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Cardiac Care Solution for Coronary Disease Follow up (BAMA)

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ClinicalTrials.gov Identifier: NCT03565978
Recruitment Status : Active, not recruiting
First Posted : June 21, 2018
Last Update Posted : June 21, 2018
Sponsor:
Collaborator:
Philips Research
Information provided by (Responsible Party):
Yong Huo, Peking University First Hospital

Brief 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).

Condition or disease Intervention/treatment Phase
ST Segment Elevation Myocardial Infarction Non-ST Segment Elevation Myocardial Infarction Unstable Angina Device: BAMA solution Not Applicable

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of a Cardiac Care Solution for Post-Hospital Management in Primary and Secondary Care of Patients Diagnosed With Coronary Artery Disease
Actual Study Start Date : April 8, 2016
Estimated Primary Completion Date : July 30, 2018
Estimated Study Completion Date : July 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BAMA solution
This group will use BAMA solution. This is an digital solution used for cardiac post-discharge management. It is an application installed on a tablet. This arm will use this application and also have usual outpatient follow up.
Device: BAMA solution
Use of BAMA cardiac post-discharge management solution for patients education and follow up management

No Intervention: Usual care
Not using the application installed on the tablet. Usual outpatient follow up.



Primary Outcome Measures :
  1. Compliance for coronary heart disease secondary prevention at 12 months [ Time Frame: 12 months ]
    Proportion of patients who use standardized secondary prevention medication according to current guidelines.


Secondary Outcome Measures :
  1. Medication compliance at the 6, 12 months using the MMAS-8 (The eight-item Morisky Medication Adherence Scale) [ Time Frame: 6 and 12 months ]
    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.

  2. Control rates of risk factors at the 6, 12 months [ Time Frame: 6 and 12 months ]
    Blood pressure, serum LDL-C level and fast serum glucose

  3. Quality of life at the 6, 12 months (EQ-5D simple score) [ Time Frame: 6 and 12 months ]
    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.

  4. Quality of life at the 6, 12 months (EQ-5D Visual Analog Score) [ Time Frame: 6 and 12 months ]
    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."

  5. Quality of life at the 6, 12 month (Seattle angina questionnaire) [ Time Frame: 6 and 12 months ]
    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. MACE within 12 months (death, nonfatal myocardial infarction, nonfatal stroke, hospitalization with heart problem, unexpected revascularization) [ Time Frame: 12 months ]
    Record events and describe

  7. Self-management behaviors evaluation at the 6, 12 months using a local questionnaire [ Time Frame: 6 and 12 months ]
    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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03565978


Locations
China
Division of Cardiology, Peking University First Hospital
Beijing, China, 100034
Sponsors and Collaborators
Peking University First Hospital
Philips Research
Investigators
Principal Investigator: Yong Huo, MD Peking University First Hospital

Responsible Party: Yong Huo, Director, Department of Cardiology, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT03565978     History of Changes
Other Study ID Numbers: BAMA 0.1
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
ST Elevation Myocardial Infarction
Angina, Unstable
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pharmaceutical Solutions