NCT06408909

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2022

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 10, 2024

Completed
Last Updated

May 13, 2024

Status Verified

May 1, 2024

Enrollment Period

6 months

First QC Date

May 7, 2024

Last Update Submit

May 10, 2024

Conditions

Keywords

HypothyroidismLevothyroxineDrug-Related ProblemClinical PharmacistMedication Adherence

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 INTERVENTION

Group 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

EXPERIMENTAL

Group 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.

Behavioral: Clinical Pharmacist Intervention Group

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.

Also known as: Intervention Group
Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

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.

MeSH Terms

Conditions

HypothyroidismHyperthyroidismThyroid DiseasesMedication Adherence

Condition Hierarchy (Ancestors)

Endocrine System DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Randomized controlled trial.
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

Locations