Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2019
INTERVENTION: Our project has two arms, the Shared Decisions Making (SDM) and Usual Decision Making (UDM). Shared Decision Making combines subject preferences with evidence‐based medicine in a collaborative conversation to help the person determine their optimal treatment approach. In SDM, both parties share information: the clinician offers options and describes their risks and benefits, and the patient expresses his or her preferences and values. Each participant is thus armed with a better understanding of the relevant factors and shares responsibility in the decision about how to proceed. This is a process of open communication or mutually acceptable decision. In this project the research staff will offer to participant personalized information about treatment and prevention options and their associated risks and benefits. The participant then should communicate to the staff his or her values, preferences and concerns related to these variables. The goal is to arrive at a joint decision regarding the best strategy. Patients will be informed, more likely to comply with the plan and more likely to be satisfied with their outcome. The Usual Decision Making (UDM) intervention or traditional biomedical care system will be the control group in this study. 600 participants from the ambulatory clinic at the Lincoln Hospital will be recruited and randomized into 2 groups, the Shared Decision Making (SDM) and Usual Decision Making (UDM) to test the effectiveness of interventions using SDM in changing participants health habits, compared to usual education and decision making (UDM). The overall goal of this study is to decrease the cardiovascular risk among the ambulatory clinic patients by utilizing a SDM intervention model to encourage health dietary choices, advocate exercise, educate, prompting patient decisions and directing self‐efficacy to the healthier choices, to accomplish weight reduction (change in weight CONDITION: Obesity, Hypertension, Cardiovascular Disease ; Circulatory System PRIMARY OUTCOME: ; At baseline, 3‐months, 6‐months, 9‐months, 12‐months:; 1. Salt intake measured using Salt questioner (adapted from WHO STEPwise approach to chronic disease risk factor surveillance of Dietary salt module); 2. Diet measured using Rate Your Plate (adapted from 2000 Brown University Center for Primary Care and Prevention, Pawtucket, RI 02860); 3. Nutrition measured using Automated Self‐Administered 24‐Hour (ASA‐24Hrs; 24‐Hour Dietary Intake Caloric Assessment from NIH Automated Self‐Administered 24‐Hour Dietary Assessment Tool); 4. Physical activity measured using IPAQ 7‐days tool; INCLUSION CRITERIA: 1. Ambulatory clinic patients that have an established record with a history of two appointments and follow‐ups 2. Age 18 years and above 3. Hypertension, medical diagnosis with no more than three anti‐hypertensive medications 4. Medical diagnosis of Diabetes Mellitus with hemoglobin A1c less than or equal to 8.0% 5. Calculated Body Mass Index between 25 kg/m2 and 40 kg/m2 SECONDARY OUTCOME: ; 1. Medical Knowledge measured using Questioner on High‐Blood Pressure (1) and Obesity (2) to gauge knowledge of the disease awareness and disease process at baseline, 6‐months, 12‐months; 2. Mental and emotional health measured using PHQ‐9 at baseline, 6‐months, 12‐months.; 3. Commitment to outcome measured using stage of change scale at baseline, 3‐months, 6‐months, 9‐months, 12‐months; 4. Self‐efficacy measured using the General Self‐Efficacy Scale (GSES) at baseline, 3‐months, 6‐months, 9‐months, 12‐months; 5. Environmental factors measured using a home and work environment questionnaire at baseline, 6‐months, 12‐months; 6. Medication Adherence measured using a modified medication adherence assessment adapted from Morisky Medication Adherence Scale at baseline, 6‐months, 12‐months; 7. Alcohol use measured using AUDIT questionnaire at baseline, 6‐months, 12‐months; 8. Smoking behavior measured using smoking questions at baseline, 6‐months, 12‐months; 9. Sleep measured using a modified version of the Pittsburgh Sleep Quality Index (PSQI) at baseline, 6‐months, 12‐months; 10. Major Stressful Life Events measured using a novel questionnaire at baseline, 6‐months, 12‐months; 11. Social Support and Relationship measured using a novel questionnaire at baseline, 6‐months, 12‐months;
Epistemonikos ID: 23212ecb6da56e148eab15d7ca7d02319d7b3f2b
First added on: Aug 24, 2024