Interventional Study to Improve Medication Adherence Using Patient Decision Aid

NCT06205303 | Completed

• 1 other identifier: 2023/2466
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypothyroidism

Keywords

thyroxine; under-replacement; medication adherence; PDA; intervention

Outcome Measures

Primary Outcomes (4)

• Knowledge about thyroxine replacement

  Change in the scores using knowledge on thyroxine replacement questionnaire; a newly developed knowledge questionnaire to access patients' understanding of thyroxine replacement comprising 16 questions scored from a scale of 0-5: 0 (Always), 1 (a few times a week), 2 (once a week or less), 3 (a few times a month), 4 (once a month or less) and 5 (Never). A higher score indicates better understanding.

  through study completion, an average of 8 weeks to 9 months

• Medication adherence

  Change in the scores using five-item Medication Adherence Report Scale (MARS-5); MARS-5 score was calculated by summing the numeric score (range 1-5) from each question for out of 25 (range 5-25). A higher score indicates better adherence.

  through study completion, an average of 8 weeks to 9 months

• Beliefs about medication

  Change in the scores using Beliefs About Medicines Questionnaire (BMQ). The BMQ is an 18-item questionnaire which consists of two components assessing patient's perceptions towards medications, BMQ-Specific and BMQ-General. The responses in both subscales are recorded on a five-point Likert scale. A higher score indicate stronger beliefs.

  through study completion, an average of 8 weeks to 9 months

• Health related Quality of life

  Change in the scores using the 5 Level EuroQol-5 Dimension (EQ-5D-5L) questionnaire; The EQ-5D-5L tool comprises five dimensions, each describing a different aspect of health: mobility, self-care, usual activities, pain/ discomfort and anxiety/ depression. Each dimension has five response levels (no problems, slight problems, moderate problems, severe problems, unable to/extreme problems). The proportion of patients reporting each level of problem on each dimension of the EuroQol-5 Dimension (EQ-5D) will be determined through study completion and compared. EuroQol Visual Analogue Scale (EQ VAS) provides a quantitative measure of the patient's perception of their overall health. The EQ VAS records the respondent's overall current health on a vertical scale (0-100), where the endpoints are labelled '0-The worst health you can imagine' and '100-The best health you can imagine'.

  through study completion, an average of 8 weeks to 9 months

Secondary Outcomes (2)

• Usability of PDA

  after the intervention up to 9 months

• Patients' understanding and acceptance

  immediately after the intervention

Study Arms (2)

intervention arm using PDA

EXPERIMENTAL

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.

Other: Patient Decision Aid (Video)

Control arm

NO INTERVENTION

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.

Interventions

Patient Decision Aid (Video) OTHER

Patient decision aid on thyroxine replacement is a video designed to assist the hypothyroid adults with under-replacement. It provides clear and balanced information about hypothyroidism, the role of thyroxine, treatment benefits, potential risks, and factors interfering thyroxine absorption and bioavailability. The PDA aims to empower patients to engage in shared decision-making with their healthcare provider, ensuring they understand the options and can make choices aligned with their preferences and values.

intervention arm using PDA

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Euthyroid state (TSH 0.65-3.70 mIU/L)
• LT4 over-replacement (TSH \<0.65 mIU/L)
• Individuals who are severely ill or with hearing impairment and mental disturbances
• Pregnant women
• Sick euthyroid syndrome

Sponsors & Collaborators

• SingHealth Polyclinics: lead

Study Sites (1)

SingHealth Polyclinics

Singapore, Singapore

Location

Related Publications (4)

• Tan NC, Chew RQ, Koh YLE, Subramanian RC, Sankari U, Meyappan M, Cho LW. Primary hypothyroidism in the community: Lower daily dosages of levothyroxine replacement therapy for Asian patients. Medicine (Baltimore). 2017 Feb;96(7):e6145. doi: 10.1097/MD.0000000000006145.

  PMID: 28207545 BACKGROUND

• Crilly M, Esmail A. Randomised controlled trial of a hypothyroid educational booklet to improve thyroxine adherence. Br J Gen Pract. 2005 May;55(514):362-8.

  PMID: 15904555 BACKGROUND

• Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42. doi: 10.1186/1748-5908-6-42.

  PMID: 21513547 BACKGROUND

• Jackson C, Eliasson L, Barber N, Weinman J. Applying COM-B to medication adherence: a suggested framework for research and interventions. Eur Health Psychol. 2014;16:7-17.

  BACKGROUND

MeSH Terms

Conditions

Hypothyroidism; Medication Adherence

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• Kalaipriya Gunasekaran, MD

  SingHealth Polyclinics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: January 16, 2024
• Study Start: March 15, 2024
• Primary Completion: October 6, 2025
• Study Completion: October 6, 2025
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)