The Effect of Mobile Application on Hypothyroid Patients

NCT ID: NCT05708456

Last Updated: 2023-02-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-15
• Study Completion Date: 2023-12-30

Brief Summary

Hypothyroidism refers to the common pathological condition of thyroid hormone deficiency. The annual incidence of hypothyroidism is 3.5 per 1000 in women and 0.6 in per 1000 men. Hypothyroidism is seen 5-8 times more frequently in women than in men. Patients with hypothyroidism have a higher prevalence of cardiovascular risk factors and often have metabolic syndrome features such as hypertension, increased waist circumference, and dyslipidemia. Other signs and symptoms include bradycardia, slow speech, swelling in the eyes and face, weight gain, decreased sweating, hair loss, pallor, forgetfulness, decreased concentration, depression, irritability, tongue growth, loss of appetite, palpitations, decreased hearing, menstrual irregularities, muscle pains, and cramps. Depending on all these signs and symptoms, hypothyroidism can negatively affect the quality of life of individuals. Therefore, it is essential to reduce symptoms and to improve patients' abilities to manage them. It is stated that the appropriate use of mobile health applications helps the patient to make informed decisions about health management and treatment. Therefore, this study plans to investigate the effect of mobile technology on symptom management in individuals with hypothyroidism, whose symptoms range from mild to severe.

Detailed Description

The research will be carried out in Sakarya University Training and Research Hospital Endocrinology Polyclinic. It is planned to include a total of 80 patients in the research (40 patients in the control group - 40 patients in the experiment group). The first step of this study is to develop the scales to be used in the study. The Hypothyroidism Symptom Management Scale and the Hypothyroidism Symptom Severity Scale will be developed. In the second stage, data will be collected. The Patient Information Form, Hypothyroidism Symptom Severity Scale, and Hypothyroidism Symptom Management Scale will be applied to the experimental group that meets the research criteria and agrees to participate. The patient's blood test findings (TSH, T3, T4, Anti-Tg, Anti TPO, Antithyroglobulin, Hmg, Hct) will also be recorded at the first meeting. The researcher will measure the patient's height, weight, and vital signs. The mobile application will be introduced to the patients and downloaded to the patient's phones, and a username and password will be created. The content of this mobile application; Interventions will be planned based on evidence-based practices to alleviate or reduce the symptoms of hypothyroidism. These initiatives are planned both in written form and in short video narration. Patients will be asked to watch the videos in the mobile application for the first week. At the end of each week, patients will be asked to report symptoms in the application and read and follow the recommendations for the relevant symptom. The usage period of the mobile application is determined as three months (12 weeks). In addition, at the end of the fourth week, patients will be followed up by having the symptom management scale and symptom severity scale applied via the mobile application. In the 6th and 12th weeks, evaluations of the patient's laboratory test results, vital signs, height, and weight measurements, will also be evaluated besides the scales. In the first interview with the individuals in the control group, after explanations are made about the research and their verbal and written consents are accordingly obtained, First, the Patient Information Form, the Hypothyroidism Symptom Severity Scale, and the Hypothyroidism Symptom Management Scale will be administered as a pre-test. At the first interview, the patient's blood test findings, height, weight, and vital signs will be recorded. Measurements will be repeated when individuals come to their outpatient clinic appointments 6 and 12 weeks after the first interview.

Conditions

Hypothyroidism; Symptom Management; Symptoms and Signs; Mobile Application; Digital Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention Group

Application of data collection forms for the initial evaluation. Teaching the use of the mobile application, monitoring the use of the mobile application in the experimental group by the researcher for 12 weeks, and applying the data collection forms to the patients in the 6th and 12th weeks.

Group Type: EXPERIMENTAL

Mobile application with symptom management

Intervention Type: OTHER

In this study, patients will be given evidence-based advice via a mobile application to manage their symptoms.

Control Group

Application of data collection forms for the initial evaluation. Application of data collection forms to the patients in the 6th and 12th weeks. No intervention will be made to the patients in the control group other than the routine service provided in the outpatient clinic.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mobile application with symptom management

In this study, patients will be given evidence-based advice via a mobile application to manage their symptoms.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Able to communicate,
• Who agrees to participate in the study,
• Able to use a mobile phone with android or ıos (iPhone os) operating system
• No vision and dexterity problems,
• Without communication difficulties and cognitive impairment,
• Literate
• Being diagnosed with hypothyroidism

Exclusion Criteria

• Pregnant patients,
• Those with a diagnosed psychiatric illness,
• Those who use antidepressants,
• Patients who experienced trauma or an acute illness during the study (12 weeks)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sakarya University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Seyma Trabzon

Sakarya, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Seyma TRABZON, MSc

Role: CONTACT

seymatrabzon@sakarya.edu.tr

+905079462377

Havva SERT, PhD

Role: CONTACT

hsert@sakarya.edu.tr

+905422512100

Facility Contacts

Seyma Trabzon

Role: primary

Havva Sert

Role: backup

Other Identifiers

SakaryaU,

Identifier Type: -

Identifier Source: org_study_id