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The Effect of Mobile Application on Hypothyroid Patients

Primary Purpose

Hypothyroidism, Symptom Management, Symptoms and Signs

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Mobile application with symptom management
Sponsored by
Sakarya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypothyroidism

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Seyma TrabzonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Symptom management scale
To detect an increase in scores on the HypothyroidismSymptom management scale at Week 12 compared to baseline.
Symptom Severity scale
To detect a decrease in the score on the Symptom Severity scale at week 12 compared to baseline.

Secondary Outcome Measures

Thyroid function (Only TSH)
The effect of the patient's thyroid function tests on the 12th week compared to the baseline. Blood test (Only TSH) will be performed during the outpatient follow-up at the first, sixth, and 12th weeks.
Blood lipid (LDL)
The effect on the patient's blood lipid profile [LDL cholesterol (low-density lipoprotein)] levels compared to baseline at week 12. Blood tests will be performed during the outpatient follow-up at the first, sixth, and 12th weeks.
Blood lipid (HDL)
The effect on the patient's blood lipid profile [HDL cholesterol (high-density lipoprotein)] levels compared to baseline at week 12. Blood tests will be performed during the outpatient follow-up at the first, sixth, and 12th weeks.
Blood lipid (total cholesterol )
The effect on the patient's blood lipid profile (Total cholesterol) levels compared to baseline at week 12. Blood tests will be performed during the outpatient follow-up at the first, sixth, and 12th weeks.
Blood pressure
The effect on the patient's blood pressure values compared to the baseline at the 12th week.The researcher will measure it.
Body Mass Index
The effect on the patient's Body Mass Index compared to baseline at week 12. The researcher will measure it. Body Mass Index is calculated by dividing the person's weight in kilograms by the square of the person's height in meters (kg/m²).

Full Information

First Posted
December 22, 2022
Last Updated
January 31, 2023
Sponsor
Sakarya University
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1. Study Identification

Unique Protocol Identification Number
NCT05708456
Brief Title
The Effect of Mobile Application on Hypothyroid Patients
Official Title
Investigation of the Effect of the Mobile Application Developed for the Management of Symptoms in Hypothyroid Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2023 (Anticipated)
Primary Completion Date
September 17, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sakarya University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothyroidism, Symptom Management, Symptoms and Signs, Mobile Application, Digital Health

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Mobile application with symptom management
Intervention Description
In this study, patients will be given evidence-based advice via a mobile application to manage their symptoms.
Primary Outcome Measure Information:
Title
Symptom management scale
Description
To detect an increase in scores on the HypothyroidismSymptom management scale at Week 12 compared to baseline.
Time Frame
Change from day 1 to week 12 of the study.
Title
Symptom Severity scale
Description
To detect a decrease in the score on the Symptom Severity scale at week 12 compared to baseline.
Time Frame
Change from day 1 to week 12 of the study
Secondary Outcome Measure Information:
Title
Thyroid function (Only TSH)
Description
The effect of the patient's thyroid function tests on the 12th week compared to the baseline. Blood test (Only TSH) will be performed during the outpatient follow-up at the first, sixth, and 12th weeks.
Time Frame
Change from day 1 to week 12 of the study.
Title
Blood lipid (LDL)
Description
The effect on the patient's blood lipid profile [LDL cholesterol (low-density lipoprotein)] levels compared to baseline at week 12. Blood tests will be performed during the outpatient follow-up at the first, sixth, and 12th weeks.
Time Frame
Change from day 1 to week 12 of the study
Title
Blood lipid (HDL)
Description
The effect on the patient's blood lipid profile [HDL cholesterol (high-density lipoprotein)] levels compared to baseline at week 12. Blood tests will be performed during the outpatient follow-up at the first, sixth, and 12th weeks.
Time Frame
Change from day 1 to week 12 of the study
Title
Blood lipid (total cholesterol )
Description
The effect on the patient's blood lipid profile (Total cholesterol) levels compared to baseline at week 12. Blood tests will be performed during the outpatient follow-up at the first, sixth, and 12th weeks.
Time Frame
Change from day 1 to week 12 of the study
Title
Blood pressure
Description
The effect on the patient's blood pressure values compared to the baseline at the 12th week.The researcher will measure it.
Time Frame
Change from day 1 to week 12 of the study
Title
Body Mass Index
Description
The effect on the patient's Body Mass Index compared to baseline at week 12. The researcher will measure it. Body Mass Index is calculated by dividing the person's weight in kilograms by the square of the person's height in meters (kg/m²).
Time Frame
Change from day 1 to week 12 of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seyma TRABZON, MSc
Phone
+905079462377
Email
seymatrabzon@sakarya.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Havva SERT, PhD
Phone
+905422512100
Email
hsert@sakarya.edu.tr
Facility Information:
Facility Name
Seyma Trabzon
City
Sakarya
ZIP/Postal Code
54100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seyma Trabzon
First Name & Middle Initial & Last Name & Degree
Havva Sert

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Mobile Application on Hypothyroid Patients

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