N/A
N=72
Efficacy of a Health Belief Model Based Intervention for Anticoagulation Adherence
Anticoagulants
Bottom Line
View on ClinicalTrials.gov: NCT03864900 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: The Short-form Adherence to Refills and Medications Scale (ARMS) — 9.6; 9.4; 8.5; 9.3 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- The medication adherence intervention (Behavioral)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- National Taipei University of Nursing and Health Sciences
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Short-form Adherence to Refills and Medications Scale (ARMS) |
9.6; 9.4; 8.5; 9.3; 8.1; 9.2 | — |
| SECONDARY The Knowledge of Warfarin Anticoagulation Treatment Scale |
35.9; 36.9; 63.9; 43.7; 66.4; 49.5 | — |
| SECONDARY The Perceived Benefits Subscale of the Beliefs About Anticoagulation Survey (BAAS) |
20.2; 19.9; 20.9; 19.8; 21.6; 20.3 | — |
| SECONDARY The Concerns About Anticoagulation Therapy Scale |
1.2; 1.8; 0.8; 1.4; 0.5; 1.1 | — |
| SECONDARY The Self-efficacy for Appropriate Medication Use Scale (SEAMS) |
32.0; 31.4; 33.7; 33.1; 35.3; 33.3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- ≥ 20 years of age
- fluent in Mandarin or Taiwanese
- diagnosed with AF
- treated with warfarin or NOACs for anticoagulation.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03864900). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.