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Clinical Trials/CTRI/2021/07/034732
CTRI/2021/07/034732Not yet recruitingNot Applicable

Prevalence and Contributing factors of Hypothyroidism and the effectiveness of a Nurse led multi intervention programme on Quality of life, Subjective well being and level of Thyroid hormones among patients with Hypothyroidism.

Aster MIMS Hospital1 site in 1 country90 target enrollmentStarted: July 30, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
90
Locations
1
Primary Endpoint
improvement in overall quality of life score

Study Overview

Brief Summary

PURPOSEOF THE STUDY

The purpose of the study is to identify theprevalence of Hypothyroidism in the Kannur district, Kerala. Further it aims toidentify the contributing factors of Hypothyroidism. Further it intends to findthe effect of nurse led multi intervention programme on Quality of Life andSubjective Well Being and Thyroid Hormone Levels.

BACKGROUNDOF THE STUDY

Thethyroid gland secretes thyroid hormones, which primarily influencethe metabolic rate and protein synthesis. The hormones also havemany other effects including those on development. Hypothyroidism,also called underactive thyroid or low thyroid, is acommon disorder of endocrine system in which the thyroidgland does not produce enough thyroid hormone. It can cause anumber of symptoms, such as poor ability to tolerate cold, a feeling oftiredness, constipation, depression, and weight gain. Disorders ofthe thyroid gland result primarily from autoimmune process that stimulate theover production of thyroid hormones or cause glandular destruction and underproduction of thyroid hormones, hypothyroidism. Worldwide, too littleiodine in the diet is the most common cause of hypothyroidism. Incountries with enough iodine in the diet, the most common cause ofhypothyroidism is the autoimmune condition called Hashimoto Thyroditis. Nearly42 million Indians reportedly have abnormal thyroid hormone levels. Indiaaccounts for 21 percent of the global population that has thyroid disorders. Nearlyevery third Indian suffers from one or the other kind of thyroid disorder,which most often causes weight gain and hormonal imbalances, and is morecommonly seen in women, according to a survey. Many patients with a diagnosisof hypothyroidism report a decreased quality of life compared to people withouthypothyroidism. Patients with untreated hypothyroidism had worse quality oflife, predominantly fatigue, compared to healthy patients withouthypothyroidism. Though India have passed two decades after the implementationof Iodine Deficiency Disease control programme and Iodisation of salt,hypothyroidism is still a concern to be tackled. It occurs in different formsvarying from congenital to auto immune types to adult form. The treatment ismore or less lifelong and quality of life and subjective well beingis affectedconsiderably.

Study Design

Study Type
Interventional
Allocation
Not Applicable
Masking
Not Applicable

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •all adults from 18 to 60 years , both male and female, who are diagnosed to have Hypothyroidism and on treatment with Eltroxine from a registered endocrinologist and who are attending selected enocrinology clinics and those who are willing to sign an informed consent will be included in the study.

Exclusion Criteria

  • •Adults who have restriction in neck movement either imposed or natural , and those who are not willing for follow up treatment will be exluded from the study.

Outcomes

Primary Outcomes

improvement in overall quality of life score

Time Frame: one month, two months and three months

Secondary Outcomes

  • improvement in subjective well being as measured by SUBI (Subjective Well Being Inventory) questionnaire.(Laboratory valiues of Thyroid Hormones specifically T4 and TSH normal)

Investigators

Sponsor
Aster MIMS Hospital
Sponsor Class
Private hospital/clinic

Study Sites (1)

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