An interventional study of Structured pharmacotherapy optimization and Usual Care in Older Adults (65 Years and Older), Polypharmacy (People Under Treatment With 5 or More Drugs) and Primary Health Care, sponsored by National Institute of Public Health, Clinical Epidemiology, and Toxicology-Lebanon (INSPECT-LB). Not yet recruiting at 1 site in Lebanon. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by National Institute of Public Health, Clinical Epidemiology, and Toxicology-Lebanon (INSPECT-LB) · Not applicable, Interventional, and Treatment
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:
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:
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.
Scientific rationale:
Polypharmacy and potentially inappropriate prescribing (PIP) are associated with adverse drug events, drug-drug interactions, prescribing cascades, falls and functional decline in older adults. PIP covers both the use of medications whose risks outweigh their benefits and the omission of clinically indicated therapies. The WHO Integrated Care for Older People (ICOPE) framework reorients geriatric care toward the preservation of intrinsic capacity (IC), defined as the composite of physical and mental capacities an individual can draw upon, across cognition, locomotion, vitality, psychological status and sensory function. Explicit criteria such as STOPP/START allow structured identification of inappropriate medications and prescribing omissions, while implicit approaches grounded in individualized clinical judgment allow decisions to be tailored to patient context and values. The effect of combining both approaches on IC has not been evaluated in a randomized design. In Lebanon, where a rapid demographic transition coincides with economic crisis and sustained pressure on the healthcare system, ICOPE has not been implemented in primary care, IC has not been systematically studied, and pharmacotherapy optimization is not routinely integrated into geriatric care.
Setting and recruitment strategy:
The trial is conducted in the primary health care centers (PHCCs) operated by the Order of Malta Lebanon and distributed across the Lebanese territory. The study is sponsored by the National Institute of Public Health, Clinical Epidemiology and Toxicology-Lebanon (INSPECT-LB), with the Centre Hospitalier Universitaire de Toulouse as collaborating institution.
Recruitment runs in parallel at all sites over a four-month period, which distributes the enrollment burden across centers. Recruitment targets are allocated in proportion to regional population density and center capacity, with larger numbers drawn from the largest centers. Participants are identified on site during routine visits by trained PHCC staff, mainly pharmacists and triage nurses; no telephone-based or remote recruitment is conducted. Eligible individuals are long-standing beneficiaries of their center who attend regularly for medical services including monthly medication refills, which provides repeated and predictable contact points for screening without requiring an additional visit. In 2025, the participating centers served approximately 14,000 unique beneficiaries aged 65 years and over. Screening logs are reviewed per center on a bi-weekly basis by the principal investigator and the co-investigator to monitor recruitment progress.
Assessment schedule:
Data are collected prospectively at the PHCC through face-to-face interviews conducted by trained staff using a standardized questionnaire. The full assessment is administered at baseline (T0) and at six months (T6). At baseline, the following set of information is obtained to capture functional, sociodemographic and clinical characteristics.
Functional status is assessed using the Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) scales. These serve both as baseline measures and as eligibility confirmation, ensuring that participants are functionally independent; individuals who do not meet the threshold are not included.
Sociodemographic and center-related data include the geographic location of the center, source of referral and duration of attendance, together with age, sex, educational level, marital status, number of children where applicable, living arrangements, caregiver status, breadwinner status, place of residence (urban or rural), household crowding index, housing ownership, employment status and healthcare coverage.
Lifestyle characteristics and clinical parameters are assessed at T0 and T6 and encompass physical activity, sleep duration, sedentary behavior, caffeine intake, smoking, alcohol consumption, vital signs (heart rate, oxygen saturation, systolic and diastolic blood pressure), laboratory results and chronic diseases.
Frailty and sarcopenia are assessed at T0 and T6 using the Fried frailty phenotype and the SARC-F screening tool. Although these measures are typically part of the Step 2 mobility assessment within the ICOPE framework, they are administered to all participants at baseline following Step 1 basic assessment, to ensure comprehensive characterization of functional status.
