NCT02096887

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 26, 2014

Status Verified

March 1, 2014

Enrollment Period

7 months

First QC Date

March 24, 2014

Last Update Submit

March 25, 2014

Conditions

Keywords

educationcompliancerisk factors

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Patient Education

OTHER

Patient Education

Behavioral: Patient Education

Interventions

Patient Education using the following two instruments: 1. Framingham Risk Score calculator: 2. Know your numbers patient booklet

Patient Education

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Patient Compliance

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the family medicine residency program

Study Record Dates

First Submitted

March 24, 2014

First Posted

March 26, 2014

Study Start

June 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2016

Last Updated

March 26, 2014

Record last verified: 2014-03