1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Researchers who provide a methodologically sound proposal.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [salina.surabhi@gmail.com].
   


6. For how long will this data be available start date provided 14-06-2022 and end date provided 15-01-2026?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

PURPOSE OF THE STUDY

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

BACKGROUND OF THE STUDY

The thyroid gland secretes thyroid hormones, which primarily influence the metabolic rate and protein synthesis. The hormones also have many other effects including those on development^. Hypothyroidism, also called underactive thyroid or low thyroid, is a common disorder of endocrine system in which the thyroid gland does not produce enough thyroid hormone. It can cause a number of symptoms, such as poor ability to tolerate cold, a feeling of tiredness, constipation, depression, and weight gain. Disorders of the thyroid gland result primarily from autoimmune process that stimulate the over production of thyroid hormones or cause glandular destruction and under production of thyroid hormones, hypothyroidism. Worldwide, too little iodine in the diet is the most common cause of hypothyroidism. In countries with enough iodine in the diet, the most common cause of hypothyroidism is the autoimmune condition called Hashimoto Thyroditis. Nearly 42 million Indians reportedly have abnormal thyroid hormone levels. India accounts for 21 percent of the global population that has thyroid disorders. Nearly every third Indian suffers from one or the other kind of thyroid disorder, which most often causes weight gain and hormonal imbalances, and is more commonly seen in women, according to a survey. Many patients with a diagnosis of hypothyroidism report a decreased quality of life compared to people without hypothyroidism. Patients with untreated hypothyroidism had worse quality of life, predominantly fatigue, compared to healthy patients without hypothyroidism. Though India have passed two decades after the implementation of Iodine Deficiency Disease control programme and Iodisation of salt, hypothyroidism is still a concern to be tackled. It occurs in different forms varying from congenital to auto immune types to adult form. The treatment is more or less lifelong and quality of life and subjective well beingis affected considerably.