20 TBC measures
- EQ5D quality-of-life scores
- number of inappropriate medications according to STOPP\&START
- number of drug interactions DDI
- pain score
- hospital admissions during the FUP period Various indicators related to pharmaceutical activity will also be collected.
This project will serve as a rationale for the long-term development of a clinical pharmacy activity at the day hospital, and will help maintain CUSL's status as an innovator in clinical pharmacy.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Other: pharmaceutical carePackage of clinical pharmacy activities including : * Medication history (during assessment consultation) * Medication review and consultation with the geriatrician * Therapeutic education (during results consultation) * Shared decision (at results consultation) * One-week follow-up call + usual care |
| controle | No intervention | –Medication history (during assessment consultation) + usual care |
Who may qualify
- Ages
- 75 to 125 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 75+
- patients admitted to the geriatric day hospital for a geriatric assessment will be eligible for the project. A geriatric assessment comprises 2 consultations at the geriatric day hospital: a "major assessment" consultation, where the patient meets the members of the multidisciplinary team, and a "results" consultation, where the geriatrician provides the patient with care recommendations.
Key exclusion criteria (3 listed)
- less than 75
- not speaking French
- exlusion based on geriatrician advice
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 |
|---|---|---|
| pharmaceutical careconsultation with a pharmacist performing advanced pharmaceutical care : Package of clinical pharmacy activities including : Medication history (during assessment consultation) Medication review and consultation with the geriatrician Therapeutic education (during results consultation) Shared decision (at results consultation) One-week follow-up call + usual care | Other | intervention |
Primary outcome
presence of barriers to adherence as measured by ASK-20 score (the sum of raw ASK-20 item scores)
Time frame: 6weeks
ASK-20 (questionnaire) consists of 20 clinically actionable items representing multiple factors that affect medication adherence. Each of the 20 items score from 1 to 5. A score of 20 means low barriers to adherence; A score of 100 means maximum barriers to adherence. Comparizon of ASK-20 score from baseline to 6weeks in both arms. Hahn SR, Park J, Skinner EP, Yu-Isenberg KS, Weaver MB, Crawford B, Flowers PW. Development of the ASK-20 adherence barrier survey. Curr Med Res Opin. 2008 Jul;24(7):2127-38. doi: 10.1185/03007990802174769. Epub 2008 Jun 12. PMID: 18554431.
6 secondary outcomes
count of barriers to adherence measured by TBC ASK-20 (Total Barrier Count)
Time frame: 6weeks
quality of life measured with EQ5D (Visual analogical scale) score
Time frame: 6weeks
number of inappropriate medications per patient according to STOPP/START
Time frame: 6weeks
number of Drug-drug interactions per patient from the Anrys list
Time frame: 6weeks
pain severity (from EQ-D)
Time frame: 6weeks
number of hospital admissions reported by patient
Time frame: 6weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pharmaceutical care in people with Adherence, Medication, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 2 inclusion and 3 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 28 Sep 2023. 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 Belgium. 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 Olivia Dalleur, PhD (+3227642360, olivia.dalleur@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of barriers to adherence as measured by ASK-20 score (the sum of raw ASK-20 item scores) (time frame: 6weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2023.