Pharmaceutical Care and Quality of Life in Conditions Related to Psychotropic Drug Use

University of Rijeka

Status: Active, not recruiting

Conditions: Mental Health Services

Treatments: Other: Common pharmacists' practice in Croatia.; Other: Pharmaceutical care in solving drug-related problems in subjects using psychotropic medicines based on standardized protocol..

Study type: Interventional

Funder types: Other

Identifiers

NCT06889636

200-07/2023-01/1_001/2023

Details and patient eligibility

About

This study aims to assess and describe the impact of pharmaceutical care on identified drug-related problems (DRPs) in subjects using psycholeptics and psychoanaleptics in primary care, improving subjects' self-assessed quality of life (QoL)

The hypothesis of the study are:

1. Side-effects are the most common DRPs in subjects using psychotropic medicines in primary care,
2. Treatment effectiveness and safety affect the subjects´ QoL

Full description

The study objectives are to:

1. assess QoL in subjects using psycholeptics and psychoanaleptics,
2. analyze identified DRPs and their causes in subjects using psycholeptics and psychoanaleptics
3. evaluate the correlation between the type and total number of DRPs identified in a single subject with QoL,
4. describe the impact of pharmacists´ intervention in the identification and resolution of the DRPs and their causes on subjects´ QoL.

Enrollment: 97 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult participants (years 18+)
• Usage of psycholeptic or psychoanaleptic medicines
• Residence in Istrian County (Croatia)

Exclusion criteria

• Minor participants
• Hospitalization during study participation
• Unable to live by themselves
• Unable to participate in study for 3 months

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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97 participants in 2 patient groups

Standardized pharmaceutical care

Experimental group

Description:

Participants in group A received pharmacists' interventions based on standardized Medication Review (MR) and Medication Therapy Management (MTM) protocols.

Treatment:

Other: Pharmaceutical care in solving drug-related problems in subjects using psychotropic medicines based on standardized protocol..

Basic counseling

Active Comparator group

Description:

Participants enrolled in group B received pharmaceutical care based on common pharmacist´s practice in Croatia.

Treatment:

Other: Common pharmacists' practice in Croatia.