Medication-related variables at baseline include the number of prescribed chronic medications, the total daily pill burden, a detailed medication list, and medication adherence assessed with the Lebanese Medication Adherence Scale adapted for the Primary Health Care setting (LMAS-PHC). Potentially inappropriate prescriptions (PIPs) are identified in all participants at baseline and at six months using the STOPP/START version 3 explicit criteria and an implicit approach. Throughout the six-month follow-up, the pharmacist updates the medication list at each monthly in-person refill visit, alongside routine counselling and education, and documents any medication change with its reason and any reported adverse event. Adherence is re-assessed with the LMAS-PHC at six months.
Quality of life is evaluated at T0 and T6 with the WHO Quality of Life-OLD brief instrument. Social determinants of health are assessed at the same timepoints using the Socioeconomic Status for Primary Healthcare (SES-PHC) scale, the Steps to Better Health Questionnaire (STBH-Q), the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being scale (FACIT-Sp-12, version 4), the UCLA Loneliness Scale (ULS-8, version 3) and the European Health Literacy Survey Questionnaire (HLS-EU-Q16).
For data elements that are clinically documented rather than self-reported, such as vital signs, laboratory results, chronic diseases and current medication lists, information may be retrieved from PHENICS, the health information system deployed by the Lebanese Ministry of Public Health across all PHCCs. This minimizes interview burden while ensuring the accuracy and completeness of routinely recorded clinical data.
Implementation of the ICOPE framework:
The ICOPE framework is implemented following a real-life approach. Step 1 basic assessment (screening) is systematically performed for all participants across the intrinsic capacity domains defined by WHO: cognition, locomotion, vitality, vision, hearing and psychological status, with vision and hearing forming the sensory domain at the scoring stage. Basic assessment enables early detection of functional decline and supports the assessment of overall intrinsic capacity. It is administered at baseline, at three months (T3) and at six months. The T3 assessment is limited to Step 1; it provides three IC measurements per participant, supports the estimation of individual trajectories, and limits the impact of loss to follow-up before T6.
Step 2 in-depth assessments, using validated tools, are conducted at baseline and at six months, in line with WHO recommendations for biannual evaluation. They are performed selectively, for the domains concerned, and are initiated only after Step 1 alerts have been reviewed and appropriately managed, in order to confirm suspected impairment or screening-detected decline in the corresponding domain. Participants screened abnormal in one or two domains undergo a Step 2 assessment targeted to those domains, while a comprehensive Step 2 evaluation across all domains is undertaken when impairment is identified in at least three domains.
Sample size justification:
The sample size was estimated for the primary outcome, IC. In the absence of published data in a comparable population, assumptions were derived from preliminary unpublished data from the ongoing INSPIRE study at CHU de Toulouse, France, in which participants aged 65 years and over had a mean IC score of 79.27 (SD 9.47; n = 549), with greater dispersion among those taking five or more medications. A between-group difference of 2.5 IC points (79.0 versus 81.5) was considered clinically plausible, and a conservative standard deviation of 9 points was retained to avoid underestimating variability in an older polymedicated population. With a two-sided alpha of 0.05, 80% power and 1:1 allocation, 203 participants per group were required. To account for an anticipated 10% rate of loss to follow-up, withdrawal of consent and missing primary-outcome data, this figure was inflated by dividing by (1 - 0.10), giving 226 participants per group.
A second, independent estimation was performed to verify the adequacy of this figure under the planned adjusted analysis. Using G*Power (version 3.1.9.7), a multiple linear regression model (fixed model, R² increase) was applied to detect the effect of the pharmacotherapy optimization intervention on IC improvement with adjustment for baseline characteristics. Parameters were set as follows: a small anticipated effect size (f² = 0.02), a two-tailed alpha of 0.05, a power of 0.80, one tested predictor (the intervention) and 30 total predictors accounting for potential confounders, including age, sex, number of medications, comorbidities and baseline intrinsic capacity measures. Under these assumptions, a minimum of 395 participants was required, corresponding to 439 participants after the same 10% inflation.
