NCT04004546

Brief Summary

This is a multi-center pilot study to examine the effectiveness of a health literacy-based intervention to improve medication adherence and self-efficacy of medication use among individuals with coronary heart disease (CHD). The specific aims are to: i) develop a health literacy-based intervention to improve medication adherence for CHD individuals with low health literacy and ii) evaluate the effects of a health literacy-based intervention on improving medication adherence and self-efficacy in CHD individuals.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 18, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 2, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

July 2, 2019

Status Verified

June 1, 2019

Enrollment Period

7 months

First QC Date

June 27, 2019

Last Update Submit

June 29, 2019

Conditions

Coronary Disease

Outcome Measures

Primary Outcomes (1)

  • Change from baseline medication adherence at 4-weeks follow-up

    Measured using the Chinese version of the Hill-Bone Medication Adherence Scale (HB-MAS). The HB-MAS is a self-reported measure of the extent of medication adherence. The HB-MAS consists of 9 questions with each item rated on a 4-point scale (1 = none of the time; 2 = some of the time; 3 = most of the time; and 4 = all of the time). The total score ranges from 9 (minimum) to 36 (maximum), where lower scores indicate higher levels of medication adherence.

    Baseline and 4-weeks follow-up

Secondary Outcomes (1)

  • Change from baseline medication self-efficacy at 4-weeks follow-up

    Baseline and 4-weeks follow-up

Other Outcomes (3)

  • Health literacy

    Baseline

  • Perceived social support

    Baseline

  • CHD knowledge

    Baseline

Study Arms (2)

Intervention group

EXPERIMENTAL

At baseline: video and education booklet. 2-weeks after enrollment: telephone call by nurse.

Behavioral: Health literacy-based intervention

Control group

NO INTERVENTION

Usual care

Interventions

Health literacy-based interventionBEHAVIORAL

Participants in the intervention group will receive a: i) 30-min video about medication adherence, ii) medication adherence booklet, and iii) 2-week telephone call by a nurse.

Intervention group

Eligibility Criteria

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

You may qualify if:

  • Aged ≥18 years and diagnosed with CHD.
  • Currently receiving pharmacological therapy such as statins, anti-platelet and/or blood thinner, beta-blockers, calcium channel blockers, nitroglycerin, and angiotensin- converting enzyme inhibitors (ACE).
  • Low health literacy score of 9 or less as measured using the short-form Mandarin Health Literacy Scale (s-MHLS).

You may not qualify if:

  • History of significant cognitive impairment, psychiatric disorders, and aphasia.
  • Without access to a telephone or unable to give telephone contact.
  • Currently enrolled in another program or clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Nethersole School of Nursing, The Chinese University of Hong Kong

Shatin, New Territories, Hong Kong

RECRUITING

School of Nursing, National Taiwan University

Taipei, Taiwan

NOT YET RECRUITING

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Elaine Siow, PhD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

  • Chang Nien-Tzu, PhD

    National Taiwan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elaine Siow, PhD

CONTACT

(+852) 39439303elainesiow@cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professional Consultant

Study Record Dates

First Submitted

June 27, 2019

First Posted

July 2, 2019

Study Start

March 18, 2019

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

July 2, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)TW(1)