NCT06059235

Brief 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, 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.

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
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 9, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2023

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

1.6 years

First QC Date

March 21, 2023

Last Update Submit

September 22, 2023

Conditions

Adherence, Medication

Keywords

pharmaceutical caregeriatricsconsultationmedication review

Outcome Measures

Primary Outcomes (1)

  • 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.

    6weeks

Secondary Outcomes (6)

  • count of barriers to adherence measured by TBC ASK-20 (Total Barrier Count)

    6weeks

  • quality of life measured with EQ5D (Visual analogical scale) score

    6weeks

  • number of inappropriate medications per patient according to STOPP/START

    6weeks

  • number of Drug-drug interactions per patient from the Anrys list

    6weeks

  • pain severity (from EQ-D)

    6weeks

  • +1 more secondary outcomes

Study Arms (2)

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

Other: pharmaceutical care

controle

NO INTERVENTION

Medication history (during assessment consultation) + usual care

Interventions

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

intervention

Eligibility Criteria

Age75 Years - 125 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • less than 75
  • not speaking French
  • exlusion based on geriatrician advice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

MeSH Terms

Conditions

Medication Adherence

Interventions

Pharmaceutical Services

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Health ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Olivia Dalleur, PhD

CONTACT

+3227642360olivia.dalleur@uclouvain.be

Fanny Vaillant, MPharm

CONTACT

+3227642360fanny.vaillant@uclouvain.be

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

March 21, 2023

First Posted

September 28, 2023

Study Start

January 9, 2023

Primary Completion

September 1, 2024

Study Completion

November 1, 2024

Last Updated

September 28, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)