Trial Outcomes & Findings for Efficacy of a Health Belief Model Based Intervention for Anticoagulation Adherence (NCT NCT03864900)

NCT ID: NCT03864900

Last Updated: 2021-09-22

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 72 participants
• Primary outcome timeframe: baseline (T1), 12th week (T2), and 24th week (T3) follow-ups.
• Results posted on: 2021-09-22

Participant Flow

Participant milestones

Measure	The Intervention Group The medication adherence intervention comprised two main components: a 60-minute individual face to face instruction and six follow-up telephone calls. The medication adherence intervention: 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 Control Group 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.
Overall Study STARTED	36	36
Overall Study COMPLETED	33	30
Overall Study NOT COMPLETED	3	6

Reasons for withdrawal

Measure	The Intervention Group The medication adherence intervention comprised two main components: a 60-minute individual face to face instruction and six follow-up telephone calls. The medication adherence intervention: 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 Control Group 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.
Overall Study Withdrawal by Subject	1	1
Overall Study medical reason: change anticoagulation drug, Hemorrhage, operation	2	5

Baseline Characteristics

Efficacy of a Health Belief Model Based Intervention for Anticoagulation Adherence

Baseline characteristics by cohort

Measure	The Intervention Group n=36 Participants The medication adherence intervention comprised two main components: a 60-minute individual face to face instruction and six follow-up telephone calls. The medication adherence intervention: 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 Control Group n=36 Participants 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.	Total n=72 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Age, Categorical >=65 years	22 Participants n=5 Participants	22 Participants n=7 Participants	44 Participants n=5 Participants
Age, Continuous	69.3 years STANDARD_DEVIATION 7.5 • n=5 Participants	73.3 years STANDARD_DEVIATION 10 • n=7 Participants	71.3 years STANDARD_DEVIATION 9.0 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	17 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	19 Participants n=7 Participants	43 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	36 Participants n=5 Participants	36 Participants n=7 Participants	72 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Taiwan	36 Participants n=5 Participants	36 Participants n=7 Participants	72 Participants n=5 Participants
Kinds of Anticoagulation Warfarin	17 participants n=5 Participants	17 participants n=7 Participants	34 participants n=5 Participants
Kinds of Anticoagulation NOACs	19 participants n=5 Participants	19 participants n=7 Participants	38 participants n=5 Participants

PRIMARY outcome

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

Population: All participants with baseline and at least fellow up for 24 weeks

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.

Outcome measures

Measure	The Intervention Group n=36 Participants The medication adherence intervention comprised two main components: a 60-minute individual face to face instruction and six follow-up telephone calls. The medication adherence intervention: 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 Control Group n=36 Participants 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.
The Short-form Adherence to Refills and Medications Scale (ARMS) baseline (T1)	9.6 score on a scale Standard Deviation 1.6	9.4 score on a scale Standard Deviation 1.7
The Short-form Adherence to Refills and Medications Scale (ARMS) 12th week (T2)	8.5 score on a scale Standard Deviation 1.7	9.3 score on a scale Standard Deviation 2.2
The Short-form Adherence to Refills and Medications Scale (ARMS) 24th week (T3)	8.1 score on a scale Standard Deviation 1.4	9.2 score on a scale Standard Deviation 2.2

SECONDARY outcome

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

The 11-item scale covers four areas of warfarin treatment knowledge: administration (e.g., dose, color, and route of administration), interaction with foods, interaction with other drugs, and side effects. There are five choices for each item, and only one of the choices is correct (scored 1). The total score of the 11 items represents the scale score, with a possible range of 0 to 11. Higher scores indicate higher levels of understanding of warfarin treatment. The scale was also modified to measure the NOACs treatment knowledge. To facilitate analysis and comparison, the score of each scale was converted to a scale of 0 to 100 (actual score/possible maximum score x 100).

Outcome measures

Measure	The Intervention Group n=36 Participants The medication adherence intervention comprised two main components: a 60-minute individual face to face instruction and six follow-up telephone calls. The medication adherence intervention: 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 Control Group n=36 Participants 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.
The Knowledge of Warfarin Anticoagulation Treatment Scale Baseline (T1)	35.9 percentage of accuracy Standard Deviation 15.7	36.9 percentage of accuracy Standard Deviation 20.0
The Knowledge of Warfarin Anticoagulation Treatment Scale 12th week (T2)	63.9 percentage of accuracy Standard Deviation 22.5	43.7 percentage of accuracy Standard Deviation 23.0
The Knowledge of Warfarin Anticoagulation Treatment Scale 24th week (T3)	66.4 percentage of accuracy Standard Deviation 18.2	49.5 percentage of accuracy Standard Deviation 21.8

SECONDARY outcome

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

The subscale covers 5 potential benefits of taking anticoagulation, including lessening the risk of having a stroke, lowering the chance of being hospitalized, feeling healthier, improving quality of life, and worrying less about the disease. For each item, the subjects indicated their levels of agreement on a 5-point Likert scale (from 1_ strongly disagree to 5_ strongly agree). The potential scores range from 5 to 25 points, with higher scores indicating higher levels of perceived benefits associated with taking anticoagulation.

