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Evaluation of a pharmaceutical service for managing minor ailments

INDICA+PRO study: evaluation of a minor ailment service in community pharmacy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17235323
Enrollment
726
Registered
2021-05-07
Start date
2017-12-01
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

Minor ailments: dermatological problems (cold sore, foot fungi), gastrointestinal disturbance (diarrhoea, flatulence, heartburn or vomiting), pain (dysmenorrhea, headache, sore throat), upper respiratory tract (cough, cold or nasal congestion) Not Applicable

Interventions

Patients requesting a non-prescription medication (direct product request) or presenting minor ailments receive the Minor Ailment Service (MAS) or usual care (UC) and are followed up by telephone 10 d

Sponsors

Spanish Society of Community Pharmacy
Lead Sponsor
Pharmaceutical Association of Valencia
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients aged =16 years or over 2 years of age if they are accompanied by a responsible adult 2. Seeking care i.e. presenting symptoms or requesting a product (direct product request) for minor ailments. The minor ailments considered in the study are: dermatological problems (cold sore, foot fungi), gastrointestinal disturbance (diarrhoea, flatulence, heartburn or vomiting), pain (dysmenorrhea, headache, sore throat) and upper respiratory tract (cough, cold or nasal congestion)

Exclusion criteria

Exclusion criteria: 1. Patients younger than 16 years old not accompanied by a responsible adult 2. Third person different than the patient consulting in community pharmacy

Design outcomes

Primary

MeasureTime frame
Measured at the pharmacist–patient consultation, completed by the pharmacist: 1. Appropriate medical referral: patient referral by the pharmacist made in accordance with the designed protocols, calculated as the proportion of patients appropriately referred divided by the total number of patients. 2. Modification of direct product request: treatment requested by the patient modified by the pharmacist due to not approved indication of use for the minor ailment, wrong dose, dosage or formulation. The summary of product characteristics determined by the Spanish Agency was used as the standard.

Secondary

MeasureTime frame
1. Symptom resolution: relief of symptoms measured using a Likert scale from 1 “not at all” to 5 “completely” at 10-day telephone follow-up with interview conducted by the research group 2. Reconsultation rate for the same minor ailment, whenever the patient had to consult again for the same ailment 3. Health-related quality of life (HRQoL) measured using EuroQol 5D-5L (EQ-VAS) and Utility at pharmacist–patient consultation and at 10-day telephone follow-up 4. Cost-effectiveness: incremental cost-effectiveness ratio (ICER) of the service measured at pharmacist–patient consultation and at 10-day telephone follow-up

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 14, 2026