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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05503576
Other study ID # 17992086462
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 2022
Est. completion date December 2023

Study information

Verified date August 2022
Source Cukurova University
Contact Pinar Kaya, 1
Phone +905071936083
Email pinarakbulut@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In patients who have undergone thyroidectomy surgery, drug use will be reminded with a mobile application in the postoperative period.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date December 2023
Est. primary completion date May 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: 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. -

Study Design


Related Conditions & MeSH terms

  • Patient Acceptance of Health Care

Intervention

Device:
reminder mobile application
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cukurova University

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 0-12 weeks
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