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NCT Number: NCT06889636

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Mental Health Services Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pharmacy Bobanovic Vujnovic Pula

Pula, 52100, Croatia

About this study

The study objectives are to:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

Pharmacists' interventions were based on Medication Review and Medication Therapy Management evaluations of a subjects' pharmacotherapy to optimize medicine use, improve treatment outcomes and quality of life. The intervention involved the identification of drug-related problems and addressing these issues through pharmacist interventions. The intervention was based on information gathered from the subjects and a list of medicines in use.

Common pharmacists' practice in Croatia.

Other

Group B participants received pharmaceutical care based on common pharmacists' practice in Croatia during the dispensing of psychotropic drugs.

Primary outcomes

  1. Assessment of the quality of life in subjects using psycholeptics and psychoanaleptics

    Time frame: Prior and after the pharmacists' intervention during three months period.

    A short version of the World Health Organization's quality of life questionnaire (WHOQOL-BREF questionnaire) is being used to assess subjects' QoL. The scale range is from 0 to 100. A higher score number indicates better QoL.

Secondary outcomes

  1. Analysis of identified drug-related problems

    Time frame: During period of three months.

    To analyze the type of DRPs, validated Classification for Drug-Related Problems from the Pharmaceutical Care Network Europe Association, version 9.1 has been used. PCNE Classification for DRPs describes each type of DRP by unique code.

Sponsors and collaborators

Lead sponsor

University of Rijeka

Other

Registry information

Official study title

Assessment of the Impact of Pharmaceutical Care on the Quality of Life in Conditions Related to Psychotropic Drug Use and Evaluation of the Intervention

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Mar 21, 2025
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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