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

June 3, 2026 updated by: Shahad Sabah Khudhair, University of Baghdad

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

  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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Iraq
      • Baghdad, Iraq
        • University of Baghdad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
receive routine care
Experimental: Intervention Group
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: medication adherence based digital intervention
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline and 3 months after intervention
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).
Baseline and 3 months after intervention.
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.
Baseline and 3 months after intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Baghdad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

May 21, 2026

First Submitted That Met QC Criteria

June 3, 2026

First Posted (Actual)

June 9, 2026

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MA-Based Digital Intervention

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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