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

NCT07636681 | Not Yet Recruiting

• 1 other identifier: MA-Based Digital Intervention
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypothyroidism

Outcome Measures

Primary Outcomes (3)

• Change in Fatigue Severity Score

  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

  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

  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.

Study Arms (2)

Control Group

NO INTERVENTION

receive routine care

Intervention Group

EXPERIMENTAL

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

Interventions

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

Also known as: intervntion group

Intervention Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

University of Baghdad

Baghdad, Iraq

Location

MeSH Terms

Conditions

Hypothyroidism

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Central Study Contacts

Shahad Sabah Khudhair

CONTACT

9647737721360; shahed.sabbah1202a@conursing.uobaghdad.edu.iq

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 9, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: June 9, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)