The Effect of Mobile Application on Hypothyroid Patients

NCT05708456 | Unknown

• 1 other identifier: SakaryaU,
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Symptom management scale

  To detect an increase in scores on the HypothyroidismSymptom management scale at Week 12 compared to baseline.

  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.

  Change from day 1 to week 12 of the study

Secondary Outcomes (6)

• Thyroid function (Only TSH)

  Change from day 1 to week 12 of the study.

• Blood lipid (LDL)

  Change from day 1 to week 12 of the study

• Blood lipid (HDL)

  Change from day 1 to week 12 of the study

• Blood lipid (total cholesterol )

  Change from day 1 to week 12 of the study

• Blood pressure

  Change from day 1 to week 12 of the study

Study Arms (2)

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.

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.

Interventions

Mobile application with symptom management OTHER

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

Intervention Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

Seyma Trabzon

Sakarya, 54100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hypothyroidism; Signs and Symptoms

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Seyma TRABZON, MSc

CONTACT

+905079462377; seymatrabzon@sakarya.edu.tr

Havva SERT, PhD

CONTACT

+905422512100; hsert@sakarya.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: February 1, 2023
• Study Start: February 15, 2023
• Primary Completion: September 17, 2023
• Study Completion: December 30, 2023
• Last Updated: February 1, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)