An Interventional Study to Improve Medication Adherence Using Patient Decision Aid Among Adults With Under-Replaced HypoThyroidism (IMPART): A Randomized Control Study

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Background: Although hypothyroidism is easily treated with levothyroxine (LT4) replacement, results from several studies indicate that people receiving LT4 replacement often have under- or over-replaced thyroid function. Poor medication adherence and factors interfering with thyroxine absorption and bioavailability may result in such under-replacement. Using the COM-B (Capability, Motivation, and Opportunity - Behavior) model, a health education intervention using patient decision aid (PDA), was developed for primary care physicians to educate individuals about thyroxine replacement. Besides imparting health literacy, PDAs provide greater comfort of the patients to participate in decision making. Intervention with the PDA aims to improve the medication adherence by increasing patients' knowledge about thyroxine replacement. Specific aims: The primary aim is to determine effectiveness of PDA in improving the knowledge, medication adherence and quality of life of the under-replaced hypothyroid adults in a primary care setting. Secondary aims are to explore their understanding and acceptance on the PDA and to assess their perceived usability of this PDA. Methodology: A randomised controlled trial will be conducted at SingHealth Polyclinics (SHP) using mixed-method study design to determine effectiveness of PDA. Patient participants will be randomly allocated in a 1:1 ratio to either the intervention or control group. A total of 236 (118 in each group) patient participants will be enrolled by simple randomization. Eligible patient must be of age ≥21 years years and have LT4 under-replacement with Thyroid stimulating hormone (TSH) \>3.7 mIU/L within the last 6 months. Relevance/significance of the study: Findings from the study may add evidence to the scientific knowledge of using PDA to improve medication adherence and recommend development of similar interventions for other chronic medical conditions.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:

• Age ≥21 years

• Able to read and speak English

• Active patient with hypothyroidism at SingHealth Polyclinics (SHP) {had minimum of 2 follow-up visits at the respective study site in the last 12 months}

• TSH \>3.70 milli-international units per liter (mIU/L)

Locations
Other Locations
Singapore
SingHealth Polyclinics
RECRUITING
Singapore
Contact Information
Primary
Kalaipriya Gunasekaran, MD
kalaipriya.gunasekaran@singhealth.com.sg
(65)98071122
Time Frame
Start Date: 2024-03-15
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 236
Treatments
Experimental: intervention arm using PDA
The intervention arm participants will watch the PDA which is estimated to take 10 minutes, after their consultation with the physician. The participants will be directed to a private room to watch the PDA.
No_intervention: Control arm
The control arm participants will receive a thyroxine replacement pamphlet at their routine clinic appointment but will not attend the health education session using the PDA.
Related Therapeutic Areas
Sponsors
Leads: SingHealth Polyclinics

This content was sourced from clinicaltrials.gov