Drug ComplianceNCT05503576
Effect of Mobile Application Usage on Drug Compliance After Thyroidectomy
A study testing reminder mobile application in people with Drug Compliance and Patient Acceptance of Health Care, run by Cukurova University.
Trial summary
In patients who have undergone thyroidectomy surgery, drug use will be reminded with a mobile application in the postoperative period. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Compliance, Patient Acceptance of Health Care
- What is being tested?
- reminder mobile application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2022to Dec 2023
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having thyroidectomy due to benign thyroids,
- Being between the ages of 18-65,
- Mental status problem,
- Psychiatric experimentation that reduces understanding and communication,
- Hearing and visual impairment,
- Being able to speak, read, read Turkish,
- Total thyroidectomy performed by the same surgeon, and
- Smart android system phone replacement.
Who cannot join
- Patients who do not meet the inclusion criteria in the sample, patients who meet the inclusion criteria but cannot use mobile applications, do not have internet access, and patients who do not approve to participate in the study will be excluded from the study.
- -
Trial locations and contacts
No sites are listed yet.
About this study
In patients who have undergone thyroidectomy surgery, drug use will be reminded with a mobile application in the postoperative period.
Read the detailed description
Summary: Thyroidectomy is frequently used in the treatment of multinodular goiter, graves' disease, multinodular toxic goiter, and thyroid malignancies in general surgery practice. The thyroid gland plays an important role in the rate of metabolism. As a result of removal of the thyroid gland, patients may experience hormonal problems. In thyroidectomy patients, hypothyroidism develops directly due to removal of the thyroid gland; Complications due to parathyroid gland damage, such as hypocalcemia, may also be encountered.
In the management of complications in the postoperative period, monitoring of thyroid hormone and calcium levels is of vital importance in patients. In the case of calcium deficiency in patients, calcium replacement is performed. Levothyroxine replacement is applied to correct thyroid hormone deficiency. When the optimal dose of levothyroxine is adjusted and used appropriately, the rate of side effects is very low. Although the appropriate dose for the patients is determined in the process, thyroid hormone stabilization has the potential to deteriorate over the years.
Medication incompatibility is an important problem in thyroidectomy patients who need to receive levothyroxine replacement throughout their lives. Many studies evaluating drug compliance in the literature have been conducted with samples of internal medicine patients. However, drug compliance after thyroidectomy is an acute and important condition. There is a need for interventions to increase drug compliance in this patient group.
Today, mobile applications are becoming a new trend among technological approaches that increase the patient and nurse contact. However, no study has been found in the literature examining the use of mobile applications and drug compliance and drug level monitoring in thyroidectomy patients. In our randomized controlled study, data will be collected from two patient groups, the experimental and control groups, and the effectiveness of the reminder mobile application will be evaluated. While no additional intervention was applied to the patients in the control group; Patients in the experimental group will be provided to use the Reminder Mobile Application. At the end of the study, it is predicted that the Reminder Mobile Application will increase drug compliance and complication management of patients after thyroidectomy.
- Conditions
- Drug Compliance, Patient Acceptance of Health Care
- Being tested
- reminder mobile application
- Keywords
- Thyroidectomy, Nurse, Medication Compliance, Reminder, mobile, application
- Medical subject headings
- Medication Adherence, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reminder mobile applicationDevice
After thyroidectomy, patients will be reminded of medication and control appointments. In addition, patients will be able to access up-to-date and short trainings.
| Study group | Role | What they receive |
|---|---|---|
| reminder mobile application group | Experimental | The mobile application will be introduced with a video demonstration. Then, with the help of the researcher, the mobile application will be downloaded to his phone. A user name and password will be created for the patient to enter the application. It will be explained that medication and appointment reminders are available in the application. It will be emphasized that the application will direct you to the hospital appointment system to create a control appointment. In addition, it will be announced that the training content prepared with the contribution of experts to increase drug compliance can be accessed through the application. It is thought that the patient will be interviewed for approximately 20 minutes for the information and procedure process. In the next process, the "Drug Protocol Information Form", "Modified Morisky Scale" and "Complications Follow-up Form" sent to the patient through the application will be filled in at the 1st, 4th, 8th and 12th weeks. Receives: Device: reminder mobile application |
| standard protocol group | No intervention | If the patient is in the control group in group assignment; After the first encounter and obtaining consent, the "Personal Information Form" will be filled in. Next 1., 4.,8. And in the 12th weeks, the "Drug Protocol Information Form", "Modified Morisky Scale" and "Complications Follow-up Form" will be filled in by telephone interviewing the patient. It is estimated that each phone call with the patient for data collection will take approximately 10 minutes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
medication compliance
Thyroidectomy summative mobile application Modified Morisky Scale total score. The scale consists of 6 items in total. Scale questions are answered as Yes/No. In the evaluation, yes is scored as 1 and no as 0 in questions 2 and 5. In other questions, yes is scored 0, no 1. If the total score of the patient in questions 1, 2 and 6 is 0 or 1, it indicates a low motivation level in terms of drug compliance. A score of 2 or above indicates a high motivation level in terms of drug compliance. If the total score obtained from questions 3, 4 and 5 is 0 or 1, it indicates a low level of knowledge about drug compliance. A score of 2 or more indicates a high level of knowledge about drug compliance.
Measured: 0-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study startDec 2022 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionDec 2023 (estimated)
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 Drug ComplianceStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pinar Kaya, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503576
- Sponsor's protocol ID
- 17992086462
- Status last verified
- Aug 2022
- First submitted
- 12 Aug 2022
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kaya P, Erden S. The effect of reminder mobile application use on medication adherence after total thyroidectomy: a randomized controlled trial. Support Care Cancer. 2026 Mar 9;34(4):295. doi: 10.1007/s00520-026-10533-0.
