Efficacy of a Health Belief Model Based Intervention for Anticoagulation Adherence

NCT03864900 | Completed Results

• 1 other identifier: 201505054
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief Summary

Inconsistent anticoagulation therapy in AF patients is associated with a higher risk of stroke and abnormal bleeding. The purpose of the study is to investigate the efficacy of a health belief model based self-management of oral anticoagulant therapy intervention on the outcome of medication adherence and the mediators of knowledge, professional support, health belief, and self-efficacy in patients treated with oral anticoagulants for atrial fibrillation. A randomized clinical trial with repeated measurements was conducted. A convenient sample of 110 adults who were treated with anticoagulants for atrial fibrillation was recruited from two teaching hospitals in northern Taiwan. Participants were randomly assigned 1:1 to either the control group (n = 36) or the intervention group (n = 36) after completion of baseline questionnaires. Patients in the experimental group received the health belief model based anticoagulation adherence intervention, including one 60-minute individual instructions and six 15-minute telephone follow-ups. Participants in the control group received regular medication education, 10-minute individual instruction for health knowledge and six follow-up telephone calls for concerning health. Patients in both groups answered the study questionnaires at three and six months. The generalized estimating equations were used to analyze the efficacy of the intervention for enhancing knowledge, knowledge, perceived benefits, perceived barriers, self-efficacy, and adherence to anticoagulant therapies in patients treated with oral anticoagulants for atrial fibrillation. The results of the study will contribute to the knowledge for improving adherence to oral anticoagulation therapies in patients with atrial fibrillation.

Conditions

Anticoagulants

Keywords

Anticoagulants; Atrial fibrillation; Adherence; Health belief model

Outcome Measures

Primary Outcomes (1)

• The Short-form Adherence to Refills and Medications Scale (ARMS)

  There are seven items in the scale. Subjects were asked to indicate how often they actually miss taking their anticoagulants in each item on a 4-point Likert scale (1\_ none of the time to 4\_ all of the time). The total score of the 7 items represents the scale score, with a possible range of 7 to 28. A higher score indicates worse adherence to anticoagulation treatment.

  baseline (T1), 12th week (T2), and 24th week (T3) follow-ups.

Secondary Outcomes (4)

• The Knowledge of Warfarin Anticoagulation Treatment Scale

  baseline (T1), 12th week (T2), and 24th week (T3) follow-ups.

• The Perceived Benefits Subscale of the Beliefs About Anticoagulation Survey (BAAS)

  baseline (T1), 12th week (T2), and 24th week (T3) follow-ups.

• The Concerns About Anticoagulation Therapy Scale

  baseline (T1), 12th week (T2), and 24th week (T3) follow-ups.

• The Self-efficacy for Appropriate Medication Use Scale (SEAMS)

  baseline (T1), 12th week (T2), and 24th week (T3) follow-ups.

Other Outcomes (1)

• The Satisfaction Scale About Service and Warfarin Treatment (SSWT)

  baseline (T1), 12th week (T2), and 24th week (T3) follow-ups

Study Arms (2)

The intervention group

EXPERIMENTAL

The medication adherence intervention comprised two main components: a 60-minute individual face to face instruction and six follow-up telephone calls.

Behavioral: The medication adherence intervention

The control group

NO INTERVENTION

Participants in the control group received regular medication education, 10-minute individual instruction for health knowledge and six follow-up telephone calls for concerning health.

Interventions

The medication adherence intervention BEHAVIORAL

The health belief model based medication adherence intervention comprised two main components: a 60-minute individual face to face instruction and six follow-up telephone calls.

The intervention group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 20 years of age
• fluent in Mandarin or Taiwanese
• diagnosed with AF
• treated with warfarin or NOACs for anticoagulation.

You may not qualify if:

• diagnosed with psychological diseases
• diagnosed with uncontrolled hypertension
• diagnosed with the New York Heart Association (NYHA) grade VI heart failure
• implanted with a cardiac pacemaker
• had cardiac surgery in the past three months
• hospitalized for AF in the past three months.

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: lead
• Taipei Medical University WanFang Hospital: collaborator
• Taipei Medical University Shuang Ho Hospital: collaborator

Study Sites (2)

Taipei Medical University Shuang Ho Hospital

Taipei County, Taipei, 235, Taiwan

Location

Taipei Medical University WanFang Hospital

Taipei, 116, Taiwan

Location

Related Publications (3)

• Chiang CE, Wu TJ, Ueng KC, Chao TF, Chang KC, Wang CC, Lin YJ, Yin WH, Kuo JY, Lin WS, Tsai CT, Liu YB, Lee KT, Lin LJ, Lin LY, Wang KL, Chen YJ, Chen MC, Cheng CC, Wen MS, Chen WJ, Chen JH, Lai WT, Chiou CW, Lin JL, Yeh SJ, Chen SA. 2016 Guidelines of the Taiwan Heart Rhythm Society and the Taiwan Society of Cardiology for the management of atrial fibrillation. J Formos Med Assoc. 2016 Nov;115(11):893-952. doi: 10.1016/j.jfma.2016.10.005. Epub 2016 Nov 24.

  PMID: 27890386 BACKGROUND

• Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Alexandru Popescu B, Schotten U, Van Putte B, Vardas P. 2016 ESC Guidelines for the Management of Atrial Fibrillation Developed in Collaboration With EACTS. Rev Esp Cardiol (Engl Ed). 2017 Jan;70(1):50. doi: 10.1016/j.rec.2016.11.033. No abstract available. English, Spanish.

  PMID: 28038729 BACKGROUND

• January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2014 Dec 2;64(21):e1-76. doi: 10.1016/j.jacc.2014.03.022. Epub 2014 Mar 28. No abstract available.

  PMID: 24685669 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Director of Nursing Department
• Organization: National Taipei University of Nursing and Health Sciences

tsaejyy@ntunhs.edu.tw

886-2-28712121

Study Officials

• Tsae Jyy Wang, PhD

  National Taipei University of Nursing and Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Both participants and care providers were unaware of the group assignment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN PhD Professor

Model Details: The health belief model based medication adherence intervention comprised two main components: a 60-minute individual face to face instruction and six follow-up telephone calls.

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: March 6, 2019
• Study Start: October 13, 2015
• Primary Completion: April 20, 2017
• Study Completion: October 20, 2017
• Last Updated: September 22, 2021
• Results First Posted: June 14, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)