Cardiac Care Solution for Coronary Disease Follow up

Unstable Angina Clinical Trial

— BAMA  

Official title:

Evaluation of a Cardiac Care Solution for Post-Hospital Management in Primary and Secondary Care of Patients Diagnosed With Coronary Artery Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03565978
• Other study ID #: BAMA 0.1
• Status: Completed
• Phase: N/A
• Start date: April 8, 2016
• Est. completion date: July 30, 2018

Study information

• Verified date: March 2020
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, randomized controlled trial. The aim of the study is to evaluate the impacts of a cardiac post-discharge management solution in the secondary prevention of Coronary Artery Disease (CAD).

Description:

The aim of the study is to evaluate the impacts of a cardiac post-discharge management solution in the population of cardiovascular (CVD) patients who were discharged from the hospital. The objectives include two parts:

Objective 1: Assess the feasibilities of using the solution by means of questionnaire.

Objective 2: Evaluate the impacts of the solution in the secondary prevention of Coronary Artery Disease (CAD).

Primary outcome: Compliance of coronary disease secondary prevention at 12 months.

Secondary outcome: Compliance of coronary disease secondary prevention at 6 months. Self-management behavior evaluation at the 6 and 12 months. Medication compliance at 6 and 12 months assessed by self-reporting questionnaire. Control rates of risk factors at the 6 and 12 months (serum LDL-C, blood pressure, fasting serum glucose); quality of life at the 6 and 12 months (EQ-5D, Seattle angina questionnaire); MACE (Major Adverse Cardiac Event) within 12 months (death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for cardiac reason, unplanned coronary revascularization).

The study will be a two arm, randomized control study. The intervention group will use an application installed on a Pad besides standard outpatient follow up, while the control group will receive standard outpatient follow up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 30, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Participants diagnosed with CAD, including either condition below: once diagnosed with myocardial infarction; or once accepted coronary artery interventional therapy;

• Participants willing to use self-management solution and complying with follow-up plan;

• At point of enrollment, the patients should be at least (>=18) years

• Basic reading skills (Chinese)

Exclusion Criteria:

• Participants that are enrolled in another interventional clinical trial

• Participants who refuse to sign informed consent or withdraw for specific reasons recorded

• Participants who have cognition disorder and unable to communicate normally

• Participants who cannot master basic mobile technology skills to operate a mobile application after training

Related Conditions & MeSH terms

• Angina, Unstable
• Infarction
• Myocardial Infarction
• Non-ST Segment Elevation Myocardial Infarction
• ST Elevation Myocardial Infarction
• ST Segment Elevation Myocardial Infarction
• Unstable Angina

Intervention

Device:
• BAMA solution
Use of BAMA cardiac post-discharge management solution for patients education and follow up management

Locations

Country	Name	City	State
China	Division of Cardiology, Peking University First Hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University First Hospital	Philips Electronics Nederland B.V. acting through Philips CTO organization

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance for coronary heart disease secondary prevention at 12 months	Proportion of patients who use standardized secondary prevention medication according to current guidelines.	12 months
Secondary	Medication compliance at the 6, 12 months using the MMAS-8 (The eight-item Morisky Medication Adherence Scale)	The Chinese version MMAS-8, a self-administered rating scale for assessing medication adherence, contains eight items. Each item is measuring a specific behavior and is not a determinant of adherence behavior. Response choices are yes/no for items 1-7 and a 5-point Likert response for the last item. Each response of "no" is rated as "1" and each "yes" is rated as "0" except for Item 5, in which each response of "yes" is rated as "1" and each "no" is rated as "0". For Item 8, responses "0", "1", "2", "3" and "4", are rated as "0", "0.25", "0.75", "0.75" and "1", respectively. The total score on the MMAS-8 can range from 0 to 8, where higher scores indicate higher adherence. The degree of adherence was determined according to the score resulting from the sum of all the correct answers: low adherence (<6 points), medium adherence (6 to <8 points), and high adherence (8 points). In this study, patients were considered adherent when they had a score equal to eight in the MMAS-8.	6 and 12 months
Secondary	Control rates of risk factors at the 6, 12 months	Blood pressure, serum LDL-C level and fast serum glucose	6 and 12 months
Secondary	Quality of life at the 6, 12 months (EQ-5D simple score)	The EQ-5D(EuroQol-5 Dimensions) is an established health-related quality of life instrument, used frequently in both clinical trials and health services research. The EQ-5D instrument classifies respondent's present-day health status in five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression); each dimension is represented by one question with three severity levels (no problems, some problems and severe problems). Scores for the five dimensions can be converted into a utility index score by applying the scores from preference weights elicited from the UK general population. This calculation produces a value between -0.59 and 1.00, and a value below 0 indicates a worse health condition than death. Higher scores indicate better health status.	6 and 12 months
Secondary	Quality of life at the 6, 12 months (EQ-5D Visual Analog Score)	EQ-5D Visual Analog Score was used in the survey, with anchor points 0 (worst health state) and 100 (best health state). The scale consisted of a horizontal line where every 10th was marked and labelled 0, 10, 20,…, 100. The question was framed: "On the scale please point out which point best represents your own health state today."	6 and 12 months
Secondary	Quality of life at the 6, 12 month (Seattle angina questionnaire)	The Seattle Angina Questionnaire (SAQ), a 19-item index, is a commonly used disease-specific instrument for assessing symptoms and their impact on daily life with CAD. SAQ comprises five domains: physical limitation (PL), anginal stability (AS), anginal frequency (AF), treatment satisfaction (TS), and the disease perception (DP). SAQ is scored by assigning each response an ordinary value, from 1 (the lowest level of functioning) to 10 (the highest level of functioning), and summing across items within each of the 5 dimensional scales. Scale scores are then transformed to a scale of 0 to 100 by subtracting the lowest possible scale score, dividing the remainder by the range of the scale, and multiplying that by 100. Higher scores on SAQ subscales indicate higher levels of functioning/satisfaction and fewer limitations. The Chinese version of SAQ has been shown to be a valid, responsive, and reliable instrument and has been used in clinical trials.	6 and 12 months
Secondary	MACE within 12 months (death, nonfatal myocardial infarction, nonfatal stroke, hospitalization with heart problem, unexpected revascularization)	Record events and describe	12 months
Secondary	Self-management behaviors evaluation at the 6, 12 months using a local questionnaire	The Coronary Heart Disease Self-Management Behavior Scale used the Likert 5-point scale method to investigate patients' self-management behavior over the past 3 months. This scale has been widely used in China for self-management behavior of patients with coronary heart disease. The measurement has a good reliability and validity. The scale has three dimensions: (1) The dimensions of daily management, including management of general life and bad habits; (2) The dimension of emotion management is the emotional cognition management; (3)The dimensions of medical management include management of symptom, first-aid, disease knowledge and treatment adherence. The scores of the items in each dimension add up and transform to represent the total score of the dimension; the sum of the dimension scores represents the total score of self-management behavior, which range from 0 to 100. The higher the score that patient had indicates the better self-management behavior.	6 and 12 months