Effect of Patient Education on Compliance and Cardiovascular Risk Parameters (FAILAKA)

Effect of Patient Awareness and Education on Compliance and Cardiovascular Risk Factor Control

Patient's awareness of their risk factors for heart disease and their active involvement in their own management plan can help improve their adherence to treatment and their risk profile. The purpose of this study is to investigate the influence of patient education and awareness of heart disease risk factors on compliance to medication and lifestyle modification.

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Risk Factors
• Intervention / Treatment: Behavioral: Patient Education

Detailed Description

Prospective cluster randomized interventional study with primary health care clinics as clusters.Clinics will be randomized to conventional care or to structured patient education in addition to care. Trained physicians will extract information from the patient medical record and will conduct a personal interview with the participants, after they finish with their routine visit, to fill a case report form (CRF)

CRF will include the following items:

• Patient Demographics,
• Socioeconomic: income, employment and education
• Past Medical History
• Smoking history
• Alcohol use
• Medications
• Adherence: Morisky scale
• Examination: BP, weight, height, waist
• Investigations: LDL-C, HbA1C 2.Compliance/adherence to the medication will be measured by using the Morisky scale, which is a validated scale for measuring adherence in hypertension and diabetic patients among other disease.

Patients attending clinics that are randomized to structured patient education will receive education targeting all the risk factors they have. They will be informed about specific evidence -based target values they should achieve for each of the risk factors. Their compliance to prescribed medications will be encouraged and specific advice about improving compliance will be given. To achieve this physicians in the education clinics are going to use two items:

1. Framingham Risk Score calculator.
2. Know your numbers patient booklet.

Follow up visits will be scheduled at 2 months, 6 months and 12 months after the initial visit. For patients in both education and conventional clinics, compliance to medications will be assessed and the degree of risk factor control will also be determined through specific measurements that include number of cigarettes smoked, systolic and diastolic blood pressure, body mass index and waist circumference, HBA1C and LDL values.

• Study Type: Interventional
• Enrollment (Anticipated): 2000
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with one or more CVD risk factors will be consecutively enrolled, smokers and obese patients should have an additional risk factors
• The risk factors are based on Framingham Risk Score calculator and include smoking, high blood pressure, high blood cholesterol ,diabetes and being overweight or obese
• All participants must be adults (30 -70 years of age) who give an informed consent
• All participants should be of Kuwaity nationality, literate and fluent in either Arabic or English
• Patients are likely to be available for a one year follow up

Exclusion Criteria:

• Patients with mental disability or severe psychiatric disorder who are unable to provide informed consent or participate in educational activities.
• Patients with severe visual or hearing disability that will prevent participation in the educational activity
• Patients <30 years or >70 years of age
• Illiterate patients
• Non Kuwaity nationals
• Patients who are not permanently resident in Kuwait
• Patient who refuse to provide the informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patient Education	Behavioral: Patient Education; Patient Education using the following two instruments: Framingham Risk Score calculator:; Know your numbers patient booklet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiovascualr risk factor control	Cardiovascular risk factors control as assessed by the following parameters: HbA1C, Blood pressure, LDL-C, BMI and smoking cessation	12 months
medication compliance	Medication compliance as assessed by Morisky scale	12 months

Collaborators and Investigators

• Sponsor: Kuwait Institute for Medical Specialization
• Collaborators: Pfizer
• Investigators: Principal Investigator: Samia Almusallam, FRCGP, Kuwait Institute for Medical Specialization; Principal Investigator: Maleka M Serour, MRCGP/ INT, Kuwait Institute for Medical Specialization; Principal Investigator: Wafa A Rashed, FRCP, Ministry of Health -Mubarak Hospital- Cardiology unit

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Anticipated): January 1, 2015
• Study Completion (Anticipated): January 1, 2016

Study Registration Dates

• First Submitted: March 24, 2014
• First Submitted That Met QC Criteria: March 25, 2014
• First Posted (Estimate): March 26, 2014

Study Record Updates

• Last Update Posted (Estimate): March 26, 2014
• Last Update Submitted That Met QC Criteria: March 25, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: compliance; risk factors; education
• Other Study ID Numbers: WS964765