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NCT Number: NCT07636681

Effect of Medication Adherence-Based Digital Intervention on Fatigue Severity, Weight, and Thyroid Hormone Regulation

1. To evaluate the effect of a medication adherence-based digital intervention on fatigue severity in patients with hypothyroidism. 2. To assess the effect of a medication adherence-based digital intervention on weight in patients with hypothyroidism. 3. To investigate the effect of a medication adherence-based digital intervention on thyroid hormone regulation in patients with hypothyroidism.

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Key information

Conditions

Hypothyroidism Endocrine System Diseases Thyroid Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Baghdad

Baghdad, Iraq

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults (≥18 years) with primary hypothyroidism.
  • On stable levothyroxine therapy for at least 3 months.
  • Able to read, understand study instructions
  • capable of using basic mobile applications
  • poor medication adherence, clinically significant fatigue, documented weight fluctuations and abnormal thyroid hormone

Exclusion criteria

  • Secondary hypothyroidism or recent thyroidectomy/radioactive iodine therapy.
  • Pregnancy or breastfeeding woman.
  • Severe psychiatric disorders or cognitive impairment
  • significant visual or hearing deficits
  • Serious comorbidities affecting medication adherence (e.g., chronic disease, renal, or hepatic disease).
  • take dietary supplements or medications that interfere with levothyroxine absorption.

Treatment and study plan

medication adherence based digital intervention

Other

participants in the intervention group will receive digital support aimed at improving their adherence to prescribed medications. This support will include a smartphone application developed specifically for the study, as well as reminder messages via WhatsApp to prompt participants to take their levothyroxine at the scheduled times

Other names: intervntion group

Primary outcomes

  1. Change in Fatigue Severity Score

    Time frame: Baseline and 3 months after intervention

    Assessment of the effectiveness of a medication adherence-based digital intervention on fatigue severity by using the Fatigue Severity Scale (FSS).

  2. Change in Body Weight

    Time frame: Baseline and 3 months after intervention.

    Assessment of the effectiveness of a medication adherence-based digital intervention on weight by assessment of changes in Body Mass Index (BMI), calculated as weight in kilograms divided by height in meters squared (kg/m²).

  3. Change in Thyroid Hormone Levels

    Time frame: Baseline and 3 months after intervention.

    Assessment of the effectiveness of a medication adherence-based digital intervention on Thyroid Hormone Levels by assessment of serum Thyroid Stimulating Hormone (TSH) and Free Thyroxine (FT4) levels.

Study contacts

Contact information is provided by the study sponsor or research team.

Shahad Sabah Khudhair

CONTACT

[email protected]

9647737721360

Sponsors and collaborators

Lead sponsor

University of Baghdad

Other

Registry information

Official study title

Effect of Medication Adherence-Based Digital Intervention on Fatigue Severity, Weight, and Thyroid Hormone Regulation in Patients With Hypothyroidism: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 9, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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