The two approaches therefore converged on a comparable magnitude, and the larger, more conservative estimate of 452 participants (226 per group) was retained as the recruitment target; at this sample size, the adjusted regression model attains a statistical power of 0.85, providing an additional margin for the multivariable analysis.
Statistical analysis:
Analyses will be performed using SPSS and R, with a two-sided alpha of 0.05 and 95% confidence intervals. Baseline characteristics will be described overall and by arm, without significance testing of between-arm differences. Analyses follow the intention-to-treat principle: all randomized participants from both arms will be analyzed in the group to which they were allocated.
The IC score is the additive ICOPE Step 1 composite score. Each domain is rescaled to 0-100 using the percentage of maximum possible method, and the score is the arithmetic mean of five domains: cognition, locomotion, vitality, sensory capacity (vision and hearing averaged) and psychological status. Step 2 data are not used in the derivation of this score.
The intervention effect on IC will be estimated using a linear mixed-effects model including group, time (T0, T3 and T6) and the group-by-time interaction as fixed effects, participant-specific random intercepts and, if supported by model fit, random slopes for time, adjusted for relevant baseline covariates. The distribution of IC scores by arm will be described in relation to published French age- and sex-specific reference centiles and to preliminary Lebanese centiles. Continuous secondary outcomes will be analyzed using the same mixed-effects approach.
Baseline PIPs, identified with the STOPP/START version 3 criteria and an implicit approach, will be described by number and type for the full baseline sample and by arm, with correlates examined using multivariable logistic regression for the presence of at least one PIP and multivariable linear regression for the number of PIPs per participant. The effect of the intervention on the number of PIPs per participant between baseline and six months will be estimated using the same mixed-effects approach.
No imputation will be performed. Baseline covariates are collected in full, and the likelihood-based mixed-effects models use all available observations under a missing-at-random assumption. Step 2 data not indicated by Step 1 basic assessment are structurally absent by design and are not treated as missing.
Exploratory analyses, conducted where data permit and considered hypothesis-generating, include a bifactor confirmatory factor analysis to derive a latent IC score, retained only if model fit and factor-score reliability are acceptable; preliminary Lebanese age- and sex-specific IC centile curves generated with GAMLSS; IC centile transitions between baseline and six months by arm; time from randomization to first medication change analyzed with Cox proportional hazards regression; psychometric evaluation of the study scales; and domain-level analyses of Step 2 data restricted to participants with impairment identified at basic assessment.
Safety monitoring and trial conduct:
A data monitoring committee of four members, independent of the sponsor, the collaborating institution, the host institution and the funders, reviews the monthly medication review records throughout the trial and meets monthly from the initiation of data collection. No interim analysis is planned, given the six-month follow-up and the profile of the intervention, which involves no novel molecule, no experimental treatment, no placebo and no withholding of indicated care, and in which all prescribing decisions remain the responsibility of the treating physician. Site pharmacists report adverse events to the principal investigator within 24 hours of identification; serious adverse events are reported to the ethics committee in accordance with its requirements. Site visits to the participating centers are conducted every one to two months to verify data quality and protocol compliance; the interval may be extended where road safety or security conditions temporarily prevent travel.
This is the only study on the registry with National Institute of Public Health, Clinical Epidemiology, and Toxicology-Lebanon (INSPECT-LB) as lead sponsor.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Nov 6, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Intervention-group participants at each Order of Malta Lebanon primary health care center (PHCC) will undergo structured pharmacotherapy optimization using the STOPP/START explicit criteria and the implicit prescribing approach, supervised by the research team with support from an expert panel in clinical pharmacy and geriatric pharmacotherapy. Patient cases will be reviewed in weekly meetings between researchers, PHCC pharmacists, and treating physicians, where identified prescribing issues and proposed optimization strategies will be discussed. Final prescribing decisions will remain with the treating physician and his/her clinical judgement, who, after discussing the agreed changes with the patient at the next monthly medication-refill visit, will amend the prescription as clinically appropriate and update it in the health information system. The pharmacist will then provide the participant with the updated medication list and individualized education on the optimized regimen.
