Quality of Life Among Egyptian Hypothyroid Patients

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05143918
Collaborator
(none)
176
24

Study Details

Study Description

Brief Summary

Assessment of quality of life among hypothyroid patients in Assiut University Hospital

Condition or Disease Intervention/Treatment Phase
  • Other: assessment of quality of life using questionnaire

Detailed Description

Hypothyroidism is an underactive thyroid gland. Hypothyroidism means that the thyroid gland can't make enough thyroid hormone to keep the body running normally. People are hypothyroid if they have too little thyroid hormone in the blood. Common causes are Iodine deficiency, autoimmune disease, such as Hashimoto's thyroiditis, surgical removal of the thyroid, and radiation treatment.

There are three types of hypothyroidism: primary, secondary and tertiary. Primary hypothyroidism results from a low level of thyroid hormone due to destruction of the thyroid gland. This condition results in increased secretion and elevation of serum thyroid-stimulating hormone (TSH) levels. If the structure of the gland remains normal, dysfunction can be caused by decreased TSH secretion from the pituitary; this Is called secondary hypothyroidism.

In tertiary hypothyroidism, a decrease in thyroid hormone arises from inadequate secretion of thyrotropin-releasing hormone (TRH) from the hypothalamus. It is not always possible to differentiate between secondary and tertiary hypothyroidism, and they are often collectively referred to as central hypothyroidism. About 99%ofhypothyroidism cases are primary hypothyroidism.

Hypothyroidism is common throughout the world. In iodine-sufficient countries, the prevalence of hypothyroidism ranges from 1% to 2%. rising to 7% in individuals aged between 85 and 89 years. In the absence of age-specific reference ranges for TSH, an ageing population is likely to result in a higher prevalence of hypothyroidism. Hypothyroidism is approximately ten times more prevalent in women than men10. the awareness of hypothyroidism has increased gradually, as has rate of initiation of levothyroxine substitution.

Symptoms usually develop slowly and the patient may not realise to have a medical problem for several years. Common symptoms include: tiredness, being sensitive to cold, weight gain, constipation, depression, slow movements and thoughts, muscle aches and weakness, muscle cramps, dry and scaly skin, brittle hair and nails, loss of libido (sex drive), pain, numbness and a tingling sensation in the hand and fingers (carpal tunnel syndrome),irregular periods or heavy periods.

Health-related quality of life (HRQL) is a subjective assessment of the effects of disease and its treatment on the physical, social, psychological, and somatic dimensions of a patient's life. Thus, HRQL is considered an important supplementary outcome measure in the management of different conditions.

Thyroid hormones are important for the body's total energy metabolism and the neuroendocrine function. Hence, it seems apparent that a dysfunction of the thyroid hormone secretion should have a major influence on the total capacity of the body, both physically and mentally. Increasing attention is being paid to assessing HRQL among patients with thyroid disorders, and previous studies have revealed that HRQL is frequently affected in patients with hypothyroidism.

Up to our knowledge, no previous study explored the quality of life and its correlates among Egyptian hypothyroidism patients. The current study aims to assess the quality of life and its predictor among hypothyroidism in Assiut University Hospital

Study Design

Study Type:
Observational
Anticipated Enrollment :
176 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Assessment of Quality of Life Among Hypothyroid Patients in Assiut University Hospitals
Anticipated Study Start Date :
Dec 31, 2021
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Hypothyroid patients as a cases

Inclusion criteria: age ranges will be 18 - 60 years both genders previously confirmed diagnosed Exclusion criteria: pregnancy other comorbidities (hypertension, diabetes, malignancy,,,etc)

Other: assessment of quality of life using questionnaire
assessment of quality of life in hypothyroid patients using SF 36 questionnaire

Control group

Healthy people without chronic disease

Other: assessment of quality of life using questionnaire
assessment of quality of life in hypothyroid patients using SF 36 questionnaire

Outcome Measures

Primary Outcome Measures

  1. predictors of quality of life among hypothyroid patients [nearly two year]

    Using the Short Form (36) Health Survey (SF-36) questionnaire all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. age ranges will be 18 - 60 years

  2. both genders

  3. previously confirmed diagnosed

Exclusion Criteria:
  • Exclusion criteria:
  1. pregnancy

  2. other comorbidities (hypertension, diabetes, malignancy,,,etc)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Chair: Nabawia M Tawfik, Assiut University
  • Study Director: Ghada Abd El Rahman, Assiut University
  • Study Director: Doaa M Osman, Assiut University
  • Principal Investigator: Noha F Radwan, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Noha Fathy Radwan Abd El Zaher, Physician at internal medicine department at Assiut University Hospital, Assiut University
ClinicalTrials.gov Identifier:
NCT05143918
Other Study ID Numbers:
  • quality of life
First Posted:
Dec 3, 2021
Last Update Posted:
Dec 20, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Noha Fathy Radwan Abd El Zaher, Physician at internal medicine department at Assiut University Hospital, Assiut University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 20, 2021