HypothyroidismNCT06408909
Pharmacist Role in Thyroid Disorders
A study testing Clinical Pharmacist Intervention Group in people with Hypothyroidism and Hyperthyroidism, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypothyroidism, Hyperthyroidism, Thyroid Diseases
- What is being tested?
- Clinical Pharmacist Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2022to 15 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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.
Who cannot join
- Being under 18 years old.
- Lost follow up in 30th day after thyroid disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Clinical Pharmacist's Effect in Achieving Treatment Goals in Hypothyroid Patients
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.
Read the 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.
- Conditions
- Hypothyroidism, Hyperthyroidism, Thyroid Diseases
- Being tested
- Clinical Pharmacist Intervention Group
- Keywords
- Hypothyroidism, Levothyroxine, Drug-Related Problem, Clinical Pharmacist, Medication Adherence
- Medical subject headings
- Hypothyroidism, Hyperthyroidism, Thyroid Diseases, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Pharmacist Intervention GroupBehavioural
Also called Intervention Group
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Clinical Pharmacist Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: From the date of randomization until there are 18 patient participants in each group. Average 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start15 Mar 2022
- Primary completion15 Sep 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypothyroidismStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization, Marmara University
- Responsible party
- Principal investigator, Muhammed Yunus Bektay, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06408909
- Sponsor's protocol ID
- Pharm. Role Thyorid Disorder
- Status last verified
- May 2024
- First submitted
- 7 May 2024
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40200273
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Pharmacist's Effect in Achieving Treatment Goals in Hypothyroid Patients
- ClinicalTrials.gov ID
- NCT06408909
- Acronym / sponsor ID
- Pharm. Role Thyorid Disorder
- Conditions
- Hypothyroidism, Hyperthyroidism, Thyroid Diseases
- Keywords
- Hypothyroidism, Levothyroxine, Drug-Related Problem, Clinical Pharmacist, Medication Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization, Marmara University
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 10 May 2024 (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.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Clinical Pharmacist Intervention GroupGroup 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Being under 18 years old.
- Lost follow up in 30th day after thyroid disease.
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 |
|---|---|---|
| Clinical Pharmacist Intervention GroupAlso: Intervention GroupGroup 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. | Behavioural | Intervention Group |
Primary outcome
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.
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.
Serum Thyroid Stimulating Hormone Levels
Time frame: From the date of randomization until there are 18 patient participants in each group. Average 6 months.
Serum Thyroid Stimulating Hormone Levels
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.
Having serum T4 Levels within the normal range
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.
Change in medication adherence rate for patients with thyroid disorders
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Derived from this study: PubMed 40200273Ayhan 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.
- 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 Clinical Pharmacist Intervention Group in people with Hypothyroidism and Hyperthyroidism, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 13 May 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06408909, which also lists 1 linked publication.
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 13 May 2024.