FAILAKA: Effect of Patient Education on Compliance and Cardiovascular Risk Parameters

• Sponsor: Kuwait Institute for Medical Specialization (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02096887
• Collaborator: Pfizer (Industry)
• Enrollment: 2,000
• Arm: 1
• Duration (Months): 19

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Risk Factors	Behavioral: Patient Education	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 2000 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Effect of Patient Awareness and Education on Compliance and Cardiovascular Risk Factor Control
• Study Start Date: Jun 1, 2014
• Anticipated Primary Completion Date: Jan 1, 2015
• Anticipated Study Completion Date: Jan 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. cardiovascualr risk factor control [12 months]

   Cardiovascular risk factors control as assessed by the following parameters: HbA1C, Blood pressure, LDL-C, BMI and smoking cessation

2. medication compliance [12 months]

   Medication compliance as assessed by Morisky scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Kuwait Institute for Medical Specialization
• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Samia Almusallam, Director of the family medicine residency program, Kuwait Institute for Medical Specialization
• ClinicalTrials.gov Identifier: NCT02096887
• Other Study ID Numbers: WS964765
• First Posted: Mar 26, 2014
• Last Update Posted: Mar 26, 2014
• Last Verified: Mar 1, 2014

• Keywords provided by Dr. Samia Almusallam, Director of the family medicine residency program, Kuwait Institute for Medical Specialization: education; compliance; risk factors

Study Results

No Results Posted as of Mar 26, 2014