NCT05828732

Brief Summary

This randomized controlled study aims to investigate the effects of using a mobile app that integrates with wearable devices to monitor heart rate, check self-reported symptoms, provide disease-related information, and set medication reminders for patients with thyrotoxicosis. The study intends to evaluate how the use of the app affects disease progression, quality of life, and health-related behaviors associated with the disease.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 12, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

1.6 years

First QC Date

April 12, 2023

Last Update Submit

April 12, 2023

Conditions

Hyperthyroidism

Outcome Measures

Primary Outcomes (8)

  • Scores of quality of life assessed by SF-36 survey

    Scores of quality of life assessed by SF-36 survey

    baseline (at enrollment)

  • Scores of quality of life assessed by SF-36 survey

    Scores of quality of life assessed by SF-36 survey

    6 weeks after baseline

  • Scores of quality of life assessed by SF-36 survey

    Scores of quality of life assessed by SF-36 survey

    10 weeks after baseline

  • Scores of quality of life assessed by SF-36 survey

    Scores of quality of life assessed by SF-36 survey

    14 weeks after baseline

  • antithyroidal drug compliance

    Medication adherence assessed by directly counting the remaining pills after taking the prescribed medication.

    6 weeks after baseline

  • antithyroidal drug compliance

    Medication adherence assessed by directly counting the remaining pills after taking the prescribed medication.

    10 weeks after baseline

  • antithyroidal drug compliance

    Medication adherence assessed by directly counting the remaining pills after taking the prescribed medication.

    14 weeks after baseline

  • Knowledge about hyperthyroidism

    A score measured through a test designed to assess the knowledge level about Graves' disease

    14 weeks after baseline

Secondary Outcomes (12)

  • free T4

    baseline

  • free T4

    6 weeks after baseline

  • free T4

    10 weeks after baseline

  • free T4

    14 weeks after baseline

  • free T3

    baseline

  • +7 more secondary outcomes

Study Arms (2)

app user group

EXPERIMENTAL

The participants in this group start using wearable devices to monitor their heart rate and a mobile app to assist with the management of hyperthyroidism after being diagnosed and beginning treatment with anti-thyroid medication.

Other: Using a mobile app that integrates with wearable devices

non-user group

NO INTERVENTION

The participants in this group begin treatment with anti-thyroid medication after being diagnosed with thyrotoxicosis, but they do not use the wearable devices or mobile app used in this study.

Interventions

Using a mobile app that integrates with wearable devicesOTHER

Using a mobile app that integrates with wearable devices to monitor heart rate, check self-reported symptoms, provide disease-related information, and set medication reminders for patients with thyrotoxicosis.

app user group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who have been newly diagnosed or are currently undergoing treatment for thyrotoxicosis at Bundang Seoul National University Hospital.
  • Subjects must be able to use the smartphone app required for the use of wearable devices and their integration.

You may not qualify if:

  • Subjects who have constraints on normal activity due to diseases other than thyroid dysfunction.
  • Subjects who are currently taking medication that affects heart rate.
  • Subjects with heart conditions such as arrhythmia that affect heart rate.
  • Subjects who cannot undergo antithyroid drug treatment and require surgery or radioactive iodine therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

MeSH Terms

Conditions

Hyperthyroidism

Interventions

Wearable Electronic Devices

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Electrical Equipment and SuppliesEquipment and Supplies

Central Study Contacts

Jae Hoon Moon, MD

CONTACT

+82-31-787-7068jaemoon76@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 12, 2023

First Posted

April 25, 2023

Study Start

March 1, 2022

Primary Completion

September 30, 2023

Study Completion

December 31, 2023

Last Updated

April 25, 2023

Record last verified: 2023-04

Locations

KR(1)