PubMed 41796253
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mobile Application Usage on Drug Compliance After Thyroidectomy
- ClinicalTrials.gov ID
- NCT05503576
- Acronym / sponsor ID
- 17992086462
- Conditions
- Drug Compliance, Patient Acceptance of Health Care
- Keywords
- Thyroidectomy, Nurse, Medication Compliance, Reminder, mobile, application
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 16 Aug 2022 (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.
In patients who have undergone thyroidectomy surgery, drug use will be reminded with a mobile application in the postoperative period.
Detailed description
Summary: Thyroidectomy is frequently used in the treatment of multinodular goiter, graves' disease, multinodular toxic goiter, and thyroid malignancies in general surgery practice. The thyroid gland plays an important role in the rate of metabolism. As a result of removal of the thyroid gland, patients may experience hormonal problems. In thyroidectomy patients, hypothyroidism develops directly due to removal of the thyroid gland; Complications due to parathyroid gland damage, such as hypocalcemia, may also be encountered.
In the management of complications in the postoperative period, monitoring of thyroid hormone and calcium levels is of vital importance in patients. In the case of calcium deficiency in patients, calcium replacement is performed. Levothyroxine replacement is applied to correct thyroid hormone deficiency. When the optimal dose of levothyroxine is adjusted and used appropriately, the rate of side effects is very low. Although the appropriate dose for the patients is determined in the process, thyroid hormone stabilization has the potential to deteriorate over the years.
Medication incompatibility is an important problem in thyroidectomy patients who need to receive levothyroxine replacement throughout their lives. Many studies evaluating drug compliance in the literature have been conducted with samples of internal medicine patients. However, drug compliance after thyroidectomy is an acute and important condition. There is a need for interventions to increase drug compliance in this patient group.
Today, mobile applications are becoming a new trend among technological approaches that increase the patient and nurse contact. However, no study has been found in the literature examining the use of mobile applications and drug compliance and drug level monitoring in thyroidectomy patients. In our randomized controlled study, data will be collected from two patient groups, the experimental and control groups, and the effectiveness of the reminder mobile application will be evaluated. While no additional intervention was applied to the patients in the control group; Patients in the experimental group will be provided to use the Reminder Mobile Application. At the end of the study, it is predicted that the Reminder Mobile Application will increase drug compliance and complication management of patients after thyroidectomy.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| reminder mobile application group | Experimental | Device: reminder mobile applicationThe mobile application will be introduced with a video demonstration. Then, with the help of the researcher, the mobile application will be downloaded to his phone. A user name and password will be created for the patient to enter the application. It will be explained that medication and appointment reminders are available in the application. It will be emphasized that the application will direct you to the hospital appointment system to create a control appointment. In addition, it will be announced that the training content prepared with the contribution of experts to increase drug compliance can be accessed through the application. It is thought that the patient will be interviewed for approximately 20 minutes for the information and procedure process. In the next process, the "Drug Protocol Information Form", "Modified Morisky Scale" and "Complications Follow-up Form" sent to the patient through the application will be filled in at the 1st, 4th, 8th and 12th weeks. |
| standard protocol group | No intervention | –If the patient is in the control group in group assignment; After the first encounter and obtaining consent, the "Personal Information Form" will be filled in. Next 1., 4.,8. And in the 12th weeks, the "Drug Protocol Information Form", "Modified Morisky Scale" and "Complications Follow-up Form" will be filled in by telephone interviewing the patient. It is estimated that each phone call with the patient for data collection will take approximately 10 minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Having thyroidectomy due to benign thyroids,
- Being between the ages of 18-65,
- Mental status problem,
- Psychiatric experimentation that reduces understanding and communication,
- Hearing and visual impairment,
Key exclusion criteria (2 listed)
- Patients who do not meet the inclusion criteria in the sample, patients who meet the inclusion criteria but cannot use mobile applications, do not have internet access, and patients who do not approve to participate in the study will be excluded from the study.
- -
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 |
|---|---|---|
| reminder mobile applicationAfter thyroidectomy, patients will be reminded of medication and control appointments. In addition, patients will be able to access up-to-date and short trainings. | Device | reminder mobile application group |
Primary outcome
medication compliance
Time frame: 0-12 weeks
Thyroidectomy summative mobile application Modified Morisky Scale total score. The scale consists of 6 items in total. Scale questions are answered as Yes/No. In the evaluation, yes is scored as 1 and no as 0 in questions 2 and 5. In other questions, yes is scored 0, no 1. If the total score of the patient in questions 1, 2 and 6 is 0 or 1, it indicates a low motivation level in terms of drug compliance. A score of 2 or above indicates a high motivation level in terms of drug compliance. If the total score obtained from questions 3, 4 and 5 is 0 or 1, it indicates a low level of knowledge about drug compliance. A score of 2 or more indicates a high level of knowledge about drug compliance.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
- Derived from this study: PubMed 41796253Kaya P, Erden S. The effect of reminder mobile application use on medication adherence after total thyroidectomy: a randomized controlled trial. Support Care Cancer. 2026 Mar 9;34(4):295. doi: 10.1007/s00520-026-10533-0.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing reminder mobile application in people with Drug Compliance and Patient Acceptance of Health Care, run by Cukurova University.
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 8 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: status not confirmed, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pinar Kaya, 1 (+905071936083, pinarakbulut@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
medication compliance (time frame: 0-12 weeks). 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 NCT05503576, 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 19 Aug 2022.