Outcome measures

Measure	The Intervention Group n=36 Participants The medication adherence intervention comprised two main components: a 60-minute individual face to face instruction and six follow-up telephone calls. The medication adherence intervention: 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 Control Group n=32 Participants 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.
The Perceived Benefits Subscale of the Beliefs About Anticoagulation Survey (BAAS) baseline (T1)	20.2 units on a scale Standard Deviation 2.6	19.9 units on a scale Standard Deviation 2.0
The Perceived Benefits Subscale of the Beliefs About Anticoagulation Survey (BAAS) 12th week (T2)	20.9 units on a scale Standard Deviation 2.6	19.8 units on a scale Standard Deviation 1.3
The Perceived Benefits Subscale of the Beliefs About Anticoagulation Survey (BAAS) 24th week (T3)	21.6 units on a scale Standard Deviation 2.6	20.3 units on a scale Standard Deviation 2.1

SECONDARY outcome

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

The scale lists ten potential concerns, including drug interactions, forgetting to take anticoagulants, side effects, hospital visits, diet interactions, activity restrictions, impact on work, not helpful, and difficulty of following instructions. The subjects were asked to indicate all concerns that apply to them. Each concern was scored 1. The potential scores range from 0 to 10, with higher scores indicating more concerns.

Outcome measures

Measure	The Intervention Group n=36 Participants The medication adherence intervention comprised two main components: a 60-minute individual face to face instruction and six follow-up telephone calls. The medication adherence intervention: 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 Control Group n=36 Participants 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.
The Concerns About Anticoagulation Therapy Scale baseline (T1)	1.2 score on a scale Standard Deviation 1.4	1.8 score on a scale Standard Deviation 1.4
The Concerns About Anticoagulation Therapy Scale 12th week (T2)	0.8 score on a scale Standard Deviation 1.4	1.4 score on a scale Standard Deviation 1.5
The Concerns About Anticoagulation Therapy Scale 24th week (T3)	0.5 score on a scale Standard Deviation 1.0	1.1 score on a scale Standard Deviation 1.2

SECONDARY outcome

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

The 13-item scale covers two dimensions of self-efficacy: for taking medications under difficult circumstances and for taking medications under uncertain or changing circumstances. For each item, the subjects indicated their level of confidence about taking medications correctly under a specific circumstance on a three-point response scale (1 _ not confident, 2 _ somewhat confident, and 3 _ very confident). The potential scores range from 13 to 39, with high scores indicating higher levels of self-efficacy for appropriate anticoagulant use.

Outcome measures

Measure	The Intervention Group n=36 Participants The medication adherence intervention comprised two main components: a 60-minute individual face to face instruction and six follow-up telephone calls. The medication adherence intervention: 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 Control Group n=36 Participants 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.
The Self-efficacy for Appropriate Medication Use Scale (SEAMS) baseline (T1)	32.0 score on a scale Standard Deviation 6.0	31.4 score on a scale Standard Deviation 6.4
The Self-efficacy for Appropriate Medication Use Scale (SEAMS) 12th week (T2)	33.7 score on a scale Standard Deviation 5.2	33.1 score on a scale Standard Deviation 5.5
The Self-efficacy for Appropriate Medication Use Scale (SEAMS) 24th week (T3)	35.3 score on a scale Standard Deviation 4.5	33.3 score on a scale Standard Deviation 4.6

OTHER_PRE_SPECIFIED outcome

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

The original scale includes seven positive statements about the services and warfarin treatment. In the current study, the term of warfarin was replaced with anticoagulants. The item 5 (regarding INR monitoring) in the original scale was deleted as it only applies to patients treated with warfarin. Therefore, there were only six items used in the current study. For each item, the subjects indicated their levels of agreement on a 5-point Likert scale (from 0_ strongly disagree to 4_ strongly agree). The total score of the 6 items represents the scale score, with a possible range of 0 to 24. Higher scores indicate higher levels of satisfaction about service and warfarin treatment.

Outcome measures

Measure	The Intervention Group n=36 Participants The medication adherence intervention comprised two main components: a 60-minute individual face to face instruction and six follow-up telephone calls. The medication adherence intervention: 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 Control Group n=36 Participants 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.
The Satisfaction Scale About Service and Warfarin Treatment (SSWT) baseline (T1)	19.7 score on a scale Standard Deviation 3.1	18.8 score on a scale Standard Deviation 2.9
The Satisfaction Scale About Service and Warfarin Treatment (SSWT) 12th week (T2)	19.4 score on a scale Standard Deviation 2.9	18.9 score on a scale Standard Deviation 2.6
The Satisfaction Scale About Service and Warfarin Treatment (SSWT) 24th week (T3)	20.6 score on a scale Standard Deviation 3.0	19.7 score on a scale Standard Deviation 3.1

Adverse Events

The Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

The Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Nursing Department

National Taipei University of Nursing and Health Sciences

Phone: 886-2-28712121

Email: tsaejyy@ntunhs.edu.tw

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place