- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06408909
Pharmacist Role in Thyroid Disorders
Evaluation of the Clinical Pharmacist's Effect in Achieving Treatment Goals in Hypothyroid Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The first choice in the treatment of hypothyroidism (HoT) is replacement therapy with levothyroxine (LT4). Factors other than the use of the drug are as crucial as the use of LT4 at the right time and in the right way. Drugs used by patients other than LT4, comorbidities, diet, age, and weight of the patient also affect the benefit seen from LT4 treatment.
LT4, which has a narrow therapeutic index, may cause drug-related problems (DRP) such as non-adherence to treatment, the timing of drug use, inappropriate use of the drug, inadequate therapeutic dose, duration of treatment, inadequate monitoring of treatment and potential drug-drug interactions (pDDI). In a study conducted in a hospital in India, DRP encountered during treatment with narrow therapeutic index drugs were compared with DRP encountered with other drugs. It was reported that DRPs were associated with pDDIs, adverse effects, dose overdose, dose underdose, untreated indications, inappropriate drug use, unnecessary drug use, and patient-related factors. In the study in which LT4 was also included, the rate of DRPs to narrow therapeutic index was 22%, and the rate of DRPs to other drugs was reported to be 8%. In a study documenting the interventions of pharmacists in hospitals in Germany, the interventions made between 2009 and 2012 were analyzed; LT4 was one of the ten drugs with the highest number of problems, and half of these problems were drug interactions and the inadequate therapeutic dose in patients with organ failure.
Aluminum hydroxide, bile acid secretagogues, calcium polystyrene sulphonate, sodium polystyrene sulphonate, calcium salts, iron preparations, multivitamin supplements containing iron, lanthanum carbonate, sevelamer, magnesium salts, orlistat, and raloxifene cause D-level drug interactions with LT4. In the concomitant use of calcium salts with LT4, it is observed that LT4 absorption and, consequently, therapeutic effect decreases [8,9]. In a systematic review of the concomitant use of LT4 and proton pump inhibitors (PPI) in hypothyroid patients with dyspepsia, gastroesophageal reflux, or peptic ulcer, a statistically significant increase in thyroid-stimulating hormone (TSH) levels was observed.
Since the therapeutic index of the LT4 drug is narrow, it emphasizes the importance of adherence to the drug in reaching ideal TSH levels. Medication adherence is a dynamic process closely linked to treatment outcomes in patients with chronic diseases. Very few studies exist on LT4 treatment and patient adherence to treatment. In their study, Yavuz et al. emphasized that almost half of HoT patients had serum TSH values outside the reference range despite receiving LT4 treatment and that adherence with LT4 treatment was one of the most critical determinants in reaching target TSH levels.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey, 34854
- Marmara University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Being under 18 years old.
- Lost follow up in 30th day after thyroid disease.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Group
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.
|
|
Experimental: Intervention Group
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.
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptance rate of suggested intervention (number)
Time Frame: From the date of randomization until there are 18 patient participants in each group. Average 6 months.
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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.
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From the date of randomization until there are 18 patient participants in each group. Average 6 months.
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Serum Thyroid Stimulating Hormone Levels
Time Frame: From the date of randomization until there are 18 patient participants in each group. Average 6 months.
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Serum Thyroid Stimulating Hormone Levels
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From the date of randomization until there are 18 patient participants in each group. Average 6 months.
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Having serum T4 Levels within the normal range
Time Frame: From the date of randomization until there are 18 patient participants in each group. Average 6 months.
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Having serum T4 Levels within the normal range
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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
Time Frame: From the date of randomization until there are 18 patient participants in each group. Average 6 months.
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Change in medication adherence rate for patients with thyroid disorders
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From the date of randomization until there are 18 patient participants in each group. Average 6 months.
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pharm. Role Thyorid Disorder
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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