Effect of Patient Education on Compliance and Cardiovascular Risk Parameters

NCT02096887

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Cardiovascular Risk Factors
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
30-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Cardiovascular Risk FactorsEffect of Patient Education on Compliance and Cardiovascular Risk Parameters
NCT02096887
ALL GENDERS
30 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Effect of Patient Education on Compliance and Cardiovascular Risk Parameters
Official Title  ICMJE Effect of Patient Awareness and Education on Compliance and Cardiovascular Risk Factor Control
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Cardiovascular Risk Factors
Intervention  ICMJE Behavioral: Patient Education

Patient Education using the following two instruments:

  1. Framingham Risk Score calculator:
  2. Know your numbers patient booklet
Study Arms  ICMJE Patient Education
Patient Education
Intervention: Behavioral: Patient Education
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 25, 2014)
2000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2016
Estimated Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 30 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02096887
Other Study ID Numbers  ICMJE WS964765
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Samia Almusallam, Kuwait Institute for Medical Specialization
Study Sponsor  ICMJE Kuwait Institute for Medical Specialization
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Samia Almusallam, FRCGPKuwait Institute for Medical Specialization
Principal Investigator:Maleka M Serour, MRCGP/ INTKuwait Institute for Medical Specialization
Principal Investigator:Wafa A Rashed, FRCPMinistry of Health -Mubarak Hospital- Cardiology unit
PRS Account Kuwait Institute for Medical Specialization
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP