ClinicalTrials.gg
Status unknownNCT02096887FAILAKAUpdated Mar 26, 2014

Effect of Patient Education on Compliance and Cardiovascular Risk Parameters

An interventional study of Patient Education in Cardiovascular Risk Factors, sponsored by Kuwait Institute for Medical Specialization. Status unknown. Open to participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-03-26.

Sponsored by Kuwait Institute for Medical Specialization · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Mar 2014), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
2,000
Allocation
Randomized
Ages
30 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cardiovascular Risk Factors

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Keywords

  • education
  • compliance
  • risk factors
03

In context

Patient Compliance

133 studies on the registry are indexed under Patient Compliance; 42 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 120 across 99 interventional studies indexed under Patient Compliance.

Browse Patient Compliance studies →

Lead sponsor

Kuwait Institute for Medical Specialization is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,000 participants (estimated)

Study arms

  • Other
    Patient Education

    Patient Education

    Behavioral: Patient Education

Interventions

  • BehavioralPatient Education

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

06

What researchers measure

Primary outcomes

  1. cardiovascualr risk factor control

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

    Time frame: 12 months

  2. medication compliance

    Medication compliance as assessed by Morisky scale

    Time frame: 12 months

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2014, a primary completion of Jan 2015 and a completion of Jan 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 24, 2014
First posted
Mar 26, 2014
Start
Jun 2014
Primary completionEst.
Jan 2015
CompletionEst.
Jan 2016
Last update
Mar 26, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 26, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02096887
Lead sponsor
Kuwait Institute for Medical Specialization
Collaborators
Pfizer
Responsible party
Dr. Samia Almusallam (Director of the family medicine residency program, Kuwait Institute for Medical Specialization) — Principal investigator
First posted
Mar 26, 2014
Start date
Jun 2014
Primary completion
Jan 2015 (estimated)
Completion
Jan 2016 (estimated)
Last update
Mar 26, 2014

Study contacts

Samia Almusallam, FRCGP
principal investigator · Kuwait Institute for Medical Specialization
Maleka M Serour, MRCGP/ INT
principal investigator · Kuwait Institute for Medical Specialization
Wafa A Rashed, FRCP
principal investigator · Ministry of Health -Mubarak Hospital- Cardiology unit

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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