Correlation Between Thyroid Function and Quality of Life in Hypothyroidism

NCT04795947 | Unknown

• 1 other identifier: 2021-PRO39-Hypothyroidism
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

According to the prevalence survey of thyroid diseases in ten cities in China in 2010, TSH\>4.2 mIU /L was the diagnostic cut-off point, and the prevalence of hypothyroidism was 17.8%, including 1.1% clinical hypothyroidism.The annual incidence of hypothyroidism in China is 2.9‰, and primary hypothyroidism is the most common.Typical patients have chilliness, fatigue, swelling of hands and feet, lethargy, memory loss, hypoperspiration, joint pain, weight gain, constipation, menstrual disorder or menorrhagia, infertility, which affects the physiological and psychological functions of patients and reduces the quality of life of patients.The treatment goal of primary clinical hypothyroidism is that the symptoms and signs of hypothyroidism disappear, and TSH, TT4 and FT4 values remain in the normal range.Levothyroxine (L-T4) is the main alternative therapy for this disease.Thyroid disease patients quality of life questionnaire (Thyroid - specific Patient Reported Outcome, ThyPRO) for the development of the Danish scholars such as WATT first can be applied to various comprehensive scale of benign Thyroid disease patients, applied in the Danish people has good reliability and validity, has been translated into ten languages application in many countries the crowd, WATT et al in 2015 developed the scale of the concise version (ThyPRO39).Studies have shown that in the treatment of patients with thyroid disease, even if thyroid function is within the normal range, there are still physiological or psychological impairments such as chills, fatigue, anxiety, depression, which reduces the quality of life of patients.Studies have shown that TSH level in patients with hypothyroidism is correlated with patients' quality of life. Even within the normal range, the higher TSH level is, the worse the patients' quality of life score is, and there is an independent correlation in fatigue and emotional susceptibility. This study except for other factors, such as merger disease with primary hypothyroidism patients quality of life assessment, observe the normal JiaJian patients, we use the current widely used thyroid disease patients to evaluate the quality of life questionnaire (ThyPRO - 39), observe thyroid hormone levels in patients with hypothyroidism and their quality of life scale and the relevance of the blood sugar, blood lipid metabolic indicators related to relevance.

Conditions

Hypothyroidism

Keywords

Hypothyroidism

Outcome Measures

Primary Outcomes (1)

• Thyroid-specific Patient Reported Outcome(ThyPRO39)

  Correlation between thyroid function level and health-related quality of life (HRQOL) and metabolic indexes.

  1year

Secondary Outcomes (1)

• the MOS 36-item Short Form Health Survey(SF36)

  baseline

Interventions

Behavioral BEHAVIORAL

There is no intervention in this study

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with hypothyroidism in Chaoyang Hospital outpatient department

You may qualify if:

• Male or female aged ≥18, ≤75 years old;
• clear diagnosis of primary hypothyroidism;
• Use the same dose of levothyroxine for ≥3 months;
• The levels of thyroid function (TSH, TT4, FT4, TT3, FT3) in hospital laboratory blood tests no more than 6 weeks before participation were within the normal range;

You may not qualify if:

• regnancy or lactation women
• affect blood sugar, blood lipid metabolism drugs
• serious heart disease
• thyroid malignant tumor
• history of mental illness

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

Study Sites (1)

BeijingCYH

Beijing, Beijing Municipality, 100020, China

Location

MeSH Terms

Conditions

Hypothyroidism

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Study Officials

• Guang Wang

  Beijing Chao-Yang Hospital, Capital Medical University, Beijing 100020, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Endocrinology

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 12, 2021
• Study Start: November 1, 2020
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: March 12, 2021

Record last verified: 2021-03

Locations

CN (1)