About this trial
Why are the researchers doing this study? Many older adults take five or more medicines every day. Some of these medicines may no longer help them. Some may even cause harm, such as falls, confusion or tiredness. At the same time, a medicine the person needs may be missing.
The researchers want to find out whether a careful review of a person's medicines helps older adults stay well. They will look at intrinsic capacity. This means the physical and mental abilities a person can draw on: memory and thinking, walking and moving, eating well, mood, eyesight and hearing. They will also look at quality of life, daily life, health and social conditions.
This kind of study has not been done before in primary health care centers in Lebanon.
Who can take part?
You may be able to join if you:
* are 65 years old or older * have been a patient at one of the health centers for at least one year * take five or more medicines for long-term health problems * can carry out your daily activities on your own What will happen in the study? About 452 people will join at the primary health care centers of the Order of Malta Lebanon.
A computer will place each person in one of two groups, by chance, like the toss of a coin. About half (226 people) will be in each group:
* In the first group, a pharmacist will go through all of the person's medicines. The pharmacist will use tools made for checking medicines in older people. The pharmacist will then send suggestions to the person's doctor. The doctor decides what to change. No medicine is changed without the doctor's agreement. * In the second group, people will keep taking the medicines their doctor already prescribed. These medicines are checked in the usual way, which is the same for all patients. They are not checked with tools made for older people.
The study does not test any new or experimental medicine. Every month, when the person comes to pick up their medicines, the pharmacist will check the medicine list. The pharmacist will write down any change and any problem the person reports.
The researchers will check the person's abilities three times: at the start, after three months, and after six months. They will also ask about quality of life, health and social conditions at the start and after six months.
Each person takes part for six months. What are the possible risks and benefits? In both groups, a person's medicines may change during the study. A medicine may be added, stopped or replaced after a review.
Medicines can cause new problems, such as side effects. This can happen with a new medicine. It can also happen with a medicine the person has taken for a long time. The pharmacist asks about such problems every month. Any change to a person's medicines is decided by their own doctor, as in normal care.
People in the study may or may not feel better. The researchers hope the results will help care for older people in Lebanon and in other countries.
What happens after the study? People in both groups keep receiving the usual care of their health center. Taking part does not change a person's right to care. Joining is a free choice. A person can stop at any time, and their care will not change.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Lebanese patients
Older patients ≥ 65 years of age
Diagnosed and treated for at least two chronic diseases*
Resorting to an OML PHCC and benefiting from chronic medication dispensing services for at least one year
Disqualifiers
Non-Lebanese patients
Patients < 65 years of age
Patients diagnosed with only one chronic disease
Beneficiaries newly registered in the PHCC
Trial design
Parallel
Treatments tested in this trial
Structured pharmacotherapy optimization
Other interventionA structured medication-review and optimization intervention based on STOPP/START explicit criteria, an implicit medication-review approach, and clinical judgment. Medication-related problems and potential optimization strategies are reviewed with the research team and treating physicians. Final prescribing decisions remain the responsibility of the treating physician. Pharmacists subsequently provide participants with medication-related education and updated medication lists during monthly refill visits.
Usual Care
Other interventionParticipants receive the usual multidisciplinary medication reconciliation provided at the participating primary healthcare centers (applied to all patients of all ages and not specifically based on the explicit criteria and implicit approach for older patients).
Treatment groups
Trial outcomes
Primary outcomes
Change in intrinsic capacity composite score
Intrinsic capacity is measured as the composite score derived from the five WHO ICOPE domains in Step 1 screening, analyzed as change from baseline (T0) to six months post-randomization (T6), and summarized as the adjusted between-group mean difference. Distribution of intrinsic capacity scores across centile categories. Participants will also be positioned on French age- and sex-specific intrinsic capacity reference centiles and on preliminary Lebanese centiles. Transitions across centile categories between baseline and six months are compared between arms.
Number of potentially inappropriate prescriptions per participant at baseline
Potentially inappropriate prescriptions (PIPs) are identified using the STOPP/START version 3 explicit criteria combined with an implicit prescribing approach. The outcome is the number of PIPs per participant, reported as the mean number per participant and the distribution of PIPs by type. As this outcome is measured before randomization, it is descriptive and is reported for the full baseline sample and by arm.
Secondary outcomes
Change in health-related quality of life (WHOQOL-OLD, brief format)
The change in health-related QOL is analyzed as change from baseline to six months, summarized as the adjusted between-group mean difference. The WHOQOL score ranges between 24 and 120.
Change in socioeconomic status (SES-PHC scale)
The change in SES-PHC scale is analyzed as change from baseline to six months, summarized as the adjusted between-group mean difference. The score ranges between 7 and 29.
Change in score on the Steps to Better Health Questionnaire (STBH-Q)
The change in score on the Steps to Better Health Questionnaire (STBH-Q) is analyzed as change from baseline to six months, summarized as the adjusted between-group mean difference. Score of the STBH-Q ranges between 0 and 152.
Change in spiritual well-being (FACIT-Sp-12, version 4)
The Change in spiritual well-being (FACIT-Sp-12, version 4) is analyzed as change from baseline to six months, summarized as the adjusted between-group mean difference. The FACIT score ranges between 0 and 48.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
National Institute of Public Health, Clinical Epidemiology, and Toxicology-Lebanon (INSPECT-LB)
Lead sponsor
University Hospital, Toulouse
Collaborator
This trial is not recruiting at the moment. You can still explore other options: