A Modification of Lifestyle - Research Proposal Example

Evidence-Based Practice Proposal- Section F: Implementation Plan Evidence-Based Practice Proposal-Section F: Implementation Plan Setting, Access, and Consent Form The study aim at the establishment on whether modification lifestyle decreases the risk of a heart attack more effectively compared to the aspirin Regime. Life style modification requires the subject to be subjected to a normal environment, but controlled eating habits, exercise, and daily routine; hence, the setting will include subjects perspective homes, a gym, and a healthcare facility where the subjects will be screened for their possibility of a heart attack. Access to the potential subjects will be through consultation of approximately five hospitals with health records for women with potential heart attack cases. Poster advertisement will then be carried out to ask those willing to participate to register with the research team after that they will be contacted directly through their phones and emails. Email contact will comprehensively explain the nature as well as the objective of the study. The research will involve human subjects, which necessitate the research team to have consent that will ensure that the subjects are protected from any physical or psychological harm during the research and willingly choose to participate. The following consent form will be used Research Consent Form Research Purpose You are invited towards the participation in a research of determining whether lifestyle modification compared to Aspirin regimen in women aged 45-75 years decrease the risk of a heart attack. The research team hopes to establish whether modified lifestyle can serve better to decrease heart attack risk compared to taking pills on daily basis. The reason you were selected in the research is that you fit to undergo the processes outlined for the study. In case you decide to reject the participation, notify (insert name) using (insert telephone No.) The study is looking for 500 women with increased risks for heart attacks within (insert region) Voluntary participation Note the participation in this research is voluntary and your decline to participate does not have any effects on your health or medical care. It is your decision to participate now, but can withdraw on your own will at any stage of the study without any loss of benefits regarding your entitled medical care. Period of Study involvement The study is scheduled to take approximately 4months; one month of active participation by each subject and 72 days of follow-up period. Procedures In case you accept to participate, the research director along with the team will change the diet table in each participant’s home. All participants will be subjected to an exercise of at least 2 hours a day during the active participation period. The purpose of changing the diet and exercises is to modify your lifestyle. If chosen to part of the control group, you will have your normal life with no changes to the diet or exercises. Each participant will be subjected to a clinical test to determine the blood pressure and blood cholesterol Responsibilities of a Participant The participant will be expected to; Follow instructions from the research team Adhere to the diet provided Adhere to gym appointments Inform the research team of any side effects of new diet and exercises. Complete the survey questions Inform the research director in case you change your mind about continuing with the study. Ask questions and clarifications Attend clinical tests Study Withdrawal If you chose to participate, you are free to pull out of the study any time after its commencement. There will be no effects on your medical acre if you choose to withdraw from the study. Given that the study does not have any other medication, there will be no consequences after withdrawal. However, change in the diet may cause increased weight. The director can also withdraw you from the study without your consent if You fail adhere to the instructions You fail to adhere to the diet You fail to attend gym exercises as prescribed. Any other anticipated circumstances arises Study is cancelled Possible discomforts, inconveniences, and risks Any study is accompanied by discomforts risks and inconveniences. These include Change in your favorite diet Change in your personal schedule due to the need to attend gym sessions Possible physical harm while exercising Changes in body weight Participants will not be allowed to use tobacco Potential benefits The research has a potential of reducing the risks of heart attacks through a change of diet and daily routine, which is safer compared to taking a pill every day. Participant’s Rights Participation is voluntary and you have right to withdraw from the study You have the right to in depth information regarding the study and comprehensive answers to your questions Confidentiality The results from the study are subject to presentation at medical conferences or being published in scientific journals. Personal patient information may be forwarded to regulatory agencies such as Food and Drug Administration. Confidential information will not be forwarded to a third party without the approval of the participant. Timeline The project is expected to take approximately 4 months Topic Finding and Dissertation Proposal Literature Review Methodology Data collection and Data analysis Remaining sections write-up Adding table of content and abstract and Proofreading October November December January 2015 February 2015 Resources The research will have a number of professionals including 10 gym instructors who will help participants carry out exercises appropriately, 5 nurses to facilitate the clinical tests that will be carried out to the participants, 2 nutritionists to facilitate the right diet for every participant. Additionally, the study will require the services of two data entry specialist that will store the blood pressure, cholesterol levels, and weight of every participant throughout the study. Table 1 Resource List S. No: Resource Quantity 1. Nurses 10 2. Gym instructors 10 3. Gyms 5 4. Nutritionists 2 5. Data entry specialists 2 6. Computers 2 7. Health facilities 2 8. Government Drugs (Aspirin) Variable Methods and Instruments The study will utilize clinical tests to monitor the proposed solution. The tests will focus on three variables including weight, blood cholesterol levels, and pressure. The base blood pressure that will be used by the test will be 120/80. Participants with higher blood pressure will be subjected to diets and exercise to control their pressure. Blood cholesterol levels will be based on the eight of the participants. Table 2 Study instruments S. no Instrument Quantity 1. Blood Pressure machines 5 2. Weighing Machines 5 3. Cholesterol Assay Kits 5 Intervention Process The participants will be divided into two equal groups, group A (250 women) and group B-control group (250 women). Group A will consist women who will be subjected to modified lifestyle while group B will consist women who will be subjected to the Aspirin regimen. There will be no much training expect for the gym instructors who will be trained to provide exercise instructions to the participants. Data Collection, Data Analysis, and Interpretation Data will be collected using computer-based software known as the IBM SPSS every week on Fridays, which will be implemented by the two data entry specialists. Weight, blood cholesterol, and blood pressure of each group A participant will be recorded on one computer (computer #1) while those of group B will be recorded in the second computer (computer #2). Statistical analysis will be applied to analyze the data collected using logistic regression that will provide the rate at which lifestyle medication reduce the risk factors associated with heart attacks as well as the Aspirin regimen. Data interpretation will be based on comparing the rate of decrease of risk factors by both life style modification and Aspirin regimen. The mean change in the three variables in group A will be compared to the mean of group B (control group) Strategies to Manage Challenges, Barriers, and Facilitators Major challenges that will be expected during the research are material constraints and changing roles. The use of effective communication is one of the strategies that will ensure that the roles of each participant and the research team are clearly communicated. Adequate and timely acquisition of material will ensure that material constraint is minimized. Facilitating collaboration among the research team members and fostering a research culture as well as environment will effectively manage the facilitators. Another challenge will be experienced in the recruitment process, which will require individual strategies such as screening timing. Pursuing alternative avenues strategy will manage the barrier of safeguarding institutions to participate. Feasibility of the Implementation Plan (Budget) The study is expected to have phases that will require funding including recruitment and data collection. The research staff will also require compensation for their services. Additionally, instruments that will not be provided by the institutions will have to be purchased. An estimated budget for the study is as follows; Table 3 Project Budget Expendables Printing/photocopying/writing materials $200 Research staff 10 nurses @ $30/hour *4 hours per week* 4 weeks $4800 10 gym instructors @ $5/hour *2hours *28 days $2800 2 data entry @ $30/hour *4hours per week*4 weeks $ 960 2 nationalists @ $35/hour *2 hours per week * 4 weeks $560 Instruments Computer software program $500 Miscellaneous supplies such as posters , flyers $700 Exercise clothing (leotard) @ 20 for group A (250 women) $5000 Drinks Water during exercise, energy drinks $1000 Total 16,520 The total budget for the study is approximately $16,520 Plans to Maintain, Extend, Revise, and Discontinue the Proposed Solution Intervention The control group B will provide the changes after the solution intervention and in case the initial results of group A will show improvement in minimizing risk factors for a heart attack, then the intervention will proceed as per the schedule. Revising of the proposed intervention will be based on individual participant conditions where some may train for less than one due to their ages. In the event where two weeks of solution intervention will not show any results, there will be no extension and the proposed intervention will be discontinued. Discontinuing the solution intervention will involve clear explanations to the participants as to the reason of terminating the schedule intervention. Read More