Mental Health ServicesNCT06889636
Pharmaceutical Care and Quality of Life in Conditions Related to Psychotropic Drug Use
A study testing Pharmaceutical care in solving drug-related problems in subjects using psychotropic medicines based on standardized protocol.. and Common pharmacists' practice in Croatia. in people with Mental Health Services, run by University of Rijeka at 1 site in Croatia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health Services
- What is being tested?
- Pharmaceutical care in solving drug-related problems in subjects using psychotropic medicines based on standardized protocol.. and Common pharmacists' practice in Croatia.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Dec 2021to Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult participants (years 18+)
- Usage of psycholeptic or psychoanaleptic medicines
- Residence in Istrian County (Croatia)
Who cannot join
- Minor participants
- Hospitalization during study participation
- Unable to live by themselves
- Unable to participate in study for 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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:
- Side-effects are the most common DRPs in subjects using psychotropic medicines in primary care,
- Treatment effectiveness and safety affect the subjects´ QoL
Read the detailed description
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.
- Conditions
- Mental Health Services
- Being tested
- Pharmaceutical care in solving drug-related problems in subjects using psychotropic medicines based on standardized protocol.., Common pharmacists' practice in Croatia.
- Keywords
- Mental disorders, Quality of life, Drug-related problems
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Standardized pharmaceutical care | Experimental | Participants in group A received pharmacists' interventions based on standardized Medication Review (MR) and Medication Therapy Management (MTM) protocols. Receives: Other: Pharmaceutical care in solving drug-related problems in subjects using psychotropic medicines based on standardized protocol.. |
| Basic counseling | Active comparator | Participants enrolled in group B received pharmaceutical care based on common pharmacist´s practice in Croatia. Receives: Other: Common pharmacists' practice in Croatia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the quality of life in subjects using psycholeptics and psychoanaleptics
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.
Measured: Prior and after the pharmacists' intervention during three months period.
Secondary outcomes (1)
Analysis of identified drug-related problems
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.
Measured: During period of three months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start1 Dec 2021
- Primary completion14 Feb 2025
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health ServicesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rijeka
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alena Tatarevic, University of Rijeka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889636
- Sponsor's protocol ID
- 200-07/2023-01/1_001/2023
- Status last verified
- Feb 2025
- First submitted
- 25 Feb 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06889636
- Acronym / sponsor ID
- 200-07/2023-01/1_001/2023
- Conditions
- Mental Health Services
- Keywords
- Mental disorders, Quality of life, Drug-related problems
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University of RijekaUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 14 Feb 2025 (actual)
- Study completion
- Apr 2025 (estimated)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Side-effects are the most common DRPs in subjects using psychotropic medicines in primary care,
- Treatment effectiveness and safety affect the subjects´ QoL
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardized pharmaceutical care | Experimental | Other: Pharmaceutical care in solving drug-related problems in subjects using psychotropic medicines based on standardized protocol..Participants in group A received pharmacists' interventions based on standardized Medication Review (MR) and Medication Therapy Management (MTM) protocols. |
| Basic counseling | Active comparator | Other: Common pharmacists' practice in Croatia.Participants enrolled in group B received pharmaceutical care based on common pharmacist´s practice in Croatia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult participants (years 18+)
- Usage of psycholeptic or psychoanaleptic medicines
- Residence in Istrian County (Croatia)
Key exclusion criteria (4 listed)
- Minor participants
- Hospitalization during study participation
- Unable to live by themselves
- Unable to participate in study for 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmaceutical care in solving drug-related problems in subjects using psychotropic medicines based on standardized protocol..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. | Other | Standardized pharmaceutical care |
| Common pharmacists' practice in Croatia.Group B participants received pharmaceutical care based on common pharmacists' practice in Croatia during the dispensing of psychotropic drugs. | Other | Basic counseling |
Primary outcome
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.
1 secondary outcome
Analysis of identified drug-related problems
Time frame: During period of three months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmaceutical care in solving drug-related problems in subjects using psychotropic medicines based on standardized protocol.. and Common pharmacists' practice in Croatia. in people with Mental Health Services, run by University of Rijeka at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the quality of life in subjects using psycholeptics and psychoanaleptics (time frame: Prior and after the pharmacists' intervention during three months period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.