HypothyroidismNCT07636681
Effect of Medication Adherence-Based Digital Intervention on Fatigue Severity, Weight, and Thyroid Hormone Regulation
A study testing medication adherence based digital intervention in people with Hypothyroidism, run by University of Baghdad at 1 site in Iraq.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hypothyroidism
- What is being tested?
- medication adherence based digital intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIraq
- Study dates
- 1 Jun 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Medication Adherence-Based Digital Intervention on Fatigue Severity, Weight, and Thyroid Hormone Regulation in Patients With Hypothyroidism: A Randomized Controlled Trial
- To evaluate the effect of a medication adherence-based digital intervention on fatigue severity in patients with hypothyroidism.
- To assess the effect of a medication adherence-based digital intervention on weight in patients with hypothyroidism.
- To investigate the effect of a medication adherence-based digital intervention on thyroid hormone regulation in patients with hypothyroidism.
- Conditions
- Hypothyroidism
- Being tested
- medication adherence based digital intervention
- Medical subject headings
- Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medication adherence based digital interventionOther
Also called intervntion 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: medication adherence based digital intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: Baseline and 3 months after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahad Sabah Khudhair, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636681
- Sponsor's protocol ID
- MA-Based Digital Intervention
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Medication Adherence-Based Digital Intervention on Fatigue Severity, Weight, and Thyroid Hormone Regulation in Patients With Hypothyroidism: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07636681
- Acronym / sponsor ID
- MA-Based Digital Intervention
- Conditions
- Hypothyroidism
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To evaluate the effect of a medication adherence-based digital intervention on fatigue severity in patients with hypothyroidism.
- To assess the effect of a medication adherence-based digital intervention on weight in patients with hypothyroidism.
- To investigate the effect of a medication adherence-based digital intervention on thyroid hormone regulation in patients with hypothyroidism.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –receive routine care |
| Intervention Group | Experimental | Other: medication adherence based digital interventionparticipants 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medication adherence based digital interventionAlso: intervntion groupparticipants 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 | Intervention Group |
Primary outcome
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).
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).
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing medication adherence based digital intervention in people with Hypothyroidism, run by University of Baghdad at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shahad Sabah Khudhair (9647737721360, shahed.sabbah1202a@conursing.uobaghdad.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fatigue Severity Score (time frame: Baseline and 3 months after intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.