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Collaborative deprescribing intervention of Proton-Pump Inhibitors among community-dwelling older adults: The C-SENIoR trial

Effectiveness and cost-effectiveness of a Collaborative deprescribing intervention of Proton-pump-inhibitors on community-dwelling older adults: Protocol for the C-SENIoR, a pragmatic non-randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN49637686
Enrollment
222
Registered
2023-06-14
Start date
2023-04-28
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overprescribing of proton-pump inhibitors Other

Interventions

The intervention is a collaborative care pathway, between community pharmacists and general practitioners aimed at deprescribing inappropriate PPI use and addressing other drug-related problems such a

Sponsors

National Association of Pharmacies
Lead Sponsor
Unidade Local de Saúde do Alto MInho
Collaborator

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Community-dwelling older adults, aged 65 years old or over 2. Continuous use for more than 8 weeks of any PPI (ATC/WHO A02BC– esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole) 3. Registered at the selected Family Health Units 4. Access to a telephone

Exclusion criteria

Exclusion criteria: 1. Live in nursing homes or assisted-living facilities 2. Unable to communicate or speak in Portuguese 3. Have any cognitive impairment or any other condition that does not allow them to understand the study objectives or the questionnaire completion as perceived by the pharmacist.

Design outcomes

Primary

MeasureTime frame
Successful discontinuation or dose decrease of any PPIs, defined as a statistically significant reduction in medication use between the intervention and control groups at 3- and 6-month follow-up. Analysis of PPI use will be conducted using pharmacy medicine sales data linked to the patients’ tax information number and confirmed through telephone interviews with the patients.

Secondary

MeasureTime frame
1. Patients’ beliefs about PPI, measured by the Beliefs about Medicines Questionnaire (BMQ-specific) at baseline and 3-month follow-up. 2. Time until withdrawal since recruitment. Other measurements at baseline and 6-month follow-up: 3. Number of long-term medications and proportion of patients on polypharmacy (patients with 5 or more medicines). 4. Health-related quality of life, assessed using the five-level version of the European Quality of Life-5 Dimensions questionnaire (EQ-5D-5L instrument). 5. Self-reported adherence measured by the 7 items Measure Treatment Adherence questionnaire (MTA) 6. Number and degree of severity of DDIs identified by the dispensing software. 7. Adverse drug events, that is the absolute and relative counts of self-reported adverse drug events and type of events experienced by patients (e.g., needed professional support). 8. Healthcare resource utilization and costs (for the economic evaluation study) 9. For the intervention group - Satisfaction with the collaborative intervention (general and health professional related) is to be assessed only at the 6-month follow-up. Process outcomes, such as the number of patients with a medical appointment and the number of pharmacist telephone follow-ups, will be collected ongoing to assess the fidelity and quality of the collaborative intervention

Countries

Portugal

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026