HypothyroidismNCT05708456
The Effect of Mobile Application on Hypothyroid Patients
A study testing Mobile application with symptom management in people with Hypothyroidism and Symptom Management, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypothyroidism, Symptom Management, Symptoms and Signs
- What is being tested?
- Mobile application with symptom management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2023to 30 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Seyma Trabzon
Sakarya, 54100
Seyma Trabzon
Havva Sert
About this study
Official title: Investigation of the Effect of the Mobile Application Developed for the Management of Symptoms in Hypothyroid Patients
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.
Read the 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
- Being tested
- Mobile application with symptom management
- Medical subject headings
- Hypothyroidism, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile application with symptom managementOther
In this study, patients will be given evidence-based advice via a mobile application to manage their symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Other: Mobile application with symptom management |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom management scale
To detect an increase in scores on the HypothyroidismSymptom management scale at Week 12 compared to baseline.
Measured: Change from day 1 to week 12 of the study.
Symptom Severity scale
To detect a decrease in the score on the Symptom Severity scale at week 12 compared to baseline.
Measured: Change from day 1 to week 12 of the study
Secondary outcomes (6)
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.
Measured: Change from day 1 to week 12 of the study.
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.
Measured: Change from day 1 to week 12 of the study
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.
Measured: Change from day 1 to week 12 of the study
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.
Measured: Change from day 1 to week 12 of the study
Blood pressure
The effect on the patient's blood pressure values compared to the baseline at the 12th week.The researcher will measure it.
Measured: Change from day 1 to week 12 of the study
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).
Measured: Change from day 1 to week 12 of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start15 Feb 2023 (estimated)
- Primary completion17 Sep 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothyroidismStudies of the same condition, open and under way.
- More trials run by Sakarya 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708456
- Sponsor's protocol ID
- SakaryaU,
- Status last verified
- Dec 2022
- First submitted
- 22 Dec 2022
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of the Mobile Application Developed for the Management of Symptoms in Hypothyroid Patients
- ClinicalTrials.gov ID
- NCT05708456
- Acronym / sponsor ID
- SakaryaU,
- Conditions
- Hypothyroidism, Symptom Management, Symptoms and Signs, Mobile Application, Digital Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 15 Feb 2023 (estimated)
- Primary completion
- 17 Sep 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 1 Feb 2023 (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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Mobile application with symptom managementApplication 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (4 listed)
- 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)
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 |
|---|---|---|
| Mobile application with symptom managementIn this study, patients will be given evidence-based advice via a mobile application to manage their symptoms. | Other | Intervention Group |
Primary outcome
Symptom management scale
Time frame: Change from day 1 to week 12 of the study.
To detect an increase in scores on the HypothyroidismSymptom management scale at Week 12 compared to baseline.
Symptom Severity scale
Time frame: Change from day 1 to week 12 of the study
To detect a decrease in the score on the Symptom Severity scale at week 12 compared to baseline.
6 secondary outcomes
Thyroid function (Only TSH)
Time frame: Change from day 1 to week 12 of the study.
Blood lipid (LDL)
Time frame: Change from day 1 to week 12 of the study
Blood lipid (HDL)
Time frame: Change from day 1 to week 12 of the study
Blood lipid (total cholesterol )
Time frame: Change from day 1 to week 12 of the study
Blood pressure
Time frame: Change from day 1 to week 12 of the study
Body Mass Index
Time frame: Change from day 1 to week 12 of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile application with symptom management in people with Hypothyroidism and Symptom Management, run by Sakarya University 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 7 inclusion and 4 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 1 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seyma TRABZON, MSc (+905079462377, seymatrabzon@sakarya.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom management scale (time frame: Change from day 1 to week 12 of the study.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2023.