Other: Structured pharmacotherapy optimization
Control-group participants will receive usual care at the participating Order of Malta Lebanon primary health care centers, without the structured pharmacotherapy optimization based on the STOPP/START criteria and the implicit prescribing approach. Usual care comprises multidisciplinary medication reconciliation, routine medication management, patient education and counseling, and dispensing.
Other: Usual Care
A 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.
Participants receive the usual multidisciplinary medication reconciliation provided at the participating primary health care centers (applied to all patients of all ages and not specifically based on the explicit criteria and implicit approach for older patients).
Change in intrinsic capacity composite score
Intrinsic capacity is measured as the composite score derived from the five WHO ICOPE domains in Step 1 basic assessment, analyzed as change from baseline (T0) to six months post-randomization (T6), and summarized as the adjusted between-group mean difference. Intrinsic capacity is also assessed at three months (T3), and all three time points are included in the longitudinal analysis. 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.
Time frame: Baseline, 3 months, and 6 months post-randomization
Change in the number of potentially inappropriate prescriptions per participant
Potentially inappropriate prescriptions (PIPs) are identified in all participants using the STOPP/START version 3 explicit criteria combined with an implicit prescribing approach. The outcome is the change in the number of PIPs per participant from baseline to six months, summarized as the adjusted between-group mean difference, together with the distribution of PIPs by type in each arm. As prescriptions in the control group may also be modified during follow-up as part of usual care, PIPs are reassessed at six months in both groups. Baseline PIPs are additionally described for the full sample and by arm.
Time frame: Baseline and 6 months post-randomization
Change in quality of life (WHOQOL-OLD, brief format)
The change in 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.
Time frame: Baseline and 6 months post-randomization
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.
Time frame: Baseline and 6 months post-randomization
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.
Time frame: Baseline and 6 months post-randomization
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.
Time frame: Baseline and 6 months post-randomization
Change in loneliness (UCLA Loneliness Scale, ULS-8, version 3)
The Change in loneliness (UCLA Loneliness Scale, ULS-8, version 3) is analyzed as change from baseline to six months, summarized as the adjusted between-group mean difference. The UCLA score ranges between 8 and 32.
Time frame: Baseline and 6 months post-randomization
Change in health literacy (HLS-EU-Q16)
The Change in health literacy (HLS-EU-Q16) is analyzed as change from baseline to six months, summarized as the adjusted between-group mean difference. The HLS score ranges between 0 and 16.
Time frame: Baseline and 6 months post-randomization
Change in frailty status (Fried frailty phenotype)
The Change in frailty status (Fried frailty phenotype) is analyzed as change from baseline to six months, summarized as the adjusted between-group mean difference. The Fried frailty score ranges between 0 and 5 criteria.
Time frame: Baseline and 6 months post-randomization
Change in sarcopenia screening score (SARC-F)
The Change in sarcopenia screening score (SARC-F) is analyzed as change from baseline to six months, summarized as the adjusted between-group mean difference. The SARC-F score ranges between 0 and 10.
Time frame: Baseline and 6 months post-randomization
Change in medication adherence (LMAS-PHC)
The Change in medication adherence (LMAS-PHC) is analyzed as change from baseline to six months, summarized as the adjusted between-group mean difference. LMAS score ranges between 0 and 66.
Time frame: Baseline and 6 months post-randomization
Proportion of participants with at least one reported adverse event
Adverse events reported by participants and documented by the pharmacist at each monthly in-person medication refill visit, analyzed as event occurrence over the follow-up period and summarized as proportions by arm.
Time frame: Randomization through six months
Proportion of participants with at least one change in medication prescription
Any medication discontinuation, dose adjustment, therapeutic substitution or initiation documented by the pharmacist at each monthly in-person refill visit, with its reason; summarized as proportions by arm.
Time frame: Randomization through six months
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.