Clinical trial NCT03864900: Efficacy of a Health Belief Model Based Intervention for Anticoagulation Adherence
Official title: Efficacy of a Health Belief Model Based Intervention for Anticoagulation Adherence in Patients With Atrial Fibrillation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anticoagulants
Keywords: Anticoagulants
Atrial fibrillation
Adherence
Health belief model
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
Collaborators: name: Taipei Medical University WanFang Hospital
name: Taipei Medical University Shuang Ho Hospital
First posted: 2019-03-06
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

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.

Detailed description: BACKGROUND: Inconsistent anticoagulation therapy in AF patients is associated with a higher risk of stroke and abnormal bleeding. However, control of oral anticoagulation therapy in AF patients has been frequently reported as inadequate. Few theoretical based interventions have been tested for enhancing medication adherence in this population. Previous studies showed that the health belief model may offer some advantage over other behavior change theories for enhancing medication adherence in adult with chronic conditions.

PURPOSE: 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.

METHODS: The study is a randomized clinical trial with repeated measurements. A convenient sample of 72 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. Allocation was balanced by site by using a minimization method. The health belief model based self-management intervention comprised two main components: a 60-minute individual face to face instruction and six follow-up telephone calls. 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. Data were collected at baseline, third month, and sixth month in both groups, by using self-administered questionnaires. The investigator administered the study questionnaire after obtaining informed consent from each subject. The data collection took place at the waiting areas outside the outpatient clinics during the patients' visits to the clinics. For subjects who were unable to read the questionnaire due to vision or other problems, the investigator read each question to help them complete the questionnaire. The instruments include the Atrial Fibrillation Knowledge Scale, Satisfaction Scale about Service and Warfarin Treatment, Belief About Anticoagulation Survey, and Self-Efficacy for Appropriate Medication Use Scale.

DATA ANALYSIS: Data were analyzed using the Statistical Package for Social Sciences 20.0 (SPSS, Inc., Chicago, IL, USA). Descriptive analyses were used to describe study variables. Independent t-tests and one-way analysis of variance (ANOVA) were performed to analyze the baseline equivalent between study groups. 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.

Eligibility criteria: Inclusion Criteria:

1. ≥ 20 years of age
2. fluent in Mandarin or Taiwanese
3. diagnosed with AF
4. treated with warfarin or NOACs for anticoagulation.

Exclusion Criteria:

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

Primary outcomes:
measure: The Short-form Adherence to Reﬁlls and Medications Scale (ARMS)
timeFrame: baseline (T1), 12th week (T2), and 24th week (T3) follow-ups.
Secondary outcomes:
measure: The Knowledge of Warfarin Anticoagulation Treatment Scale
timeFrame: baseline (T1), 12th week (T2), and 24th week (T3) follow-ups.
measure: The Perceived Benefits Subscale of the Beliefs About Anticoagulation Survey (BAAS)
timeFrame: baseline (T1), 12th week (T2), and 24th week (T3) follow-ups.
measure: The Concerns About Anticoagulation Therapy Scale
timeFrame: baseline (T1), 12th week (T2), and 24th week (T3) follow-ups.
measure: The Self-efficacy for Appropriate Medication Use Scale (SEAMS)
timeFrame: baseline (T1), 12th week (T2), and 24th week (T3) follow-ups.
Other outcomes:
measure: The Satisfaction Scale About Service and Warfarin Treatment (SSWT)
timeFrame: baseline (T1), 12th week (T2), and 24th week (T3) follow-ups
Locations:
city: Taipei county
country: Taiwan
facility: Taipei Medical University Shuang Ho Hospital
state: Taipei
city: Taipei
country: Taiwan
facility: Taipei Medical University WanFang Hospital
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences
name: Tsae Jyy Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.