Pharmacist Role in Thyroid Disorders
Evaluation of the Clinical Pharmacist's Effect in Achieving Treatment Goals in Hypothyroid Patients
1 other identifier
interventional
44
1 country
1
Brief Summary
Hypothyroidism (HoT) treatment involves lifelong thyroxine replacement therapy and regular monitoring. The objective of this study was to assess the impact of clinical pharmacist (CP) intervention in managing drug-related problems (DRPs) on outcomes among hypothyroid patients receiving levothyroxine (LT4) therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2022
CompletedFirst Submitted
Initial submission to the registry
May 7, 2024
CompletedFirst Posted
Study publicly available on registry
May 10, 2024
CompletedMay 13, 2024
May 1, 2024
6 months
May 7, 2024
May 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Acceptance rate of suggested intervention (number)
Acceptance rate of suggested intervention. Drug-related problems and recommendations are classified according to PCNE (Pharmaceutical Care Network Europe) version 9.1. It was recorded how many suggestions were made in the intervention group and how many of these suggestions were accepted.
From the date of randomization until there are 18 patient participants in each group. Average 6 months.
Serum Thyroid Stimulating Hormone Levels
Serum Thyroid Stimulating Hormone Levels
From the date of randomization until there are 18 patient participants in each group. Average 6 months.
Having serum T4 Levels within the normal range
Having serum T4 Levels within the normal range
From the date of randomization until there are 18 patient participants in each group. Average 6 months.
Change in medication adherence rate for patients with thyroid disorders
Change in medication adherence rate for patients with thyroid disorders
From the date of randomization until there are 18 patient participants in each group. Average 6 months.
Study Arms (2)
Control Group
NO INTERVENTIONGroup in which only observation is made by the clinical pharmacist For patients in this group, no intervention (i.e. recommendation) will be made to physicians by the clinical pharmacist. Within the intervention group, patient characteristics such as the underlying conditions, and the appropriateness of prescribed medications were evaluated for the patients who received levothyroxine treatment for thyroid diseases and met the inclusion criteria. The participant will take standard treatment. Evaluations will be recorded.
Intervention Group
EXPERIMENTALGroup to which the clinical pharmacist makes recommendations For patients in this group, intervention (i.e. recommendation) will be made to physician in charge by the clinical pharmacist. Within the intervention group, patient characteristics such as the underlying conditions, and the appropriateness of prescribed medications were evaluated for the patients who received treatment for thyroid diseases and met the inclusion criteria. Through medication reviews, evaluations were made to identify drug-related problems and provide solutions to these problems. The clinical pharmacist provided recommendations to the physicians regarding significant clinically important problems.
Interventions
Group to which the clinical pharmacist makes recommendations The drugs administered to patients during scheduled hospital visits will be recorded. A detailed medication review will be conducted by the clinical pharmacist. As a result of a comprehensive evaluation, recommendations were made to doctors regarding drug-related problems and were recorded.
Eligibility Criteria
You may qualify if:
- A confirmed diagnosis of Thyroid Disease (ICD-10 codes: E03.9)
- Patients visited the endocrinology diseases outpatient clinic
- Being 18 years or older.
- Patients who could be evaluated by the clinical pharmacist for at least 24 hours within the intervention group.
You may not qualify if:
- Being under 18 years old.
- Lost follow up in 30th day after thyroid disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Marmara University
Istanbul, 34854, Turkey (Türkiye)
Related Publications (1)
Ayhan YE, Bektay MY, Gogas Yavuz D, Sancar M. Evaluation of the clinical pharmacist's effect on achieving treatment goals in patients with hypothyroidism: a randomized controlled trial. BMC Endocr Disord. 2025 Apr 8;25(1):94. doi: 10.1186/s12902-025-01914-3.
PMID: 40200273DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 7, 2024
First Posted
May 10, 2024
Study Start
March 15, 2022
Primary Completion
September 15, 2022
Study Completion
September 15, 2022
Last Updated
May 13, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share